FDA budget request seeks increased oversight of food ingredients, including GRAS compliance, dietary supplement information, warnings of shortages

The agency’s fiscal 2025 budget, released last month, “makes more targeted investments” in the ongoing top three priorities for the proposed Human Foods Program, which is expected to be approved this year.

“While our proposal for a unified Human Foods Program goes through the external review process required for all major federal organizations, our vision for this work has already taken shape. Now, and into the future, we are focusing our work around three priorities: ensuring food safety, enhancing food chemical safety and reducing diet related chronic disease through improved nutrition,” Jim Jones, the first deputy commissioner for human foods, said last week during a webinar hosted by the Alliance for a Stronger FDA.

Lamenting a funding “gap between what is needed and what is available,” Jones said the agency has requested a $15m increase to strengthen and modernize FDA’s capacity to promote a safe, nutritious US food supply, including $6.5m to prevent foodborne illness, $4.5m to ensure chemicals in food are safe and $4m to reduce diet related chronic disease.

“The new funding will reinforce existing activities and support new initiatives to ensure the agency remains on the cutting edge of the latest advancements in food safety and nutrition science,” he explained.

FDA seeks authority to encourage GRAS notification, compliance​

Among these “new initiatives” is a plan to develop and implement an enhanced post market reassessment of chemicals, both additives and contaminants, that occur in food, and encourage more companies to file with the FDA determinations that new ingredients are Generally Recognized As Safe (GRAS), Jones said.

“Reassessments are necessary to ensure that current scientific knowledge is brought to bear and safety assessments and authorizations continue to meet the safety standard … and those that do not will be regulated appropriately,” he explained.

FDA has come under pressure recently for food additives that are allowed in the US but not in some other countries, prompting several states, including California, to see local bans.

In response, Jones says FDA plans to review the safety of more food additives, but to do so effectively, the agency needs additional funds “to improve information gathering, detection of signals, safety assessment processes and reporting systems to enhance transparency and stakeholder engagement on the safety and status review of ingredients and chemicals in food.”

In addition, Jones said, “we expect some portion of the FY 25 funds to strengthen the compliance program to incentivize industry to meet all appropriate requirements in its use of the GRAS program for food additives and food contact materials.”

While Jones acknowledged that “no one is required to submit a GRAS notification [to FDA],” companies “still have to be compliant with the requirements of GRAS.”

He added FDA officials “think that the confidence in the food supply is increased when there is a notification” filed with FDA, because agency experts then have a chance to determine whether or not companies are actually in compliance with the requirements.

Some companies may self-determine a new ingredient is GRAS but not file a notification with FDA because they want to protect the research or details about the ingredient, and when a GRAS notification is submitted to FDA all relevant research must be made public.

Jones was fuzzy on how the agency would identify new ingredients for which GRAS determinations have not been filed with FDA, but suggested when the agency identifies such cases it may review them for compliance with GRAS regulations.

He added that FDA is “committed to sharing updates throughout our process and providing consumers with information that helps them put these updates into context by developing materials aimed at improving knowledge and understanding of the role of chemicals in food.”

FDA wants to require all dietary supplements be listed with the agency​

Similar to FDA’s increased interested in GRAS determinations not filed with the agency, Jones said he is seeking additional authorities to increase visibility into the dietary supplement space.

“We are requesting that our authorities be amended to require all dietary supplements be listed with FDA – including product specific information, such as brand name, ingredients and the amounts of each ingredient,” said Jones.

“These amendments would help FDA to know when new products are introduced, and quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary,” he added.

‘Nutrition offers one of the highest returns on investment’​

FDA also is requesting an additional nine full time equivalents to expand the nutrition program within the planned Nutrition Center of Excellence to help develop evidence-based policies and regulations that address hunger, nutrition, and health – with an emphasis on early childhood nutrition.

“As a public health intervention, there is no question that nutrition offers one of the highest returns on investment. Based on the cost of diet related disease and estimated total public health benefits, we estimate that for every $1 invested by FDA in nutrition, there is an estimated annual return on investment of $119,” said Jones.

The request would also help the agency empower parents and caregivers in making informed choices in the foods they purchase to help establish healthy eating patterns in their children early in life, he said.

He explained: “The new funding may also support collaboration with other partners in government and academia, in the development of information for consumers on early childhood nutrition, especially on reducing added sugars in the diet.

“To support this work, FDA will need to onboard scientists to develop regulations and guidance on claims important to maintaining healthy dietary practices, and reducing the risk of diet related chronic disease across across the lifespan, such as those related to whole grains, added sugars, and other health related claims, as well as new scientists and biostatisticians to develop regulations and guidance for labeling of toddler drinks, including products marketed and sold online.”

The agency’s work on nutrition would be long-awaited front-of-pack label updates, which Jones said will come this summer, and an updated definition of healthy and corresponding icon for labels.

FDA seeks clarification on reporting obligations related to supply chain disruptions​

Finally, to further support nutrition by mitigating potential disruptions and inform decision-making during a crisis situation, like the recent infant formula recall, Jones said, the agency seeks clarification on its authority received in 2022 to require manufacturers of critical foods to notify it if they anticipate a meaningful disruption in supply.

“This change will clarify that we can require critical food manufacturers to report certain information and impose additional conditions on the scope, timing, frequency and manner of notifications,” he explained.

He justified the authority, noting, “the FDA has a critical role to play in preventing shortages and helping industry overcome supply chain challenges. And an investment in resources and additional authorities will help us meet this responsibility.”