Food Business News - March 30, 2021 - 22

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WASHINGTON

Allergens in the crosshairs
2021 expected to see more vigorous actions on allergens

B

oth Congress and federal regulators
have accelerated efforts to defend
populations whose sensitivity to
major food allergens puts them at risk
for illness or even death. In Congress,
legislation requiring sesame be added to
the existing list of eight major allergens
subject to labeling requirements advanced
with the Senate's unanimous passage of
the Food Allergy, Safety, Treatment, Education (FASTER) Act on March 3.
At the same time, the Food and Drug
Administration in recent statements and
through warning letters affirmed its commitment to ensuring food manufacturers
comply with existing regulations pertaining to labeling allergens when they are
present in foods. The FDA also warned food
companies to ensure their manufacturing
practices effectively prevent contamination
of foods that are supposed to be free from
the major allergens.
On the legislative front, with the passage of the FASTER Act in the Senate, attention shifted to the House of Representatives,
where the bill was introduced on Feb. 22.
Both the Senate and House passed the
FASTER Act in 2020, but the 116th Congress
was adjourned before the House could consider the Senate's revised version of the bill.
This lapse left the bill to be reintroduced in
each chamber when the 117th Congress convened. Final passage was not in question.
In addition to declaring sesame the
ninth food allergen for which the FDA
requires plain-language labeling, the
FASTER Act would establish a process and
framework for determining what additional allergens should be covered by the
Federal Food, Drug, and Cosmetic Act.
Susan T. Mayne, PhD, director of the
FDA's Center for Food Safety and Applied
Nutrition, in a statement, acknowledged
22

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022_FBN_March30_21.indd 22

the agency was aware of other allergens
beyond the eight now subject to labeling
requirements - milk, eggs, fish, shellfish,
tree nuts, peanuts, wheat and soybeans
- that may be subject to future actions,
including sesame.
" Our goals are to provide consumers
with the information they need to make
informed decisions, to enforce regulations
that require the industry to properly label
food allergens, and to significantly minimize
or prevent the presence of undeclared major
food allergens in food, " Dr. Mayne asserted.
With regard to sesame, Dr. Mayne
pointed to the FDA's draft guidance for
industry issued in November 2020 that
encouraged manufacturers to voluntarily
declare sesame in the ingredient list when
it is used as a flavoring or spice, or when
the common or usual name, such as tahini, does not specify sesame.
" This draft guidance is an initial first
step while we explore other potential actions to protect consumers who may have
allergies to sesame or other food allergens beyond the major eight, " Dr. Mayne
explained.
" Approximately one-third of foods
reported to the FDA through the Reportable
Food Registry as serious health risks involve
undeclared food allergens, " Dr. Mayne said.
" Since March 2020, the FDA has sent warning letters to eight registered food facilities
that have manufactured and distributed
foods with undeclared food allergens that
resulted in Class I recalls. Those registered
food facilities are required by statute to
implement food safety preventive controls
that significantly minimize or prevent the
hazard of undeclared major food allergens
before the food is distributed. "
Dr. Mayne also said the FDA in
December 2020 sent a warning letter to

Whole Foods Market for a series of major
allergen food recalls.
" This warning letter is the first time
the FDA has warned a retailer for engaging in a pattern of misbranding food that
they labeled, " Dr. Mayne said. " The food
industry must and can do better to prevent
exposing consumers to incorrectly labeled
packaged food, which can cause serious
and life-threatening harm. "
Anna El-Zein and John Johnson III of
the law firm Shook, Hardy & Bacon LLP,
in the firm's March 12 Food and Beverage
Litigation Update, said, " Recent actions
by the US Food and Drug Administration
suggest that in 2021 the agency will sharpen its focus on enforcement efforts to ensure packaged foods appropriately declare
the presence of major food allergens. "
" In a series of high-profile warning
letters and press releases, FDA confirmed
that it is moving beyond expecting
non-compliant food to be recalled and
is concentrating on how companies are
preventing the issue, " Ms. El-Zein and Mr.
Johnson said. " Manufacturers and private
labelers need to audit their practices and
expect an FDA inspection, especially if
they have had an allergen-related recall. "
David Acheson, MD, founder of the
Acheson Group (TAG), said of the FASTER
Act, " As major legislation in and of itself,
the pending act is also indicative of the increased food regulation and enforcement
that TAG sees as becoming a hallmark of
2021. As we gradually come out the pandemic - with more people vaccinated and
vaccines hopefully providing control of
the variants as well - the food regulatory
agencies will be back on the trail. " FBN
Jay Sjerven
jsjerven@sosland.com
March 30, 2021

3/26/2021 9:16:15 AM



Food Business News - March 30, 2021

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