The FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response recently published a list of guidance topics, two specifically addressing labeling, that are a priority for the FDA to complete during the next 12 months.

The list focuses on “Level 1” draft and final guidances. FDA “Level 1” guidances provide the agency’s initial interpretations of significant new regulatory requirements, describe substantial changes in FDA’s earlier interpretation or policy, and address complex scientific or highly controversial issues.

Guidance documents represent the FDA’s current thinking on a specific topic and the information can help stakeholders plan for potential changes that may impact their businesses and organizations. They do not impose legally enforceable requirements. CFSAN anticipates publishing many of the documents included on the list by June 2022.

Specific Topics Under Consideration

The two labeling guidances are as follows: 

• “Draft Guidance for Industry: Labeling of Plant-based Milk Alternatives”; and
• “Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling.”

There has been rising interest in recent years from stakeholders and others for the FDA to reconsider its standards of identity for various food products, particularly dairy products. Almost 12,000 comments were received in response to an FDA request for information in 2018 seeking input on how consumers use plant-based dairy products and how they understand terms such as “milk” or “yogurt” when included in the labeling of such products (83 Fed. Reg. 49103).

Bipartisan legislation has been introduced during several recent sessions of Congress that would require the FDA to act against food manufacturers that label plant-based products as “dairy.” The Defending Against Imitations and Replacements of Yogurt, milk and cheese to Promote Regular Intake of Dairy Everyday Act (DAIRY PRIDE Act) directs the FDA to move against “the proliferation of plant-based products in the marketplace that are mislabeled as milk.”

In the June 11 Federal Register (86 Fed. Reg. 31117), the FDA issued a final rule to amend and modernize the standard of identity for yogurt by accommodating greater flexibilities and technological advances in production. The final rule was part of the FDA’s Nutrition Innovation Strategy, which began in 2008 and includes as a goal the modernization of “food standards to maintain the basic nature and nutritional integrity of products while allowing industry flexibility for innovation to produce more healthful foods.”

Two years ago, the National Milk Producers Federation (NMPF) submitted a citizen petition to the FDA requesting that the agency undertake efforts “to stem the tide of nutritionally inferior, nondairy, plant-based foods that are being labeled and marketed in a manner that misrepresents these foods as forms of” milk, yogurt, cheese, ice cream and butter. NMPF wants the FDA to enforce what is calls “existing ‘imitation’ labeling requirements against nutritionally inferior nondairy substitutes for standardized dairy foods.”

Other guidances in the recently posted list relate to allergens and dietary supplements, including the following:

• “Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act”;
• “Draft Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5)”; and
• “Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications.”

List Changes May Be Appropriate

In the future, the FDA intends to release the list of anticipated human food and cosmetic guidance topics at the beginning of each calendar year with updates scheduled for mid-year. The recent listing will be updated next January. Several factors may impact FDA’s ability to issue the listed guidances, including, for example, new priorities, emerging public health issues or other significant events. Public comments on the list, including suggestions for alternatives or recommendations on the topics FDA is considering, can be submitted to Regulations.gov (Docket No. FDA-2021-N-0553).

The FDA’s list of guidance topics is just one resource that the foods program routinely shares with stakeholders and partners to help inform them of agency priorities. Most planned proposed and final rules can be found on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published twice a year by the Office of Information and Regulatory Affairs in the Office of Management and Budget.