While Congress has not modified FDA's authority for promulgating standards of identity, it has called for FDA to promulgate specific standards for certain foods. FDA Standards of Identity

A standard of identity establishes the composition of a food, including mandatory and optional ingredients, and fixes the amounts or relative proportions of each ingredient or a specific method of manufacture. Section 401 of the FFDCA provides the primary statutory authority for the FDA to promulgate standards of identity for food via regulation. Thus, an appropriate standard of identity for a particular food is one that "will promote honesty and fair dealing in the interest of consumers." Section 403(g) of the FFDCA states that the FDA shall deem a food misbranded if "it purports to be or is represented as" a food for which the FDA has established a standard of identity and whose composition deviates from the standard. Legislative History of Section 401

Congress first authorized the promulgation of standards of identity for foods with the Federal Food, Drug, and Cosmetic Act of 1938. Regulatory Process for Adoption of Food Standards

The FDA promulgates standards of identity for food through the rulemaking process. First, the FDA or any "interested person" via a citizen petition may propose a standard of identity for adoption. Judicial Review

The FDA's final standard of identity constitutes a final agency action that is eligible for judicial review. FDA Enforcement of Standards of Identity

The FDA enforces standards of identity through the misbranding provision in the FFDCA (Section 403). Once the agency deems a food to be misbranded under this provision, then the agency can exercise various enforcement options against the manufacturer or other industry representatives. Related Legislation in the 114th Congress

While Congress has not amended the FDA's legal authority to create standards of identity, Congress has introduced legislation in the past to encourage FDA's promulgation of specific standards of identity. For example, the Trade Facilitation and Trade Enforcement Act of 2015 includes a provision declaring that it "is the sense of Congress that the Commissioner of Food and Drugs should promptly establish a national standard of identity for honey for the Commissioner responsible for U.S. Customs and Border Protection to use to ensure that imports of honey are (1) classified accurately and for purposes of assessing duties; and (2) denied entry into the United States if such imports pose a threat to the health or safety of consumers in the United States."
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.
Section 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 "promote honesty and fair dealing in the interest of consumers."
Congress first authorized the promulgation of standards of identity for foods in 1938 in response to the failure of the federal government's enforcement actions to regulate "imitation" foods.
The 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's promulgation of a final standard of identity constitutes a final agency action that is eligible for judicial review.
The FDA enforces standards of identity through the misbranding provision in the FFDCA, which states that a food is misbranded if "it purports to be or is represented as" 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.
Congress generally has not modified FDA's 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.