The newly created Human Foods Program (HFP) within the U.S. Food and Drug Administration (FDA) will initially focus on three areas: the Nutrition Center of Excellence; the Office of Microbiological Food Safety; and the Office of Food Chemical Safety, Dietary Supplements, and Innovation.¹ This article will focus on the third area and its potential impact on food packaging. First, though, let us review some background on the decision to create the HFP.

In January 2023, FDA Commissioner Dr. Robert Califf announced a proposed change in the Agency's structure to create the HFP, following the December 2022 release of the report, "Operational Evaluation of the FDA Human Foods Program."² The report was prepared by an expert panel at the Reagan-Udall Foundation, convened at the request of Commissioner Califf, that was charged with assessing the processes and procedures, resourcing, and organizational structure for FDA's Foods Program.

James "Jim" Jones, who had served on the Regan-Udall Foundation's expert panel, joined FDA in September 2023 as the Agency's first Deputy Commissioner for Human Foods. He reports directly to Commissioner Califf. Prior to joining FDA, Jones spent most of his career in various positions at the U.S. Environmental Protection Agency (EPA), where he focused, among other things, on chemical safety in the chemical control and pesticide divisions of EPA, and which included a focus on the impact that chemical substances may have on the U.S. food supply. He was one of the Agency's principals responsible for implementation of the 2016 overhaul of the Toxic Substances Control Act and also responsible for decision-making related to the regulation of pesticides and commercial chemicals. He is expected by some to bring a different perspective to chemical regulation than has been seen at FDA in the past.

In his new position, Deputy Commissioner Jones has already pledged to bolster the Agency's control over chemicals in food. Speaking on a webinar held by the Alliance for a Stronger FDA on April 5, 2024, Jones said, "The year ahead will also be one where we invest in food chemical safety, in particular the development and implementation of post-market reassessment of chemicals, both additives and contaminants, which occur in foods."³

Deputy Commissioner Jones explained that the reassessments will consider current scientific knowledge and involve monitoring the current uses and exposures of food chemicals to identify significant changes in patterns in food consumption and, therefore, related chemical intake. He also suggested that additional personnel will be needed.

As part of the reassessment process, Jones stated, "FDA will aim to improve information gathering, detection of signals, safety assessment processes, and reporting systems to enhance transparency and stakeholder engagement on the safety and status of review for ingredients and chemicals in food."³

“It can be expected that FDA's post-market surveillance program targeting PFAS materials and their uses will take aim at other chemical substances found in food and food packaging, and may involve FDA inspection visits...”

Chemicals Under Agency Review

FDA first published a "List of Select Chemicals in the Food Supply Under FDA Review"⁵ in July 2023, with the goal of regularly updating it. The updated list includes food ingredients, food contact substances, and environmental and other contaminants, and it provides information about the status of FDA's post-market assessment for these series of chemical substances.

For example, two categories of per- and polyfluoroalkyl substances (PFAS) in food contact applications are on the list. Concerning one of the categories—certain short-chain PFAS in food contact and paperboard—FDA explains that it is working with industry to phase out these PFAS. The Agency also noted in a February 28, 2024 announcement that grease-proofing substances containing PFAS are no longer being sold by manufacturers in the U.S. market.⁶

The February 28 announcement came about as a result of a post-market safety assessment completed in 2020, following which three manufacturers came to an agreement with FDA to voluntarily phase out U.S. sales of certain short-chain PFAS that contained 6:2 fluorotelomer alcohol (6:2 FTOH) by the end of 2023. A fourth manufacturer had stopped selling such products in 2019. At that time, there were 15 Food Contact Notifications (FCNs) held by the four manufacturers that contained 6:2 FTOH.

FDA's announcement concerning these products was preceded by the action of other manufacturers to voluntarily withdraw long chain (C8) PFAS products in 2011, and Agency revocation of the food additive regulations authorizing the remaining uses of these long-chain PFAS in food packaging in 2016.⁷ As of the date of the revocations, long-chain PFAS cleared by the regulations were no longer being used in food contact applications sold in the U.S.

Following the voluntary manufacturer phase-out of PFAS 6:2 FTOH in 2020, FDA began in March 2024 conducting a surveillance sampling assignment to monitor the presence of PFAS in grease-proofed food contact paper and packaging. The sampling was scheduled to conclude in September 2024. FDA explained that it planned to collect 150 samples, including butter or margarine paper and wrap, microwave popcorn bags, frozen entrée molded fiber trays and boards, and boxed fatty shelf-stable food boxes and cartons.⁸ The product sampling did not include plastic- or wax-coated materials, such as milk cartons, and infant- or toddler-specific food items.

With respect to food packaging containing PFAS from other countries, on March 20, 2024, FDA announced the issuance of Import Alert 99-48 ("Detention without Physical Examination of Foods Due to Chemical Contamination"), which provides FDA with the ability to prevent entry of human food products into the U.S. if found to contain detectable levels of chemical contaminants that may present a safety concern to human health, including benzene, dioxins, polychlorinated biphenyls (PCBs), and PFAS.

It can be expected that FDA's post-market surveillance program targeting PFAS materials and their uses will take aim at other chemical substances found in food and food packaging, and may involve FDA inspection visits, in which requests may be made for samples.

Strengthening Compliance of the GRAS Program

Deputy Commissioner Jones also mentioned during the April 5 webinar that FDA planned to strengthen its compliance program to incentivize industry's proper use of the Generally Recognized as Safe (GRAS) program for food additives and food contact material. GRAS substances are not subject to the premarket approval requirements applicable to food additives under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the law, product manufacturers and others may make their own determination as to whether a substance is GRAS for its intended use in food or in contact with food. In 2016, FDA promulgated a regulation⁹ establishing a procedure for voluntary submission to FDA of a notice of self-determination. FDA does not, however, provide a formal approval or affirmation for these notices.

While companies are not required to submit a GRAS notification, there are regulatory criteria which must be met to support a GRAS determination. For one, the underlying data necessary to establish safety must be publicly available, and it must be clear that qualified experts in the field would generally recognize a substance as safe based on that data. Importantly, GRAS substances must meet the same safety standard with respect to the quantity and quality of the data as food additives, which are subject to the premarket clearance process. In November 2017, FDA published a guidance that describes the regulatory framework that should be followed for substances intended for use in human or animal food on the basis of the GRAS provision of the FD&C Act.¹⁰

Acknowledging that no one is required to submit a GRAS notification, Jones said, "[W]e think that confidence in the food supply is increased when there is a notification." He added, "[W]e expect some portion of the Fiscal Year 2025 funds to strengthen the compliance program to incentivize industry to meet all appropriate requirements and its use of the GRAS program for food additives and food contact materials."³

“Several states have now established priority lists of chemical substances which, in the ensuing years, will require assessments with an eye on restrictions for use or outright bans… Could we see the same patchwork of laws as has sprung up with respect to PFAS for other substances?”

State Involvement Adds Confusion

One area of concern for food manufacturers and the packaging industry is the plethora of varying state laws banning chemicals used in food contact materials. Several states have now established priority lists of chemical substances which, in the ensuing years, will require assessments with an eye on restrictions for use or outright bans.¹¹ Other state legislatures are leaping over the assessment step and passing outright bans on specified additives for food, such as brominated vegetable oil (BVO), potassium bromate, propylparaben, and red dye No. 3.¹² Other states are following suit with proposed legislation of their own.

Could we see the same patchwork of laws as has sprung up with respect to PFAS for other substances? Washington and Maine were the first states to ban PFAS in food packaging, and both of these states require alternative assessments before specific uses can be banned. A number of other states have subsequently enacted PFAS bans, none of which require an alternative assessment. However, specifics vary. For example, California bans the sale of "plant fiber-based food packaging" that contains PFAS that has been intentionally added to have a functional or technical effect in the product or is present in the product at or above 100 ppm. Meanwhile, Oregon, New York, and Minnesota have banned the sale of all food packaging containing intentionally added PFAS that provides a functional or technical effect in the finished product.

Rhode Island goes one step further, however, in specifying that "intentional use" includes "use of a regulated chemical as a processing agent, mold release agent, or intermediate… where the regulated chemical is detected in the final package or packaging component." This goes beyond FDA findings on safety for such uses. FDA has concluded that, "the amount of PFAS used as processing aids in the manufacture of other food contact polymers is so small that a negligible amount of PFAS is capable of migrating to food from this use."¹³

In a blog titled, "Food Safety Focus: Why FDA's Pre- and Post-Market Authority is Critical," Jared Rothstein, Senior Director of Regulatory and Technical Affairs for the Consumer Brands Association, writes:

"At the state level, legislation is creating a patchwork of laws and regulations for food ingredients, which is becoming increasingly unmanageable for companies operating in and manufacturing products for a national marketplace. These state actions are occurring without regard to current scientific evidence or FDA's expert opinions. It is critical, then, that the FDA get out ahead of this recent spate of state food ingredient bans to ensure there is regulatory predictability and uniformity."¹⁴

In a seeming echo of these comments, FDA's Jim Jones noted on an Alliance for a Stronger FDA webinar held on March 8, 2024, "[A] strong national food safety system is not built state by state. Clearly, having states issue these types of bans—while within their rights under our current regulatory system—is not ideal." He added, "Coordinating our efforts [with states] is integral to our success. But the 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."¹⁵

Increased Transparency Needed

Another topic that Deputy Commissioner Jones discussed during the webinar on April 4 was the need for increased transparency. Pointing out that, currently, it is not always apparent how FDA selects which chemicals to reassess, Jones said that there needs to be a systematic process for how chemicals for reassessment are selected and a clear path on how FDA will go from prioritizing selection of chemicals to risk assessment to risk management. There also needs to be more clarity around public participation. Jones explained that FDA is working on when the public will have an opportunity to give its input. He added, "It does not happen overnight, but they are all things that we are working on and will be part of our systematic existing chemicals reassessment program."³

In August, FDA published a discussion paper, “Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food,”⁴ to obtain public comment on the process of developing the post-market chemicals program and has scheduled a public meeting in late September to further consider the issues involved. Jones explained that he is currently working with his team on transparency and as a result is seeing improvement. He said that he is hearing from stakeholders that they are beginning to feel more transparency.

In discussing FDA's budget on April 4, Jones pointed out that FDA oversees 80 percent of the nation's food supply, in addition to the safety and labeling of dietary supplements, yet the U.S. Department of Agriculture (USDA) has approximately the same budget for its oversight of approximately 20 percent of the U.S. food supply. He noted that FDA's FY 2025 budget was largely in place when he joined the Agency at the end of September 2023, but he was hopeful that the FY 2025 budget will have realistic timeframes.³

"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, one unit dedicated to pre-market safety evaluations, and one dedicated to post-market safety reviews," he said, adding that starting with the FY 2026 budget, there will be a unified Human Foods Program budget.³

Stay tuned. As Bob Dylan sang, "The Times They Are A-Changin'."

References

1. U.S. Food and Drug Administration (FDA). "Proposed Human Foods Program Organization Chart." June 27, 2023. https://www.fda.gov/media/169814/download.
2. Reagan-Udall Foundation. "Operational Evaluation of the FDA Human Foods Program." December 2022. https://reaganudall.org/sites/default/files/2022-12/Human%20Foods%20Program%20Independent%20Expert%20Panel%20Final%20Report%20120622.pdf.
3. Alliance for a Stronger FDA. "Alliance Webinar Budget Series: Webinar Transcript of Jim Jones, FDA's Deputy Commissioner for Human Foods." April 5, 2024. https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:c93c9f5e-07a5-40c4-bad5-8f5a23c2c518?viewer%21megaVerb=group-discover.
4. FDA. “Discussion Paper: Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food.” August 2024. https://www.fda.gov/media/180942/download.
5. FDA. "List of Select Chemicals in the Food Supply Under FDA Review." Current as of March 4, 2024. https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review.
6. FDA. "FDA, Industry Actions End Sales of PFAS Used in US Food Packaging." February 28, 2024. https://www.fda.gov/news-events/press-announcements/fda-industry-actions-end-sales-pfas-used-us-food-packaging.
7. FDA. "81 Federal Register 5," January 4, 2016, and "81 Federal Register 83672," November 22, 2016.
8. FDA. "FDA Sampling of Food Contact Paper/Packaging for PFAS." June 2024. Keller and Heckman LLP. https://www.khlaw.com/sites/default/files/2024-06/FDA%20Sampling%20of%20Food%20Contact%20PaperPackaging%20for%20PFAS_0.pdf.
9. FDA. "81 Federal Register 54960," August 17, 2016, and "21 CFRPart 170, subpart E (for substances to be used in human food)," and "21 CFR Part 570, subpart E (for substances to be used in animal food)."
10. FDA. Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act. November 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-regulatory-framework-substances-intended-use-human-food-or-animal-food-basis.
11. Maine Department of Environmental Protection. "Maine Toxics in Food Packaging Program." https://www.maine.gov/dep/safechem/packaging/index.html. Note: For example, Maine's Toxic Chemicals in Packaging Law (Public Law c. 277), along with prohibiting the use of certain chemicals including PFAS and phthalates in food packaging, also required the Maine Department of Environmental Protection to develop a list of "Chemicals of High Concern," which may in future years be subject to restrictions or bans on use in Maine.
12. California AB-418. The California Food Safety Act. October 9, 2023. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB418.
13. FDA. "Authorized Uses of PFAS in Food Contact Applications." February 24, 2022. https://www.fda.gov/food/chemical-contaminants-food/authorized-uses-pfas-food-contact-applications.
14. Rothstein, Jared. "Food Safety Focus: Why FDA's Pre- and Post-Market Authority is Critical." Consumer Brands Association. April 11, 2024. https://consumerbrandsassociation.org/blog/food-safety-focus-why-fdas-pre-and-post-market-authority-is-critical/.
15. Alliance for a Stronger FDA. "Alliance Webinar Series: Webinar Transcript of Jim Jones, FDA's Deputy Commissioner for Human Foods." March 8, 2024. https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:1a575ac2-3d48-41df-8bfd-fc810b251abc?viewer%21megaVerb=group-discover.