Ervin Cohen & Jessup LLP

On June 30, 2021, the House Committee on Appropriations (the “Committee”) issued a report accompanying a bill making appropriations for the U.S. Department of Agriculture, Food and Drug Administration (“FDA”), and related agencies for fiscal year 2022.

The report includes the Committee’s review and direction as to the FDA’s work. While most of this guidance was focused on drug-related regulation, the Committee offered some specific directives on food and beverage regulation that may guide the FDA’s future work. The topics of interest in the report related to the food and beverage industry are included below. The Committee’s guidance and direction to the FDA on these topics is likely to impact the direction of the agency and be reflected in future rulemaking and regulations in the following year.

Guidance Regarding General Food and Beverage FDA Regulation and Labeling

  • Food Additives – The Commissioner should provide a report within one year of enactment on options to systematically reassess the safety of food additives and Generally Recognized as Safe substances including how to 1) set priorities for review; 2) obtain the information on use; and 3) update its safety assessment methods to more effectively utilize modern scientific tools to evaluate the toxicity of and exposure to substances added to foods. The report should include resource needs including staffing dedicated exclusively to performing reassessment.”
  • Plant-Based Product Labeling – The Committee is aware of the ongoing debate around plant-based product labels and the use of traditional meat, dairy and egg terminology. However, the Committee is concerned by the assertions being made that labeling of these products are misleading, deceptive and confusing to consumers. The Committee directs FDA to provide clarity around the labeling of plant-based foods that use traditional meat, dairy and egg terminology.”
  • Dietary Supplements – The Committee is concerned with the lack of robust regulation of dietary supplements, some of which cause an estimated 23,000 emergency room visits per year that include life-threatening illnesses and deaths, and encourages the FDA to issue regulations requiring mandatory product listing and registration to create transparency in the supply chain.”
  • Front of Package Labeling – The Committee is concerned with elevated rates of diet-related disease and encourages the FDA to explore issuing regulations requiring mandatory labeling to appear on the front of package for food products, allowing consumers to quickly assess the healthfulness of foods.”
  • Standard of Identity Activities for Foods – The Committee is concerned with the lack of transparency and progress in modernizing the FDA’s standards of identity regulations. To fulfill the Committee’s previous instructions, not later than 30 days after the date of enactment of this Act, and annually thereafter, the FDA shall submit to the Committees, and make publicly available online, a report outlining its progress on modernizing its standards of identity regulations, including demonstration of improved transparency and improved progress.”
  • Traceback – The Committee recognizes that the ability to trace back contaminated products is critical to containing food safety outbreaks but that challenges associated with tracing these products from the end-consumer through the supply chain continue to persist. The Committee directs FDA to emphasize in its final rulemaking the importance of capturing at the point of sale details such as the lot number and product identifier instead of prescribing the mechanism by which the information is shared through the supply chain. The Committee also directs FDA to ensure these details are maintained from the point of origination, creation, and/or transformation through to the retail food or food service establishment. To avoid duplication, the Committee urges FDA to clearly define traceability requirements that, where possible, align with existing consensus standards for traceability utilized by industry and allow for records to be maintained in electronic and paper form.”
  • Food Traceability – The Committee provides an increase of $9,500,000 to facilitate traceability and enhance outbreak response to prevent further illnesses. The Committee is encouraged by the work FDA has done in developing a blueprint to outline strategies to develop a wide-scale traceability system that helps companies and government agencies more rapidly trace foods implicated in disease outbreaks and subject to recall through their New Era of Smarter Food Safety Initiative.”
  • PFAS in Food – FDA should continue its work to investigate PFAS in our national diet and in food packaging that contacts food.”
  • Net Weights – The Committee encourages FDA to continue devoting appropriate efforts to address suspected economic integrity issues, particularly with respect to net weights, and treatment of seafood. The Committee believes ‘‘short-weighted’’ labeled products are violating FDA laws and that, despite industry reporting such examples, FDA has not prioritized enforcement. The Committee requests an update from FDA on its efforts to enforce net weight requirements with respect to seafood products.”

Guidance Regarding Specific Categories of Food and Beverage Products 

  • Dairy Standard of Identity – The Committee is pleased that the FDA has begun a deliberative process to review how it will enforce the standards of identity for dairy products as described in 21 Code of Federal Regulations parts 131, 133 and 135. The Committee continues to hear concerns with the labeling of certain foods and beverages as dairy products when the products are plant-based rather than derived from an animal. As such, the Committee urges the FDA to continue its work toward ultimately enforcing standards of identity for dairy products.”
  • Gluten – The Committee is aware that celiac disease is a serious, genetic autoimmune disorder, affecting nearly 3 million Americans, in which ingesting gluten causes damage to the villi of the small intestine. The only treatment is the total elimination of gluten-containing products. In 2017, FDA issued Draft Guidance encouraging drug manufacturers to disclose the presence of gluten. While some manufacturers have taken this step, it has not been implemented consistently. This may lead consumers to face continued uncertainty about whether their medicine will do more harm than good. The Committee continues to encourage FDA to consider docket comments received from stakeholders, including consumers, and to work expeditiously to publish a final guidance document.”
  • Seafood Product Labeling – The Committee notes that certain foods are labeled as a fish or seafood product when the products are highly processed plant-based foods rather than derived from actual fish or seafood. The Committee directs the FDA to continue to assess products on the market to determine whether action is necessary to ensure consumers are not misled regarding such product labeling.”
  • Sesame – The committee is concerned that the recent FDA Draft Guidance for Industry on Voluntary Disclosure of Sesame is insufficient to protect Americans with sesame allergy and directs FDA to consider further action to require sesame to be labeled the same as other major allergens.”
  • Canned Tuna – The Committee remains concerned that FDA has not revised the standard of identity for canned tuna to adopt the drained weight fill of container standard despite having received two citizens petitions, as far back as 1994. FDA is directed to promulgate proposed regulations revising the standard of identity for canned tuna consistent with the drained weight standard adopted for canned tuna by the Codex Alimentarius Commission and the Association of Official Analytical Chemists canned tuna, FDA shall, to the extent consistent with applicable regulations, continue to approve in a timely manner temporary marketing permits that adopt the drained weight method consistent with international standards and to approve in a timely manner updates to product labeling under existing temporary marketing permits.”
  • Botanical Dietary Supplements Quality and Safety – The Committee encourages the continued work between the National Center for Natural Products Research and the FDA to conduct research on biological and chemical properties of plants used in dietary supplements, in order to ensure the quality and safety of these products. This collaborative effort helps develop the science base for ensuring the authenticity, quality and safety of botanicals sold as dietary supplements in the U.S.”
  • Olive Oil Standards of Identity – The Committee is aware that the United States continues to be an important producer of olive oils and one of the largest olive oil markets globally. Accordingly, the Committee believes that the establishment of a uniform set of standards would better protect and inform consumers, and directs the FDA to continue to explore a Standard of Identity for different grades of olive oil as required in H. Rpt. 116–446 and provide an updated report to the Committees no later than December 31, 2021.”
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