FDA Explains Proposed Process for Post-Market Assessment of Chemicals in Food
The U.S. Food and Drug Administration (FDA) held a public meeting on September 25, 2024, to explain and solicit input on the Agency’s development of an enhanced systematic process for post-market assessment of chemicals in food. This process is intended to serve as the vehicle used by the agency to enhance food chemical safety, which as Deputy Commissioner for Human Foods Jim Jones explained, “is among our top priorities in the new human foods program.” FDA has posted a recording, transcript, and meeting summary for the proceeding.
The previous month, FDA published a Discussion Paper that outlined the general approach for the process, which was the subject of the meeting discussion. That process would emanate from the agency’s “review of information” that includes identifying new information on various chemicals through monitoring of new submissions to the agency, international and US regulatory activities, adverse event reports, news reports, trade press, and social media. This would be followed by a preliminary assessment of the information to determine if a post-market assessment is needed.
If such an assessment was found necessary, a decision would be made as to whether to conduct a “focused” or “comprehensive” assessment based upon the likely complexity of the assessment needed; for example, whether the assessment involved a single study or multiple studies, or may raise other complexities, or is likely to be of significant public interest. Risk management actions would follow a completed assessment, as needed. The Discussion Paper noted that transparency and external engagement will be important parts of its planned process for post-market assessment of chemicals in food.
At the meeting, Deputy Commissioner for Human Foods Jim Jones explained that FDA has not had a robust post-market review program largely because of a lack of a statutory mandate for such a program or to share safety data testing “with FDA after a chemical is introduced into the market.” Deputy Commissioner Jones noted that the Agency has taken “an ad hoc approach to post-market safety.” This new program is intended to modernize that approach.
Importantly, the Deputy Commissioner recognized the increasing number of state bills banning certain food additives and limiting certain chemical contaminants in food. Referring to these state bills, he stated, “A strong national food safety system is not built state by state.” He added that FDA has not received an increased budget, but he is committed to doing as much as possible with available resources.
FDA’s lack of a systematic process for post-market review of chemicals was also mentioned by Dr. Kristi Muldoon Jacobs, Director of FDA’s Office of Food Additive Safety. She explained that FDA tends to be reactive by responding to a petition or significant public interest. She added that some post-market reviews of chemicals are initiated by FDA staff when new science is available.
Dr. Jacobs also commented that, currently, there is limited external engagement and limited release of information. She suggested that the program needs to incorporate recognized and repeatable risk assessment principles, focus on public health, and ensure flexibility and transparency.
During a question-and-answer session in which several questions were raised about the expertise, internal and external that FDA would utilize in undertaking these assessments, Dr. Jacobs said at one point that the assessments will be conducted internally, but also indicated that external peer review and other means would be considered in choosing the most appropriate and acknowledged that FDA will work with outside experts. She did also, however, note the expertise and impartiality of FDA staff and seemed to present a clear preference for use of the latter.
In response to another question, she also indicated that the agency is aiming for full implementation of the program by the end of 2025.
The meeting also included presentations from representatives of industry, consumer advocacy groups, and academia. Sarah Gallo, Sr. VP, Product Policy and Federal Affairs, Consumer Brands Association, cautioned that while the amount of related information has exploded, not all the information is of equal quality. She encouraged FDA to rely on reputable scientific sources rather than social media.
U.S. Representative Jan Schakowsky (IL) encouraged FDA to support the Food Chemical Reassessment Act, which would create an Office of Food Safety Reassessment within FDA that would study the safety of at least ten chemicals in food packaging every three years.
During that session, Pennsylvania House Representative Natalie Mihalek told attendees that until FDA finds a way to remove harmful chemicals, states will have to take up the fight.
More information on FDA modernization efforts for establishing a Unified Human Foods Program can be found here.