FDA extends comment period for proposed post-market food chemical review

The agency will give stakeholders until Jan. 21 to submit comments – an additional 31 business days from the original Dec. 6 deadline – following a request from industry stakeholders for more time due in part to the holiday season and “numerous ongoing regulatory initiatives,” the agency said in a Federal Register notice​ slated for publication Nov. 21.

The extension is half the amount of time requested​ by the Food & Beverage Issue Alliance (FIBA), which includes the International Food Additives Council, the Alliance for Chemical Distribution and several other trade groups that represent specific segments of the market, such as coffee, confections, juice, baked goods and frozen foods.

FIBA asked FDA for a 60-day extension to Feb. 4, so that it could “fully engage” its membership and “gather comprehensive feedback and submit detailed, thoughtful comments” on the agency’s proposal.

It noted “several significant challenges” hindered its ability to provide well-informed feedback by the original deadline, including how the public meeting at which FDA shared its proposal to update the post-market assessment of chemicals in food was not held until Sept. 25 – more than a month after agency set the original deadline for comment in an Aug. 1 Federal Register notice.

In addition, it argued, “the comment period overlaps with the start of the holiday season,” which effectively limited the working days to “just 46.”

Finally, it noted, “during this same time frame, we are managing multiple critical regulatory initiatives from the FDA, including the final rule on the nutrient content claim ‘healthy’ and the proposed rule on the Front-of Package Nutrition Labeling, among others. These competing priorities create substantial strain on our resources, limiting our ability to provide the thorough and constructive input that FDA seeks” on this issue.

While FDA did not extend the comment period for the full requested duration, it said the new deadline of Jan. 21 should “allow adequate time for interested persons to submit comments.”

Stakeholders seek more details about review process​

At the public hearing in September, FDA outlined​ its much-anticipated and highly-needed proposal to update its post-market safety review process for chemicals in foods, which has become a political flashpoint with state legislators and consumer advocates pushing to ban select additives they deem dangerous.

While it is within states’ rights to prohibit the sale of certain ingredients within their borders, FDA Deputy Commissioner for Human Foods Jim Jones argued at the meeting that a strong national food system is not built state-by-state, but rather should be led by FDA and based on science and data.

He acknowledged that the current post-market safety review program for chemicals in foods is not robust, but said FDA seeks to change its “ad hoc” approach to post-market assessment by leaning on programs of well-respected authorities around the world and new technology, including machine learning and AI.

Under the proposed system, FDA would undertake either a “focused” or a “comprehensive” reassessment of chemicals when a “signal” is identified and validated.

While industry stakeholders lauded the agency for grounding its proposal in science and creating multiple paths to ensure resources are well spent and decisions are made in a timely fashion, they complained that the agency was light on details.

The Environmental Working Group, for example, would like more opportunities for public input in the review process and more clearly established criteria for determining which path to follow based on public health endpoints. It also said it would like to know how FDA will examine the safety of chemicals that companies self-determine as GRAS but for which they do not notify the agency.