S ection 401 of Federal Food, Drug and Cosmetic Act (FFDCA) grants the Food and Drug Administration (FDA) the authority to promulgate regulations that create "standards of identity" for certain foods. These standards establish the composition of the food, including mandatory and optional ingredients. Industry participants who do not follow the standard of identity for a particular food may be liable for misbranding under the FFDCA, which could lead to FDA enforcement action. FDA creates standards of identity through the administrative rulemaking process, with opportunity for public notice and comment. 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. For example, the proposed Trade Facilitation and Trade Enforcement Act of 2015 ( H.R. 644 ) includes a provision that would encourage a standard of identity for honey. This report discusses various legal issues related to food standards of identity. These issues include the legal authority for the FDA to promulgate regulations creating standards of identity, FDA's administrative rulemaking process to create standards of identity, and FDA's enforcement of these standards. This report also provides an overview of related legislation in the 114 th Congress. 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. Congress intended that standards of identity would resemble "recipes" for specific foods. These standards of identity seek to prohibit economic adulteration and mislabeling of food by providing consumers with the "assurance that they will get what they may reasonably expect to receive." Section 401 of the FFDCA provides the primary statutory authority for the FDA to promulgate standards of identity for food via regulation. The provision states that [w]henever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of container. Thus, an appropriate standard of identity for a particular food is one that "will promote honesty and fair dealing in the interest of consumers." Once the FDA creates a standard of identity, no product that fails to meet the composition requirements of that standard may be marketed under the name the FDA has appropriated to that particular standard. 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. After the enactment of the Nutrition Labeling and Education Act (NLEA), the FDA promulgated regulations that allow for the addition of safe and suitable ingredients to a "standardized" food. Under these regulations, a manufacturer may refer to the adapted standardized food by the nutrient content claim and the original standardized food term. For example, under FDA regulations, a manufacturer may use safe and suitable artificial sweeteners that are not expressly listed in a particular standard of identity. According to the FDA, these regulations "assist consumers in maintaining healthy dietary practices by providing for a modified version of a traditional standardized food to achieve a nutritional goal ... [while maintaining] a descriptive name that is meaningful to consumers." The FDA relies on concepts like "safe and suitable" when regulating food to allow for technological flexibility with food development. Permitting such flexibility, according to the FDA, encourages oversight of food "without adversely affecting the characteristics of food" and "minimizes any future amendment of the standards for additional specific ingredients." The FDA also adopts food standards established by the Codex Alimentarius Commission, formed by the World Health Organization and the Food and Agriculture Organization of the United Nations. The Codex Alimentarius is a collection of international recognized food standards and guidelines promoting food safety. The FDA publishes these food standards in the Federal Register for public review and comment before accepting the standard with or without any changes. Congress first authorized the promulgation of standards of identity for foods with the Federal Food, Drug, and Cosmetic Act of 1938. The Pure Food and Drugs Act of 1906, the predecessor of the 1938 act, did not provide the legal authority for the government to promulgate such food standards, leaving the federal government with limited oversight of "imitation" products. During the 1920s and 1930s, the U.S. government brought adulteration and misbranding claims under the 1906 act against a product called "Bred Spred," a fruit product containing 20% fruit. The government claimed that consumers regarded the product as jam, but the product did not have the 45% fruit content generally associated with jam. The manufacturer argued that Bred Spred was not misbranded as it did not purport to be jam. The courts agreed with the manufacturer, holding that the product was not misbranded under the 1906 act because the government did not offer any evidence of false or misleading statements on the label. For the court, the imitation of a product was not sufficient evidence of misbranding under the act. Leading up to the passage of the 1938 act, Congress faced concerns about products such as Bred Spred and the potential fraud and the subsequent loss of consumer confidence that may follow from the purchase of similar foods. According to the legislative history of the 1938 act, Congress primarily authorized the creation of standards of identity as a regulatory tool "under which the integrity of food products can be effectively maintained." During the passage of the 1938 act, Congress acknowledged that "one great weakness in the present food and drugs law [1906 Act] is the absence of authoritative definitions and standards of identity." Referring to the Bred Spred cases, the House report for the 1938 act stated that "the government repeatedly has had difficulty in holding such articles as commercial jams and preserves and many other foods to the time-honored standards employed by housewives and reputable manufacturers." The report also claimed that the government lost these cases because the courts held that these "home" standards are not legally binding under existing law. Thus, Congress intended that the authorization of standards of identity would "meet[] the demands of legitimate industry[,]... [would] effectively prevent the chiseling operations of the small minority of manufacturers, [would] in many cases expand the market for agricultural products, particularly for fruits, and finally [would] insure fair dealing in the interest of the consumer." The Supreme Court has interpreted this legislative history as Congress's recognition of the inability of consumers to determine the relative merits of similar products solely on the basis of the labeling information. The FDA promulgates standards of identity for food through the rulemaking process. The formal rulemaking procedure followed by the FDA in adopting a standard of identity can be organized into three stages. First, the FDA or any "interested person" via a citizen petition may propose a standard of identity for adoption. A private petitioner must state "reasonable grounds" for the proposal in order for the FDA to publish the order and proceed with the process. Thus, a successful petition must assert provable facts demonstrating that the proposal, if adopted, "would promote honesty and fair dealing in the interest of consumers." The petitioner must also assert that he commits himself to substantiate the information in the petition with additional evidence in a public hearing, if such a hearing becomes necessary. If the proposal satisfies this requirement, the FDA publishes the proposal in the Federal Register as a "Notice of Proposed Rulemaking," and all interested persons are invited to file comments orally or in writing. After the agency studies the public comments submitted, the agency can decide to reject the proposal or to accept the proposal by publishing an order. The agency is not bound to issue the order within a specific timeframe after the comment period. Generally, the order, which establishes the standard of identity, is effective on the date specified in the order. Within 30 days of the order's publication, the agency begins the second stage of the rulemaking process. During this stage, all persons adversely affected by the order may submit objections and demand a public evidentiary hearing to resolve disputed factual issues that the objections have raised. The filing of such objections serves as a stay of the disputed provisions in the order, until the FDA takes final action. The public hearing is open to all interested persons and is on the record. The participants of the hearing may present documentary evidence and oral testimony and have the ability to cross-examine the witnesses. Following the hearing, the final stage of the process involves the agency issuing a tentative order, including detailed findings of fact and conclusions upon which the order is based. Any party of record may object to this proposed order and request an oral argument before the FDA. The FDA then publishes the final order setting forth the standard of identity. The FDA's final standard of identity constitutes a final agency action that is eligible for judicial review. A party adversely affected by the standard of identity order may seek judicial review in the U.S. Court of Appeals for the circuit in which the party resides or has a principal place of business. An adverse effect that is too remote or indirect generally does not provide a petitioner sufficient standing to petition a review of the order. Upon such a petition for judicial review, the court then has jurisdiction to affirm the order, or to set the order aside in whole or in part, temporarily or permanently. In reaching such a decision, the court considers whether the FDA's findings regarding the standard of identity order are supported by substantial evidence. According to the FFDCA, the FDA's findings of fact relating to the particular standard up for review "if supported by substantial evidence ... shall be conclusive." According to the Supreme Court, this scope of judicial review is appropriate for the review of "regulations of general application adopted by an administrative agency under its rulemaking power in carrying out the policy of a statute with whose enforcement it is charged."