FDA and FSIS Withdraw 2005 Proposed Rule on General Principles for Foods Standards Modernization
 
FDA and USDA’s FSIS are withdrawing the 2005 joint proposed rule that would have established general principles for food standards modernization.  FDA states that when it reopened the proposed rule in 2020 for further comment, many commenters “suggested that the general principles be revised and consolidated to make the principles easier to understand and implement.” FDA and FSIS are withdrawing the proposed rule “to reconsider how best to approach general principles and food standards modernization to ensure any future revised general principles are consistent with the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the FD&C Act.”
 
Why it matters: Though FDA and FSIS do not address whether they will adopt an approach more in line with the food industry’s recommendation to pursue horizontal changes to food standards that would provide flexibility across multiple standards of identity, we view this as a positive step. Nevertheless, we expect meaningful food standards modernization will be a long road ahead. Indeed, FDA has not previewed any rulemakings or guidance documents on broad food standards modernization that are expected to be issued in the next year.
 
FSIS Proposes New Requirements for “Made in USA” Claims
 
FSIS issued a proposed rule that would change the criteria for making voluntary “Product of USA” or “Made in USA” claims for meat, poultry, and egg products. Under the proposal, these products could bear the claims "Product of USA" or "Made in USA" only if (1) all meat or poultry components are from animals born, raised, harvested, and processed in the United States and (2) if all other components in a multi-component product are of domestic origin. Comments are due by May 12, 2023.  For more detailed information, see HL Update here.
 
Why it matters: The proposed rule would restrict the scope of products eligible for this claim, and it would more closely align FSIS’s policy for “Made in the USA” claims with the Federal Trade Commission’s policy, which is applied to FDA-regulated foods and other consumer products. Updating this standard has been a long-running Biden Administration priority. 
 
NAD Finds Against JBS Net Zero Emission Claims; NARB Upholds NAD Decision Against ABA
 
The National Advertising Division (NAD) issued a decision involving JBS USA Holdings, finding that various advertising claims about the company’s 2040 net-zero commitment conveyed implied claims that the company had not adequately substantiated. In a challenge lodged by the Institute for Agriculture & Trade Policy, NAD reviewed several JBS claims articulating the company’s commitment to achieve net-zero emissions by 2040, such as “JBS is committing to be net zero by 2040.” In each instance, although JBS had taken steps such as funding research, beginning strategic planning, or agreeing with a third-party organization to develop a scientific benchmarking scheme, the NAD found that the claims implied JBS had in fact already taken steps in an operational plan designed to meet its net-zero commitment by 2040. JBS indicated it would appeal the decision.

In a related development, NAD’s appellate body, the National Advertising Review Board, upheld a November 2022 NAD decision recommending that the American Beverage Association (ABA) modify several claims made in connection with its Every Bottle Back plastics recycling initiative. NARB agreed with NAD that the claims on appeal (e.g., “They’re collected and separated from other plastics so they can be turned back into materials that we use to make new bottles”) conflate current recycling practices with aspirations for recycling practices and outcomes over time. ABA said it disagrees with NARB’s conclusions but will explore how to modify the claims in accordance with the decision. 
 
Why it matters: These cases provide important datapoints on the NAD/NARB perspective on aspirational environmental claims, in which a company or some portion of industry has committed to meeting a specific future goal but may still be in the early stages of developing its strategy for meeting that goal.  As industry develops and communicates about increasingly sophisticated ESG commitments, it will be important to understand how advertising regulators interpret those commitments and what guardrails are necessary when discussing those commitments in consumer-facing materials.  
 
FDA Completes Second Cell-Cultured Product Consultation
 
FDA recently announced that it has completed its second Cell Culture Consultation process.  On March 20, FDA published a letter of no objection and related materials for GOOD Meat, Inc.’s cell cultured chicken product.  GOOD Meat in its submission describes its product as chicken cells intended to be “mixed with other safe and suitable ingredients” to create a final product that “resembles a conventional chicken product (e.g., chicken bites and boneless chicken breasts).”  As part of the consultation process, FDA published GOOD Meat’s publicly releasable safety assessment, FDA’s no questions letter, and a scientific memo summarizing FDA’s review of the company’s submission.  Additional steps remain before the product can be brought to market.  FSIS will have jurisdiction over the post-harvest processing and labeling of this product, and FSIS policy requires that all labels for amenable cell-cultured products have to go through sketch approval before products are marketed. 
 
Why it matters: FDA has now completed two premarket consultation processes for cell cultured products: UPSIDE Foods’ last fall and now GOOD Meat’s this month. Both products involve chicken cells. This completed consultation reinforces that cell cultured products can clear FDA’s review process, and the publicly available materials provide additional guidance on the type of information FDA expects to see as part of the safety assessment.  This development also provides some insight into timing: GOOD Meat’s submission was dated March 2022, meaning the formal review process took a year, although the company likely had engaged in informal discussions with FDA well in advance of submitting its final consultation package.
 
EPA Issues Proposed Rule for PFAS in Drinking Water, Future Implications for Bottled Water
 
The Environmental Protection Agency (EPA) recently published a proposed National Primary Drinking Water Regulation (NPDWR) that would set maximum levels for six PFAS in drinking water (i.e., municipal or tap water), including for PFOA and PFOS as individual contaminants at 4 ppt, and PFHxS, PFNA, PFBS, and GenX Chemicals as a PFAS mixture. The maximum levels would become effective three years after a final rule is issued, allowing drinking water systems time to achieve compliance. Comments on the proposed rule are due May 30, 2023.

Why it matters: Under the so-called “hammer provision,” when EPA establishes NPDWRs for contaminants, FDA must incorporate the same contaminant level into its standard of identity for bottled water within 180 days of the effective date of the EPA rule, unless it finds the contaminant is not present in bottled water. If FDA fails to promulgate this regulation or otherwise publish its reasoning that the regulation is not necessary within 180 days, the EPA NPDWR is considered effective for bottled water.
 
FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements
 
FDA announced the launch of a new Dietary Supplement Ingredient Directory website that lists dietary ingredients about which FDA has raised health concerns.  Although positioned as an ingredient directory, the website primarily collects ingredients FDA views as posing a health risk.  The website identifies the dietary ingredient, lists commonly used names, and provides links to FDA warnings or enforcement actions related to those ingredients.  FDA indicates it intends to update the directory periodically and cautions that it is not intended to be a comprehensive list.  
 
Why it matters: The new Directory provides a consolidated, although possibly incomplete, resource that companies can use when screening dietary ingredients or products for known health or enforcement risks.  Similarly, although publicly available FDA statements already exist for the ingredients listed in the Directory, creating a single listing of ingredients FDA views as unsafe will likely increase the litigation risk associated with products containing those ingredients.
 
FDA Provides Update on Plans to Restructure Human Foods Program
 
FDA provided a further update on how it plans to restructure its oversight and regulation of human foods. Following its January announcement that CFSAN, the Office of Food Policy and Response, and certain functions within the Office of Regulatory Affairs (ORA) would be combined into a single organization under the leadership of a Deputy Commissioner for Human Foods, FDA advised in February that it has begun a national search for the new Deputy Commissioner; plans to move cosmetics regulation and color certification activities out of CFSAN into the Office of the Chief Scientist; and, led by Principal Deputy Commissioner Janet Woodcock, has initiated several internal workstreams (e.g., budget, laboratory coordination; new inspections workflow system) that will help inform the agency’s detailed proposal for reorganization, which it anticipates sending to Congress for approval this fall. 
 
Why it matters: Expect FDA to go quiet for several months as it works out the details of its reorganization plan but criticism that the agency’s proposed reorganization falls short of what is needed to address the organizational and leadership shortcomings identified in the Reagan Udall report seems likely to continue. Some want foods removed from the agency completely; others are highly dissatisfied with the decision not to give the Deputy Commissioner direct line management authority over all of ORA’s human food activities. Time will tell whether those calls, action by Congress, or both result in a change in direction. 
 
FDA Submits FY 2024 Budget Request; Seeks Additional Legal Authority
 
FDA submitted a $7.2 billion budget request for FY 2024, an increase of $372 million over FY 2023. Of the total requested, $1.36 billion would go to foods. FDA would devote approximately $133 million in new funding for foods to food safety and nutrition “modernization” efforts including strengthening infant formula oversight, “empower[ing] consumers to make healthier food choices,” and “reduc[ing] exposure to toxic elements.” Paired with the budget request are several legislative proposals that, if enacted, would expand the agency’s food-related authorities (e.g., allow FDA to set limits on  heavy metals via administrative order and require formula manufacturers to report positive pathogen results to FDA; mandate heavy metals testing of finished products intended for infants and young children). 
 
Why it matters: More than a year after the Abbott infant formula recall, concerns about the agency’s handling of pathogen contamination in that sector continue to generate negative headlines and attention from Congress. While that plus questions about the adequacy of FDA’s restructuring plan for foods do not rule out FDA getting more money from Congress, it may mean that money comes with a few more strings attached. Over the next few months, look for FDA to do all it can to make tangible progress on heavy metals, infant formula oversight, and food labeling to prove it deserves Congress’ trust.