Will 2022 be the year the FDA finally weighs in on CBD regulations, or defines 'natural'? Will we see guidance from the FDA on the pre-market consultation process for cell-cultured meat? Is compliance with the bioengineered food disclosure standard going to be a problem? FoodNavigator-USA quizzed leading food law attorneys to find out what's on their radar as 2021 draws to a close... Image: Getty Images-24K-Production
Claudia Lewis, partner, Venable: There is often a fine line between permissible immune function claims and impermissible disease prevention claims. As the pandemic continues, I am curious as to where FDA will draw the line...
While HR 8179 (to legalize hemp and hemp-derived CBD for use in dietary supplements) is pending, I will be watching how, what and when FDA may take enforcement action on such products.
Finally, 'healthy' food products are usually considered to be low in fat, sodium, and cholesterol; but the plaintiff’s bar seems to evaluating the use of the term in a much broader way. Even if FDA’s standard is met, the plaintiff’s bar seems to be viewing the food profile (i.e., product name, ingredients, daily value, phytochemicals, additives, etc.) and the purpose the food product is meant to serve to evaluate whether it is in fact healthy. I will be keeping an eye on this.
Dale Giali, partner, Mayer Brown: This holiday season, I’m looking for the gift of complete clarity regarding front-of-pack protein content statements, particularly on vegetarian and vegan food. As all good girls and boys know – and as the court appears now to understand – a front-of-pack protein quantitative statement is not only permitted, but should be derived using the nitrogen method and without correction for digestibility. Now THAT’s worth joyous holiday celebration!
Meghana Shah, partner, Eversheds Sutherland: I’ll be keeping my eye on CBD. The industry is experiencing exponential growth and crying out for federal regulatory clarity. With the recent introduction of the CBD Product Safety and Standardization Act in Congress, I expect, at the very least, increased dialogue around the optimal framework for federal CBD regulation in 2022.
Rebecca Cross, founding partner, Greenfare Law: The most relevant issue for my practice will be the FDA’s possible upcoming guidance regarding labeling of plant-based milks. It will be interesting to see whether the FDA truly 'modernizes' its approach to standards of identity (as it suggested back in 2018) by re-affirming the position it has held for the past 50 years: that standardized names can be used on foods that are not, in all respects, the standardized foods. It would be sort of tragic for the FDA to reverse course at this time when innovation in the food industry is so crucial to the health of our planet... and of course, that would be subject to legal challenge...
Jeni Lamb Rogers, associate general counsel, BRANDED: As we enter 2022, supplier qualification and FDA compliance, as businesses continue to operate within the COVID environment, are top of mind for me. Although remote inspection and audits have become a significant and important tool to monitor supply chain compliance, there still has been less activity and opportunity for companies to monitor their suppliers with the same consistency that they could before COVID.
Moreover, with the reduced number of FDA inspections occurring and continued focus on mission critical inspection, there simply is less information available to inform regulatory diligence assessments. I will be watching closely how the agency enforces the dietary supplement CGMP and the Preventive Controls Rules against own label distributors and contract manufacturers, and how the agency responds to continued challenges in auditing and inspecting food facilities.
Ivan Wasserman, managing partner, Amin Talati Wasserman: While it's not FDA’s mission to help reduce food labeling related class action litigation, we are going to look for anything it does that may help, including on the standards for ‘natural’ and ‘healthy.’ With or without that, we are going to watch and remain hopeful that the Second, Ninth, and other federal judicial Circuits will continue to put teeth in the 'reasonable consumer standard' (a/k/a 'are you kidding me?') and dismiss unreasonable claims at the pleading stages.
Ryan Kaiser partner Amin Talati Upadhye: In addition to the usual suspects, like cannabis, 'healthy,' and 'natural' claims, food safety will take center stage as well. Given the growth of grocery e-commerce and food delivery services, I am keenly interested in FDA’s efforts to strengthen food safety protections in a post-COVID world. With more consumers buying food online, FDA has recently questioned how to apply the right regulatory framework to the e-commerce model to ensure foods are properly labeled and delivered safely.
Brian P. Sylvester, special counsel, Covington & Burling: As cultured (i.e., cultivated) meat scales up, we're very likely to see additional regulatory clarity from FDA and USDA in the near term, particularly in light of rulemaking kicked off by USDA's recent ANPR on labeling for cultured meat and poultry products. Comments received on this ANPR will likely also influence FDA's approach to labeling for a range of alternative protein products as FDA and USDA plan to align on key labeling principles.
Bruce Silverglade, principal, Olsson Frank Weeda Terman Matz PC: FDA is under pressure by leading members of Congress, consumer groups, and the public health community to require clearer labeling of alternative sweeteners.
William Acevedo, partner, Wendel Rosen: In 2022, food companies should be focused on traceability within their supply chains. Businesses would do well to remember that in September 2020, the FDA issued the Food Traceability Proposed Rule. We are currently awaiting the final rule, which when promulgated, will establish various traceability and record-keeping obligations to improve the safety of our food and minimize potential disruptions in the food supply in the event of future public health crises or other national emergencies.
This focus will pave the way for a deeper use of and reliance upon technology and data analytics by food companies. How this is implemented by the government and the food industry, and at what speed, will surely be topics on the minds of companies that manufacture, process, pack or hold foods included on the Food Traceability List.
This initiative is a significant part of the FDA’s New Era of Smarter Food Safety Blueprint and the ongoing implantation of the FDA Food Safety Modernization Act, and it will require significant outreach to, education of, and planning by the food industry to achieve meaningful adoption on an industry-wide basis. Technology has been steadily making inroads into the food industry for years now, but the final rule will likely accelerate this trend.
Ben Wolf, senior associate, Alston & Bird: There continues to be a push to bring new food and dietary ingredients to market based on developing technology and interest in nontraditional medicine. These include products made using fermentation processes and cannabinoids like CBD. Determination that an ingredient is Generally Recognized as Safe (GRAS), one of the primary pathways to bring new products to market, was recently affirmed by the courts as viable in Center for Food Safety v. Becerra, and we expect this pathway to continue to be very heavily utilized. In some cases where FDA has commented on the use of a compound, like FDA’s position that CBD may not be included in food or dietary supplements, or there is otherwise considerable interest in an ingredient, we may also see legislation permitting marketing contrary to FDA’s current authority.
Sam Jockel, senior associate, Alston & Bird: One thing I’m watching for in 2022 is the role of changes to labeling requirements in product and packaging formulation decisions. This may include, for example, reformulation of products to comply with the expected revision to FDA’s 'healthy' nutrient content claim, shifts in the ingredient supply chain in response to mandatory bioengineered food disclosure, or closer scrutiny placed on the use of food packaging materials in response to updated requirements for environmental marketing claims. COVID-19 will likely continue to impact these decisions with disrupted ingredient and packaging supply chains into 2022.
