“I’m Interested in a Revolution” -- RFK, Jr. Outlines His FDA Priorities in the Regulation of Food Ingredients and Food Packaging
Health and Human Services Secretary Robert F. Kennedy, Jr. recently addressed a diverse group of stakeholders at the “Chemicals of Concern Policy Summit,” stressing the need for industry, regulators, and public advocacy groups—aka non-governmental organizations (NGOs)—to work together to reduce exposures to toxic chemicals, to which Secretary Kennedy attributes, at least in part, to the rise of chronic disease in the United States, particularly in children.
“Microplastics and chemicals from food production, assembly lines and packaging not only end up in our food, they also contaminate our soil, our water, our oceans, and from there, they re-enter the food supply,” he said. (His presentation can be found here.)
Secretary Kennedy followed his talk as a participant in a panel discussion with scientists from NGOs and academia to discuss actionable policy pathways to achieve his stated goal of addressing what he referred to as “a meteoric rise in chronic disease.” The panel focused on ways to minimize exposure to perceived harmful substances in food and food packaging.
During his presentation, Kennedy made the following promise:
Over the next four years, I’m going to use every lever of power that my Agency has, every weapon in the HHS arsenal, to change the regulatory environment.
The Secretary outlined six specific ways FDA will seek to carry out this agenda.
- Revise the generally recognized as safe (GRAS) process. Secretary Kennedy has already directed FDA to consider rulemaking to eliminate the self-GRAS compliance path that is in the Federal Food Drug and Cosmetic Act. RFK’s goal is to enhance transparency for consumers and require FDA review of all food contact substances. See Keller and Heckman’s article, “Could Self-GRAS Determinations be Eliminated?” for our analysis of the HHS mandate to FDA and the potential challenges the Agency may encounter.
- Implement a systematic post-market program to review previously approved “food additive chemicals and food contact chemicals.” FDA proposed a process last year to implement post-market review mechanisms within the Human Foods Program. It appears that this will be a continued priority for the current Administration. More information on FDA’s discussion paper, public meeting, and potential implementation plans for its post-market review process can be found here.
- Expand toxicology reviews for direct and indirect food additives to include assessments for endocrine and neurobehavioral effects.
- Focus on sensitive populations. The Secretary said FDA will prioritize the development of safety factors for pregnant and breastfeeding women.
- Implement “Integrative Emergency Test Techniques” across all agencies within HHS.
- Consider cumulative and mixture effects. FDA will consider the cumulative and mixture of effects of chemical exposures in the food supply, including substances used in food and food packaging.
Speaking specifically to industry, Kennedy said, “Regulations define the bare minimum; they define what you must do but they don’t limit what you can do so I want to encourage industry to go beyond what is required.” Secretary Kennedy also suggested that industry can be incentivized “to invest in sustainable packaging solutions that are non-toxic, recyclable, compostable, and to develop regulations that prevent new harmful chemicals from entering the market and break the cycle of toxic exposure.”
In addition, he implored NGOs to “be combing through the FDA regulations” and identifying “places that [he] can act” through the regulatory process, which he promised could get done “in 90 days,” and to recommend policy changes that he can accomplish “with a stroke of a pen.”
“Healthy packaging and healthy food are the future,” the Secretary said. “And after decades of neglect, HHS is leading the charge.”
The Summit took place April 22-23 in Charlotte, NC, and was sponsored by The Ocean Plastics Leadership Network and Atlantic Packaging.