FDA adds chemicals targeted by state bans to its post-market safety review list

“It is clear that Americans expect the FDA to be doing more to ensure the safety of their foods. We can see this in the state legislative agendas both in bills introduced and passed. There is significant movement to ban certain food additives and to establish the limits of environmental contaminants and food,” FDA’s new Deputy Director for the proposed Human Foods Program Jim Jones told stakeholders last week during a webinar hosted by the Alliance for a Stronger FDA.

While he acknowledged states are well within their rights to ban ingredients of concern, as California recently did​ for propylparaben, brominated vegetable oil, Red Dye No. 3 and potassium bromate, it “is not ideal,” he said.

He argued, “FDA needs to lead the way in food chemical safety, because your access to safe foods should not depend on where you live in the United States.”

To this end, he said, FDA is creating an risk-based framework and approach to enhance food chemical safety that will be housed under the proposed Human Foods Program, which Jones is helping to create and will lead.

Effectively executing this framework, however, will require more resources than FDA currency has, added Jones.

“Even the most targeted and efficient approach can only take you so far. You need the resources to support the work,” he said. “We must be resourced to do the labor intensive work that is required by a science-based agency in chemical reassessment. And as things state, we are not. A proliferation of new food ingredients, food contact materials and production techniques ahs not only increased the workload in this area,but has also increased the complexity of the work.”

FDA requested its “largest budget increase ever” for fiscal year 2024, which included a request for $90m and 40 full-time equivalent positions for chemical reassessment.

This request “would have allowed us to be much more ambitious in the number of existing chemicals being assessed and increased the speed at which we are able to do this work. Developing a systematic and more nimble process for evaluating chemicals in the food supply is a major undertaking and the requested funding would have allowed us to increase our capacity higher,” he explained.

He also noted that Congress is unlikely to fulfill this request. After several continuing resolutions to extend the prior year’s budget, Jones said he now expects “essentially a flat budget compared to FY ’23.”

Failing to account for inflation means FDA’s “resource base is actually decreasing,” said Jones. “We are limited in how much we can do in the space. The extent to which we conduct chemical reassessments in a budget constrained environment is reflected in our most recent update to the chemicals under review for 2024.”

FDA updates list of chemical reviews ​

While the current budget may not allow FDA to increase the number or speed of chemical reviews, Jones said the agency can and is increasing transparency into the review process.

Last week the agency updated the list of chemicals it is assessing, adding mycotoxins (T-2 toxin, HT-2 toxin and zearalenone), potassium bromate, and propylparaben. The list also includes 3-Monochloropropane-1,2-diol (MCPD) esters and Glycidyl Esters (GE); 4-MEI 4-Methylimidazole CAS Number 822-36-6; arsenic, authorized PFAS including certain short-chain per- and polyfluoroalkyl substances in food contact and paperboard, authorized PFAS in food contact applications, bisphenol A, brominated vegetable oil, cadmium, Red Dye No. 3, fluorinated high-density polyethylene, irgafos 168, lead, mercury, partially hydrogenated oil, per-  and polyfluoroalkyl, phthalates, thallium, and titanium dioxide

“This is what is doable with our current staffing. These are staff that are stretched in conducting both pre-market and post-market safety reviews. We hope to help address this issue under the proposed Human Foods Program where we will have staff dedicated to specific scientific chemical assessment teams. … This will help ensure there is adequate attention to both sides of our Food Chemical Safety framework and that it is properly resourced.”

FDA offers increased visibility instead of an increased number of reviews​

Until that point, Jones said he intends to add to this list throughout the year, and “at a minimum” update it annually to share where the agency is in the review process for the chemicals listed.

“With the latest iteration of the review list, the evolution of our approach is not demonstrated by the number of chemicals, but rather in the level of information we are sharing about our review process. We have taken our first steps toward providing more transparency on where we are in our chemical reassessment process as it pertains to specific chemicals,” Jones said.

He explained before last July, FDA shared very little about the reassessment of chemicals, but now it intends to “give a greater level of visibility into where we are along the continuum from reviewing information to risk management action.”

He added that despite resource constraints he has moved five FTEs to to create a group dedicated to post market reassessment in the Office of Food Data of Safety under the proposed reorganization.

“We have envisioned this group to become an office dedicated to post-market activities,” he said, reiterating that he knows advancing food chemical safety is key to public health.