Key Takeaways:
- Per- and polyfluoroalkyl substances (PFAS) have been widely used in food and consumer products worldwide, but exposure to these substances is a growing public health concern.
- The Food and Drug Administration (FDA) recently took steps to eliminate the sale of PFAS in the U.S. for use as grease-proofing food contact surface agents on paper food packaging, a major source of dietary exposure to PFAS from food packaging.
- FDA continues to review the use of certain chemicals in food and cosmetic applications, but some states have not been satisfied with the pace or scope of FDA's actions and have instituted their own bans of these substances.
- The resulting patchwork of regulations is creating a complex compliance regime for manufacturers, distributors, and retailers of products that include these substances.
Increased public health interest in "forever
chemicals" is leading to a new, complex regulatory landscape
for manufacturers, distributors, and retailers of foods, cosmetics,
and other consumer products. As FDA and other federal regulators
and organizations commission studies on these substances, more
federal and state laws and regulations to limit the use of PFAS and
other chemicals in foods, cosmetics, and consumer products may be
forthcoming.
PFAS-Containing Grease-Proofing Agent
Phase-Out
FDA announced in February 2024 that the major
source of dietary exposure to PFAS in the U.S. from food packaging
was being eliminated through a voluntary collaboration between the
agency and industry. According to an FDA statement,
"grease-proofing materials containing per- and polyfluoroalkyl
substances (PFAS) are no longer being sold for use in food
packaging in the U.S." These materials were used in a variety
of types of food packaging, including fast-food wrappers, microwave
popcorn bags, take-out paperboard containers and pet food bags, to
prevent leaking of grease or oil. Rather than issue a rule banning
PFAS substances in food packaging materials, FDA agreed to
voluntary commitments by manufacturers to stop selling
such food packaging products after a scientific review conducted by
FDA indicated raised safety concerns about their use.
This announcement marks the conclusion of a roughly four-year
phase-out process whereby manufacturers committed to discontinue
selling other food contact substances with grease-proofing
materials containing PFAS. Substances containing PFAS may still be
used in other food contact applications, such as on nonstick
coatings on pots and pans, in sealing gaskets for food processing
equipment, and as manufacturing aids added to other food contact
polymers.
FDA subsequently issued an import alert to help prevent entry of human
food products into the U.S. if they are found to be contaminated
with a broad range of human-made chemicals including PFAS. FDA plans to continue testing foods to estimate
U.S. consumers' exposure to PFAS from foods, with plastic water
bottles and seafood testing being the next main areas of agency
research. In the meantime, FDA plans to continue its surveillance activities
to monitor the market disappearance of PFAS coatings from paper
packaging.
Why Didn't FDA Just Ban the Use of PFAS in Food
Packaging Materials?
As noted above, the removal of these food packaging materials from
the U.S. market resulted from a voluntary commitment by
manufacturers to stop selling such food packaging products, not a
rule banning PFAS substances in food packaging materials. This
regulatory approach is in contrast with FDA's proposal last year to revoke the regulation
authorizing the use of Brominated Vegetable Oil (BVO) as a food
additive. While FDA's actions with respect to PFAS and BVO
relate to the safety of chemicals in the food supply, food additive
ingredients and food contact substances are used and consumed
differently and are thus regulated differently. Accordingly, the
procedures to withdraw harmful food additive ingredients and food
contact substances are not the same.
Food contact substances, such as PFAS, are subject to food contact
notifications (FCNs), unless FDA requires a food additive petition.
FCNs are required to set forth scientific information demonstrating
that a food contact substance (FCS) is safe for the intended use.
After the relevant FCNs for the grease-proofing materials became
effective, FDA conducted a comprehensive review of the safety of
certain short-chain PFAS compounds. Based on this assessment, FDA
informed the manufacturers that additional testing would be needed
to address safety questions concerning effects of the compounds on
pre- and post-natal development, reproductive health and function,
and carcinogenicity and that such testing would need to be of an
extended nature to account for the expected body burden levels
resulting from chronic exposure to these biopersistent FCSs. The
manufacturers opted to discontinue the manufacture of their
products rather than submit to the additional testing to support
their FCNs.
In contrast, BVO is a food additive that must be authorized by
regulation as an ingredient that can be used in food or beverages.
FDA conducted a reevaluation of numerous food additive ingredients
in 2014 and concluded that high quality data were needed to address
the knowledge gaps regarding the safety of BVO. A series of
follow-up animal studies were concluded in 2022, which demonstrated
heightened toxicity associated with BVO. Following the reevaluation
and recent studies, FDA issued a proposed rule in November 2023 to
remove BVO from the list of interim permitted food additives in 21
CFR Part 180. If the rule is finalized, the substance will be
banned for use in food.
State-Level Food Additive Bans
A few states, unsatisfied with the pace and scope of FDA ingredient
bans and investigations, have considered or enacted their own bans.
These bans affect a range of products and
participants in the supply chain. The California Food Safety
Act, for example, was enacted in October 2023. The law prohibits
the manufacture, distribution, and sale of food and beverages
containing BVO, potassium bromate, propylparaben, and Red Dye 3.
The law takes effect in January 2027 and allows the California
Attorney General or local prosecutors to bring civil actions
against any person or entity for violations. Civil penalties can be
as high as $5,000 for the first violation and $10,000 for
subsequent ones.
Illinois may be poised to join California after its senate passed a
bill in April 2024 that would ban the same four ingredients as
California's ban with similar $5,000 and $10,000 bans. The
Illinois bill would also require studies of the potential health
risks of BHA and BHT (Butylated hydroxytoluene and Butylated
hydroxyanisole). Pending legislation in New York would also ban the
four ingredients from California's law along with BHA, titanium
dioxide, and azodicarbonamide. Washington and Missouri have also
considered food additive bans, but the legislation in these states
has stalled. While state legislators demonstrate increased interest
in food additive bans, the state bans could be subject to
challenges based on federal preemption.
FDA is aware that states have started to take action with respect
to food additives and has indicated that it is reviewing and reassessing
the safety of the other three ingredients that California has
banned. In particular, the FDA is currently reviewing the color
additive regulations authorizing the use of Red Dye No. 3 in food,
dietary supplements, and ingested drugs in response to a petition filed by a number of
public interest groups to revoke this additive. In 2022, FDA banned the use of several phthalates in food
contact applications in response to a food additive petition
submitted by the Flexible Vinyl Alliance, because the uses had been
abandoned by industry. The agency is currently evaluating the safety of the
remaining phthalates that are authorized for use as plascticizers
in food contact applications.
Several states, including California, Colorado, and Maine, have
also banned the use of intentionally added PFAS in cosmetics and
other consumer products, and other states have proposed similar
legislation. FDA is also evaluating the safety of PFAS in
cosmetics, pursuant to a mandate in the Modernization of Cosmetics
Regulation act of 2022 (MoCRA), and the agency has asked for funds in its most recent budget
request to fulfill this responsibility.
Conclusion
Congress has bestowed FDA with the authority to regulate additives
used in foods and cosmetics, and the agency has taken numerous
steps to remove specific chemicals in various food applications,
and it continues to review the safety of other chemicals used in
foods and cosmetics. Recent state-level initiatives, motivated by
doubts about the sufficiency of federal activities, are creating a
complex compliance landscape for manufacturers, distributors, and
retailers of foods and cosmetics that include these chemicals. It
remains to be seen whether the new state standards will ultimately
set the bar nationwide as manufacturers reconfigure their products
to comply with these regulations.
As scientific understanding of PFAS grows, further regulatory
developments at both federal and state levels are anticipated. The
resulting patchwork of varying and rapidly changing state-level
additive bans, however, will inevitably create a compliance
nightmare for manufacturers, distributors, and retailers.
Consequently, state-level additive bans are likely to be challenged
on preemption grounds as they continue to be enacted. In the
meantime, there is a need for FDA to expedite its review of these
chemicals and their related applications. Industry groups should
cooperate with FDA and public health advocates to ensure
nationwide, consistent regulatory standards related to the
substances under investigation.
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