{
  "id": "R44393",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "R44393",
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  "source": "EveryCRSReport.com",
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      "source": "EveryCRSReport.com",
      "id": 450908,
      "date": "2016-02-22",
      "retrieved": "2016-04-06T22:42:52.309886",
      "title": "Legal Issues Associated with FDA Standards of Identity: In Brief",
      "summary": "Standards of identity for foods overseen by the Food and Drug Administration (FDA) generally define the composition of a food, prescribing both mandatory and optional ingredients and fixing the relative proportions of each ingredient. This report addresses the following legal issues associated with the promulgation and enforcement of standards of identity for foods. \nSection 401 of the Federal Food, Drug, and Cosmetic Act (FFDCA) establishes the legal authority for the FDA to promulgate standards of identity for food. According to this statutory authority, a standard of identity for a particular food is necessary if such a standard would \u201cpromote honesty and fair dealing in the interest of consumers.\u201d\nCongress first authorized the promulgation of standards of identity for foods in 1938 in response to the failure of the federal government\u2019s enforcement actions to regulate \u201cimitation\u201d foods.\nThe FDA creates standards of identity for food through the rulemaking process. The FDA or an interested person via a citizen petition may propose a standard of identity for adoption. After the FDA publishes the proposed standard of identity in the Federal Register, members of the public may submit objections and demand a public hearing. The standard of identity is effective once the FDA publishes the final order in the Federal Register. The FDA\u2019s promulgation of a final standard of identity constitutes a final agency action that is eligible for judicial review. \nThe FDA enforces standards of identity through the misbranding provision in the FFDCA, which states that a food is misbranded if \u201cit purports to be or is represented as\u201d a food for which the FDA has established a standard of identity and deviates from that standard. Once the agency deems a food to be misbranded under this provision, then the agency can exercise various enforcement options. \nCongress generally has not modified FDA\u2019s authority for promulgating standards of identity. However, Congress has introduced legislation calling for the FDA to promulgate standards for specific foods. For example, the Trade Facilitation and Trade Enforcement Act of 2015 (H.R. 644, S. 1269) of the 114th Congress includes a provision to encourage a standard of identity for honey.",
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