On Sept. 25, the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather feedback on its proposed framework for an enhanced systemic post-market assessment process for chemicals in food. The International Dairy Foods Association (IDFA) — a vocal advocate for a more proactive, science-based approach to this process — joined stakeholders from the food industry, academia, consumer and environmental advocacy groups, and others who commented on the lack of specificity in FDA’s proposed framework. 

There was general agreement that the framework must be proactive, robust, science-based, and transparent; provide ample opportunities for stakeholder feedback; impose agency accountability for timely decision making and action; and include regulatory oversight. 

While there are differences in opinion on application in practice, the dairy industry strives to provide consumers with safe and nutritious products, beginning with assurances of the safety of the ingredients used. At the same time, dairy companies need timely and sufficient regulatory certainty to support their research and development of novel ingredients and products and to assure a manageable global business environment. 

Here’s how IDFA is approaching our advocacy on this issue:

FDA’s need for a cultural shift to action

For FDA’s proactive post-market assessment program for food chemicals to instill trust, the agency must address its historically slow, reactive approach which has among other things  resulted in the agency always playing catch up. More recently, state legislatures have been stepping in where they believe the FDA has failed to act.

IDFA and other stakeholders agree that accountability demands predictable and timely action through accelerated timelines with milestones for concluding FDA’s proposed “focused and comprehensive assessments.” That said, FDA’s human foods program has a well-established culture of inaction that will require more than a new structure and leadership to reverse. The strategy used for post-market assessments of food chemicals, if done right, just may be what is needed to begin FDA’s shift to action.

Public communication: Avoiding confusion and market disruption

For this proposal to work, the FDA will need to focus carefully on how it communicates to the public about its post-market assessment process and outcomes to avoid consumer confusion and premature market disruptions. FDA needs to keep the public informed about the prioritization process and its purpose. The listing of a substance used in food for post-market review should not signal to consumers to avoid foods that include that substance in fear that it is unsafe. Equally important, FDA needs to publicly defend substances it has assessed and confirmed remain safe for consumers and communicate clearly how such decisions were made. 

To be clear, FDA will need additional resources to implement this post-market process the right way. As a start, IDFA and a broad diverse coalition asked Congressional appropriators for $30 million in additional funding. While this first effort failed, we will continue to urge Congress for the additional funding needed so the FDA can adequately manage this important work.

The GRAS controversy: Industry’s role in ensuring safety

At the public meeting, many non-governmental organizations (NGOs) expressed concerns about the GRAS (Generally Recognized as Safe) system, suggesting that thousands of ingredients lack proper safety assessments. However, IDFA and others in the food industry believe these claims are overstated. The self-GRAS rule was finalized out of necessity given FDA’s limited resources resulting in agency reviews that could not be completed quickly enough to keep pace with food industry innovation and market demands. 

Importantly, since the self-GRAS final rule was issued, the 1,194 voluntary GRAS notifications listed on FDA’s website all underwent rigorous safety reviews by the agency. The majority of these resulted in a “no questions” letter, when warranted, and took eight months to a year for FDA to complete.

IDFA recognizes the industry’s responsibility in ensuring the GRAS system functions effectively. By voluntarily notifying the FDA of GRAS substances and cooperating with enhanced surveillance efforts, companies can build consumer trust and help uphold safety standards.

Food chemical substances play important functional roles in dairy foods. IDFA will continue to push for a transparent, proactive, science-based post-market assessment program at FDA that provides regulatory certainty, assures food safety, instills consumer trust, and, through timely decision-making, supports industry innovation.