FDA Regulation of Cosmetics and Personal Care Products Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

October 30, 2023 R47826

FDA Regulation of Cosmetics and
October 30, 2023
Personal Care Products Under the
Nora Wells
Modernization of Cosmetics Regulation Act of
Analyst in Health Policy

2022 (MoCRA)
For a copy of the full report,
please call 7-5700 or visit
The Food and Drug Administration (FDA) has the authority to regulate cosmetic products and
www.crs.gov.
their ingredients. This authority was granted by the 1938 Federal Food, Drug, and Cosmetic Act
(FFDCA), which included provisions regarding the adulteration and misbranding of cosmetics. Cosmetic products are also
regulated under the Fair Packaging and Labeling Act (FPLA) and related legislation. Although the Color Additive
Amendments Act of 1960 and the Poison Prevention Packaging Act of 1970 amended some of FFDCA’s provisions,
cosmetics regulation remained largely unchanged from the original FFDCA until 2022, when the Modernization of
Cosmetics Regulation Act (MoCRA) was enacted. Most of MoCRA’s provisions will take effect at the close of 2023.
Prior to the passage of MoCRA, FDA had limited authority regarding cosmetic product registration; testing; premarket
notification, clearance, or approval; good manufacturing practices; mandatory risk labeling; adverse event reports; and
recalls. FDA could not impose registration requirements on cosmetic manufacturers. Rather, manufacturers could voluntarily
comply with FDA registration regulations. Additionally, with the exception of color additives, FDA did not require
premarket notification, safety testing, review, or approval of the chemicals used in cosmetic products. Although FDA had
released draft good manufacturing practices (GMP) guidelines for cosmetic manufacturers, they were not required to adhere
to them, nor were manufacturers required to file ingredient information with, or report adverse reactions to, the agency.
Instead, under a voluntary FDA program, cosmetic manufacturers and packagers could choose to report the ingredients used
in their product formulations. FDA also did not have the authority to require a manufacturer to recall a cosmetic product from
the marketplace, although the agency did issue general regulations on voluntary recalls.
With the passage of MoCRA, FDA’s regulatory authority over cosmetics has been expanded. Under MoCRA, FDA will now
require facility registration and listing of cosmetics products with the agency, as well as certain product labeling information.
FDA will also promulgate final GMP regulations, require the reporting of serious adverse events, and gain the ability to issue
mandatory product recalls. Moreover, manufacturers must substantiate cosmetic product safety and maintain related records.
The passage of MoCRA, however, will not require cosmetics to be subject to premarket review.
FDA’s authority over cosmetics, both pre- and post-MoCRA, overlaps in some ways with other FDA-regulated products,
such as food, drugs, medical devices, and tobacco. For example, prior to MoCRA, FDA had the authority to take certain
enforcement actions—such as seizures, injunctions, and criminal penalties—against adulterated or misbranded cosmetics, as
it does with foods, drugs, devices, and tobacco products. In addition, FDA could inspect cosmetic manufacturing facilities, as
it may with drug and food companies, and prohibit the importation of cosmetics that violate the FFDCA. Moreover, the
agency has issued rules restricting the use of ingredients that it determines are poisonous or deleterious.
Despite these similarities in applicability FDA’s authority over cosmetics in certain respects remains less comprehensive than
its authority over other FDA-regulated products.
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Introduction
The U.S. cosmetic, beauty supply, and perfume retail industry consists of over 184,000
establishments, with a projected combined annual revenue of about $45.2 billion by the close of
2023.1 Worldwide, the cosmetics and personal care products industry collects more than $529.3
billion in annual retail sales.2 The cosmetic market includes numerous personal care products
other than the facial makeup that the term “cosmetics” typically implies.3 Domestic industry sales
are concentrated in the following areas (percentage of sales by product category): (1) cosmetics,
37.9%; (2) haircare products, 27.1%; (3) skincare products, 20.9%; and (4) nail products,
deodorants, and other products, 14.1%.4
The Food and Drug Administration (FDA) has the authority, generally under the Federal Food,
Drug, and Cosmetic Act (FFDCA), to regulate cosmetic products and their ingredients. In this
context, the agency’s primary regulatory responsibilities include ensuring that cosmetics are not
adulterated or misbranded.5 FDA’s authority over cosmetic products has been greatly expanded
via the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This report (1) describes the definitional differences between cosmetics, drugs, and cosmetic/drug
combinations; (2) outlines the statutory provisions and rules under which FDA regulates
cosmetics, including those newly introduced under MoCRA; and (3) identifies outstanding
considerations about FDA’s authority over cosmetics. The report focuses on FDA regulation of
cosmetics under MoCRA; it does not discuss Federal Trade Commission (FTC) regulation of
cosmetics advertising or the regulation of potentially dangerous chemicals, pesticides, or other
products by other agencies.6

1 Alexia M. Zambrano, Beauty, Cosmetics & Fragrance Stores in the US: Industry Performance, IBISWorld, April
2023, https://my.ibisworld.com/us/en/industry/44612/industry-performance.
2 Personal Care Products Council, “About PCPC,” https://www.personalcarecouncil.org/about-us/. Note: this value was
calculated using data from 2021. Personal Care Products Council, Year in Review 2022, p. 7,
https://www.personalcarecouncil.org/wp-content/uploads/2023/03/PCPC_YIR2022_DIGITAL-SINGLE.pdf.
3 The Food and Drug Administration (FDA) estimates that most Americans use 6 to 12 cosmetic products every day.
FDA, “Modernization of Cosmetics Regulation Act of 2022,” https://www.fda.gov/cosmetics/cosmetics-laws-
regulations/modernization-cosmetics-regulation-act-2022. Additionally, the gender distribution of traditional makeup
product usage has shifted in recent years. Surveys have documented that anywhere between 20% and 50% of American
men have reported using traditional makeup products, including concealer, foundation, bronzer, lip products, and eye
makeup, among others. See, for example, Forbes, “Why Cosmetic Companies Targeting Male Consumers are
Marketing on the Down-Low,” https://www.forbes.com/sites/jackiehuba/2020/10/22/why-cosmetic-companies-
targeting-male-consumers-are-marketing-on-the-down-low/?sh=6d3f95839b46; NPR, “My Journey Into the World of
Men’s Beauty,” https://www.npr.org/2019/11/12/776744697/my-journey-into-the-world-of-mens-beauty; Prim&Prep,
“The Changing Views of Men Using Makeup (2019 Survey Results),” https://www.primandprep.com/the-changing-
views-of-men-using-makeup/.
4 Alexia M. Zambrano, IBISWorld, “Beauty, Cosmetics & Fragrance Stores in the US: Products & Markets,”
https://my.ibisworld.com/us/en/industry/44612/products-and-markets.
5 Federal Food, Drug, and Cosmetic Act (FFDCA) §§601, 602 (21 U.S.C. §§361, 362). See the “Adulterated and
Misbranded Cosmetics” section of this report.
6 P.L. 117-328, Division FF, Title III, Subtitle E—Cosmetics. Under Section 12 of the Federal Trade Commission Act,
“[i]t shall be unlawful for any person ... to disseminate, or cause to be disseminated, any false advertisement—(1) By
United States mails, or in or having an effect upon commerce, by any means, for the purpose of inducing, or which is
likely to induce, directly or indirectly the purchase of ... cosmetics; or (2) By any means, for the purpose of inducing, or
which is likely to induce, directly or indirectly, the purchase in or having an effect upon commerce, of ... cosmetics”
(15 U.S.C. §52). In addition, cosmetics are explicitly excluded from the definition of “consumer product” in Section
3(a)(5)(H) of the Consumer Product Safety Act, which is enforced by the Consumer Product Safety Commission (15
U.S.C. §2052(a)(5)(H)).
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History of FDA’s Cosmetics Regulation Authority
Scope and Definitions: Cosmetics, Drugs, and
Cosmetic/Drug Combinations
This section discusses how the FFDCA defines cosmetics and drugs. The distinction between
them, which determines how products are classified, is a concern for manufacturers because
cosmetics are not subject to the same approval, regulatory, or registration requirements as drugs,
unless the cosmetic also meets the definition a drug.7 Having a product classified as cosmetic
only—not as a drug or cosmetic/drug combination—saves manufacturers time and expense and
enables them to market their products with less regulatory oversight.
Cosmetics
FFDCA defines a “cosmetic” as an article intended to be “applied to the human body … for
cleansing, beautifying, promoting attractiveness, or altering the appearance.”8 The term covers a
broad range of FDA-regulated products that may be used externally and internally.9 Cosmetics
include products for the eyes, face, nails, hair, skin, and mouth, such as makeup, nail polish, hair
dyes and coloring, suntan preparations, fragrances, oral care, and bath products.10 Although soap
was explicitly exempted from the definition of a cosmetic, it may be regulated by the FDA as a
cosmetic product in certain instances.11 In addition, coal-tar hair dye was provided a limited
exemption from the FFDCA’s adulteration provisions.12 Inks used for tattooing are also classified
as cosmetics under the FFDCA.13 Under MoCRA, FFDCA will separately define a “cosmetic
product” as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set
composition for use in a finished product.”14

7 FFDCA §509 (21 U.S.C. §359). Under MoCRA, cosmetic/drug combinations are treated as drugs for listing and
selected other provisions. See FFDCA §613(a) (21 U.S.C. §364i(a)).
8 FFDCA §201(i) (21 U.S.C. §321(i)).
9 Examples of cosmetics “that may be introduced into the body are limited, but include mouthwashes, breath
fresheners, and vaginal douches.” John E. Bailey, “Organization and Priorities of FDA’s Office of Cosmetics and
Colors,” in Cosmetic Regulation in a Competitive Environment, Norman F. Estrin & James M. Akerson, eds., p. 217,
2000.
10 21 C.F.R. §720.4(c).
11 FDA regulations define “soap” as applying only to articles for which “(1) [t]he bulk of the nonvolatile matter in the
product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid
compounds; and (2) [t]he product is labeled, sold, and represented only as soap” (21 C.F.R. §701.20(a)). A product
intended not only for cleansing, but also for other cosmetic uses, such as beautifying, moisturizing, or deodorizing,
would be regulated by FDA as a cosmetic. A soap-like product may also be a drug if it is intended to cure, treat, or
prevent disease, or to affect the structure or any function of the human body. For example, a soap-like product that is
not only intended for cleansing, but also for moisturizing or deodorizing and that contains a medication preventing
fungal growth, may be regulated as both a cosmetic and a drug product. The intended use of a product is determined by
several factors, including claims stated on the product label, in advertising, or other promotional materials; consumer
perception and the product’s reputation; and ingredients that may cause the product to be considered a drug by industry
standards or public perception. See FDA, “Is It a Cosmetic, a Drug, or Both (Or Is It Soap?),” https://www.fda.gov/
cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap.
12 FFDCA §601(a) (21 U.S.C. §361(a)). Coal-tar hair dyes include permanent, semipermanent, and temporary hair
dyes. FDA, “Hair Dyes,” https://www.fda.gov/cosmetics/cosmetic-products/hair-dyes.
13 FDA, “Tattoos, Temporary Tattoos & Permanent Makeup,” https://www.fda.gov/cosmetics/cosmetic-products/
tattoos-temporary-tattoos-permanent-makeup.
14 FFDCA §604(2) (21 U.S.C. §364(2)).
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Drugs
The FFDCA defines a “drug” in part as “articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease”; articles “(other than food) intended to affect the
structure or any function of the body”; and “articles intended for use as a component” of such
drugs.15
Drug manufacturers must comply with Current Good Manufacturing Practices (CGMP) rules for
drugs.16 Failure to comply will cause a drug to be considered adulterated.17 Drug manufacturers
are required to register their facilities,18 list their drug products with the agency,19 and report
adverse events to FDA, among other requirements.20
Unlike cosmetics and their ingredients (with the exception of color additives), drugs are subject to
FDA approval before entering interstate commerce. Drugs must either (1) receive the agency’s
premarket approval under a new drug application (NDA), or an abbreviated NDA (ANDA),21 in
the case of a generic drug, or (2) conform to a set of FDA requirements known as a monograph.22
Monographs govern the manufacture and marketing of most over-the-counter (OTC) drugs and
specify the conditions under which OTC drugs in a particular category (such as antidandruff
shampoos or antiperspirants) will be considered generally recognized as safe and effective
(GRASE).23 Monographs also indicate how OTC drugs must be labeled so they are not deemed
misbranded.24

15 FFDCA §201(g)(1) (21 U.S.C. §321(g)(1)).
16 Current Good Manufacturing Practices set the “minimum requirements for the methods, facilities, and controls used
in manufacturing, processing, and packing of a drug product.” For general information, see FDA, “Current Good
Manufacturing Practice (CGMP) Regulations,” https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-
good-manufacturing-practice-cgmp-regulations.
17 FFDCA §501(a)(2)(B) (21 U.S.C. §351(a)(2)(B)).
18 FFDCA §510 (21 U.S.C. §360), 21 C.F.R. Part 207.
19 Ibid.
20 21 C.F.R. §310.305; 21 C.F.R. §314.80; 21 C.F.R. §314.98.
21 FFDCA §505 (21 U.S.C. §355). A new drug application (NDA) is the process through which drug sponsors propose
that FDA approve a new pharmaceutical for sale and marketing in the United States. The agency approves an NDA
after examining reports and investigations that demonstrate the drug’s safety and effectiveness, among other
considerations.
22 An OTC drug monograph is similar to a recipe in that it covers active ingredients, dosages, formulations, and
labeling claims. If an OTC drug product complies with the relevant monograph, it does not need FDA approval prior to
marketing. FDA assesses monograph compliance as part of its inspection process. Historically, monographs have been
established and amended through rulemaking. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act;
P.L. 116-136), enacted on March 27, 2020, replaced the rulemaking process with the administrative order process—a
less burdensome alternative. For additional information, see CRS Report R46985, FDA Regulation of Over-the-
Counter (OTC) Drugs: Overview and Issues for Congress.
23 21 C.F.R. §§330-358.
24 Labels must include a Drug Facts panel, which lists the product’s active ingredients, purposes, uses, applicable
warnings, directions, other information, and inactive ingredients, and may contain a telephone number for questions
about the product. See 21 C.F.R. §201.66(c).
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Cosmetics Containing Drug Ingredients
Although the term “cosmeceutical” has been used to refer to combination cosmetic/drug products,
such products have no statutory or regulatory definition.25 Historically, FDA has indicated that
cosmetic/drug combinations are subject to FDA’s regulations for both cosmetics and drugs.26
Determining whether a cosmetic is also a drug, and therefore subject to the additional statutory
requirements that apply to drugs, depends on the distributor’s claims regarding the drug’s intent
or intended use.27 A product’s intended use may be established in several ways, such as claims on
the label or in advertising or promotional materials, customer perception of the product, and the
inclusion of ingredients that cause the product to be considered a drug because of a known
therapeutic use.28 For example, if a lipstick (a cosmetic) contains sunscreen (a drug), historically,
the mere inclusion of the term “sunscreen” in the product’s labeling required the product to be
regulated as a drug as well as a cosmetic.29 The text box below provides examples of other
cosmetic/drug combinations and compares cosmetic and drug classifications.30
Comparison of Cosmetic and Drug Product Classifications
A suntan product is a cosmetic, but a sunscreen product is a drug.
A deodorant is a cosmetic, but an antiperspirant is a drug.
A shampoo is a cosmetic, but an antidandruff shampoo is a drug.
A toothpaste is a cosmetic, but an anticaries toothpaste is a drug.
A skin exfoliant is a cosmetic, but a skin peel is a drug.
A mouthwash is a cosmetic, but an antigingivitis mouthwash is a drug.
A hair bulking product is a cosmetic, but a hair growth product is a drug.
A skin product to hide acne is a cosmetic, but an antiacne product is a drug.
An antibacterial deodorant soap is a cosmetic, but an antibacterial anti-infective soap is a drug.
A skin moisturizer is a cosmetic, but a wrinkle remover is a drug.
A lip softener is a cosmetic, but a product for chapped lips is a drug.
Source: Peter B. Hutt, “Legal Distinction in the United States between a Cosmetic and a Drug,” in
Cosmeceuticals and Active Cosmetics, ed. Raja K. Sivamani et al., 3rd ed. (Boca Raton, FL: Taylor & Francis Group,
2016), p. 432.

25 FDA, “Cosmeceutical,” https://www.fda.gov/cosmetics/cosmetics-labeling-claims/cosmeceutical.
26 FDA, “Is it a Cosmetic, a Drug, or Both (Or Is it Soap?),” https://www.fda.gov/cosmetics/cosmetics-laws-
regulations/it-cosmetic-drug-or-both-or-it-soap. Note, however, that this will no longer always be the case post-
MoCRA. See FFDCA §613(a) (21 U.S.C. §364i(a)); FDA, Registration and Listing of Cosmetic Product Facilities and
Products: Guidance for Industry (Draft Guidance), August 2023, p. 11, https://www.fda.gov/media/170732/download.
27 FFDCA §201(g) (21 U.S.C. §321(g)).
28 FDA, “Is It a Cosmetic, a Drug, or Both (Or Is It Soap?),” https://www.fda.gov/cosmetics/cosmetics-laws-
regulations/it-cosmetic-drug-or-both-or-it-soap.
29 21 C.F.R. §700.35(a). “A product that includes the term ‘sunscreen’ in its labeling ... comes within the definition of a
drug.... [T]he use of the term ‘sunscreen’ or similar sun protection terminology in a product’s labeling generally causes
the product to be subject to regulation as a drug.”
30 In addition, some of the products commonly referred to as “personal care products” may be considered either
cosmetics, drugs, or other regulatory categories, depending on the intended use of the product. For more information,
see FDA, “Are All ‘Personal Care Products’ Regulated as Cosmetics?,” https://www.fda.gov/industry/fda-basics-
industry/are-all-personal-care-products-regulated-cosmetics. FDA has distinguished between cosmetics and medical
devices in the past as well. FDA, “Warning Letters Highlight Differences Between Cosmetics and Medical Devices,”
https://www.fda.gov/cosmetics/warning-letters-related-cosmetics/warning-letters-highlight-differences-between-
cosmetics-and-medical-devices.
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History
Prior to the enactment of the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1938, cosmetics
were not regulated by the federal government.31 Instead, they were regulated under a collection of
state laws that had been enacted to regulate food and drugs.32 At that time, multiple “cosmetics
and drugs were made from the same natural materials” and often the “laws did not include
explicit definitions of the products regulated.”33 Following several incidents in which cosmetics
were allegedly the cause of serious health problems, as well as industry concerns about states
enacting their own laws, provisions were included in the FFDCA that prohibited the sale of
adulterated or misbranded cosmetics in interstate commerce.34 The FFDCA also established
uniform regulation of FDA-regulated cosmetic products nationwide.35 However, state laws
regarding cosmetics regulation have continued to evolve since FFDCA’s passage, with some
states implementing stricter measures than others.36
In addition to their regulation under the FFDCA, cosmetics are regulated under the Fair
Packaging and Labeling Act (FPLA) and related regulations.37 The FPLA applies to the
packaging and labeling of “consumer commodities,” which include cosmetics “customarily
produced or distributed for sale through retail sales agencies or instrumentalities for consumption
by individuals, or use by individuals for purposes of personal care ... and which [are] usually
consumed or expended in the course of such consumption or use.”38 The FPLA does not apply to
“wholesale or retail distributors of consumer commodities, except to the extent that such persons
• are engaged in the packaging or labeling of such commodities, or
• prescribe or specify ... the manner in which such commodities are packaged or
labeled.”39
The FFDCA prohibits the adulteration and misbranding of cosmetics in interstate commerce and
the introduction, receipt, and delivery of adulterated or misbranded cosmetics into interstate
commerce.40 From 1938 until 2022, with the exception of provisions governing color additives,
the FFDCA statutory provisions addressing cosmetics remained basically unchanged, though the

31 Senate Committee on Commerce, S.Rept. 91, 75th Cong., p. 5, 1937.
32 Peter B. Hutt, “A History of Government Regulation of Adulteration and Misbranding of Cosmetics,” in Cosmetic
Regulation in a Competitive Environment, ed. Norman F. Estrin & James M. Akerson (New York, NY: Marcel Dekker,
Inc., 2000), p. 2, (hereinafter, Hutt, “A History of Government Regulation of Adulteration and Misbranding of
Cosmetics”).
33 Hutt, “A History of Government Regulation of Adulteration and Misbranding of Cosmetics,” p. 2.
34 Hutt, “A History of Government Regulation of Adulteration and Misbranding of Cosmetics,” p. 6; Jacqueline A.
Greff, “Regulation of Cosmetics That are Also Drugs,” Food and Drug Law Journal, vol. 51, no. 2 (1996), pp. 243-
244.
35 Hutt, “A History of Government Regulation of Adulteration and Misbranding of Cosmetics,” pp. 2-3, 6.
36 See, for example, Lisa Benson and Karen Reczek, A Guide to United States Cosmetic Products Compliance
Requirements, National Institute of Standards and Technology, NISTIR 8178, May 31, 2017, pp. 22-28,
https://nvlpubs.nist.gov/nistpubs/ir/2017/nist.ir.8178.pdf.
37 P.L. 89-755 (15 U.S.C. §1451 et seq.).
38 FPLA §10(a) (15 U.S.C. §1459(a)). FPLA specifically regulates “any person engaged in the packaging or labeling of
any consumer commodity … for distribution in commerce, or … any person [(with some exceptions)] … engaged in
the distribution in commerce of any packaged or labeled consumer commodity.” §3(a) (15 U.S.C. §1452(a)).
39 FPLA §3(b) (15 U.S.C. §1452(b)).
40 FFDCA §§301(a)-(c) (21 U.S.C. §§331(a)-(c)). See the “Adulterated and Misbranded Cosmetics” section of this
report.
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cosmetic industry has continuously grown over the past 80 years. Consequently, the concerns of
consumer and industry groups have often remained similar since the enactment of the FFDCA.
Prior to MoCRA, due to statutory authority limitations, certain FDA cosmetics regulations and
procedures relied on voluntary manufacturer compliance, even though similar regulations and
procedures were mandatory for other FDA-regulated products (such as drugs). For example, FDA
had promulgated regulations for the voluntary registration of establishments that manufactured or
packaged cosmetics.41 In contrast, mandatory registration requirements existed for other FDA
product-category manufacturers (e.g., drugs, food).42 Moreover, unlike drug manufacturers,
cosmetic manufacturers were not required to submit safety data on ingredients or to report
cosmetic-related injuries to FDA.43 Instead, under a voluntary FDA program, cosmetic
manufacturers and packagers could choose to report the ingredients used in their product
formulations.44 Furthermore, consumers, health care professionals, and cosmetic manufacturers
could voluntarily report adverse reactions to cosmetics to FDA.45 Finally, FDA did not have
mandatory recall authority to require a cosmetic manufacturer to recall a product from the
marketplace. However, the agency could request a voluntary recall, and FDA has issued general
regulations outlining its expectations for manufacturers during such recalls.46 Although FDA did
not have the authority to require compliance with these regulations, it could take action against
adulterated or misbranded cosmetics.47
FDA’s authority over cosmetics prior to MoCRA was less comprehensive than its authority over
other FDA-regulated products with regard to good manufacturing practices (GMP), premarket
clearance or approval, testing, and mandatory risk labeling.48 FDA released GMP guidelines for
cosmetic manufacturers49 and stated that “[f]ailure to adhere to GMP may result in an adulterated
or misbranded product.”50 FDA did not review or approve ingredients used in cosmetic products
other than color additives, although cosmetic manufacturers were responsible for substantiating
the safety of their products and ingredients before marketing.51 Drug products, on the other hand,

41 21 C.F.R. Part 710; FDA, “Voluntary Cosmetic Registration Program,” https://www.fda.gov/cosmetics/voluntary-
cosmetic-registration-program.
42 FFDCA §415 (21 U.S.C. §350d) (food); FFDCA §510 (21 U.S.C. §360) (drugs and devices); FFDCA §905 (21
U.S.C. §387e) (tobacco).
43 Donald R. Johnson, “Not in My Makeup: The Need for Enhanced Premarket Regulatory Authority Over Cosmetics
in Light of Increased Usage of Engineered Nanoparticles,” Journal of Contemporary Health Law and Policy, vol. 26,
no. 1 (2009), pp. 82, 114.
44 21 C.F.R. §720.4.
45 FDA, “Using Adverse Event Reports to Monitor Cosmetic Safety,” https://www.fda.gov/cosmetics/how-report-
cosmetic-related-complaint/using-adverse-event-reports-monitor-cosmetic-safety.
46 21 C.F.R. Part 7, Subpart C. Note: these regulations apply to all products subject to FDA’s jurisdiction.
47 FFDCA §§301-304 (21 U.S.C. §§331-334).
48 FDA’s authority over cosmetic products is based primarily on FFDCA provisions on cosmetics, color additives, and
drugs. The agency also has authority under FPLA for labeling requirements. Other agencies may use their own
authorities to regulate certain aspects of cosmetic products (e.g., the Federal Trade Commission regulates the
advertising of cosmetics).
49 FDA, “Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist,” https://www.fda.gov/cosmetics/
cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics.
50 FDA, “Inspection of Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-compliance-enforcement/inspection-
cosmetics.
51 FFDCA §721 (21 U.S.C. §379e); FFDCA §509 (21 U.S.C. §359). Premarket approval for color additives was
established in 1960 with the Color Additive Amendments of 1960 (P.L. 86-618). A color additive is basically defined
as a substance that, when added or applied to a cosmetic or the body, is capable of imparting coloring. Examples of
cosmetics with color additives include lipstick, blush, and eye makeup. FFDCA §201(t) (21 U.S.C. §321(t)). Regarding
(continued...)
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generally are reviewed by FDA prior to marketing to ensure they meet FFDCA requirements for
safety and effectiveness.52
After decades of minimal regulatory development for cosmetic products, on December 29, 2022,
Congress enacted the Consolidated Appropriations Act, 2023 (CAA, 2023).53 The CAA, 2023,
included MoCRA,54 which has established several new FDA authorities and responsibilities
related to cosmetics regulation. Although MoCRA addresses many stakeholder concerns, some
remain outstanding.
The Modernization of Cosmetics Regulation Act of
2022 (MoCRA)
Table 1. New FFDCA Sections Added by MoCRA Section 3502
FFDCA Section 604
Definitions
FFDCA Section 605
Adverse Events
FFDCA Section 606
Good Manufacturing Practice
FFDCA Section 607
Registration and Product Listing
FFDCA Section 608
Safety Substantiation
FFDCA Section 609
Labeling
FFDCA Section 610
Records
FFDCA Section 611
Mandatory Recall Authority
FFDCA Section 612
Small Businesses
FFDCA Section 613
Exemption for Certain Products and Facilities
FFDCA Section 614
Preemption
Source: P.L. 117-328, Division FF, Title III, Subtitle E—Cosmetics, §3502.
According to FDA, MoCRA is “the most significant expansion of the FDA’s authority to regulate
cosmetics since the [FFDCA] was passed in 1938.”55 The bulk of amendments made to the
FFDCA are outlined in Section 3502 of MoCRA.56 Broadly, MoCRA grants FDA a host of new
authorities to protect consumer safety. These authorities include the ability, under some
circumstances, for FDA to access specific types of cosmetic product records and issue mandatory
cosmetic product recalls.57 In addition, MoCRA establishes new industry requirements, including
reporting adverse events to FDA, registering manufacturing and processing facilities with FDA,
listing marketed products and their ingredients with FDA, and maintaining records of safety

safety substantiation expectations, see 21 C.F.R. §740.10 and FDA, “Food, Drug, and Cosmetic Products Warning
Statements,” 40 Federal Register 8912, 8916, March 3, 1975.
52 FFDCA §505 (21 U.S.C. §355).
53 P.L. 117-328.
54 P.L. 117-328, Division FF, Title III, Subtitle E—Cosmetics.
55 FDA, “Modernization of Cosmetics Regulation Act of 2022,” https://www.fda.gov/cosmetics/cosmetics-laws-
regulations/modernization-cosmetics-regulation-act-2022.
56 MoCRA §3502.
57 Ibid.
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substantiation for cosmetic products.58 Furthermore, MoCRA requires that industry follow
forthcoming FDA regulations regarding good manufacturing practices (GMP) for cosmetic
manufacturing facilities, fragrance allergen labeling, and standardized testing methods for
detecting and identifying asbestos in talc-containing cosmetics.59 For some small businesses,
certain exemptions to specific requirements introduced under MoCRA may also apply.60 These
new requirements for cosmetics pursuant to MoCRA, as well as select enforcement mechanisms
related to those requirements, are described below.
Cosmetic Regulatory Controls
Premarket Requirements
Unlike its authority over drugs and some devices, FDA does not have the authority, either pre- or
post-MoCRA, to require premarket approval of cosmetics or their ingredients, except for color
additives.61 Prior to MoCRA, it was FDA’s position that manufacturers were responsible for
substantiating the safety of their products and ingredients before the products were marketed.62
With the passage of MoCRA, manufacturers are now statutorily required to substantiate the safety
of their products. MoCRA also expands upon required recordkeeping by manufacturers, packers,
and distributors. A “responsible person”63 for a cosmetic product must ensure that it has been
adequately tested to substantiate safety,64 and that records supporting this substantiation are
maintained by the same responsible person.65 Certain products and facilities already regulated
under Chapter V of FFDCA as a drug or device are exempt from MoCRA’s safety substantiation
and recordkeeping requirements.66 However, if such a facility also manufactures or processes
cosmetic products not subject to FFDCA Chapter V, the exemption does not apply to those
particular cosmetic products.67

58 Ibid.
59 Ibid.
60 Ibid.
61 FDA, “FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated,”
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-
approved-are-fda-regulated. FFDCA §721 (21 U.S.C. §379e) addresses color additive safety.
62 FDA, “Product Testing of Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-science-research/product-testing-
cosmetics.
63 Under the newly MoCRA-added FFDCA §604(4) (21 U.S.C. §364(4)), a “responsible person” is defined as “the
manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in
accordance with section 609(a) of [the FFDCA] or section 4(a) of the Fair Packaging and Labeling Act.”
64 Under FFDCA §608(c)(1) (21 U.S.C. §364d(c)(1)), “adequate substantiation of safety” is defined as “tests or studies,
research, analyses, or other evidence or information that is considered, among experts qualified by scientific training
and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable
certainty that a cosmetic product is safe.” In turn, “safe” means “the cosmetic product, including any ingredient thereof,
is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as
are customary or usual.” It is noted that a cosmetic ingredient will not be considered injurious if it simply causes
“minor and transient reactions or minor and transient skin irritations in some users.” To determine safety, “the
Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic
product, including any ingredient thereof.” FFDCA §608(c)(2) (21 U.S.C. §364d(c)(2)).
65 FFDCA §608(a) (21 U.S.C. §364d(a)). The coal-tar hair dye exemption is preserved under MoCRA, though a
responsible person must maintain records related to the safety of coal-tar hair dye products. FFDCA §608(b) (21 U.S.C.
§364d(b)). For more information on the coal-tar hair dye exemption, see footnote 96.
66 FFDCA §613(a) (21 U.S.C. §364i(a)).
67 FFDCA §613(b) (21 U.S.C. §364i(b)).
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Enforcement
Among various enforcement mechanisms, under MoCRA, FDA may access and copy all records
related to a cosmetic product that it reasonably believes is likely adulterated and a serious danger
to humans. FDA may access and copy all records necessary to determine whether a cosmetic or
related product is adulterated and a serious threat to human health, barring certain cosmetic
formula, personnel, research, and financial data records. Accessible records include those related
to safety substantiation data for cosmetic products and their ingredients.68
Registration and Listing
Prior to MoCRA, cosmetic manufacturers were not required to register their establishments or list
their products with FDA. Instead, according to FDA regulations, owners or operators of
establishments that manufactured or packaged cosmetics were requested to register with FDA.69
Likewise, previous to MoCRA, manufacturers, packers, and distributors of cosmetic products
were requested to file a cosmetic product ingredient statement (CPIS) containing certain
information on each cosmetic product they marketed.70 Entities could submit registration
information and CPISs to FDA’s Voluntary Cosmetic Registration Program (VCRP).71
Under MoCRA, both facility72 registration and product listings are now required.73 Existing and
new facilities that manufacture or process cosmetic products for distribution in the United States
must be registered with FDA. These registrations must be renewed every two years and updated
within 60 days of a content revision.74 Domestic facilities registering with FDA must provide the
facility’s name, physical address, email address, and phone number, while foreign facilities must
provide contact information for an agent within the United States and, if available, electronic
contact information. Additionally, a facility must include its registration number, if one was
previously assigned, and all brand names associated with cosmetic products sold that were
manufactured or processed at that facility. The product categories and responsible person for each
cosmetic product manufactured or processed at the facility must also be provided.75
Each responsible person must also ensure the submission of a cosmetic product listing with FDA
that is renewed and updated annually.76 The product listing must contain the manufacturing or
processing facility’s registration number, the responsible person’s name and contact number, the
name of the cosmetic product as it appears on the label, the categories the cosmetic product falls
under, and the product’s listing number. Additionally, the product listing must include a list of the
cosmetic product’s ingredients, “including any fragrances, flavors, or colors, with each ingredient

68 FFDCA §610 (21 U.S.C. §364f).
69 21 C.F.R. §710.
70 21 C.F.R. Part 720.
71 FDA, “Voluntary Cosmetic Registration Program,” https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-
program.
72 A “facility” is generally defined as “any establishment (including an establishment of an importer) that manufactures
or processes cosmetic products distributed in the United States.” FFDCA §604(3) (21 U.S.C. §364(3)).
73 FFDCA §607 (21 U.S.C. §364c).
74 FFDCA §607(a) (21 U.S.C. §364c(a)).
75 FFDCA §607(b) (21 U.S.C. §364c(b)).
76 For existing facilities engaging in the manufacturing or processing of cosmetic products at the time of MoCRA’s
enactment, such registration must occur no later than December 29, 2023. For facilities that begin manufacturing or
processing cosmetic products after MoCRA’s enactment, such registration must occur within 60 days of initial activity
or 60 days after December 29, 2023, whichever is later. FFDCA §607(a) (21 U.S.C. §364c(a)).
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identified by name.”77 FDA will assign private product and facility identification numbers upon
initial listing submission or registration.78
With the advent of MoCRA, FDA reported the VCRP had been discontinued and was no longer
accepting submissions. In a draft guidance released in August 2023, FDA stated it is developing a
new electronic submission portal for registration and listing information.79 FDA noted that this
new portal is expected to be available by October 2023.80 In the interim, FDA requests that no
registration or listing information be sent to the agency, adding that information previously listed
in the VCRP will not be transferred.81 In September 2023, FDA released for comment draft
versions of the prospective electronic submission portal, Cosmetics Direct, and paper forms.82
MoCRA exempts certain small businesses83 from both facility registration and product listing
requirements.84 However, a small business is not exempt from these requirements if it is engaged
in the manufacturing or processing of higher-risk cosmetic products that “regularly come into
contact with [the] mucus membrane of the eye under conditions of use that are customary or
usual,” “[c]osmetic products that are injected” (see the text box below), “intended for internal
use,” or that are meant to “alter [one’s] appearance for more than 24 hours under conditions of
use that are customary or usual and removal by the consumer is not part of such conditions of use
that are customary or usual.”85
Injected Cosmetics: Tattoo Inks
In 2019, one in three Americans reported having at least one tattoo. The ink used in tattooing, including for both
decorative and medical purposes, is classified by FDA as a cosmetic. Consequently, the pigments used in tattoo
inks are considered color additives and would typically be subject to premarket review. Traditionally, FDA has
chosen not to enforce this authority, citing “competing public health priorities and a previous lack of evidence of
safety problems specifically associated with these pigments.” However, over the years, reports of adverse events
related to tattooing have prompted increased FDA scrutiny. For example, there have been multiple voluntary
recalls of tattoo inks, often due to microbial contamination. In one independent survey of sealed tattoo and
permanent makeup inks in the United States cited by FDA, 49% were contaminated with microorganisms,
including fungi and pathogenic bacteria. Other pigments that have been identified in tattoo inks are chemically
similar or identical to industrial paints and printer inks. MoCRA specifically amends FFDCA by adding Section
612(b)(2), which ensures that injected cosmetics may not be exempted from future GMP and registration and
product listing requirements. In June 2023, FDA released a draft guidance for industry entitled “Insanitary
Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.”

77 FFDCA §607(c) (21 U.S.C. §364c(c)).
78 FFDCA §607(d) (21 U.S.C. §364c(d)).
79 FDA, Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry, FDA-2023-D-
1716, August 2023, p. 10.
80 FDA, “FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products,”
https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-draft-guidance-registration-and-listing-cosmetic-
product-facilities-and-products?utm_medium=email&utm_source=govdelivery.
81 FDA, “FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP),”
https://www.fda.gov/food/cfsan-constituent-updates/fda-has-stopped-accepting-submissions-voluntary-cosmetic-
registration-program-vcrp.
82 FDA, “FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products,”
https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-draft-guidance-registration-and-listing-cosmetic-
product-facilities-and-products.
83 A “small business” is defined as a facility that has “average gross annual sales in the United States of cosmetic
products for the previous 3-year period [that are] less than $1,000,000, adjusted for inflation.” FFDCA §612(a) (21
U.S.C. §364h(a)).
84 FFDCA §612(a) (21 U.S.C. §364h(a)).
85 FFDCA §612(b) (21 U.S.C. §364h(b)).
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Sources: Jessica C. Dixon, “The Perils of Body Art: FDA Regulation of Tattoo and Micropigmentation
Pigments,” Administrative Law Review, vol. 58, no. 3 (Summer 2006), p. 668; FDA, Insanitary Conditions in the
Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry, FDA-
2023-D-1083, June 2023; FDA, “Tattoos & Permanent Makeup: Fact Sheet,” https://www.fda.gov/cosmetics/
cosmetic-products/tattoos-permanent-makeup-fact-sheet; and S.W. Nho et al., “Microbiological Survey of
Commercial Tattoo and Permanent Makeup Inks Available in the United States,” Journal of Applied Microbiology,
vol. 124, no. 5 (May 2018), p. 1296.
Additionally, certain products and facilities already regulated under Chapter V of FFDCA as a
drug or device are exempt from facility registration and product listing requirements.86 However,
if such a facility also manufactures or processes cosmetic products not subject to FFDCA Chapter
V, the exemption does not apply.87
Enforcement
Under MoCRA, if FDA determines that a cosmetic product has a reasonable probability of
causing serious harm to human health, and if FDA has a reasonable belief that other products
manufactured or processed at the same facility may be similarly affected, FDA may suspend the
registration of the facility connected with such products.88 If a facility’s registration is suspended,
any cosmetic product from that facility is barred from introduction or delivery for introduction
into U.S. commerce.89
Before suspending a facility’s registration, the FDA must provide notice to a responsible person
for the facility specifying the reason for suspension, as well as an opportunity, within five
business days of the notice, to present a plan to correct the issue identified.90 FDA must provide
the responsible person with the opportunity for an informal hearing to review actions required for
registration reinstatement and why the facility registration should be reinstated.91 If, based upon
the evidence presented at this informal hearing, FDA determines there are inadequate grounds to
continue the suspension, the facility registration will be restored.92 However, if there is
insufficient evidence presented, the suspension may continue, and FDA shall require the
responsible person to submit a corrective action plan for review.93
If at any point FDA determines there is inadequate evidence to justify the continued suspension of
a facility’s registration, the registration shall be promptly reinstated.94
Adulterated and Misbranded Cosmetics
Since its passage in 1938, the FFDCA has prohibited the adulteration and misbranding of
cosmetics. It also prohibits the introduction, receipt, and delivery of adulterated or misbranded
cosmetics into interstate commerce and may take enforcement actions in such instances.95
A cosmetic is deemed adulterated—and potentially subject to FDA enforcement actions—if it

86 FFDCA §613(a) (21 U.S.C. §364i(a)).
87 FFDCA §613(b) (21 U.S.C. §364i(b)).
88 FFDCA §607(f) (21 U.S.C. §364c(f)).
89 Ibid.
90 Ibid.
91 Ibid.
92 Ibid.
93 Ibid.
94 Ibid.
95 FFDCA §§301(a)-(c) (21 U.S.C. §§331(a)-(c)).
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• “bears or contains any poisonous or deleterious substance which may render it
injurious to users under the conditions of use prescribed in the labeling ... except
that this provision shall not apply to coal-tar hair dye”; 96
• consists of “any filthy, putrid, or decomposed substance”;
• was “prepared, packed, or held under insanitary conditions whereby it may have
become contaminated” or “rendered injurious to health”;
• is in a container composed of “any poisonous or deleterious substance which may
render the contents injurious to health”;
• contains an unsafe color additive, except for hair dyes;97
• “has been manufactured or processed under conditions that do not meet the good
manufacturing practice requirements of [FFDCA] section 606”; or
• “is a cosmetic product, and the cosmetic product, including each ingredient in the
cosmetic product, does not have adequate substantiation for safety, as defined in
[FFDCA] section 608(c).’’98
FDA has issued rules restricting the use of certain ingredients in cosmetic products. If FDA
determines that a cosmetic’s ingredients are poisonous or deleterious, that cosmetic is considered
adulterated.99 One example of an adulterated cosmetic is the use of henna, also known as mehndi,
for temporary skin decoration.100 Although the color additive used in henna products is allowed
for hair dye, it is not allowed for direct skin contact.101 Therefore, under FDA regulations, the use
of henna for skin decoration renders the product “adulterated.”102
Under the FFDCA, a cosmetic is deemed misbranded if
• the “labeling is false or misleading in any particular”;
• the label lacks required information;103

96 FFDCA §601 (21 U.S.C. §361). 21 C.F.R. §740.18. “The coal tar hair dye exemption allows coal tar hair dyes, not
intended for use on eyelashes or eyebrows, to be marketed to consumers, even if they have been found to be injurious
to the user under conditions of use” (see footnote 9, Bailey, p. 220). The label for coal-tar hair dye products must
contain the statutorily required caution statement to be considered unadulterated, as well as “adequate directions for
conducting such preliminary testing,” which are not specified by FDA, but rather have been set as a self-evaluation
patch test with a wait time of 48 hours by the industry-established Cosmetic Ingredient Review (CIR) (Bailey, pp. 219-
220). If the coal-tar hair dye product does not contain that information, the coal-tar dye is “subject to regulation as a
cosmetic coal additive and must be approved by FDA and listed in the CFR before marketing” (Bailey, p. 220). In
1952, a congressional committee report recommended the elimination of the coal-tar hair dye exemption (Hutt, “A
History of Government Regulation of Adulteration and Misbranding of Cosmetics,” p. 25). The Government
Accountability Office (GAO) also issued a report in the late 1970s recommending the elimination of this exemption
(Hutt, p. 27).
97 FFDCA §601 (21 U.S.C. §361).
98 FFDCA §601 (21 U.S.C. §361). Note that the last two bullets were added under MoCRA §3503.
99 FFDCA §601(a) (21 U.S.C. §361(a)).
100 Henna, also known as mehndi, is a form of temporary body-decoration that uses a colored paste, derived from the
henna plant, directly applied to the skin. Carrie G. Basas, “Henna Tattooing: Cultural Tradition Meets Regulation,”
Food and Drug Law Journal, vol. 62, no. 4 (2007), pp. 779, 781.
101 Ibid. FDA Import Alert 53-19, December, 2010, https://www.accessdata.fda.gov/cms_ia/importalert_138.html.
102 Ibid.
103 FFDCA §602 (21. U.S.C. §362). 21 C.F.R. §701.11 (identity labeling); 21 C.F.R. §701.12 (name and place of
business or manufacturer, packer, or distributor); 21 C.F.R. §701.13 (declaration of net quantity of contents); 21 C.F.R.
701.3 (designation of ingredients); 21 C.F.R. §201.66 (format and content requirements for over-the-counter [OTC]
drug product labeling); 21 C.F.R. §1.21 (failure to reveal material facts); 21 C.F.R. Parts 700 (general) and 740
(continued...)
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• the required labeling information is not prominently placed and “in such terms as
to render it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use”;
• the “container is so made, formed, or filled as to be misleading”;
• the use of a color additive does not conform to packaging and labeling
requirements; or
• the packaging or labeling violates the regulations issued under the Poison
Prevention Packaging Act of 1970.104
Cosmetic products that meet the FPLA’s definition of a “consumer commodity”105 are considered
misbranded under the FFDCA if they do not comply with FPLA’s requirements.106 Consumer
commodity (retail) cosmetic products subject to the FPLA are required to bear a label that
identifies the product and the name and place of business of the manufacturer, packer, or
distributor, as well as the net quantity of contents on the principal display panel.107 The net
quantity of contents information must be declared in a legible type size that is uniform for
packages of about the same size.108 FDA’s ingredient labeling rules, issued under the authority of
the FPLA, require ingredients be listed on cosmetic products in descending order of
predominance.109

(cosmetic product warning statements). Note that FFDCA §602(b) (21 U.S.C. §362(b)) has been amended under
MoCRA §3503.
104 FFDCA §602 (21 U.S.C. §362). FDA regulations provide that “[t]he labeling of a cosmetic which contains two or
more ingredients may be misleading by reason ... of the designation of such cosmetic in such labeling by a name which
includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients
are stated elsewhere in the labeling.” 21 C.F.R. §701.1(b).
105 “Consumer commodity” refers to those cosmetic items as defined by FFDCA §201(i) that are usually produced or
distributed for sale for use by individuals. FPLA §10(a) (15 U.S.C. §1459(a)).
106 FPLA §7(a) (15 U.S.C. §1456(a)). The FPLA provision on unfair and deceptive packaging and labeling makes it
unlawful for persons engaged in packing or labeling consumer commodities to distribute, or cause to be distributed, a
consumer commodity in a package or with a label that does not meet the FPLA provisions. FPLA §3(a) (15 U.S.C.
§1452(a)).
107 FPLA §4 (15 U.S.C. §1453). The principal display panel is “that part of a label that is most likely to be displayed,
presented, shown, or examined under normal and customary conditions of display for retail sale.” FPLA §10(f) (15
U.S.C. §1459(f)); 21 C.F.R. §701.10.
108 FPLA §4(a)(3) (15 U.S.C. §1453(a)(3)); 21 C.F.R. §701.2 (form of stating labeling requirements).
109 FPLA §5(c)(3) (15 U.S.C. §1454(c)(3)); 21 C.F.R. §701.3(a). However, FDA’s regulation does “not require the
declaration of incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or
functional effect in the cosmetic,” such as processing aids. 21 C.F.R. §701.3(l).
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Enforcement
If a cosmetic is deemed adulterated or misbranded, FDA may take enforcement actions.110 FDA
may issue import alerts111 and warning letters112 to entities that manufacture or distribute a
violative product. Other enforcement actions may include, with assistance from the Department
of Justice, seeking an injunction (which could prevent a company from making or distributing the
violative product), seizing the violative product, or seeking criminal penalties.113
Mandatory Recall
Prior to MoCRA, FDA did not have the authority to order mandatory recalls of cosmetic
products. The agency could, however, request a company to voluntarily recall cosmetic products
of concern.114 Under MoCRA, a responsible person may still have the opportunity to voluntarily
recall an adulterated or misbranded cosmetic; however, now FDA also has the authority to issue a
mandatory recall.115 A mandatory recall may be initiated “[i]f the Secretary determines that there
is a reasonable probability that a cosmetic is adulterated … or misbranded … and the use of or
exposure to such cosmetic will cause serious adverse health consequences or death,” and the
responsible person refuses to comply with a voluntary recall in a timely manner. Upon FDA
issuing an order for a mandatory recall, the responsible person must immediately stop distributing
the identified product.116
If such an order is issued, the responsible person is entitled to an opportunity for a timely
informal hearing to review the adequacy of evidence for the order.117 Depending on the outcome
of this review, the order may be vacated, continued until a specified date, or amended to further
require the recall of the cosmetic product, along with other measures regarding notifications,
timetables, and updates.118 FDA may require the responsible person to issue a notice of recall or
ceased distribution to appropriate persons, including manufacturers, distributors, importers, and

110 FDA, “FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated,”
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-
approved-are-fda-regulated. Note, however, that FDA has enforcement discretion, meaning the agency may choose not
to enforce certain provisions of the FFDCA depending on factors such as agency priorities and available resources. See
CRS Report R43609, Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues (particularly the “Does
FDA Address Every Violation of the FD&C Act?” section).
111 FDA, “Cosmetics Importers,” https://www.fda.gov/cosmetics/cosmetics-international-activities/cosmetics-
importers. Import alerts inform both FDA employees and members of the public that FDA has enough evidence to
detain certain products that appear to be in violation of FDA regulations. For more information, see FDA, “Import
Alerts,” https://www.fda.gov/industry/actions-enforcement/import-alerts.
112 Warning letters notify entities that FDA believes they have violated a regulation or law and sets forth what
corrective action the entity needs to take to rectify the situation. Warning letters have been issued to a number of
entities for a variety of cosmetics-related issues. For more information, see FDA, “Warning Letters Related to
Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-compliance-enforcement/warning-letters-related-cosmetics.
113 FDA, “FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated,”
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-
approved-are-fda-regulated; FFDCA §§301-304 (21 U.S.C. §§331-334).
114 FDA, “FDA Recall Policy for Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-recall-policy-
cosmetics; 21 C.F.R. §7.40(b); FDA, Regulatory Procedures Manual, July 2021, chap. 7, at https://www.fda.gov/
media/71814/download.
115 FFDCA §611 (21 U.S.C. §364g).
116 FFDCA §611(a) (21 U.S.C. §364g(a)).
117 FFDCA §611(b) (21 U.S.C. §364g(b)).
118 FFDCA §611(c) (21 U.S.C. §364g(c)).
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sellers.119 If a product is recalled, FDA must ensure that a press release announcing the action is
published, as well as appropriate alerts and public notices, to provide consumers and retailers
with information about the cosmetic product and the circumstances of the recall. If an image of
the product is available and appropriate, FDA shall also ensure the publication of that image on
its website.120 Certain products and facilities already regulated under Chapter V of FFDCA as a
drug or device are exempt from MoCRA’s mandatory recall authority.121 However, if such a
facility also manufactures or processes cosmetic products not subject to FFDCA Chapter V, the
exemption does not apply to those particular cosmetic products.122
Enforcement
Again, under MoCRA, FDA may access and copy all records related to a cosmetic product that it
reasonably believes is likely adulterated and a serious danger to humans.123
Labeling
Consumers may seek out particular cosmetics based on their labeling, such as those claiming to
be made with organic ingredients or not tested on animals. However, FDA does not define certain
terms used by manufacturers, including “organic” and “not tested on animals.”124 Though this
specifically has not changed under MoCRA, the new act does introduce certain labeling
requirements.125
Under MoCRA, cosmetic product labels must include a domestic address, domestic phone
number, or electronic contact information (e.g., a website) through which a responsible person
may be contacted regarding adverse events in response to usage of the product.126 Cosmetic
product labels must also identify each fragrance allergen contained in the product.127 For cosmetic
products intended only for professional use,128 labels must include “a clear and prominent
statement that the product shall be administered or used only by licensed professionals,” and meet
the labelling requirements of the FFDCA and FPLA Section 4(a).129

119 FFDCA §611(e) (21 U.S.C. §364g(e)).
120 FFDCA §611(f) (21 U.S.C. §364g(f)).
121 FFDCA §613(a) (21 U.S.C. §364i(a)).
122 FFDCA §613(b) (21 U.S.C. §364i(b)).
123 FFDCA §610 (21 U.S.C. §364f). For further details on records access, see the “Enforcement” subsection in the
“Premarket Requirements” section of this report.
124 FDA, “‘Organic’ Cosmetics,” https://www.fda.gov/cosmetics/cosmetics-labeling-claims/organic-cosmetics; FDA,
“‘Cruelty Free’/‘Not Tested on Animals,’” https://www.fda.gov/cosmetics/cosmetics-labeling-claims/cruelty-freenot-
tested-animals.
125 MoCRA §3507 does, however, state that “[i]t is the sense of the Congress that animal testing should not be used for
the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate
allowances.”
126 FFDCA §609(a) (21 U.S.C. §364e(a)). FFDCA §609(a) is to take effect on December 29, 2024. MoCRA
§3503(b)(2) (21 U.S.C. §364e note). FFDCA §609(a) does not apply if the cosmetic product or facility is already
regulated under Chapter V of FFDCA as a drug or device. FFDCA §613(a) (21 U.S.C. §364i(a)). However, if such a
facility also manufactures or processes cosmetic products not subject to FFDCA Chapter V, the exemption does not
apply to those particular cosmetic products. FFDCA §613(b) (21 U.S.C. §364i(b)).
127 FFDCA §609(b) (21 U.S.C. §364e(b)).
128 In this context, “professional” is defined as “an individual who is licensed by an official State authority to practice
in the field of cosmetology, nail care, barbering, or esthetics.” FFDCA §609(c)(1) (21 U.S.C. §364e(c)(1)).
129 FFDCA §609(c)(2) (21 U.S.C. §364e(c)(2)).
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Enforcement
What constitutes a fragrance allergen is to be decided by FDA via rulemaking. Pursuant to this
rulemaking, FDA is to consider “international, State, and local requirements for allergen
disclosure, including the substance and format of requirements in the European Union, and may
establish threshold levels of amounts of substances subject to disclosure.”130 A notice of proposed
rulemaking must be issued no later than June 29, 2024, with a final rule promulgated no later than
180 days after the close of the proposed rule’s public comment period.131
Good Manufacturing Practices
Prior to MoCRA, cosmetic product manufacturing was not subject to good manufacturing
practices (GMP). Instead, FDA had published a draft guidance in 1997, which was later updated
in 2008 and 2013, recommending GMP for cosmetic products.132 FDA had also published a web
page containing cosmetic establishment instructions, adapted from its Inspection Operations
Manual, meant to “serve as guidelines for effective [establishment] self-inspection.” FDA noted
that “[a] good inspection score means that an establishment follows good manufacturing
practices.”133
With the passage of MoCRA, FDA has been tasked with establishing GMP via rulemaking.134
Subsequently, FDA announced that it plans to withdraw or revise, then reissue, the 2013 draft
guidance.135 Under MoCRA, these GMP should be consistent with, to the degree practicable,
national and international standards.136 The intent of the GMP should be to “protect the public
health and ensure that cosmetic products are not adulterated.”137 These requirements must also be
scalable to the size and scope of the businesses subject to them to ensure that smaller businesses
are not exposed to undue hardship.138 In developing these GMP, FDA is to consult with cosmetic
manufacturers, including smaller businesses.139

130 FFDCA §609(b) (21 U.S.C. §364e(b)).
131 Ibid.
132 FDA, Guidance for Industry: Cosmetic Good Manufacturing Practices (Draft Guidance), June 2013.
133 FDA, “Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics,” https://www.fda.gov/
cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics.
134 FFDCA §606(a) (21 U.S.C. §364b(a)).
135 FDA, “Draft Guidance for Industry: Cosmetic Good Manufacturing Practices,” https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices.
136 FFDCA §606(a) (21 U.S.C. §364b(a)).
137 Ibid.
138 FFDCA §606(b) (21 U.S.C. §364b(b)). FFDCA Section 606 (GMP) does not apply to certain small businesses.
FFDCA §612(a) (21 U.S.C. §364h(a)). However, a small business is not exempt from these GMP requirements if it is
engaged in the manufacturing or processing of cosmetic products that “regularly come into contact with [the] mucus
membrane of the eye under conditions of use that are customary or usual,” “[c]osmetic products that are injected,”
“intended for internal use,” or that are meant to “alter [one’s] appearance for more than 24 hours under conditions of
use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or
usual.” FFDCA §612(b) (21 U.S.C. §364h(b)). Additionally, certain products and facilities that are already regulated
under Chapter V of FFDCA as a drug or device are exempt from GMP. FFDCA §613(a) (21 U.S.C. §364i(a)).
However, if such a facility also manufactures or processes cosmetic products not subject to FFDCA Chapter V, the
exemption does not apply to those particular cosmetic products. FFDCA §613(b) (21 U.S.C. §364i(b)).
139 Ibid. FDA held a listening session to facilitate these consultations on June 1, 2023. FDA, “Public Meeting: Good
Manufacturing Practices for Cosmetic Products,” https://www.fda.gov/cosmetics/cosmetics-news-events/public-
meeting-good-manufacturing-practices-cosmetic-products-06012023.
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Enforcement
To ensure these GMP are followed, MoCRA allows for the inspection of facility records to
demonstrate compliance during a larger facility inspection, an authority that predated MoCRA.140
Regarding a timeline for the implementation of these GMP, MoCRA requires that a notice of
proposed rulemaking be published no later than December 29, 2024, and that a final rule
published no later than December 29, 2025.141
Reporting Adverse Events and Reactions to Cosmetics
Prior to MoCRA, FDA did not have the statutory authority to require cosmetic manufacturers to
notify the agency of adverse events associated with their products, nor could it require cosmetic
companies to report information received from consumers and others regarding adverse events.142
Consequently, before MoCRA was enacted, FDA relied exclusively on voluntary reports of
adverse events from cosmetic companies and consumers. The public could report adverse events
to FDA via MedWatch, the FDA’s product safety reporting program.143
Under MoCRA, a responsible person for a particular cosmetic product used domestically must
report associated serious adverse events144 to FDA.145 It is expected that the responsible person
will be informed of such events via the required contact information listed on the product’s
label.146 Upon learning of an adverse event, a responsible person must relay this information to
FDA, along with a copy of the specific product’s label, within 15 business days.147 For one year
following this initial report, the responsible person must update FDA on “any new and material
medical information” related to the serious adverse event within 15 business days of receipt.148 In
addition to reporting a serious adverse event, the responsible person must also maintain related
records for a period of six years.149 However, if a responsible person represents a small business
that does not engage in the manufacturing or processing of higher-risk cosmetic products, records

140 FFDCA §606(a) (21 U.S.C. §364b(a)). FDA has the authority to inspect any establishment in which cosmetics are
manufactured, processed, packed, or held, before or after introduction into interstate commerce, and any vehicle used to
transport such cosmetics in interstate commerce. FFDCA §704(a) (21 U.S.C. §374(a)).
141 FFDCA §606(c) (21 U.S.C. §364b(c)).
142 FDA, “How to Report a Cosmetic Related Complaint,” https://www.fda.gov/cosmetics/cosmetics-compliance-
enforcement/how-report-cosmetic-related-complaint.
143 FDA, “MedWatch: The FDA Safety Information and Adverse Event Reporting Program,” https://www.fda.gov/
safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
144 An “adverse event” is defined as “any health-related event associated with the use of a cosmetic product that is
adverse.” FFDCA §604(1) (21 U.S.C. §364(1)). A “serious adverse event” is categorized as “an adverse event that …
results in … death[,] a life-threatening experience[,] inpatient hospitalization[,] a persistent or significant disability or
incapacity[,] a congenital anomaly or birth defect[,] an infection[,] or significant disfigurement (including serious and
persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of
appearance), other than as intended, under conditions of use that are customary or usual.” Additionally, an event that
“requires, based on reasonable medical judgment, a medical or surgical intervention to prevent … outcome[s]
[previously] described” qualifies as a serious adverse event. FFDCA §604(5) (21 U.S.C. §364(5)).
145 FFDCA §605(a) (21 U.S.C. §364a(a)).
146 FFDCA §605(d) (21 U.S.C. §364a(d)).
147 FFDCA §605(b)(1) (21 U.S.C. §364a(b)(1)). It appears that this information should still be submitted to FDA
through MedWatch under MoCRA. FDA, “FDA Provides Draft Recommendations to Help Reduce Microbial
Contamination in Tattoo Inks,” https://www.fda.gov/news-events/press-announcements/fda-provides-draft-
recommendations-help-reduce-microbial-contamination-tattoo-inks.
148 FFDCA §605(b)(2) (21 U.S.C. §364a(b)(2)).
149 FFDCA §605(e)(1) (21 U.S.C. §364a(e)(1)).
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need only be maintained for three years.150 Exemptions to the requirements surrounding serious
adverse events may be established by regulation if FDA determines they “would have no
significant adverse effect on public health.”151
Additionally, if FDA reasonably believes that a fragrance or flavor ingredient contributed to a
reported serious adverse event, the agency may request a written list of ingredients or ingredient
categories in the fragrance or flavor of concern. A responsible person must convey this
information to FDA within 30 days of the request.152
Enforcement
Under MoCRA, records kept regarding adverse events are subject to inspection.153 A responsible
person must allow an authorized person154 access to these records during a larger facility
inspection.155
Regulation of Specific Cosmetic Ingredients
Some ingredients used in cosmetic products have received particular attention due to concerns
about their potential health risks. For example, there have been long-standing concerns regarding
the use of coal-tar hair dyes as color additives. Concerns have also been raised about a group of
synthetic compounds known as per- and polyfluoroalkyl substances (PFAS).156 Both coal-tar hair
dyes and PFAS have been the focus of congressional interest. However, these substances are not
the only ingredients to have raised concern. FDA has online resources with information regarding
other ingredients that consumers have inquired about, including talc, parabens, and phthalates,
among others.157
Talc
Talc is a naturally occurring mineral composed of magnesium, silicon, oxygen, and hydrogen.158
It is used in many cosmetics, often to “absorb moisture, … prevent caking, … make facial
makeup opaque, … [and] improve the feel of a product.”159 Safety concerns regarding talc have
existed for decades, with published literature in the 1960s suggesting a possible connection
between talc and ovarian cancer, followed in the 1970s by concerns about asbestos
contamination. Asbestos, also a naturally occurring mineral, is a proven carcinogen, and often

150 Ibid.
151 FFDCA §605(c) (21 U.S.C. §364a(c)).
152 FFDCA §605(f) (21 U.S.C §364a(f)).
153 FFDCA §605(e)(2) (21 U.S.C. §364a(e)(2)).
154 An “authorized person” is “an officer or employee of the Department of Health and Human Services who has …
appropriate credentials, as determined by the Secretary; and … been duly designated by the Secretary to have access to
the records required under this section.” FFDCA §605(e)(2)(B) (21 U.S.C. §364a(e)(2)(B)).
155 FFDCA §605(e)(2) (21 U.S.C. §364a(e)(2)). FFDCA Section 605 does not apply if the cosmetic product or facility
is already regulated under Chapter V of FFDCA as a drug or device. FFDCA §613(a) (21 U.S.C. §364i(a)). However, if
such a facility also manufactures or processes cosmetic products not subject to FFDCA Chapter V, the exemption does
not apply to those particular cosmetic products. FFDCA §613(b) (21 U.S.C. §364i(b)).
156 FDA, “Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics,” https://www.fda.gov/cosmetics/cosmetic-
ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics.
157 FDA, “Cosmetic Products & Ingredients,” https://www.fda.gov/cosmetics/cosmetic-products-ingredients.
158 FDA, “Talc,” https://www.fda.gov/cosmetics/cosmetic-ingredients/talc.
159 Ibid.
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geologically forms in proximity to talc. Thus, when talc is mined, asbestos may sometimes
become inadvertently commingled. FDA conducts ongoing research on the safety of talc, and in
2022, the agency published a report testing selected talc-containing cosmetics for asbestos.160 Of
the 50 cosmetic samples tested for the report, none contained asbestos.161
Due to the potential for talc to be contaminated by asbestos, FDA has noted the importance of
selecting “talc mining sites carefully and tak[ing] steps to test the ore sufficiently.”162
Consequently, MoCRA directs FDA to, no later than December 29, 2023, “promulgate proposed
regulations to establish and require standardized testing methods for detecting and identifying
asbestos in talc-containing cosmetic products.”163 FDA must publish a final regulation within 180
days after the public comment period closes.164
PFAS
PFAS are a group of synthesized chemical compounds used in a range of industrial and consumer
products, including cosmetics. Although PFAS are sometimes referred to as “forever chemicals,”
their persistence varies—both between longer-chain versus shorter-chain PFAS, and between
more fluorinated versus less fluorinated PFAS—thus potential health effects may also vary.165
PFAS ingredients may intentionally be added to certain cosmetics to improve their texture or
consistency, condition and smooth skin, or give skin a shiny appearance.166 PFAS are used as
ingredients in lotions, cleansers, nail polishes, shaving creams, and some makeup products (e.g.,
lipstick, eyeliner, eyeshadow, and mascara).167 PFAS may be unintentionally added to cosmetics
via raw material impurities or the breakdown of PFAS ingredients that form other types of
PFAS.168 Although intentionally added PFAS ingredients are typically declared on a cosmetic
product’s label, unintentional PFAS may not be.169
According to FDA, research on the presence of PFAS in cosmetics is limited, and it is unclear
whether PFAS in cosmetics are absorbed through the skin at levels harmful to humans. Studies
have found varying concentrations of PFAS in cosmetics, ranging “from the parts per billion level

160 Ibid.
161 FDA, “FDA Releases Data from the Agency’s 2022 Testing of Talc-Containing Cosmetic Products for Asbestos,”
https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-data-agencys-2022-testing-talc-containing-cosmetic-
products-asbestos.
162 FDA, “Talc,” https://www.fda.gov/cosmetics/cosmetic-ingredients/talc.
163 MoCRA §3505(1) (21 U.S.C. §364d note).
164 MoCRA §3505(2) (21 U.S.C. §364d note).
165 CRS Report R45986, Federal Role in Responding to Potential Risks of Per- and Polyfluoroalkyl Substances
(PFAS).
Any compound that has the chemical structure of at least one carbon atom attached to two or more
fluorine atoms, or a chain of at least two carbon atoms attached to two or more fluorine atoms, may
be considered a PFAS. Individual PFAS vary in terms of the numbers of fluorinated carbon atoms.
The extent to which a chain of carbon atoms is fluorinated would determine whether a chemical may
be considered a perfluoroalkyl substance or a polyfluoroalkyl substance. Given the possible
variations in the length of the carbon chain, number of fluorinated carbon atoms, and other atoms
attached to the chain, PFAS potentially could include thousands of chemical compounds if every
possible combination were created. Ibid.
166 FDA, “Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics,” https://www.fda.gov/cosmetics/cosmetic-
ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics.
167 Ibid.
168 Ibid.
169 Ibid.
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to the 100s of parts per million range.”170 FDA has called for more research into PFAS, and some
Members of Congress have introduced legislation regarding research needs and the use of these
compounds in certain consumer goods.171
MoCRA directly addresses this lack of information. Under Section 3506, FDA is tasked with
assessing the use of PFAS “in cosmetic products and the scientific evidence regarding the safety
of such use in cosmetic products, including any risks associated with such use.”172 FDA may
consult with the National Center for Toxicological Research during this assessment.173 FDA must
publish a report summarizing the assessment on its website no later than December 29, 2025.174
FDA’s Authority to Regulate Cosmetics in
the Future
Prior to MoCRA, various stakeholders, GAO, and some Members of Congress identified
limitations to FDA’s authority to regulate cosmetics, noting that these limitations could expose
consumers to unnecessary health risks. Some advocacy groups, for example, cited regulatory
schemes adopted by foreign governments for cosmetic products and contended that these schemes
allowed those governments a greater degree of control over the manufacturing and selling of
cosmetic goods.175 Some of the limitations identified by stakeholders included FDA’s lack of
authority to require premarket approval for cosmetic products,176 order mandatory recalls,177
require cosmetics facility registration,178 make risk assessments more robust,179 require mandatory
reporting of adverse events related to cosmetics,180 and issue cosmetic GMP regulations.181
The passage of MoCRA may alleviate many stakeholder concerns regarding FDA’s cosmetic
regulatory capacity, such as FDA’s authority to issue a mandatory recall, require cosmetics

170 Ibid.
171 Ibid., and see, for example, the No PFAS in Cosmetics Act (117th Congress, S. 2047 and H.R. 3990).
172 MoCRA §3506(a).
173 Ibid.
174 MoCRA §3506(b).
175 See, for example, Brandon Inouye, Environmental Working Group, “On Protecting Consumers from Toxics in
Cosmetics, U.S. Lags at Least 80 Countries,” https://www.ewg.org/news-insights/news/2021/08/protecting-consumers-
toxics-cosmetics-us-lags-least-80-countries.
176 FDA, “Using Adverse Event Reports to Monitor Cosmetic Safety,” https://www.fda.gov/cosmetics/how-report-
cosmetic-related-complaint/using-adverse-event-reports-monitor-cosmetic-safety.
177 See, for example, the Cosmetic Safety Enhancement Act of 2019 (116th Congress, H.R. 5279), the Safe Cosmetics
and Personal Care Products Act of 2019 (116th Congress, H.R. 4296), and the Personal Care Products Safety Act (117th
Congress, S. 2100).
178 See, for example, the Cosmetic Modernization Amendments of 2017 (115th Congress, H.R. 575), the FDA Cosmetic
Safety and Modernization Act (115th Congress, S. 2003), the Cosmetic Safety Enhancement Act of 2019 (116th
Congress, H.R. 5279), the Safe Cosmetics and Personal Care Products Act of 2019 (116th Congress, H.R. 4296), and
the Personal Care Products Safety Act (117th Congress, S. 2100).
179 Grace Wallack, “Rethinking FDA’s Regulation of Cosmetics,” Harvard Journal on Legislation, vol. 56, no. 1
(2019), p. 336.
180 See, for example, the Cosmetic Modernization Amendments of 2017 (115th Congress, H.R. 575), the FDA Cosmetic
Safety and Modernization Act (115th Congress, S. 2003), the Cosmetic Safety Enhancement Act of 2019 (116th
Congress, H.R. 5279), the Safe Cosmetics and Personal Care Products Act of 2019 (116th Congress, H.R. 4296), and
the Personal Care Products Safety Act (117th Congress, S. 2100).
181 See, for example, the FDA Cosmetic Safety and Modernization Act (115th Congress, S. 2003), the Cosmetic Safety
Enhancement Act of 2019 (116th Congress, H.R. 5279), the Safe Cosmetics and Personal Care Products Act of 2019
(116th Congress, H.R. 4296), and the Personal Care Products Safety Act (117th Congress, S. 2100).
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facility registration, require mandatory reporting of adverse events, and issue cosmetic GMP.
Furthermore, the safety assessment report required for PFAS may allay some concerns about a
lack of risk assessment robusticity.
However, even with the enactment of MoCRA, some previously identified issues remain—
primarily the ongoing lack of premarket approval for cosmetics and many other ingredients of
concern not selected for risk assessment. Among these unaddressed ingredients are parabens, “a
family of related chemicals that are commonly used as preservatives” to prevent the
contamination and spoilage of many cosmetic products.182 The most common types of parabens
found in cosmetics include methylparaben, propylparaben, butylparaben, and ethylparaben.183
FDA has received many consumer inquiries about the safety of parabens due to public concerns,
often raised by advocacy groups, primarily about potential links between the ingredient family
and endocrine disruption.184 According to the Centers for Disease Control and Prevention (CDC),
“[h]uman health effects from environmental exposure to low levels of parabens are unknown.”185
In turn, FDA states that it does not currently “have information showing that parabens as they are
used in cosmetics have an effect on human health.”186 However, FDA notes that it continuously
reviews published studies on paraben safety and will alert industry and consumers if a health
hazard is determined to exist.187
At present, the implementation of MoCRA introduces some uncertainties, such as certain
enforcement timelines and what constitutes sufficient safety substantiation. Regarding timelines,
some stakeholders have pointed out that enforcement timelines for certain provisions may differ;
for example, adulteration provisions are slated for enforcement by the close of 2023, even though
they are predicated in part on the promulgation of GMP, which could remain in the rulemaking
process until the close of 2025.188 Others have pointed out that MoCRA does not specifically state
what will satisfy the requirement for adequate cosmetic product safety substantiation, and have
noted that cosmetics companies may need to look elsewhere for guidance.189 Moreover, in the
context of these uncertainties, FDA has indicated that cosmetics regulation may be moved to a
new office within FDA, in part to better implement MoCRA.190

182 Examples of some cosmetic product types that may contain parabens include makeup, moisturizers, hair products,
shaving products, and potentially some deodorants. FDA, “Parabens in Cosmetics,” https://www.fda.gov/cosmetics/
cosmetic-ingredients/parabens-cosmetics. Parabens are also used in many drug and food products. Ibid.
183 Often, multiple parabens are used in combination with one another or other preservatives to increase efficacy. Ibid.
184 See, for example, Campaign for Safe Cosmetics, “Parabens,” https://www.safecosmetics.org/chemicals/parabens/;
Environmental Working Group, “What Are Parabens, and Why Don’t They Belong in Cosmetics?,”
https://www.ewg.org/what-are-parabens.
185 CDC, “Parabens Factsheet,” https://www.cdc.gov/biomonitoring/Parabens_FactSheet.html.
186 FDA, “Parabens in Cosmetics,” https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics.
187 Ibid.
188 See, for example, Cooley, “FDA Regulatory Framework for Cosmetics Gets Major Overhaul,”
https://www.cooley.com/news/insight/2023/2023-01-06-fda-regulatory-framework-for-cosmetics-gets-major-overhaul.
189 See, for example, Food and Drug Law Institute, “MoCRA is Here—Now What? Unpacking Litigation and
Regulatory Risk for Cosmetics Brands Following MoCRA’s Enactment,” https://www.fdli.org/2023/02/mocra-is-here-
now-what-unpacking-litigation-and-regulatory-risk-for-cosmetics-brands-following-mocras-enactment/.
190 FDA, “FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring,”
https://www.fda.gov/news-events/press-announcements/fda-provides-update-proposed-human-foods-program-and-
office-regulatory-affairs-restructuring.
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Conclusion
Historically, FDA’s regulatory authority over cosmetics has been more limited and static than its
regulatory authority over other FDA-regulated products. However, 84 years after the passage of
the FFDCA, the enactment of MoCRA represents a significant expansion of FDA’s cosmetic
regulatory authority. MoCRA authorizes for appropriation funds through 2027 to accomplish its
goals.191 MoCRA’s full effect will be determined over the course of its future implementation.

Author Information

Nora Wells

Analyst in Health Policy

Acknowledgments
Hassan Z. Sheikh, Analyst in Health Policy, and Agata Bodie, Analyst in Health Policy, authored a prior
report (CRS Report R42594, FDA Regulation of Cosmetics and Personal Care Products) that was partially
adapted for this report.
For assistance with legal issues on this topic, congressional clients may contact Jennifer Staman,
Legislative Attorney.

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in
its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or
material from a third party, you may need to obtain the permission of the copyright holder if you wish to
copy or otherwise use copyrighted material.

191 Under MoCRA Section 3508, “[t]here is authorized to be appropriated $14,200,000 for fiscal year 2023,
$25,960,000 for fiscal year 2024, and $41,890,000 for each of fiscal years 2025 through 2027.”
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