Although the FDA intends to publish draft or final guidance[1] by June 2022[2] for each of the topics on the priority list, the agency acknowledged it may need to adjust priorities to support emerging issues and other Administration priorities. Going forward, the FDA will issue a list of anticipated human food guidance documents at the beginning of each calendar year with mid-year updates; the list published today will be updated in January 2022.[3] Insight into emerging and changing FDA policy priorities is essential to all stakeholders who seek to anticipate, comment on, and be well-positioned to adapt to emerging policies.
Labeling and nutrition guidance priorities
Labeling-related guidance documents: Plant-based milk alternatives and dietary guidance statements
- Plant-based milks: The FDA indicates it intends to publish draft guidance on the labeling of plant-based milk alternatives. Although the title of the guidance suggests that it is limited to plant-based milk alternatives, this guidance could have potential implications for the labeling of other FDA-regulated plant-based products.
- Dietary guidance statements: The FDA also intends to publish a Q&A-style draft guidance on dietary guidance statements in food labeling. Although dietary guidance statements are a topic previously embraced at times by FDA, the agency has not provided clear parameters on these types of claims.
Nutrition-related guidance: Voluntary sodium reduction goals and protein quality of new infant formula
- Sodium reductions: The FDA will issue final guidance related to the voluntary sodium reduction goals and target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods. The guidance listed in the agenda does not specify whether it will address the short-term (2-year) or long-term (10-year) sodium reduction goals (or both), but the FDA has previously said it intends to finalize the draft short-term targets first.
- Protein quality of new infant formula: For infant formula, the FDA intends on issuing a new draft guidance on Protein Efficiency Ratio (PER) rat bioassays to demonstrate the quality factor of sufficient biological quality of protein for new infant formulas.
Food Allergens
The FDA will update its allergen labeling guidance documents to reflect the addition of sesame as a major food allergen as a result of the FASTER Act.[4] The FDA also anticipates issuing a draft guidance on how to evaluate other food allergens that are not currently treated as major food allergens.
Food Safety Guidance Priorities
Heavy metals in foods for babies and young children
Consistent with Phase 1 of the FDA’s “Closer to Zero” action plan to reduce exposure to toxic elements in foods for babies and young children,[5] the FDA intends to publish three guidance documents over the next year addressing action levels for inorganic arsenic and lead in certain foods for babies and young children. The FDA intends to finalize its draft guidance on an inorganic arsenic action level in apple juice. During this time, the FDA will also gather data on arsenic to work toward establishing an interim reference level (IRL). The FDA also plans to issue two draft guidance documents related to action levels for lead in (1) juice and (2) categories of foods consumed by babies and young children.
FSMA
With respect to guidance documents related to the implementation of the Food Safety Modernization Act (FSMA), the agency plans to move forward with finalizing several existing guidance documents and issuing additional anticipated chapters of the Hazard Analysis and Risk-Based Preventive Controls for Human Foods draft guidance. These include:
- Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry[6]
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready-to-Eat; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
- Questions and Answers Regarding the Accredited Third-Party Certification Program: Draft Guidance for Industry
- Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Guidance for Industry
Other food safety guidance priorities
The FDA intends to update its draft Compliance Policy Guide for FDA staff on Listeria monocytogenes in human food, although the FDA has indicated it will remain in draft form. The FDA also aims to finalize existing draft guidance documents on reducing microbial hazards in the production of seeds for sprouting and prevention of Salmonella Enteritidis in shell eggs.
Finally, the FDA intends to release two new draft guidance documents related to fish and fishery products:
- Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer's Goods from DWPE; Draft Guidance for Industry
- Scombrotoxin (Histamine)-Forming Fish and Fishery Products--Decomposition and Histamine; Draft Guidance for FDA Staff
Guidance priorities related to premarket requirements for foods and dietary supplements
The FDA intends to issue a new guidance document on New Dietary Ingredient Notifications (NDINs) entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications,” although it is unclear which dietary ingredients and dietary supplements will be the subject of the guidance.
The FDA also anticipates finalizing its guidance on best practices for convening an expert panel for generally recognized as safe (GRAS) determinations.
Next steps
Each one of the planned guidance initiatives identified as a priority by the FDA could have a potentially significant impact on the food industry. The ambitious agenda also signals a very active year ahead at the FDA, and, in turn, by regulated companies who strive to understand and ensure regulatory compliance in critical areas that affect nearly every aspect of how foods are made, distributed, and marketed. Anticipating and planning is essential for all stakeholders. We will continue to monitor the FDA’s issuance of guidance documents affecting the food and dietary supplement industry. If you have any questions about FDA guidance documents in development, please do not hesitate to contact us.
References
1 FDA, Foods Program Guidance Under Development, https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development.
2 FDA Constituent Update, FDA Releases List of Guidance Topics for Foods Program, 29 June 2021, https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-list-guidance-topics-foods-program.
3 FDA’s Center for Veterinary Medicine released a similar list of guidance documents under development for 2021, https://www.fda.gov/animal-veterinary/guidance-industry/guidances-under-development-2021.
4 Hogan Lovells, U.S. Congress passes the FASTER Act to require sesame allergen labeling (15 April 2021), available at https://www.engage.hoganlovells.com/knowledgeservices/news/us-congress-passes-the-faster-act-to-require-sesame-allergen-labeling.
5 Hogan Lovells, FDA releases Closer to Zero: An action plan to reduce exposure to toxic elements in children’s foods (9 April 2021), available at: https://www.engage.hoganlovells.com/knowledgeservices/news/fda-releases-closer-to-zero-an-action-plan-to-reduce-exposure-to-toxic-elements-in-childrens-foods.
6 This guidance document likely refers to an update of a guidance document previously issued by the FDA addressing a stay of written assurance requirements among as well as other specific, narrow enforcement policies related to FSMA. See Hogan Lovells, FDA Announces Enforcement Discretion for Certain FSMA Provisions (8 January 2018), available at https://www.hlfoodlaw.com/wp-content/uploads/sites/357/2018/01/HL-Memo-FDA-Announces-Enforcement-Discretion-for-Certain-FSMA-Provisions.pdf.
Authored by Steven Steinborn, Veronica Colas, and Sam Dietle.
