Douglas Stearn, a top official at the Food and Drug Administration (FDA), kicked off IDFA’s Regulatory RoundUP last week with a discussion of the agency’s ongoing efforts on food safety and nutrition issues, especially those that affect dairy. Regulatory RoundUP offers dairy professionals the opportunity to hear directly from decision-makers who have responsibility for the rules that affect dairy plants, products and personnel. The event also features experts who provide insight into emerging issues affecting the industry.

Smarter Food Safety

Stearn is deputy director for regulatory affairs at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and oversees the regulatory programs that cover compliance, nutrition and food labeling, as well as consumer outreach and international affairs. In his keynote address, Stearn began with an overview of the rules issued by FDA to help with implementation of the Food Safety Modernization Act (FSMA).

Phase II of FSMA implementation, he said, will focus on stream-lined decision-making by staff members with specialized skills. He also mentioned FDA’s goals for finalizing guidance and beginning inspections in connection with the Intentional Adulteration rule.

Overall, Stearns said FDA is focusing on “smarter food safety” with an emphasis on using technology to enable faster response and traceability, enhance risk-based analyses and allow for novel food technologies and evolving food business models. He also shared FDA’s efforts to reduce the presence of toxic chemicals in food, including the creation of a working group and  strategy to ensure consistency and collaboration across all policy decisions.

Regarding nutrition, Stearn highlighted the agency’s progress on its multi-year Nutrition Innovation Strategy, which includes several priority issues for IDFA members, such as modernizing standards, claims and ingredient information. The agency also is seeking ways to reduce sodium in the diet with a gradual approach and draft targets that will be a basis for continued dialogue, he said.

The two-day program continued with presentations from other federal officials and industry experts who provided insight on important regulatory issues for dairy.

Food Litigation

Many companies are closely following the rise in class action lawsuits involving food manufacturers. In her session, “Food Fights in the Courtroom,” Veronica Colas, senior associate at Hogan Lovells US LLP, explained why class action litigation and consumer expectations are driving the way dairy companies label their products.

The early stages of litigation, she said, focused on claims regarding the use of the term “natural,” but those lawsuits have evolved into litigation over the definition of “milk,” the health benefits of foods and ingredients, and non-GMO claims.

Noting that future litigation likely will follow consumer interest, Colas predicted a focus on labeling for plant-based products, no-added-sugar claims, protein claims, and the use of “real” or “made with” and “no preservatives” or “no artificial ingredients” claims on labels.  

Navigating Regulations

In his session, “Regulations for Novel Foods and Technologies,” Stephen Ostroff, M.D., former deputy commissioner of foods and veterinary medicine at FDA, discussed how companies can enhance food safety practices and maximize innovation while minimizing regulatory roadblocks.

Drawing on years of experience and leadership at FDA, Ostroff delved into recent trends in foodborne illness statistics and the need for additional technology and tools that can provide smarter food safety.

He also provided updates on reforms the agency is undertaking and the challenges it’s facing, such as keeping up with the exploding use of e-commerce and food delivery systems, as well as the growing popularity of lab-grown meats and plant-based foods. Noting the surge of innovation in the food supply, he said, “Inevitably the marketplace will decide as long as consumers can make informed decisions.”

Intentional Adulteration

Two experts in food defense held a session on “Intentional Adulteration Rule Compliance: Is Your Plant Ready?” and discussed the guidance document on intentional adulteration issued by FDA in March. Companies are required to finalize their food defense plans by July 26, and inspections under the new rule will begin in March 2020.

Jon Woody, Captain, U.S. Public Health Service, and director, food defense and emergency coordination staff, CFSAN, FDA, discussed FDA’s planned inspection strategies, which will start with quick checks and evolve into more comprehensive food defense inspections.

Emily Lyons, associate at Husch Blackwell, outlined the compliance challenges facing the food industry. She shared several strategies for improving compliance, such as building strong food defense plans, teams and cultures within the company and selecting effective mitigation strategies.

Managing  Recalls

The presentation on “Managing Recalls for Dairy” provided perspectives from both public and private sectors.

Scott MacIntire, director of the division of enforcement at FDA’s Office of Regulatory Affairs, explained the agency’s process for conducting a recall. He called attention to policy changes outlined in new guidance released in February, which spell out how food companies should notify the public of a recall. He also said the agency plans to release additional guidance to help food companies become “recall ready.”

According to MacIntire, of the 586 voluntary food recalls in 2018, 195 were deemed Class I, which means there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

Joe Levitt, partner at Hogan Lovells US LLP, provided practical advice companies can use to prepare for and navigate a recall. Because many firms have never experienced a recall, the first time can be difficult, he said, but it’s important to act quickly. Taking the proper steps without delay may help to narrow the scope of the recall, because today’s complex supply chain allows many foods to be used as down-stream ingredients in other food products as well.

Levitt urged companies to be prepared, adding that knowing the right people to contact is key. Companies can find their regional FDA Recall Coordinator here.

Additional presenters discussed the impact that global nutrition policy is having on U.S. policies and provided updates on federal regulatory actions related to per- and polyfluoroalkyl substances (PFAS).

For more information, contact:

• Cary Frye, IDFA senior vice president of regulatory affairs, cfrye@idfa.org
• John Allan, IDFA vice president of regulatory affairs and international standards, jallan@idfa.org
• Danielle Quist, IDFA senior director of regulatory affairs and counsel, dquist@idfa.org