Contents

• Introduction
• Overview of the Food, Drug, and Cosmetic Act
• General Questions About the Enforcement of the FDCA
FD&C Act
• Who Enforces the FDCA?
• What Limits Are There to the Enforcement Jurisdiction of the FDCA?
• IsFD&C Act?
• What is FDA's Enforcement Jurisdiction?
Does FDA Address Every Violation of the FDCA EnforcedFD&C Act?
• Civil Enforcement of the FDCA
• Civil MonetaryFD&C Act
• Warning and Untitled Letters
• Import Alerts
• Recalls
• Debarment
Civil Money Penalties
• Seizures
• Injunctions
• Criminal Enforcement of the FDCA
FD&C Act
• Criminal Violations of the FDCA
FD&C Act
• Criminal Penalties Resulting from an FDCAFD&C Act Violation

Summary

In an increasingly interconnected countryworld, public health concerns and crises originating from any state have the potential to impact the entire nation. A critical law to help promote national public health and preventhave domestic and international implications. In the United States, the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act or the Act) promotes public health by preventing fraudulent activity with respect to food, drugs, and an array of other public health products that enter interstate commerce is the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA or the Act). Indeed, the primary purpose of the Act. Indeed, the Act's primary purpose is to "safeguard" and "protect" the consumer from being exposedconsumers from exposure to dangerous products affecting public health and safety, and the FDCA. The FD&C Act does this by regulating covered articles from the moment of their introduction into interstate commerce all the way to the moment ofto their delivery to the ultimate consumer. This report provides an overview of the FDCAFD&C Act, answers frequently asked questions about the enforcement of the Act, and concludes with an overview of theAct's enforcement, and discusses the Act's various civil and criminal enforcement provisions contained within the FDCA.

The FDCAFD&C Act is the centralmain federal law regulating the safety of most foods, food additives, color additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products. While the Act regulates a host of disparate products, the FDCA, in Section 301,it generally prohibits two basic acts: "adulteration" and "misbranding." Specifically, FD&C Act Section 301 makes it illegal to distribute directly or indirectly distribute a covered product in interstate commerce that is adulterated or misbranded. Many other provisions of the Act are devoted to defining whatThe Act defines the terms "adulteration" and "misbranding" mean with respect to the specific products covered under the Act.

The FDCA is centrallyFD&C Act is chiefly enforced by the U.S. Food and Drug Administration (FDA), an agency whose general mission is to promote and protect the public health by ensuring the safety, efficacy, and truthful labeling of the products it regulates.mission is to "assure that the products it regulates are safe and truthfully labeled." The FDA enforces the Act through a series of administrative mechanisms, such as pre-market reviews of certain products, examinations and investigations, and the dissemination of information to the public. Nonetheless, because the FDA does not have independent litigating authority, the agency must rely on the Department of Justice (DOJ) if a particular matter requires utilization of criminal or civil remedies. While private parties do not have the right to enforce the FDCA's mandates through a lawsuit, in addition to the DOJ, a host of other federal agencies help enforce discrete parts of the Act. Still, the FDA remains the primary agency charged with enforcing the FDCA, and the FDA's authority reaches to even purely intrastate activities that have some sort of nexus with interstate commerce, so long as the activity in question respects a product that is covered under the Act. Supreme Court case law confirms that the FDA enjoys significant discretion in choosing when to enforce most provisions of the FDCA, although certain mandates can eliminate the FDA's discretion and impose a mandate on the agency to enforce the Act in specific circumstances.

If the agency, with the help of the DOJ, considers a particular matter sufficiently serious, the FDCA provides a wide range of civil and criminal remedies to enforce the substantive provisions of the Act. For example, the FDCA provides the government with the ability to sue violators of the Act in Court to punish or prevent future violations of the FDCA. Civil actions include the imposition of civil monetary penalties, injunctions, and seizures. If someone's conduct is extremely serious, in rare cases, the FDA and DOJ have collaborated to bring criminal charges against those who violate the Act. While a criminal violation of the FDCA does not require that the perpetrator be aware of his conduct, intentional or repeated violations of the Act can result in multiple years of imprisonment and hefty criminal fines.

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Introduction

In an increasingly interconnected country, public health concerns and crises originating from any state have the potential to impact the entire nation. For example, in 2006, an E coli outbreak associated with prepacked spinach cultivated at a ranch in California affected over 200 people in 26 different states.¹ Public health crises, of course, can originate from other sources than food-borne illnesses. An October 2012 outbreak of fungal meningitis resulting from steroid injections prepared at a Massachusetts compounding pharmacy resulted in over 60 deaths.² And beyond preventing public health crises akin to the 2006 spinach outbreak or the drug compounding crisis of 2012, there is strong interest in Congress and elsewhere in ensuring that that public health products that are consumed by Americans work as they should and are truthfully labeled.³

A critical law to help promote national public health and prevent fraudulent activity with respect to food, drugs, and an array of other public health products that substantially affect interstate commerce is the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA or the Act).⁴ As noted in a series of CRS reports, the FDCA and its implementing regulations contain a host of substantive standards that aim to protect and promote public health, such as the FDCA's requirements with respect to the approval of prescription drugs⁵ or the FDCA's provisions aiming to promote food safety.⁶ This report provides a brief overview of how the Act's various provisions are enforced. The report begins by providing an overview of the FDCA, discussing the various limitations on the ability of the federal government to enforce the FDCA's provisions, and concludes with an overview of the various civil and criminal enforcement provisions contained within the Act.

Overview of the Food, Drug, and Cosmetic Act

Federal regulation of the safety of most foods,⁷ food additives,⁸ color additives,⁹ dietary supplements,¹⁰ prescription and non-prescription drugs,¹¹ medical devices,¹² cosmetics,¹³ and tobacco products¹⁴ have their central basis in the FDCA.¹⁵ Congress enacted the FDCA in its original form in 1938,¹⁶ acting pursuant to its constitutional authority to regulate interstate commerce.¹⁷ The primary purpose of the Act is to "safeguard" and "protect" the consumer from being exposed to "dangerous products" affecting public health and safety, and the FDCA does this by regulating covered articles from the "moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer."¹⁸ The mandates of the FDCA are enforced through a variety of legal measures such as formal and informal administrative actions, criminal and civil penalties, injunctions, recalls, and/or seizures of FDCA-covered goods.¹⁹

Though the FDCA has been "substantially amended since 1938," the Act "still retains its basic structure."²⁰ The "heart of the enforcement provisions of the" FDCA, if not the entire Act, is Section 301, which enumerates the specific acts that are prohibited by the statute.²¹ The acts that are prohibited by the FDCA have been described as "a catalogue of definitions elaborating two basic concepts: 'adulteration' and 'misbranding.'"²² Section 301 generally makes it illegal to directly or indirectly distribute a covered product in interstate commerce that is "adulterated" or "misbranded."²³ The term "adulteration" has its common law origins referencing the corrupting or debasing of a good resulting in its diminished quality,²⁴ and "misbranding" commonly refers to providing a false or misleading label for a given product.²⁵ Notwithstanding these general understandings of the two words, the FDCA uses the two terms in a "sense more extended and varying somewhat in substance from their popular definition."²⁶ Put another way, "much of the [Act] is devoted to ascribing the labels 'adulterated' or 'misbranded' to products whose composition, production or labeling fails" to meet the substantive requirements of the FDCA.²⁷ For example, a "food" is deemed adulterated if it has been held under "insanitary conditions,"²⁸ and a "drug" is misbranded if its label does not contain the "name and place of business of the manufacturer, packer, or distributor."²⁹ The language of the FDCA is "purposefully broad," ³⁰ delegating a significant amount of discretion to the executive branch to issue rules and guidelines that fill in the gaps created by the legislative scheme.³¹ Table 1 notes the various sections of the FDCA that define and specify when a particular product can be deemed "adulterated" or "misbranded."

General Questions About the Enforcement of the FDCA

Before delving into the specific ways that the FDCA is enforced, thisFD&C Act This section answers several basic and overarching questions about the enforcement of the ActAct's enforcement.

Who Enforces the FDCA?

The Food and Drug Administration (FDA), established under Section 1003 of the FDCA,FD&C Act? Established under FD&C Act Section 1003, the U.S. Food and Drug Administration (FDA) is the primary agency that administers and enforces the Act.³² The central mission of the FDA is to "assure that the products it regulates are safe and truthfully labeled."³³ In line with this mission, the FDA is statutorily empowered to not only provide administrative guidance as to what the FDCA's broad mandates specifically entail,³⁴ but to also enforce the FDCA's mandates through a host of30 Generally, FDA's mission is to promote and protect public health by ensuring the safety, efficacy, and truthful labeling of products subject to the Act.³¹ Consistent with this mission, FDA is statutorily empowered to provide administrative guidance on the FD&C Act's broad mandates³² and to enforce the Act through administrative actions. For example, before certain articles canmay lawfully be sold in interstate commerce, the FDA must evaluate those goods through a rigorous review process and approve them ifFDA must rigorously review them to ensure that they meet certain standards, such as being safe and effective for the product'stheir intended use.³⁵33 In addition to such pre-market authorities, the authority, FDA also possesses significant "post-market" authorities that enable the agencypost-market authority to monitor a regulated product that has alreadyproducts that have entered interstate commerce to ensure the product continues to adhere to the FDCA's mandates.³⁶ The FDCA empowers the FDA to, for example,Act.³⁴ For example, the Act empowers FDA to request information from a pharmaceutical manufacturer,³⁷ conduct inspections of the facilities of a food producer,³⁸ or order a recall of a medical device thought tomanufacturers,³⁵ to inspect food producer facilities,³⁶ or to order recalls of medical devices that may cause "serious, adverse health consequences."³⁹ The FDCA also provides the FDA with the general authority37 The FD&C Act also authorizes FDA to "conduct examinations and investigations" in the aid of administeringto administer the Act,⁴⁰38 to disseminate information about regulated products that involveinvolving "imminent danger to health" or "gross deception to the consumer,"⁴¹39 and to issuepublicize information to the public on all formal enforcement actions resolved in court.⁴² The40 FDA also utilizesuses "other enforcement tools not detailed in the FDCAFD&C Act," such as issuing warning and information letters to regulated entities that note violations ofare violating the Act.⁴³

The 41 These practices are discussed later in this report.⁴² FDA, however, is not the only federal agency tasked with enforcing the FDCAthat enforces the FD&C Act. Indeed, while the FDA has significant authority to promote compliance with the Act and to investigate violations of the FDCA, faced with a case of noncompliance, the FDA, lacking independent litigating authority, must rely onAct, FDA, like most executive agencies, does not have independent litigating authority.⁴³ Thus, to address noncompliance, FDA must coordinate with the Department of Justice (DOJ) to enforce the Act through product seizures, injunctions, civil penalty proceedings, or criminal prosecutions.⁴⁴ As a consequence, when the To this end, when FDA discovers a violation ofthat the Act has occurred or continues to occurbeen or is being violated, the relevant FDA district office, in consultation with the FDA's Chief Counsel's office will generally evaluate the nature ofFDA's Office of the Chief Counsel, generally evaluates the violation and determine whether a violation warrants referring a matterdetermines whether to refer it to DOJ's Office of Consumer Litigation (OCL).⁴⁵ The OCL and.⁴⁵ The Office of Consumer Litigation and the DOJ's field representative, the U.S. Attorney for the judicial district in which the FDA seeksFDA anticipates seeking judicial relief, in consultation with their agency client, will make the ultimate decision onFDA, ultimately decide whether to seek judicial relief on behalf of the FDA.⁴⁶

In addition to the DOJ, several other agencies have roles in enforcing the mandates of the FDCA. The U.S. Customs and Border Protection (CBP), in administering federal laws relating to the import, export, and collection of duties, "must work in close cooperation" with the FDA when refusing to admit certain articles into the United States that fail to comply with the FDCA.⁴⁷ As a result, the CBP will alert the FDA when a product under its purview arrives at a port of entry, and the FDA, after determining the importation of a particular product would be in violation of the Act, will askDOJ, several other agencies have FD&C Act enforcement roles. To administer federal laws relating to imports, exports, and duties, the U.S. Customs and Border Protection (CBP) "must work in close cooperation" with FDA to prevent articles that violate the FD&C Act from entering the United States.⁴⁷ As a result, CBP alerts FDA when an FD&C Act-regulated product arrives at a port of entry. If FDA finds the product's importation would violate the Act, FDA asks CBP to issue a "Notice of Refusal of Admission" to the importer and to destroy any shipment that is not exported within 90 days.⁴⁸

More broadly, because of the breadth of products and subject matters regulated by the FDCA, the enforcement of the Act necessarily concerns the interests of other federal and state agencies and, accordingly, other entities besides the FDA do sometimes play discrete roles in regulating products that fall under the FDCA's umbrellathe Act covers a range of products and subject matters, other federal and state agencies have roles in regulating FD&C Act-covered products. For example, under the Act, the FDA mustFDA is to ensure that drug and device manufacturers properly label their products so as to notnot to mislead consumers,⁴⁹ a power that has beencourts have broadly interpreted to allow the FDA to regulate any advertising associated with a drugadvertising relating to drugs or medical devicedevices.⁵⁰ However, the Federal Trade Commission (FTC), a whollyan independent agency that is tasked under the Federal Trade Commission Acttasked with promoting economic competition and consumer protection by eliminating acts or practices that are "unfair or deceptive,"⁵¹ likewise has considerable discretion in regulating the advertising of goods in interstate commerce, a power that necessarily includes the regulation of the advertising of drugs or medical devices.⁵² Because of their overlapping jurisdictions, the FDA and the "unfair or deceptive" acts or practices,⁵¹ likewise has authority over advertising of goods, including drugs and medical devices, in interstate commerce.⁵² Because their jurisdictions overlap, FDA and FTC have entered into a memorandum of understanding (MOU) wherein the two agencies share responsibilities in overseeing the marketing of products regulated by the FDCAregarding their respective authorities over the marketing of FD&C Act-regulated products.⁵³ As a consequence, the FTC is the primary oversight agency with respect toagency overseeing over-the-counter drugs and medical device advertising.⁵⁴ The FDA has also entered into similar MOUs with a host of differentother government agencies, including the U.S. Department of Agriculture (USDA),⁵⁵ the Department of the Treasury,⁵⁶ and the Department of Defense.⁵⁷ (DoD),⁵⁷ and the Centers for Disease Control and Prevention (CDC).⁵⁸ Other "principal cooperating agencies" the FDA must interactthat FDA works with include the Environmental Protection Agency, the Consumer Product Safety Commission, the Drug Enforcement AgencyAdministration, the National InstituteInstitutes of Health, the Nuclear Regulatory Commission, the Office of Management and Budget, and the Securities and Exchange Commission.⁵⁸ In addition to these various federal agencies, the FDCA59 In addition, the FD&C Act authorizes state governments, working in conjunction with the FDA, to enforce certain aspects of the Act.⁵⁹60 In short, while the FDA is the leadprimary agency in enforcing the FDCA, other entities may have more minor roles in effectuating the Act's mandates.

Importantly, the FDCAFD&C Act, other entities have roles. Significantly, the FD&C Act does not contain a private right of action inunder which members of the public can sue to enforce the Act's provisions.⁶⁰.⁶¹ Instead, under the FDCAFD&C Act, generally all proceedings "for the enforcement, or to restrain violations, of" the Act must be in the name of the United States.⁶¹ Put another way, as62 As the Supreme Court recently remarkedhas noted, "the FDCA[FD&C Act] and its regulations provide the United States with nearly exclusive enforcement authority," and "[p]rivate parties may not bring enforcement suits."⁶²63 While the Supreme Court has recognized that laws with mandates similar to those contained in the FDCA can be enforced through private lawsuits,⁶³ the onus for ensuring the Act's provisions are enforcedprivate lawsuits can be used to enforce laws with mandates similar to those of the FD&C Act,⁶⁴ the onus for enforcing the Act lies almost exclusively with the federal government.

What Limits Are There to the Enforcement Jurisdiction of the FDCA?

The limits to the FDA's jurisdiction in enforcing the Act are necessarily a product of the constitutional limits imposed upon Congress under the Commerce Clause, the source of power Congress relied upon in enacting the FDCA. ⁶⁴ Article I, Section 8is FDA's Enforcement Jurisdiction? FDA's regulatory authority comes from Congress's constitutional power to regulate interstate commerce.⁶⁵ Article I, Section 8, Clause 3 of the U.S. Constitution grants Congress the power "[t]o regulate commerce with foreign nations, and among the several States, and with the Indian Tribes."⁶⁵66 While early 20^th century case law interpreted Congress's commerce powerthe Commerce Clause narrowly to prevent thepreclude federal regulation of local economic activity that had anonly "indirect" impactimpacts on interstate commerce,⁶⁶ beginning67 in 1937, the Supreme Court began to read the commerce powerreading the Commerce Clause more expansively,⁶⁷ extending the power such that Congress could regulate wholly intrastate activity that was economic in nature.⁶⁸ This relatively broad understanding of the constitutional commerce power continues today.⁶⁹ Given the modern case law respecting the commerce power, there is little question with respect to Congress's constitutional power to regulate in this area. Indeed, the Supreme Court in a case predating the modern interpretation of the Commerce Clause upheld the Pure Food and Drug Act of 1908, the FDCA's predecessor, against a challenge that the law's provisions that allowed for the seizure and condemnation of adulterated goods were an illegitimate exercise of the commerce power.⁷⁰ This case law coupled with the later expansion of the constitutional limits to the commerce power supports the suggestion of one commentator68 finding Congress to have power to regulate intrastate economic activity that has "a substantial effect on interstate commerce."⁶⁹ The Court's expansive interpretations of the Commerce Clause have led one commentator to state that "Congress ... appears to retain virtually unlimited power to regulate even the wholly intrastate production and sale of food, drugs, devices, and cosmetics."⁷¹

Notwithstanding the constitutional limits to the FDA's enforcement jurisdiction, the ability to enforce the FDCA is also circumscribed as a statutory matter. The original 1938 Act, which was enacted in the immediate wake of the 1937 change in constitutional jurisprudence, was "largely limited to products that have moved, are moving, or will be moving in interstate commerce."⁷² Nonetheless, even as Congress has expanded the FDA's power over intrastate activities respecting FDCA covered articles, the Act still requires that the regulated activity still have some nexus with interstate commerce.⁷³ For example, the "prohibited acts" in Section 301 of the Act are generally limited to articles that were, are, or will be interstate commerce.⁷⁴

The statutory required nexus with interstate commerce can come from a host of70 A product's nexus with interstate commerce may arise from many activities. For example, an individual can "introduce" an adulterated good into interstate commerce by directly selling and shipping the good into another state, contracting to do so, or even by selling or shipping a good with the knowledge that it will enter another state.⁷⁵71 Moreover, an individual can violate the Act by selling or "holding for sale" a misbranded article after its shipment in interstate commerce "without regard to how long after the shipment the misbranding occurred, how many intrastate sales had intervened, or who had received the articles at the end of the interstate shipment."⁷⁶ At72 Under the most expansive, courts have held that the fact that a product contains even interpretations of the FD&C Act, courts have held that FDA has jurisdiction over products that contain only a single ingredient that has beenwas shipped in interstate commerce is sufficient to confer enforcement jurisdiction for the FDA.⁷⁷ Thus, the FDCA's reach, while not coterminous with the constitutional limits of the commerce power that have the potential to reach any intrastate economic class of activities that have.⁷³ Thus, although Congress has not provided FDA with all Congress's commerce clause, the FD&C Act's reach, which extends to any intrastate economic activities having a substantial effect on interstate commerce,⁷⁸74 is significant, and as. As a consequence, recent federal court decisions have found that the FD&C Act requirement that articles be in interstate commerce poses "no obstacle" to FDA enforcingthe interstate commerce nexus required by the FDCA to pose "no obstacle" to allowing the FDA to enforce the Act with respect to seemingly wholly intrastate activities.⁷⁹

The fact that the FDA has the75 FDA authority to enforce the FDCA with respect to wholly intrastate activities does not mean that the agency's authority is limitless. Rather, while there may be no clear geographic limit to the FDA's authority, the central statutory restriction on the agency's powers resides in the FDCA's defined limits with respect to the articles regulated under the Act. For example, prior to the enactment of apply the FD&C Act to seemingly wholly intrastate activities is limited: the FD&C Act applies only to certain articles. For example, prior to enactment of the Family Smoking Prevention and Tobacco Control Act of 2009,⁸⁰ the FDCA contained no explicit authority that allowed the76 the FD&C Act did not appear to authorize FDA to regulate tobacco products expressly. In 1996, FDA issued. In 1996, after years of expressly disavowing the authority to regulate tobacco use, the FDA issued a host of regulations governing "access to and promotion of nicotine-containing cigarettes and smokeless tobacco to children and adolescents," relying " on the argumentgrounds that nicotine is a "drug."⁸¹ The Supreme Court, in77 In FDA v. Brown & Williamson Tobacco Corp., rejected thethe Supreme Court rejected FDA's argument, holding that Congress had "clearly precluded the FDA from asserting jurisdiction to regulateover tobacco products."⁸²78 While Congress has since provided the FDA with the explicit statutory authority to regulate tobacco products that the Court found lacking in Brown & Williamson,⁸³ the case,⁷⁹ Brown & Williamson illustrates that the FDA's enforcement authority is not limitless and that the reach of the FDA's authority, as several courts have recognized, may ultimately be circumscribed by the definition attached to a regulated article.⁸⁴

IsFDA's authority under the Act has limits.⁸⁰ Does FDA Address Every Violation of the FDCA EnforcedFD&C Act?

Given the breadth of the articles regulated by the FDCAarticles that the FD&C Act regulates and the reach of the FDA's enforcement authority, questions often arise as to the amount of discretion, if any, the agency has in choosing whether to initiate an enforcement proceedingwhether FDA has discretion over initiating enforcement proceedings under the Act. The Supreme Court's decision in Heckler v. Cheney is the starting point for any discussion about the FDCA's enforcement discretion.⁸⁵ discussed FDA's enforcement discretion in Heckler v. Cheney.⁸¹ In Heckler, a death row inmate sentenced to die by lethal injection petitioned the FDA to take enforcement actions against state officials who were administering the drug cocktail to be used in the execution.⁸⁶82 The petitioner argued that the injection would constitute the use of a misbranded drug, as using the drug cocktail for a human execution was an "unapproved use of an approved drug" in violation of Sections 301(a) and 502(f) of the FDCA.⁸⁷ Nonetheless, theFD&C Act.⁸³ The Supreme Court refused to reachdid not address the merits of the petitioner's misbranding argument, unanimously holding that the FDA's decision notFDA generally has "absolute discretion" over whether to prosecute or enforce a matterFD&C Act violations through civil or criminal processes is generally a decision committed to the agency's "absolute discretion."⁸⁸ For the Court, the FDCA's general provision governing enforcement, Section 702, merely "authorized.⁸⁴ For the Court, the FD&C Act's general enforcement provision, Section 702, was permissive in nature, merely "authorizing" the Secretary of Health and Human Services (and through a delegation of that authority, the Commissioner of the FDA) "to conduct examinations and investigations for the purposes of" the Act, language that was "permissive" in nature and indicative ofand indicated Congress's intent to give FDA discretion over initiating enforcement proceedings.⁸⁵ Described intent to commit the initiation of enforcement proceedings to the FDA's discretion.⁸⁹ Heckler has been described as the "high-water mark of FDA discretionary selection of remedies," as it forms the legal basis under which the FDA can select its targets for enforcement of the FDCA.⁹⁰

Heckler established that FDA has discretion over FD&C Act enforcement.⁸⁶

Notwithstanding Heckler's ultimate holding, it is important to note that the Supreme Court in Heckler did limit its ruling, asholding, the Supreme Court recognized that an executive agency's nonenforcement decisions are only "presumptively" unreviewable.⁹¹87 Put another way, the presumption providingthat an executive agency withhas enforcement discretion "may be rebutted where the substantive statute has provided guidelines for the agency to follow in exercising its enforcement powers."⁹² And, indeed, courts have found that other provisions of the FDCA have overcome88 Courts have found that the presumption against reviewing the FDA's enforcement decisionsFDA's Section 702 enforcement decisions does not apply to other FD&C Act provisions. For example, in Cook v. FDA, a case with strikingly similar factssimilar to Heckler, a group of death row inmates sued the FDA for allowing several state correctional facilities to import sodium thiopental, arguing that the drug, as used in lethal injections, was "a misbranded and unapproved new drug" and its import into the country violated Section 801 of the FDCA.⁹³FD&C Act.⁸⁹ In ruling against the FDA, the D.C. Circuit Court of Appeals distinguished Heckler, noting that Section 801 of the FDCA mandates that, when the FDA, through the CBP, examinesCBP, identifies certain imported drugs that are adulterated, misbranded, or unapproved by the FDA, the drugs "shall be refused admission," language thatand that this language "unambiguously imposes mandatory duties upon the FDA" to refuse admission to the drugs.⁹⁴90 In other words, while Heckler provided the FDA withrecognized that FDA had significant discretion inover enforcing the FDCA, asSection 702, in Cook, the D.C. Circuit held that Congress had limited FDA's discretion over enforcing Section 801.⁹¹

FDA's enforcement discretion is central to many of the most contentious political disputes surrounding the agency. FDA is often faced with the difficult decision of whether to "ignore a safety issue and [potentially] precipitate deaths through nonfeasance" or "shut down an entire industry within a week through maximum sanctions."⁹² FDA has set enforcement priorities through policy statements, such as choosing to take actions against drugs with safety risks before taking actions against drugs that lack proof of effectiveness.⁹³ The agency's enforcement discretion is of "perennial" interest to Congress.⁹⁴

Civil Enforcement of the FD&C Act

Enforcement actions for FD&C Act violations can be civil or criminal in nature. Absent DOJ involvement, FDA has several administrative tools for enforcing the Act, including warning and untitled letters, import alerts, recalls, debarments, and civil money penalties. FDA's other civil enforcement actions, including injunctions and seizures, require DOJ assistance.

Warning and Untitled Letters

Although not required by law, depending on the type of FD&C Act violation and the public health threat, FDA usually provides individuals or firms with an opportunity to comply voluntarily before initiating other enforcement actions.⁹⁵ FDA does this by issuing "advisory action letters," also referred to as "regulatory letters," which include both "warning" and "untitled" letters.⁹⁶

FDA issues warning letters to alert individuals or firms that the agency has identified "violations of regulatory significance" and to request corrective action, with the expectation that most recipients will voluntarily come into compliance with the law.⁹⁷ While warning letters may include notice of FDA's intention to take further enforcement actions if the recipient does not comply, FDA considers these letters to be informal and advisory in nature.⁹⁸ Consequently, FDA has maintained that warning letters do not constitute "final agency action,"⁹⁹ a prerequisite for filing a lawsuit against a federal agency under the Administrative Procedure Act (APA).¹⁰⁰ Courts have largely agreed with FDA's position, holding that an APA suit may not be based on a warning letter.¹⁰¹

Similarly, FDA considers untitled letters to be advisory and uses them to address violations that do not merit a warning letter.¹⁰² For example, FDA may issue an untitled letter to a firm when its promotional materials omit certain risk information and are misleading.¹⁰³ Alternatively, FDA may issue a warning letter if FDA had previously communicated the same concerns to the firm, if the promotional materials failed to include any risk information at all, or if the risks omitted are particularly serious.¹⁰⁴ Untitled letters do not include a warning that failure to comply may result in subsequent enforcement action.¹⁰⁵ Because untitled letters are less serious than warning letters, it is unlikely that recipients could challenge untitled letters under the APA as final agency action.¹⁰⁶

Import Alerts

FDA bases its authority to issue import alerts, or automatic detention lists, on Section 801(a) of the FD&C Act, which provides that articles "appear[ing], from samples or otherwise," to violate the Act "shall be refused admission" into the United States.¹⁰⁷ Thus, if persuasive evidence exists, such as a history of violations or a failed facility inspection,¹⁰⁸ that an article may violate the FD&C Act, FDA may place that entity or product on an import alert list to communicate to border officials that such articles should be automatically detained without physical examination until further notice.¹⁰⁹ Once articles are detained, the owner or consignee has the opportunity to testify on the articles' admissibility.¹¹⁰ Depending on this information, FDA may either permit or refuse the articles' entry into the United States.¹¹¹

FDA's use of import alerts to detain articles automatically prior to inspection has been challenged in court, primarily on procedural grounds. Plaintiffs have generally prevailed in cases where FDA effectively used an import alert to change the rules of admissibility for a range of products without prior notice. For example, in Bellarno International Ltd.v. FDA, a federal district court in New York held that FDA violated the APA by failing to conduct notice-and-comment rulemaking procedures prior to instituting a rule, by way of an import alert, that required articles to have a complete chain of custody prior to entry.¹¹² Finding that the rule provided no enforcement discretion and was, therefore, a "substantive rule of general applicability ... rather than a discretionary statement of policy,"¹¹³ the court held that the rule was subject to APA-required notice-and-comment rulemaking.¹¹⁴ Likewise, in Benten v. Kessler, a district court determined that an import alert, banning abortifacient drugs previously admissible under the agency's personal importation policy, constituted a substantive rule subject to notice-and-comment rulemaking because it was essentially binding in its effect, leaving no room for enforcement discretion.¹¹⁵

Alternatively, FDA has prevailed when it used import alerts to identify and detain articles suspected of violating existing rules. For instance, in Seabrook International Foods Inc. v. Harris, a federal district court in the District of Columbia held that "[section 801 (a) of the FD&C Act] authorizes the [refusal of] admission of an article, without the introduction of testimony or evidence, as long as that article 'appears' to be adulterated."¹¹⁶ Accordingly, the court held that, because FDA officials had already identified a number of Indian shrimp facilities as having sanitation issues, the agency was "justified in concluding that the shrimp 'appeared' adulterated and should be barred [absent any] satisfactory showing by the importer that it was not harvested from or packed in the insanity sites earlier observed by FDA inspectors in India."¹¹⁷

Recalls

FD&C Act regulated articles that are already in distribution may be "recalled" or removed from market if FDA identifies FD&C Act violations that present consumer safety issues.¹¹⁸ Recalls may be more efficient than other formal or administrative processes for removing potentially hazardous products from market and alerting the public, thereby creating additional incentive for companies to comply with the Act.¹¹⁹

Recalls may be voluntary or mandatory.¹²⁰ Most recalls are voluntary¹²¹—that is, either requested by FDA or initiated by the firm or manufacturer itself.¹²² Firms or manufacturers must report any voluntary recalls they initiate to FDA and are subject to agency oversight.¹²³ FDA can request a recall when it determines that a regulated product in distribution presents a "risk of illness, injury, or gross consumer deception" that necessitates agency action to protect public health.¹²⁴ FDA typically requests recalls in urgent situations where FDA has evidence to support formal legal action, such as seizure.¹²⁵ While a firm may disregard an FDA-requested recall, it does so at the risk of a subsequent FDA enforcement action. Alternatively, FDA has limited authority to mandate or order a firm to recall its products. More specifically, when certain criteria are met, FDA has mandatory recall authority over medical devices,¹²⁶ biological products,¹²⁷ human tissue intended for transplantation,¹²⁸ infant formula,¹²⁹ tobacco products,¹³⁰ and foods,¹³¹ but it does not have mandatory recall authority over drug products.¹³² The procedures for mandatory recalls depend upon the product at issue, but generally, FDA institutes a mandatory recall by issuing an administrative order, which provides the recipient an opportunity to present its views on the order at an informal hearing before a presiding officer.¹³³

Debarment

Under section 306 of the FD&C Act, FDA is authorized to "debar" or prohibit corporations or individuals from participating in certain FDA-regulated activities based on their related conduct.¹³⁴ For example, FDA may debar a clinical investigator, who was convicted of falsifying records in a clinical study, from "providing any services in any capacity to a person that has an approved or pending drug product application."¹³⁵ Because debarment poses significant consequences for those participating in FDA-regulated industries, possibly necessitating career changes, debarment appears to create strong incentives to comply with the FD&C Act.¹³⁶

The FD&C Act sets forth two types of debarment—mandatory and permissive.¹³⁷ The statute also describes the criteria applying to individuals and corporations involved in the drug industry, as well as food importers.¹³⁸ For mandatory debarment, debarment is permanent. For permissive debarment, debarment is for a period of "not more than five years," the length of which is based on six factors.¹³⁹ FDA provides a notice of proposal for debarment to persons it seeks to debar, who may then request a hearing to show why debarment is not appropriate.¹⁴⁰ Persons subject to permissive debarment may apply for a termination of debarment.¹⁴¹ Persons subject to debarment may also petition the United States Court of Appeals for the District of Columbia or the circuit in which they reside to review whether the debarment should be modified or set aside.¹⁴²

Civil Money Penalties

Under the FD&C Act, FDA may impose monetary civil penalties¹⁴³ for specified violations of the Act. These include violations relating to prescription drug marketing practices,¹⁴⁴ medical devices,¹⁴⁵ electronic products,¹⁴⁶ tobacco products,¹⁴⁷ pesticide residues in food,¹⁴⁸ generic drug applications,¹⁴⁹ and improper dissemination of direct-to-consumer advertisements for approved drugs or biological products.¹⁵⁰ The maximum penalty that FDA may assess ranges from approximately $1,000 to over $1 million per violation depending on the prohibited act.¹⁵¹ To determine the penalty for many violations, the agency must consider the nature and circumstances surrounding the violation, the person's ability to pay, the effect on the person's ability to continue to do business, and any history of similar acts.¹⁵² FDA may assess penalties against both individuals and corporations.

If FDA finds that a monetary civil penalty is warranted, it may assess the penalty absent DOJ's or the courts' involvement.¹⁵³ Under FDA's regulations, FDA initiates a penalty proceeding by serving a complaint that alleges that the recipient is violating the Act and seeks a civil money penalty.¹⁵⁴ The recipient must answer the complaint and may request a hearing on it.¹⁵⁵ Following the hearing, an administrative law judge renders a decision, which may be appealed to the Department of Health and Human Service's Departmental Appeals Board (DAB).¹⁵⁶ A decision by the DAB is considered final agency action ripe for judicial review.¹⁵⁷

Seizures

To prevent harmful goods from reaching consumers, the FD&C Act provides for the seizure of foods, drugs, devices, cosmetics, and tobacco products that are adulterated or misbranded.¹⁵⁸ According to a House report accompanying the FD&C Act, a seizure is considered the harshest civil remedy under the Act, and "should be discouraged or confined to those cases where the public protection requires such action."¹⁵⁹ Seizures may be small, involving only a specific lot or batch of defective products, or large,¹⁶⁰ involving multiple seizure actions filed simultaneously in various locations and potentially halting the national distribution of a product.¹⁶¹

While FDA lacks authority to seize products, the U.S. Attorney may take such actions based on FDA's recommendation. In general, the U.S. Attorney commences a seizure action by filing a complaint in federal court on behalf of FDA and obtaining a warrant that directs the U.S. Marshal to take custody of the goods.¹⁶² FDA is not obligated to notify a manufacturer that its products violate the FD&C Act before undertaking a seizure action, and the Supreme Court has found that seizing products without a prior judicial hearing does not raise due process concerns.¹⁶³

Under the FD&C Act, when a product may be seized depends on the product type and the alleged violation.¹⁶⁴ In general, seizure proceedings involving food, drugs, and cosmetics may be initiated "when introduced into or while in interstate commerce or while held for sale ... after shipment in interstate commerce."¹⁶⁵ However, for counterfeit drugs and the materials used to make them, as well as adulterated or misbranded medical devices and tobacco products, seizure may occur at any time (and before a complaint is filed).¹⁶⁶ With some exceptions, FDA may not initiate seizure actions against a food that is misbranded due to its advertising, or that is being sold to consumers in an establishment not owned or operated by the food's manufacturer, packer, or distributor.¹⁶⁷

If goods are seized, a company with an ownership interest in the goods has the option of claiming the article and contesting the seizure by filing an answer to the complaint.¹⁶⁸ Often, the company will have the option of filing a claim to the article while admitting the violation and entering into a Consent Decree with the government.¹⁶⁹ It has been noted that more than 90% of FDA seizure actions are not contested.¹⁷⁰

Injunctions

The FD&C Act authorizes federal district courts to issue injunctions to prevent violations of the Act.¹⁷¹ Under the Act, injunctions are used to stem the flow of adulterated, misbranded, or otherwise violative goods in interstate commerce and to correct conditions causing violations.¹⁷² Injunctions can take the form of a prohibition, such as an order not to distribute a product, or a command to take certain actions, such as an order to clean a facility.¹⁷³ Injunctions may be temporary or permanent in nature.

According to FDA guidance, an injunction "may be considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified."¹⁷⁴ the D.C. Circuit held in Cook with respect to Section 801, Congress, when it speaks with sufficient clarity, can limit the FDA's exercise of its enforcement powers.⁹⁵

Aside from the legal issues respecting the FDA's discretion to enforce parts of the Act, as a matter of policy, as one commentator noted, it is a "basic economic fact" that the FDA simply cannot investigate and attempt to enforce every potential violation of the Act.⁹⁶ Indeed, the FDA's enforcement discretion is at the heart of many of the most contentious political disputes surrounding the agency. The FDA is often faced with the difficult decision to "on the one hand" "ignore a safety issue and [potentially] precipitate deaths through nonfeasance" or "on the other hand ... shut down an entire industry within a week through maximum sanctions."⁹⁷ The FDA has continually set enforcement priorities through policy statements, such as choosing to take actions against drugs with safety risks before taking action against drugs that lack proof of effectiveness.⁹⁸ Nonetheless, the inevitable result of such policy decisions is that the agency's enforcement decisions will be of "perennial" interest to Congress.⁹⁹

Civil Enforcement of the FDCA

As noted above, the FDA has several enforcement tools it may use to address violations of the FDCA. The Act provides the agency with certain administrative enforcement powers that it can exercise on its own, and the statute also contains judicial enforcement mechanisms that require the agency to go to court. Enforcement actions may be civil or criminal in nature. Civil actions include the imposition of civil monetary penalties, injunctions, and seizures.

Civil Monetary Penalties

Under the FDCA, the FDA may impose civil monetary penalties¹⁰⁰ for certain specified violations of the Act. These include violations relating to prescription drug marketing practices,¹⁰¹ medical devices,¹⁰² electronic products,¹⁰³ tobacco products,¹⁰⁴ pesticide residues in food,¹⁰⁵ generic drug applications,¹⁰⁶ and improper dissemination of direct-to-consumer advertisements for approved drugs or biological products.¹⁰⁷ The maximum amount of the penalty that may be assessed by the FDA varies greatly depending on the particular prohibited act, ranging from approximately $1,000 per violation to over $1 million.¹⁰⁸ In determining the amount of the penalty for many of these violations, the agency is required to take into account the nature and circumstances surrounding the violation, as well as factors such as the person's ability to pay, the effect on the person's ability to continue to do business, and any history of similar prior acts.¹⁰⁹ Penalties may be assessed against both individuals and corporations.

While the agency is under no statutory obligation to provide notification, the FDA has indicated that its normal practice is to provide some form of warning to companies before seeking a civil money penalty, typically in the form of a warning letter.¹¹⁰ Should the agency determine that a civil monetary penalty is warranted, regulations set forth procedures under which the FDA imposes civil money penalties without the involvement of the Department of Justice or the courts.¹¹¹ Under these regulations, a penalty proceeding is initiated that is similar to a civil suit in court, whereby the FDA serves a complaint on an individual or corporation, alleging a violation, and seeking a penalty.¹¹² This party (i.e., the respondent) is required to answer the complaint, and may request a hearing on the issue.¹¹³ Following the hearing, a decision is rendered by an administrative law judge, and the decision may be appealed.¹¹⁴

Seizures

In order to prevent harmful goods from reaching a consumer, the FDCA authorizes the seizure of foods, drugs, devices, cosmetics, and tobacco products that are adulterated or misbranded.¹¹⁵ According to a House report accompanying the FDCA, a seizure is considered the harshest civil remedy under the Act, and it "should be discouraged or confined to those cases where the public protection requires such action."¹¹⁶ Seizures may be smaller in nature, involving only a specific lot or batch of a defective product, but they may also be large in scale, e.g., in situations where multiple seizure actions are filed simultaneously in a number of geographic locations, potentially halting the national distribution of a product.¹¹⁷

While the FDA itself lacks the authority to seize products, these actions may be carried out by the U.S. Attorney in a given judicial district based on the agency's recommendation. In general, the U.S. Attorney commences a seizure action by filing a complaint in federal court on behalf of FDA and obtaining a warrant that directs the U.S. Marshal to take custody of the goods.¹¹⁸ The FDA is under no obligation to notify a manufacturer that its products violate the FDCA before undertaking a seizure action, and the Supreme Court has found that seizing products without any prior judicial hearing does not raise due process concerns.¹¹⁹ However, the FDA may choose to notify an owner of these products and give them an opportunity to take corrective action prior to initiating a seizure.

Under the FDCA, the point at which a product may be seized may depend on the type of product and the alleged violation.¹²⁰ In general, seizure proceedings involving food, drugs, and cosmetics may be initiated "when introduced into or while in interstate commerce or while held for sale ... after shipment in interstate commerce."¹²¹ However, with respect to counterfeit drugs and the materials used to make them, as well as adulterated or misbranded medical devices and tobacco products, a FDA seizure may occur at any time (and before a complaint is filed).¹²² Certain restrictions apply to seizure actions against a food that is misbranded because of its advertising, or that is being held for sale to consumers in an establishment not owned or operated by the food's manufacturer, packer, or distributor.¹²³

Once goods have been seized, a company with an ownership interest in the goods has at least two main options: it can do nothing and allow the products to be condemned and disposed of, or it can claim the article and contest the seizure action by filing an answer to the complaint.¹²⁴ It has been noted that more than 90% of FDA seizure actions are not contested.¹²⁵

Injunctions

The FDCA authorizes federal district courts to issue injunctions in order to restrain almost every violation of the Act. ¹²⁶ Injunctions under the FDCA are designed to stem the flow of adulterated, misbranded, or otherwise violative goods in interstate commerce, and to correct the conditions that caused the violation to occur.¹²⁷ Injunctions can take the form of a prohibition, e.g., an order barring a company from distributing a certain product, or a command to take a certain action, such as an order to clean up a facility.¹²⁸ These judicial orders may be issued for the range of FDA-regulated products, and they may be temporary or permanent in nature.

According to FDA guidance, an injunction "may be considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified."¹²⁹ The FDA has indicated that an injunction is the agency's remedy of choice when there are

• current and definite health hazards or a gross consumer deception requiring immediate action to stop the violative practice and a seizure is impractical;
• significant amounts of violative products owned by the same person, a voluntary recall by the firm was refused or is significantly inadequate to protect the public, and a seizure is impractical or uneconomical; or
• long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through use of voluntary or other regulatory approaches.¹³⁰175

Similar to seizures, injunctions involve cooperation between the FDA and the Department of Justice. Based on a recommendation from the FDAFDA and DOJ cooperation. Based on FDA's recommendation, the U.S. Attorney files an injunction action, in federal district court to enjoin one or more individuals and/or acourt, to enjoin an individual or company from violating the FDCA.¹³¹Act.¹⁷⁶ In general, courts have granted injunctions where it has been when DOJ has demonstrated that the defendants violated the FDCA and there is a likelihood of recurring violations.¹³²and are likely to continue to violate the FD&C Act.¹⁷⁷ If the court enters thean injunction, the individual or company must comply immediately, unless it obtains a stay of the court order, pending an appeal. Most injunction cases under the FDCAFD&C Act are resolved through the entry of a negotiated consent decree.¹³³

178

Criminal Enforcement of the FDCA

FD&C Act

In addition to civil enforcement mechanisms, the FDCAFD&C Act also subjects individuals to criminal penalties, including fines and imprisonment, for violating certain provisions of the Act.¹³⁴179 Criminal prosecutions under the FDCA are rare:FD&C Act are rare, with one commentator finding that "only a miniscule fraction of 1 per cent of the [FDA's] inspections will result in criminal prosecution,"¹⁸⁰ and "¹³⁵ and violations of the Act resulting from "extremely technical infractions" of the Act are very unlikely to result in criminal punishment.¹³⁶ In fact, according to the181 According to FDA's enforcement manuals, criminal prosecutions rarely occur ifmanual, the agency usually affords individuals and firms an opportunity to comply voluntarily prior to initiating a criminal prosecution, as long as "a violative situation does not present a danger to health or does not constitute intentional, gross or flagrant violations."¹³⁷ Notwithstanding the rarity of criminal prosecution under the FDCA182 Although criminal prosecutions are rare under the Act, the threat of criminal penalties is regarded as an extremely effective tool in ensuring compliance with the statute.¹³⁸may create incentives to comply.¹⁸³ Whereas economic penalties resulting from the civil enforcement tools "might ... be seen as merely an extra cost of business" for an entity regulated under the FDCAFD&C Act, criminal penalties, which potentially threaten the liberty interests of a host of individuals such as the "factory manager, the corporate chief executive, or the researcher," has, according to one commentator, produced the "most rapid results" for the FDA with respect to enforcing compliance with the Act.¹³⁹."

The FDA's Office of Criminal Investigations (OCI) is the primary entity tasked with "investigatingthat investigates suspected criminal violations of the [FDCA] and otherFD&C Act and related laws."¹⁴⁰ The OCI, which recruits experienced investigators from other government agencies, such as the Federal Bureau of Investigation or the Secret Service,¹⁴¹employ "customary federal law enforcement methods and techniques" in conducting criminal investigations.¹⁴² Upon determining that prosecution is the appropriate course of action, OCI makes a recommendation to the DOJ, as the DOJ possesses the authority to prosecute those individuals and corporations suspected of violating the FDCA.¹⁴³ However, pursuant to Section 305 of the Act, before any violation of the FDCA is reported to "any United States attorney for institution of a criminal proceeding," the "person against whom such proceeding is contemplated" should be provided with184 If OCI finds prosecution to be appropriate, FDA may give the alleged violator notice and an opportunity to present his "views ... with regard to such contemplated proceeding."¹⁴⁴ Notwithstanding the text of the FDCA," pursuant to Section 305.¹⁸⁵ Although the Supreme Court has held that a hearing ishearings are not required,¹⁴⁵ and, while the prevailing practice is to afford a Section 305 hearing to an alleged violator, FDA regulations specify certain circumstances in which the FDA Commissioner need not provide such a hearing.¹⁴⁶ Once the FDA has recommended a criminal prosecution to the DOJ, the Justice Department186 FDA generally provides hearings absent a regulatory bar.¹⁸⁷ If prosecution is appropriate, OCI makes a recommendation to DOJ, which has authority to prosecute FD&C Act violations.¹⁸⁸ DOJ, including the local U.S. Attorney's office, will review thethen reviews FDA's recommendation and, if warranted, instituteinstitutes criminal proceedings against the alleged violator.¹⁴⁷ While as a matter of law the 189 While DOJ has the discretion to reject the FDA's recommendation, as a matter of course, the DOJ will typically "adhere to the recommendations of the FDA" and "act, as closely as possible, in partnership with attorneys from the FDA."¹⁴⁸

190

Criminal Violations of the FDCA

Criminal convictions under the FDCAFD&C Act Under the FD&C Act, criminal convictions generally require proof of three central elements. First, the government must prove that the article at the center of, which the statutory violation concerns, is either a "food," "drug," "device," "tobacco," or "cosmetic."¹⁴⁹191 Second, the article at issue generally¹⁵⁰192 must be "adulterated" or "misbranded."¹⁵¹193 Third, the article at issue must have been introduced into interstate commerce.¹⁵²194 Importantly, contrary to the typical requirement of Anglo-American criminal law, FDCAFD&C Act criminal provisions do not include a mens rea or "guilty mind" requirement.¹⁵³ Put another way195 Instead, the standard for criminal liability under the FDCAFD&C Act is strict liability, such that a defendant can be held criminally liable without proof of knowledge of the event or intention to perform the act that results in a violation.¹⁵⁴196

Two Supreme Court cases established this principle. In United States v. Dotterweich, Justice Frankfurter, writing for a five-member majority, explained that the FDCAFD&C Act "dispenses with the conventional requirement for criminal conduct awareness of some wrongdoing"¹⁵⁵197 and that criminal accountability extends to all those who have "a responsible share in the furtherance of the transaction which the statute outlaws."¹⁵⁶198 The Court reasoned that the strict liability standard was necessitatednecessary because "[i]n the interest of the larger good [the Act placed] the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger."⁵⁸199 Over thirty years later, in United States v. Park, the Supreme Court reaffirmed Dotterweich, holding that a showing of liability under the FDCA. In articulating what is known as the "responsible corporate officer" or "Park" doctrine, the Court held that a showing of criminal liability under the FD&C Act did not require an "awareness of some wrongdoing" by the defendant, but instead merely required the defendant to be in a "position in [a] corporation" so thatin which he had the "responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so."¹⁵⁷200 In so holding, the Court noted that while the strict liability standard imposed by the FDCAFD&C Act is "beyond question demanding" the standard is "no more stringent" than what should be expected of "those who voluntarily assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them."¹⁵⁸

201

While the lack of a mens rea element in FDCAFD&C Act criminal cases could theoretically allow the FDA and the Justice DepartmentFDA and DOJ to "bring a criminal action ... in virtually every serious case" of an FDCAFD&C Act violation,¹⁵⁹202 two common defenses may diminish the potential reach of the FDCAAct's criminal sanctions. First, an individual accused of an FDCAFD&C Act crime could raise the affirmative defense of "impossibility." The "impossibility defense" is available to a corporate officer who can introduce evidence that "he exercised extraordinary care, but was nevertheless unable to prevent violations of [the FDCA]."¹⁶⁰FD&C Act]."²⁰³ Upon such a showing, the burden of proof then shifts to the government to prove beyond a reasonable doubt that the officer was not actually powerless to prevent or correct the violation.¹⁶¹204 Second, under the "guaranty clause" contained in Section 303(c) of the FDCAFD&C Act, a person who in "good faith" merely receives and later delivers an illegal article cannot be subjected to criminal penalties under the Act.¹⁶²205 Likewise, a person who introduced a misbranded or adulterated product into commerce is also exempt under Section 303(c) if that person received the article in "good faith" and has obtained a written guaranty that the product is not in violation ofdoes not violate the Act.¹⁶³ The206 Under the guaranty clause has allowed, pharmacists who have, in good faith, distributed misbranded or adulterated drugs from a drug manufacturer or distributor to escapehave escaped criminal liability.¹⁶⁴

207

Criminal Penalties Resulting from an FDCAFD&C Act Violation

Under Section 303(a)(1) of the FDCAFD&C Act, criminal violations of the Act are generally treated as misdemeanors,¹⁶⁵208 meaning a crime that isthey are punishable by a fine or imprisonment of a year or less.¹⁶⁶209 Nonetheless, violations of the Act FD&C Act violations may constitute a felony if the actviolation is a second offense or is done with the "intent to defraud or mislead."¹⁶⁷ In order for210 For a defendant to act with an "intent to defraud or mislead" under the FDCAAct, the defendant must "design[] his conduct to avoid the regulatory scrutiny of the FDA,"¹⁶⁸211 meaning that in order, for a defendant to incur a felony conviction under the FDCA a defendant's intent to defraud or mislead may be directed at not only the ultimate consumers of a product,Act, he must have intended to defraud or mislead not only the product's ultimate consumers but also state and federal government enforcement agencies.¹⁶⁹212

Section 303(a) contains theestablishes default criminal penalty provisionspenalties for individuals who commit either a misdemeanor or a felony under the Act.¹⁷⁰ Those who have committed a simple violation of the Act are, pursuant to the text of the FDCA, subject to a fine of $1,000misdemeanors or felonies under the FD&C Act.²¹³ The Act provides for a $1,000 fine, imprisonment of up to one year, or both.¹⁷¹ Subsequent convictions or convictions demonstrating an intent to defraud or mislead may, according to the text of the FDCA, result in for simple violations of the Act.²¹⁴ The Act further provides for fines of up to $10,000, imprisonment for up to three years, or both for subsequent convictions or convictions demonstrating intent to defraud or mislead.²¹⁵.¹⁷² However, under the Sentencing Reform Act of 1984, as amended by the Criminal Fines Improvement Act of 1987, all criminal fines are subject to certain uniform levels, modifying all fines imposed in the United States Code, including those imposed by the FDCA. ¹⁷³ As a result of those two laws, the current maximum fine for an individual who has committed an FDCA misdemeanor that does not result in death is $100,000,¹⁷⁴ and an individual who has committed an FDCA misdemeanor that does result in death or an FDCA felony could be subject to a fine of up to $250,000.¹⁷⁵ Likewise, under current law, an organization could be forced to pay a maximum fine of $200,000 if guilty of an FDCA misdemeanor¹⁷⁶ and a maximum fine of $500,000 for an FDCA misdemeanor resulting in death or an FDCA felony.¹⁷⁷in the United States Code, including FD&C Act fines, are subject to modification to achieve certain uniform levels.²¹⁶ Consequently, for FD&C Act misdemeanors not resulting in death, the current maximum fine for an individual is $100,000,²¹⁷ while for FD&C Act misdemeanors resulting in death or for FD&C Act felonies, the current maximum fine for an individual is $250,000.²¹⁸ Likewise, for FD&C Act misdemeanors, the current maximum fine for an organization is $200,000²¹⁹ while, for FD&C Act misdemeanors resulting in death or for FD&C Act felonies, the current maximum fine for an organization is $500,000.²²⁰

Pursuant to the U.S. Sentencing Guidelines, defendants convicted of violating the Act are providedreceive a base offense level of six,¹⁷⁸221 resulting in a guideline recommendation of a final sentence of zero to eighteen months in prison, depending on the defendant's individual criminal history.¹⁷⁹ The sentence could increase considerably if the offense was committed after sustaining a prior violation of the FDCA222 If the defendant had previously violated the Act or if the offense involved fraud, the sentence could increase considerably.²²³.¹⁸⁰ The Sentencing Guidelines also provide that an "upward departure" "may be warranted" if the offense "created a substantial risk of bodily injury or death; or bodily injury, death, extreme psychological injury, property damage, or monetary loss resulted from the offense."¹⁸¹

224

Author Contact Information

[author name scrubbed], Legislative Attorney ([email address scrubbed], [phone number scrubbed])

[author name scrubbed], Legislative Attorney ([email address scrubbed], [phone number scrubbed])

Footnotes

1.

CDC, Multistate Outbreak of Salmonella Poona Infections Linked to Imported Cucumbers, https://www.cdc.gov/salmonella/poona-09-15/index.html (last visited Nov. 16, 2017).

Footnotes

United States v. Lee, 131 F.2d 464, 466 (7^th Cir. 1941) (noting Congress's interest in promoting public health and preventing fraud).

43.

See Id.

Id. at 22239 (noting that the "centralization of FD&C Act enforcement authority in the Federal government does not indicate that Congress intended to foreclose private enforcement of other federal statutes," such as the Lanham Act); see also Wyeth v. Levine, 555 U.S. 555, 574 (2009) (concluding that Congress intended private state law tort claims regarding drug labeling to proceed despite the existence of the FDCAFD&C Act).

See Regulatory Procedures Manual, Ch. 7-5-2 (2017). Seeid. at § 262(d)(1), see also 21 C.F.R. § 1271.440.

134 21 U.S.C. § 333(f)(9).

See 21 U.S.C. § 335a(a)-(b. Id. § 333(g. See O' Reilly, supra note 28. See generally Regulatory Procedures Manual, § 6-1, available at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176733.htm (September 2011Ch. 6-1 (2015).

Regulatory Procedures Manual, § 6-1-9, available at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176733.htm (September 2011).

Ch. 6-1-9 (2015).

See O'Reilly, supra note 28, at § 8.3.

200.

1.	Centers for Disease Control and Prevention, Investigation of an Escherichia coli 0157:H7 Outbreak Associated with Dole Pre-Packaged Spinach, http://www.cdc.gov/nceh/ehs/Docs/Investigation_of_an_E_Coli_Outbreak_Associated_with_Dole_Pre-Packaged_Spinach.pdf.
2.	Centers for Disease Control and Prevention, CDC, Multistate Fungal Meningitis Outbreak Investigation—Current Case Count, http (2015) https://www.cdc.gov/hai/outbreaks/meningitis-map-large.html.
3.	See The Partnership for Safe Online Pharmacies, Counterfeit Heparin Blamed for Worldwide Deaths (Aug. 30, 2009), http://www.safemedicines.org/2009/08/counterfeit-he.html; see also Ed Edelson, Report Confirms Source of Contaminated Heparin, Wash. Post (Dec. 3, 2008), http://www.washingtonpost.com/wp-dyn/content/article/2008/12/03/AR2008120302758.html.	4.
45.	21 U.S.C. §§ 301, et seq.
56.	CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by [author name scrubbed].
67.	CRS Report RS22600, The Federal Food Safety System: A Primer, by [author name scrubbed].
78.	The FDCAFD&C Act generally defines the term "food" as "(1) articles used for food or drink for man or other animals, (2)  chewing gum, and (3) articles used for components of any such article." 21 U.S.C. § 321(f).
89.	The FDCAFD&C Act generally defines the phrase "food additive" as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food ... if such substance is not generally recognized ... to be safe under the conditions of its intended use." 21 U.S.CId. § 321(s).
910.	The FDCAFD&C Act generally defines the phrase "color additive" as "a material which – –(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and (B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto.... " 21 U.S.CId. § 321(t).
1011.	The FDCAFD&C Act generally defines the phrase "dietary supplement" as meansto mean "a product ... intended to supplement the diet that bears or contains one or more of the following dietary ingredients:       (A) a vitamin;       (B) a mineral;       (C) an herb or other botanical;       (D) an amino acid;       (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or       (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E)." 21 U.S.CId. § 321(ff).
1112.	The FDCAFD&C Act generally defines the term "drug" as " (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C)." 21 U.S.CId. § 321(g).
1213.	The FDCAFD&C Act generally defines the term "device" as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is - (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.CId. § 321(h).
1314.	The FDCAFD&C Act generally defines the term "cosmetic" as "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap." 21 U.S.CId. § 321(i).
1415.	The FDCAFD&C Act generally defines the term "tobacco product" as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." 21 U.S.C. § Id. § 321(rr).
1516.	For a general description of the scope of products regulated under the FDCA, seeFD&C Act, see Peter Barton Hutt, Richard A. Merrill, and Lewis A. Grossman, Food and Drug Law 12-16 (Foundation Press, 3d ed. 2007).
1617.	P.L.Pub. L. No. 75-717, 52 Stat. 1057 (1938).
1718.	Hipolite Egg Co. v. United States, 220 U.S. 45, 57 (1911) (noting that the Pure Food and Drug Act of 1906, the precursor to the FDCAFD&C Act, rested "upon the power of Congress to regulate interstate commerce").
1819.	United States v. Sullivan, 332 U.S. 689, 696 (1948).
1920.	See infra "Civil Enforcement of the FDCAFD&C Act."
2021.	See Diana R. H. Winters, Not Sick Yet: Food-Safety-Impact Litigation and Barriers to Justiciability, 77 Brooklyn L. Rev. 905, 911 (Spring 2013).
2122.	See Hutt, Merrill, and Grossman, supra note 1516, at 1196. Section 301 is codified at 21 U.S.C. § 331.
2223.	See Hutt, Merrill, and Grossman, supra note 1516, at 13.
2324.	See 21 U.S.C. § 331(a)-(c).
24.	See, e.g., Pennsylvania v. Curry, 4 Pa. Super. 356, 360 (Super. Ct. 1897) ("The term adulteration is derived from the Latin adultero, which ... signifies to defile, to debase, to corrupt, ... to counterfeit, etc."); see generally 2 C.J.S. Adulteration § 1 (2003) ("The word 'adulteration' ordinarily signifies the act of corrupting or debasing, the act of mixing something impure with something pure and genuine or of mixing an inferior article with a superior one of the same kind.").
25.	See, e.g., Hatcher v. Dunn, 102 Iowa 411, 415 (1897).
26.	See 2 C.J.S. Adulteration § 1 (2003).
2725.	See Hutt, Merrill, and Grossman, supra note 1516, at 13.
2826.	21 U.S.C. § 342(a)(4).
2927.	21 U.S.CId. § 352(b)(1).
3028.	See James T. O'Reilly, Food and Drug Administration § 6.1 (2d ed. 2005).
3129.	21 U.S.C. § 371 (providing the Secretary of Health and Human Services with "the authority to promulgate regulations for the efficient enforcement of" the FDCAFD&C Act).
3230.	21 U.S.C. § 393(a).
3331.	See Hutt, Merrill, and Grossman, supra note 15, at 5U.S. Food & Drug Admin., What We Do, https://www.fda.gov/AboutFDA/WhatWeDo/ (last visited Nov. 16, 2017); see also 21 U.S.C. § 393(b).
3432.	See 21 U.S.C. § 371.
3533.	See, e.g. 21 U.S.C, id. § 348 (imposing a premarket approval requirement for food additives); 21 U.S.Cid. § 379e (requiring premarket approval for color additives); 21 U.S.Cid. § 355 (prohibiting the introduction or delivery into interstate commerce of any new drug, unless the FDA has approved a new drug application); 21 U.S.Cid. § 360b (extending the new drug premarket approval process to new animal drugs); 21 U.S.Cid. § 360c(a)(1)(C) (subjecting certain medical devices to a premarket approval process); 21 U.S.Cid. § 387j(a)(2) (requiring "new tobacco products" to undergo premarket review).
3634.	See generally O'Reilly, supra note 3028, at § 6.1 (noting thethat FDA has an "effective arsenal of weapons to deal with large, medium and small violations" of the FDCAFD&C Act).
3735.	See 21 U.S.C. § 355(k)(2).
3836.	See id21 U.S.C. § 374.
3937.	See 21 U.S.C. § 360h(e).
4038.	21 U.S.CId. § 372(a).
4139.	21 U.S.CId. § 375(b)
4240.	21 U.S.CId. § 375(a).
4341.	See Roseann B. Termini, Food and Drug Law 40 (6th ed. 2013); see also Hutt, Merrill, and Grossman, supra note 1516, at 1339 (describing "warning letters" as letters that "warn[] a violator that a formal enforcement [is] likely in the absence of voluntary compliance" and "information letters" as letters that "request[] voluntary correction but ma[ke] no representation that formal enforcement action [is] imminent.").
4442.	See infra "Civil Enforcement of the FD&C Act."	See Linda Horton, International Harmonization and Mutual Recognition Agreements, 29 Seton Hall L. Rev 692, 698 (1998).	44.
45.	Vandya Swaminathan and Matthew Avery, FDA Enforcement of Criminal Liability for Clinical Investigator Fraud, 4 Hastings Sci. & Tech. L.J. 325, 350 (Summer 2012); see also Hutt, Merrill, and Grossman, supra note 1516, at 1217.
46.	See O'Reilly, supra note 3028, at § 6.1; see generally U.S. Dep't Justice, Monograph, Office of Consumer Litigation, http 2-3 (2011) https://www.justice.gov/civil/docs_forms/OCPL_Monograph.pdf, at pp. 2-3. sites/default/files/civil/legacy/2011/09/06/CPB_Monograph.pdf
47.	U.S. Food & Drug Admin., FDA Regulatory Procedures Manual, 9-2 http://www.fda.gov/downloads/ (hereinafter "Regulatory Procedures Manual"), Ch. 9-1-2 (2017) https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf (April 2013)default.htm.
48.	Id. at pp. 9-36.
49.	21 U.S.C. § 352.
50.	See Kordel v. United States, 335 U.S. 345, 349-51 (1948).
51.	15 U.S.C. § 45.
52.	See FTC v. Colgate-Palmolive Co., 380 U.S. 374, 392 (1965).
53.	FTC-FDA Memorandum of Understanding, 36 Fed. Reg. 18,539 (1971).
54.	See 15 U.S.C. §§ 41, 52-53; see also FTC-FDA Memorandum, 36 Fed. Reg. at 18,539 (explaining that FTC, not FDA, has the authorityprimary responsibility for overseeing the advertising of over over-the-counter drugs and medical devices).
55.	See, e.g., Memorandum of Understanding Between the Food and Drug Administration, U.S. Department of Health and Human Services, and the Food Safety and Inspection Service, U.S. Department of Agriculture, Regarding the Listing or Approval of Food Ingredients and Sources of Radiation Used in the Production of Meat and Poultry Products, 65 Fed. Reg. 33,330 (May 23, 2000) (establishing the working relationship between FDA and USDA's Food Safety and Inspection Service with respect to the sanctioning of food ingredients and sources of radiation subject to FDA regulation and intended for use in the production of meat and meat products); see generally U.S. ); see generally Food & Drug Admin., Investigations Operations Manual, 3.2.1.4 (2017), https, http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123506.pdf (September 2013) (discussing the various MOUs entered between different sub-agencies within the USDA and the FDA).
56.	See, e.g., FDA and BATF, Memorandum of Understanding, 52 Fed. Reg. 45,502 (Nov. 30, 1987).
57.	See, e.g., Memorandum of Understanding Between the Department of Defense and the Food and Drug Administration, 52 Fed. Reg. 33,472 (Sept. 3, 1987).
58.	See O'Reilly, supra note 30, at § 24.1.
59.	See Hutt, Merrill, and Grossman, supra note 15, at 1369-70.
60.	See 21 U.S.C. § 337(a).
61.	Id.
62.	See POM Wonderful LLC v. Coca-Cola Co.,—S. Ct.—, 2014 WL 2608859, at * 5 (June 12, 2014).
63.	Id. at *10 (noting that the "centralization of FDCAMemorandum of Understanding Between the Food and Drug Administration and the [Department of the Treasury's] Bureau of Alcohol, Tobacco, and Firearms , 52 Fed. Reg. 45,502 (Nov. 30, 1987) (delineating the responsibilities of each agency with respect alcoholic beverages considered adulterated under the FD&C Act and for other related purposes).
57.	See, e.g., Memorandum of Understanding Between the Department of Defense and the Food and Drug Administration, 52 Fed. Reg. 33,472 (1987) (establishing the procedures to be followed by DoD regarding the investigational use of drugs, including antibiotics and biologics, and medical devices).
58.	See, e.g. Memorandum of Understanding Between the Food and Drug Administration and the Centers for Disease Control and Prevention, 71 Fed. Reg. 43,491 (Aug. 1, 2006) (providing the principles and procedures by which information exchanges between the two agencies shall take place).
59.	See O'Reilly, supra note 28, at § 24.1.
60.	See 21 U.S.C. § 337(b) (authorizing the states to enforce some of the FD&C Act's food labeling requirements if certain criteria are met); see also Hutt, Merrill, and Grossman, supra note 16, at 1369-70.
61.	See 21 U.S.C. § 337(a).
62.	Id.
63.	See POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228, 2235 (2014).
64.
6465.	See Hipolite Egg Co. v. United States, 220 U.S. 45, 57 (1911) (noting that the Pure Food and Drug Act of 1906, the precursor to the FDCAFD&C Act, rested "upon the power of Congress to regulate interstate commerce").
6566.	U.S. Const., Art. I, § 8, cl. 3.
6667.	See, e.g., Hammer v. Dagenhart, 247 U.S. 251, 273 (1918); Carter v. Carter Coal Co., 298 U.S. 238, 308 (1936).
6768.	See NLRB v. Jones & Laughlin Steel Corp., 301 U.S. 1 (1937).
68.	See Wickard v. Filburn, 317 U.S. 111 (1942, 41(1937) (holding that, "[w]e have often said interstate commerce itself is a practical conception. It is equally true that interferences with that commerce must be appraised by a judgement that does not ignore actual experience.").
69.	See Gonzales v. Raich, 545 U.S. 1, 17 (2005) ("Our case law firmly establishes Congress' power to regulate purely local activities that are part of an economic "'class of activities"' that have a substantial effect on interstate commerce."); but see United States v. Lopez, 514 U.S. 549 (1995); United States v. Morrison, 529 U.S. 598 (2000).
70.	See Hipolite Egg, 220 U.S. at 58 ("The question in the case, therefore is, What power has Congress over such articles? ... The power ... is certainly appropriate to the right to bar them from interstate commerce, and completes its purpose, which is not to prevent merely the physical movement of adulterated articles, but the use of them, or rather to prevent trade in them between the States ... And appropriate means to that end, which we have seen is legitimate, are the seizure and condemnation of the articles at their point of destination ... The selection of such means is certainly within that breadth of discretion which we have said Congress possesses in the execution of the powers conferred upon it by the Constitution.").
71. See Wickard v. Filburn, 317 U.S. 111, 128-29 (1942) (holding that, "the power to regulate commerce includes the power to regulate the prices at which commodities in that commerce are dealt in and practices affecting such prices…[thus,] Congress may have properly considered that wheat consumed on the farm where grown if wholly outside the scheme of regulation would have a substantial effect in defeating and obstructing its purpose to stimulate trade therein at increased prices."). 70.	See Hutt, Merrill, and Grossman, supra note 1516, at 1220 (citing Raich, 545 U.S. 1). 71, at 1220 (citing Raich, 545 U.S. 1).
72.	See Hutt, Merrill, and Grossman, supra note 15, at 1220.
73.	Id. at 1221. Pursuant to Section 709 of the Act, the nexus with interstate commerce is presumed to exist and need not be demonstrated as an initial matter by the government. See 21 U.S.C. § 379a.
74.	See, e.g., 21 U.S.C. § 331(a) (prohibiting the introduction or delivery for introduction into interstate commerce of any adulterated or misbranded food, drug, device, tobacco product, or cosmetic); id. § 331(b) (prohibiting the adulteration or misbranding of any covered article in interstate commerce); id. § 331(c) (prohibiting the receipt in interstate commerce of any adulterated or misbranded article that is then delivered or proffered for delivery for pay).
75.	See United States v. 7 Barrels, etc. of Spray Dried Whole Egg, 141 F.2d 767, 770 (7th Cir. 1944); see also United States v. Sanders, 196 F.2d 895, 898 (10th Cir. 1952) ("To be guilty of violating the Act, it was not necessary that appellee be engaged in interstate commerce with respect to a misbranded drug. It was sufficient if he was engaged in delivering such a drug for introduction into interstate commerce.").
7672.	United States v. Sullivan, 332 U.S. 689, 696 (1948).
7773.	See Baker v. United States, 932 F.2d 813 (9th Cir. 1991); United States v. An Article of Food, 752 F.2d 11, 14 (1st Cir. 1985) ("Because it is undisputed that the potassium nitrate added to the seized beverages was shipped in interstate commerce, those beverages [, although mixed and sold only intrastate,] clearly fall within the scope of statutory forfeiture jurisdiction.").
7874.	See RaichGonzales v. Raich, 545 U.S. at 17. 1, 17 (2005).
7975.	United States v. Regenerative Scis., LLC, 741 F.3d 1314, 1320 (D.C. Cir. 2014). It should be noted that just because the FDA likely possesses the legal power to enforce the FDCAFD&C Act's provisions against many purely local activities, such as with respect to a local grocery, restaurant or vending machine, the FDA hasFDA, as a matter of its discretion, has largely "ceded the regulation of such establishments to state and local governments." See Hutt, Merrill, and Grossman, supra note 1516, at 1234.
8076.	See P.L. 111-31, 123 Stat 1776 (2009).
8177.	See 61 Fed. Reg. 44396, 44632-44633 (1996).
8278.	529 U.S. 120, 126 (2000).
8379.	See Family Smoking Prevention and Tobacco Control Act, P.L. 111-31, 123 Stat 1776 (2009).
8480.	See, e.g., United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209, 1243-44 (M.D. FlFla. 2011) (holding that FDA's authorities over "new drugs" did not provide the agency with the authority to regulate the traditional pharmacy compounding of animal drugs); see also Independent Turtle Farmers of La., Inc. v. United States, 703 F. Supp. 2d 604, 618 (W.D. La. 2010) (questioning whether the FDCAFD&C Act provided the FDA with the authority to regulate the sale of animals); United States v. 29 Cartons of ... an Article of Food, 987 F.2d 33, 38 (1st Cir. 1993) (holding that the FDA did not have the authority to regulate dietary supplements under its "food additive" authorities).
8581.	The text of the FDCAFD&C Act does explicitly state that the Act should not be construed to require the FDA to refer "minor violations of the Act" for prosecution or the institution of injunctive relief to the DOJ. See 21 U.S.C. § 336. The Supreme Court has construed this provision to only apply to the FDA's discretion "where a violation has already been established to the satisfaction of the agency." Heckler v. Chaney, 470 U.S. 821, 837 (1985).
8682.	Id. at 823-24.
8783.	Id.
8884.	SeeId. at 831.
8985.	Id. at 835.
9086.	See O'Reilly, supra note 3028, at § 6.1
9187.	470 U.S. at 832.
9288.	Id. at 833.
9389.	Cook v. FDA, 733 F.3d 1, 3 (D.C. Cir. 2013).
9490.	Id. at 10.
9591.	Id. at 12.
96.	Mark Klock, A Modest Proposal to Rename the FDA, 36 Ariz. St. L.J. 1161, 1180 (Winter 2004); see generally United States v. Thriftimart, Inc., 429 F.2d 1006, 1011 (9th Cir. 1970) ([The FDCA] giving the FDA discretion whether to proceed criminally or civilly is constitutional; the FDA is not required to prosecute every violation.").
97.	See O'Reilly, supra note 30, at § 6.1.
98.	See generally Hutt, Merrill, and Grossman, supra note 15, at 1197-1200
99.	See O'Reilly, supra note 30, at § 6.1.
10092.	See O'Reilly, supra note 28, at § 6.1.
93.	See generally Hutt, Merrill, and Grossman, supra note 16, at 1197-1200.
94.	See O'Reilly, supra note 28, at § 6.1.
95.	See Regulatory Procedures Manual, 4-1-1 (2017).
96.	Id. at 4-1, 4-2.
97.	Id. at 4-1-1.
98.	Id.
99.	The Supreme Court in Bennett v. Spear set out a two-part test for what constitutes final agency action. See 520 U.S. 154, 177-78 (1997) ("As a general matter, two conditions must be satisfied for agency action to be 'final': First, the action must mark the 'consummation' of the agency's decisionmaking process—it must not be of a merely tentative or interlocutory nature. And second, the action must be one by which "rights or obligations have been determined,' or from which 'legal consequences will flow.'").
100.	5 U.S.C. § 704.
101.	See Holistic Candlers and Consumers Ass'n v. U.S. Food and Drug Admin., 664 F.3d 940, 944-45 (D.C. Cir. 2012) (holding that, "like other agency advice letters that we have reviewed over the years, FDA warning letters do not represent final agency action subject to judicial review."); see also Cody Laboratories, Inc. v. Sebelius, 446 Fed. Appx. 964, 969 (10th Cir. 2011) (noting that, "[i]t appears that every court to consider the question has held that an FDA warning letter does not constitute 'final agency action.'").
102.	See U.S. Food and Drug Admin., Advisory Action Letters, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm042132.htm (last visited Nov. 16, 2017), see also Arthur Levine, FDA Enforcement Manual, Volume I, § 1071, available at http://prod-admin1.tmg.atex.cniweb.net:8080/preview/www/2.3427/2.5267 (Nov. 16, 2017).
103.	See generally U.S. Food and Drug Admin., Warning Letters and Notice of Violation Letters to Pharmaceutical Companies, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm (last visited Nov. 16, 2017).
104.	Id.
105.	Id.
106.	Cf. Holistic Candlers and Consumers Ass'n v. U.S. Food and Drug Admin., 664 F.3d 940, 944-45 (D.C. Cir. 2012) (holding that, "like other agency advice letters that we have reviewed over the years, FDA warning letters do not represent final agency action subject to judicial review.").
107.	See 21 U.S.C. § 381(a). See also Regulatory Procedures Manual, Ch. 9-8, 9-15 (2017).
108.	See U.S. Food and Drug Admin. Import Alert 66-40, https://www.accessdata.fda.gov/cms_ia/importalert_189.html (last visited Nov. 16, 2017).
109.	See Regulatory Procedures Manual, Ch. 9-8, 9-15 (2017). As discussed above, the 2013 ruling in Cook v. FDA stands for the proposition that upon knowing that an article is in violation of the FD&C Act, FDA must refuse that product admission. See 733 F.3d 1, 10 (D.C. Cir. 2013). It is unclear whether there is a similar obligation on the agency requiring that it place a product on import alert upon notice of an appearance of a violation.
110.	See Regulatory Procedures Manual, Ch. 9-8-2 (2017).
111.	Id.
112.	See 678 F. Supp. 410, 416 (E.D.N.Y. 1988).
113.	Id. at 415. In reaching its conclusion, the court articulated four interrelated factors for determining whether an import alert constitutes a substantive or legislative rule subject to notice and comment rulemaking, as opposed to an interpretative rule or general statement of policy that is not subject to those procedures: (1) the binding effect of the pronouncement; (2) the degree of discretion accorded the agency in applying the pronouncement; (3) the language of the pronouncement itself; and (4) the deference to the agency's characterization of the pronouncement. Id. at 412-16.
114.	Id. at 415. For further discussion of the APA's notice and comment requirements for agency rulemaking, see CRS Report R44356, The Good Cause Exception to Notice and Comment Rulemaking: Judicial Review of Agency Action, by [author name scrubbed].
115.	See 799 F. Supp. 281, 288 (E.D.N.Y. 1992).
116.	501 F. Supp. 1086, 1090-91 (D.D.C. 1980).
117.	Id. at 1093.
118.	See Regulatory Procedures Manual, Ch. 7-2 (2017).
119.	See Regulatory Procedures Manual, Ch. 7-2, 7-7 (2017).
120.	See Regulatory Procedures Manual, Ch. 7-3 (2017).
121.	U.S. Food and Drug Admin., FDA 101: Product Recalls, https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm (last visited Nov. 17, 2017) ("Recalls are almost always voluntary.").
122.	Products voluntarily removed from market will only be considered "recalled" if FDA regards the product as involving a violation of the FD&C Act subject to legal action. In such cases, the firm must provide certain information regarding the recall to FDA. See 21 C.F. R. § 7.46.
123.	See id. See also, Regulatory Procedures Manual, Ch. 7-5-1 (2017).
124.	See 21. C.F.R. § 7.45.
125.	See 21 C.F.R § 17.1 for a complete list of civil monetary penalties that may be imposed administratively by the FDA.
101126.	See 21 U.S.C. § 333(b). 360h(e)(1), see also 21 C.F.R. part 810.
102127.	21See 42 U.S.C. § 333(f)(1)262(d).	128.
103129.	See 21 U.S.C. § 360pp(b)350a(e), see also 21 C.F.R. part 107, subpart E.
104130.	See 21 U.S.C. § 387h(c)(1).
131.	See id. § 350l(a).
132.	For a description of the various sections of law that authorize FDA to order a recall, see Regulatory Procedures Manual, Ch. 7-5-3 (2017).
133.	See supra notes 126-131 and accompanying text.
105.	See 21 U.S.C. §333(f)(2)(A 335a. For a more thorough description of the FD&C Act's debarment provisions, see John R. Fleder, The History, Provisions, and Implementation of the Generic Drug Enforcement Act of 1992, 49 Food & Drug L.J., 89, 92-100 (1994).
106135.	See 21 U.S.C. § 335b.
107355a(a)(2); see, e.g., 76 Fed. Reg. 19100-01 (Apr. 6, 2011) (permanently disbarring clinical investigator for failing to maintain accurate records with an intent to defraud or mislead).
136.	See Fleder, supra note 144, at 95. ("There can be no serious dispute that a debarment would have a major impact on a person regulated by the FDA. The heart and soul of the [statute authorizing debarment] is to alter a person's ability to maintain his or her prior regulatory relationship with the FDA in situations where the person, in the Congress' view, has violated the public trust.").
137.	21 U.S.C. § 333(g).
108.	The FDA is required to adjust these amounts at least once every four years, pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990. See 28 U.S.C. § 2461 note; and 21 C.F.R. § 17.2 for a table entitled "Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amount."
109).
138.	Id.
139.	The six factors the agency considers when assessing the appropriate period for permissive debarment include (1) the nature and the seriousness of the offense; (2) the nature and extent of management participation involved; (3) the nature and extent of voluntary steps to mitigate the impact on the public; (4) whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not recur; (5) whether there is evidence to show that the current production of drugs subject to abbreviated drug applications and all pending abbreviated drug applications are free of fraud or material false statements; and (6) whether there are prior convictions under the FD&C Act or other acts administered by FDA. See id. § 335a(c).
140.	See 21 U.S.C. § 335a(i), 21 C.F.R. part 12.
141.	See 21 U.S.C. § 335a(d).
142.	See id. § 335a(j).
143.	For a complete list of civil money penalties that may be imposed administratively by FDA, see 21 C.F.R § 17.1.
144.	21 U.S.C. § 333(b).
145.	Id. § 333(f)(1).
146.	Id. § 360pp(b).
147.	Id. § 333(f)(9).
148.	Id. §333(f)(2)(A).
149.	Id. § 335b.
150.	See 21 U.S.C. § 335b(b)(2); 21 U.S.C. § 333(f)(5)(B).
110151.	Arthur Levine, FDA Enforcement Manual, Volume I, § 1071, available at http://prod-admin1.tmg.atex.cniweb.net:8080/preview/www/2.3427/2.5267.
111.	21 C.F.R. § 17.1 et seq. However, it should be noted that under the FDCA, some provisions expressly provide that the relevant civil monetary penalty action must be imposed by a federal court, not by the FDA. See, e.g., 21 U.S.C. § 360pp (civil monetary penalties related to the distribution of electronic products).
112.	21 C.F.R. § 17.5.
113.	21 C.F.R. § 17.13.
114.	21 C.F.R. § 17.51.
115.	21 U.S.C. § 334. See generally O'Reilly, supra footnote 30, at § 7:3.
116.	See Erika King and Elizabeth M. Walsh, The Authority of a Court to Order Disgorgement for Violations of the Current Good Manufacturing Practices Requirement of the Federal Food, Drug, and Cosmetic Act, 58 Food Drug L.J. 149, 158 (2003) (citing H.R. REP. NO. 75-2139, at 4 (1938).
117Pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990, FDA is required to adjust these amounts at least once every four years. See 28 U.S.C. § 2461 note. For a table entitled "Civil Monetary Penalties Authorities Administered by HHS Agencies and Penalty Amount," see 45 C.F.R. § 102.3.
152.	See 21 U.S.C. § 335b(b)(2); id. § 333(f)(5)(B).
153.	21 C.F.R. §§ 17.1-17.54. However, under the FD&C Act, some provisions expressly provide that the relevant civil money penalty action must be imposed by a federal court. See, e.g., 21 U.S.C. § 360pp (providing that civil money penalties related to the distribution of electronic products must be enforced in the district courts of the United States).
154.	21 C.F.R. § 17.5.
155.	Id. §§ 17.9- 17.13. Note that if the respondent does not answer the complaint, the opportunity for a hearing is forfeited.
156.	Id. §§ 17.45-17.47.
157.	Id. § 17.51.
158.	21 U.S.C. § 334. See generally O'Reilly, supra note 28, at § 7:3.
159.	See H.R. Rep. No. 75-2139, at 4 (1938).
160.	See O' Reilly, note 30, at § 7:10.
118161.	See generally Food & Drug Admin., FDA See id.	162.
119163.	See, Ewing v. Casselberry, 339 U.S. 594, 601 (1950) (holding that, "[t]he decision of Congress was that the administrative determination to make multiple seizures should be made without a hearing. We cannot say that due process requires one at that stage.") (1950); see also U.S.United States v. One Unlabeled Unit, More or Less, of an Article of Device and Promotional Brochures, 885 F. Supp. 1025, 1028 (ND Ohio 1995) (holding that, "[t]he Supreme Court long ago concluded that the government's interest in protecting the public from potentially dangerous products permitted Congress to establish a procedure for post-seizure hearings in the [FD&C] Act." (ND Ohio 1995).
120164.	See Patrick O'Leary, Credible Deterrence: FDA and the ParkPark Doctrine in the 21st Century, 68 Food Drug L.J. 137, 176156 n.135 (2013).
121165.	21 U.S.C. § 334(a)(1).
122166.	See 21 U.S.Cid. §§ 334(a)(2) and 372(e)(5).
123167.	21 U.S.CId. § 334(a)(3).
124168.	21 U.S.CId. § 334(d); Food & Drug Admin., FDARegulatory Procedures Manual, Ch. 6-1-9 (2015).	169.
125170.	Levine, note 106Levine, supra note 102, at § 1160. The lack of challenges generally stems from the likelihood that the FDA prevails in these actions, as well as the expense of litigation. Id.
126171.	21 U.S.C. § 332.
127172.	Food & Drug Admin., FDA Regulatory Procedures Manual, § 6-2, available at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176733.htm (September 2011Ch. 6-2 (2015).
128173.	It has been noted that the three most common violations that result in FDA injunction cases are (1) deviations from the good manufacturing practice regulations for the various FDA-regulated products; (2) marketing a product without the required FDA approval; and (3) deviations from FDA requirements concerning labeling and promotion. Levine, note 106Levine, supra note 102, at § 1202.
129174.	Food & Drug Admin., FDA Regulatory Procedures Manual, § 6-2-4, available at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176733.htm (September 2011Ch.6-2-4 (2015).
130175.	Id. The FDA has also stated that in some instances, a history of prior violations, and that previous attempts to correct these acts, may be considered. Id.
131176.	Levine, note 106Levine, supra note 102, at § 1200.
132177.	See, e.g., United States v. EndotecN.Y. Fish, Inc., No. 6:06-cv-1281, 2009 U.S. Dist. LEXIS 93985 (M.D. Fla. Sept. 28, 2009., 10 F. Supp. 3d 355, 379 (E.D.N.Y. 2014); United States v. Organic Pastures Dairy Co., 708 F. Supp. 2d 1005, 1011 (E.D. Cal. 2010); United States v. Endotec, Inc., No. 6:06-cv-1281, 2009 U.S. Dist. LEXIS 93985, at *21-22 (M.D. Fla. Sept. 28, 2009).
133178.	Levine, note 106Levine, supra note 102, at § 1250.
134179.	See 21 U.S.C. § 333.
135180.	See O'Reilly, supra note 3028, at § 8.2.
136181.	Id. at § 8.1.
137182.	See Food & Drug Admin., FDA Regulatory Procedures Manual, Ch. 6-5-13 (20156-5-13, http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176738.htm (January 2011).
138183.	See O'Reilly, supra note 3028, at § 8.1.
139.	Id.
140184.	See Food & Drug Admin., Inspections, Compliance, Enforcement, and Criminal Investigations: Mission, http://www.fda.gov/ICECI/CriminalInvestigaions/ucm123027.htm (September 10, 2013).
141.	See Steven M. Kowal, Execution of a Criminal Search Warrant by FDA—Effective Preparation and Response, 52 Food Drug L.J. 117, 120 (1997).
142.	See Food & Drug Admin., Inspections, Compliance, Enforcement, and Criminal Investigations: What OCI Investigates, httpInvestigations: about oci, (Nov. 17, 2017), https://www.fda.gov/ICECI/CriminalInvestigations/ucm123062.htm (August 3, 2009).
143.	See O'Reilly, supra note 30, at § 8.3.
144ucm550316.htm 185.	21 U.S.C. § 335.
145186.	United States v. Dotterweich, 320 U.S. 277, 279 (1943) ("We agree with the Circuit Court of Appeals that the giving of such an opportunity, which was not accorded to Dotterweich, is not a prerequisite to prosecution.").
146187.	See 21 C.F.R. § 7.84(a) (providing that a Section 305 administrative hearing is not needed if (1) if the Commissioner has reason to believe that notice and an opportunity may result in the alteration or destruction of evidence or in the prospective defendant's fleeing to avoid prosecution; or (2) if the Commissioner is considering recommending further investigation by the Department of Justice.). DOJ).	188.
147189.	See John W. Lundquist and Sandra L. Conroy, Defending Against Food & Drug Prosecutions, 21 Champion 20, 21 (July 1997).
148190.	Id. (internal citations omitted).
149191.	See, e.g., 21 U.S.C. § 331(a)-(c).
150192.	Section 301 of the FDCAFD&C Act, which contains the Act's prohibited acts, generally centers its prohibitions on the concepts of adulteration and misbranding. See suprainfra "Overview of the Food, Drug, and Cosmetics Act." Nonetheless, the Act does contain several provisions where adulteration or misbranding may be irrelevant with respect to a particular prohibited actcontains other prohibited acts that do not rely upon adulteration or misbranding charges. Most notably, under Section 301(d), the introduction of a drug into interstate commerce in violation of the Act's "new drug" provisions, which require the FDA to approve a new drug application before a drug can enter interstate commerce, violates the FDCAFD&C Act. See 21 U.S.C. § 331(d).
151193.	Id. See Hutt, Merrill, and Grossman, supra note 16, at 1310.
152194.	Id.
153195.	See Hutt, Merrill, and Grossman, supra note 15, at 1310Id.
154196.	Id.
155197.	320 U.S. 277, 281 (1943).
156198.	Id. at 284.
157199.	Id. at 281.	421 U.S. 658, 673-74 (1975).
158672-74 (1975). In 2016 the Supreme Court denied a petition to review whether the Park doctrine should be overruled after the U.S. Court of Appeals for the Eighth Circuit upheld a three-month prison term for two "responsible corporate officers" that plead guilty to misdemeanor violations of the FD&C Act. See United States v. DeCoster, 828 F.3d 626, 629 (8th Cir. 2016), cert. denied, 137 S. Ct. 2160, 198 L. Ed. 2d 232 (2017). 201.	Id. at 672.
159202.	See O'Reilly, supra note 3028, at § 8.2 .
160203.	United States v. Gel Spice Co., 773 F.2d 427, 434-35 (2d Cir. 1985) (quoting United States v. New England Grocers Co., 488 F. Supp. 230, 234 (D. Mass. 1980)).
161204.	Id. Some commentators have raised concerns about how successful the impossibility defense is in FDCAFD&C Act criminal cases. See, e.g., Andrew C. Baird, The New Park Doctrine: Missing the Mark, 91 N.C.L. Rev. 949, 978 n.179 (2013) ("A search of every case that cites Park wherein the objective impossibility defense was raised and addressed reveals that no court, state or federal, has ever sided with a defendant raising this argument.").
162205.	See 21 U.S.C. § 333(c)(1).
163206.	Id. § 333(c)(2). Giving a false guaranty that a product is not adulterated or misbranded is prohibited under Section 301(h) of the FDCAFD&C Act. See 21 U.S.C. § 331(h).
164207.	See Richard R. Abood, Physician Dispensing: Issues of Law, Legislation and Social Policy, 14 Am. J. L. & Med. 307, 341 n.186 (1989).
165208.	See 21 U.S.C. § 333(a)(1).
166209.	See generally United States v. Graham, 169 F.3d 787, 792 (3d Cir. 1999).
167210.	21 U.S.C. § 333(a)(2).
168211.	See United States v. Ellis, 326 F.3d 550, 554 (4th Cir. 2003).
169212.	See United States v. Bradshaw, 840 F.2d 871, 874-75 (11th Cir. 1988); see also United States v. Cambra, 933 F.2d 752, 755 (9th Cir. 1991); United States v. Arlen, 947 F.2d 139, 143 (5th Cir. 1991).
170213.	See 21 U.S.C. § 333(a). The FDCAFD&C Act does contain some exceptions to the default criminal penalties provided for in Section 303(a). For example, a person who "knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition" may be punished by a maximum term of imprisonment of five years. See id21 U.S.C. § 333(e)(1).
171214.	21 U.S.CId. § 333(a)(1).
172215.	Id. § 333(a)(2).
173216.	See Sentencing Reform Act of 1984, P.L. 98-473, 98 Stat. 1837; Criminal Fine Improvements Act of 1987, P.L. 100-185, 101 Stat. 1279.
174217.	18 U.S.C. § 3571(b)(5).
175218.	Id. § 3571(b)(3)-(4).
176219.	Id. § 3571(c)(5) .
177220.	Id. § 3571(c)(3)-(4). Other criminal laws may be invoked in the enforcement of the FDCAFD&C Act, including federal criminal conspiracy laws, federal mail and wire fraud laws, or federal laws punishing false statements or perjury. See Hutt, Merrill, and Grossman, supra note 1516, at 1328-29 (collecting various cases).
178221.	See U.S.S.G. Manual § 2N2.1.
179222.	See U.S.S.G. Manualid. Chapter 5, Part A.
180223.	See U.S.S.G. Manual id. § 2N2.1.
181224.	See U.S.S.G. Manual id. § 2N2.1, cmt. 3.