[Congressional Record Volume 166, Number 195 (Tuesday, November 17, 2020)]
[House]
[Pages H5813-H5814]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
{time} 1300
FOOD ALLERGY SAFETY, TREATMENT, EDUCATION, AND RESEARCH ACT OF 2020
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 2117) to improve the health and safety of Americans living
with food allergies and related disorders, including potentially life-
threatening anaphylaxis, food protein-induced enterocolitis syndrome,
and eosinophilic gastrointestinal diseases, and for other purposes, as
amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 2117
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food Allergy Safety,
Treatment, Education, and Research Act of 2020'' or the
``FASTER Act of 2020''.
SEC. 2. FOOD ALLERGY SAFETY RECOMMENDATIONS OF THE NATIONAL
ACADEMY OF MEDICINE.
(a) Collection of Food Allergy Data.--The Public Health
Service Act is amended by inserting before section 318 of
such Act (42 U.S.C. 247c) the following new section:
``SEC. 317W. COLLECTION OF FOOD ALLERGY DATA.
``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall--
``(1) expand and intensify the collection of information on
the prevalence of food allergies for specific allergens in
the United States, such as through the National Health and
Nutrition Examination Survey and the National Health
Interview Survey;
``(2) include such information within annual or other
periodic reporting to the Congress and the public on other
surveillance activities; and
``(3) encourage research to improve the accuracy of food
allergy prevalence data.
``(b) Biomarkers.--Any research conducted pursuant to
subsection (a)(3) shall include--
``(1) the identification of biomarkers and tests to
validate data generated from such research; and
``(2) the investigation of the use of identified biomarkers
and tests in national surveys conducted as part of that
research.''.
(b) Allergen Labeling.--
(1) Major food allergen definition.--
(A) In general.--Section 201(qq)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is amended by
striking ``and soybeans'' and inserting ``soybeans, and
sesame''.
(B) Effective date.--The amendment made by subparagraph (A)
shall apply with respect to food introduced or delivered for
introduction into interstate commerce on or after January 1,
2022.
(2) Additional allergens.--Section 201(qq) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is amended
by adding at the end the following:
``(3) Any other food ingredient that the Secretary
determines by regulation to be a major food allergen, based
on the scientific criteria determined by the Secretary
(including the prevalence and severity of allergic reactions
to the food ingredient) that establish that such food
ingredient is an allergen of public health concern.''.
(3) Technical corrections.--Section 201(qq)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(2))
is amended by striking ``paragraph'' each place it appears
and inserting ``subparagraph''.
SEC. 3. REPORT ON USE BY FDA OF PATIENT EXPERIENCE DATA ON
TREATMENTS FOR PATIENTS WITH FOOD ALLERGIES.
Section 3004 of the 21st Century Cures Act (21 U.S.C. 355
note) is amended--
(1) by striking ``Not later than'' and inserting the
following:
``(a) In General.--Not later than''; and
(2) by adding at the end the following:
``(b) Treatments for Patients With Food Allergies.--Each
report under subsection (a) shall include a synopsis of the
use by the Food and Drug Administration in regulatory
decisionmaking of patient experience data on products with an
indication for the treatment of a food allergy.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 2117.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 2117, the Food Allergy
Safety, Treatment, Education, and Research Act, or the FASTER Act.
Mr. Speaker, an estimated 32 million Americans, including
approximately 1 in every 13 children, are affected by food allergies.
These allergies pose risks to millions of families, and these risks
grow dramatically when inaccurate labels fail to warn consumers about
the presence of some of these allergens.
Under current law, eight allergens are considered major food
allergens. They include milk, eggs, fish, shellfish, tree nuts, wheat,
peanuts, and soybeans. Due to their status as major food allergens,
manufacturers must clearly state the presence of any of these
ingredients on labels.
Notably missing from this list of allergens is sesame. That is
concerning, considering it is an allergen of growing concern and its
inclusion in food products has more than doubled over the last decade.
In some cases, sesame may not be listed at all on ingredient labels,
being referred to instead through nonspecific terms like ``flavors'' or
words that may not easily be recognized by consumers as containing
sesame, such as tahini.
While it may seem like a small issue to some, this lack of
information could mean life or death for those who are allergic to
sesame. Clearly, this information should be prominently featured on
packaged food labels.
This is an issue we have been working on for quite some time. Several
years ago, I introduced a bill that would list sesame as a major food
allergen, and although the Food and Drug Administration opened a docket
to solicit feedback about the sesame labeling and recently released
guidance recommending voluntary labeling of sesame, the agency has not
been able to require the listing of sesame due to overly long
regulatory processes.
As we learn more about food allergens, our regulations should be able
to adapt to align with the latest science. This process should not take
years.
[[Page H5814]]
Families should have reliable access to this information, and they
should have it now.
Today we are taking action, Mr. Speaker. The appropriately named
FASTER Act would quickly move this process along by recognizing sesame
as a major food allergen, requiring its listing on new food labels
after a phase-in process.
Importantly, the bill would also streamline processes at FDA to allow
for additional allergens to be listed as major food allergens based on
scientific criteria, including the prevalence and the severity of the
allergens.
The bill would also help develop quality research into food allergens
by directing the Centers for Disease Control and Prevention to expand
and intensify its collection of data on food allergens and by directing
FDA to report on its use of patient experience data.
I want to thank Representative Matsui for her tireless efforts in
support of families affected by food allergens and for introducing this
bill.
I am a strong supporter of the bill, and I encourage all Members to
support it.
Mr. Speaker, I reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I rise in support of H.R. 2117, the Food
Allergy Safety, Treatment, Education, and Research Act.
This legislation codifies sesame as a major food allergen. This means
that, with enactment of the legislation, products containing sesame
would have to list this ingredient on the food packaging label. That is
really important for consumers.
Recent studies indicate that sesame allergies in the United States
have a prevalence rate on par with the allergies for soy and fish,
which are both listed as major allergens under the Federal Food, Drug,
and Cosmetic Act.
It is commonsense legislation. It provides consumers with important
and, perhaps, even lifesaving information to protect themselves and
their families from dangerous allergic reactions.
Mr. Speaker, I urge support of the bill, and I yield back the balance
of my time.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
California (Ms. Matsui), the sponsor of the legislation.
Ms. MATSUI. Mr. Speaker, I rise to speak in support of two of my
bills being considered today: the FASTER Act and the MODERN Labeling
Act.
There are more than 32 million Americans living with potentially
life-threatening food allergies who rely on accurate food ingredient
labels to make safe decisions for themselves and their family members.
Under current law, mandatory labeling is required for major food
allergens recognized by the FDA, like milk, eggs, and peanuts. My
grandson Robby has a peanut allergy, and for families like mine,
checking food labels is as vital to our everyday lives as breathing.
Unfortunately, FDA labeling requirements do not include the
ingredient sesame, leaving more than 1.6 million Americans with a
sesame allergy in the dark about what foods and products to avoid. That
is why I have been working closely with my colleagues and advocates in
the food allergy community to advance the FASTER Act, legislation that
updates food allergen labeling laws to include sesame.
Importantly, the FASTER Act also lays critical groundwork for
conducting the research necessary to better understand, treat, and, one
day, prevent food allergies.
From ingredients in a food product to the prescribing information for
a prescription drug, FDA labels play a critical role in protecting
public health and empowering Americans to make safe decisions.
This year, our friends in the cancer community brought a real problem
to my attention. Despite the important role drug labels play in
informing treatment decisions, many generic drug labels are
considerably out of date, and there is no existing mechanism to update
these labels to reflect new clinical evidence.
That is why I introduced the MODERN Labeling Act, legislation that
supports FDA's ability to require modifications to outdated generic
drug labels so they reflect new, relevant information.
Accurate, up-to-date generic drug labels are key to optimizing use,
enhancing patient benefit, and facilitating greater use of lower cost
generics.
These are both important labeling laws, and both labeling bills are
bipartisan, commonsense solutions that take important steps to
safeguard our public health. I urge my colleagues to support the FASTER
Act and the MODERN Labeling Act.
Mr. PALLONE. Mr. Speaker, I ask my colleagues to support this
legislation, and I yield back the balance of my time.
Ms. ESHOO. Mr. Speaker, I rise in support of H.R. 2117, the FASTER
Act. I'm proud to have advanced this bipartisan bill through my Health
Subcommittee and I'm proud to support it on the Floor today.
The FASTER Act was introduced by Representative Doris Matsui. It adds
sesame as a major allergen for food labeling and allows the FDA,
through regulation, to add other food ingredients as major allergens
based on the prevalence and severity of allergic reactions to the food
ingredient.
The FASTER Act will have an enormous impact on the 32 million
Americans living with food allergies and their families.
Hospitalizations for allergic reactions have risen 400 percent over
the past decade with 1 in 13 children having a life-threatening food
allergy, and many of them are allergic to sesame.
Sesame remains the most common allergen that is NOT required to be
written on food labels and is often hidden on labels as ``Spices'' or
``Natural Flavors.'' Parents and children cannot easily avoid sesame if
it's not clearly labeled. Anyone who's ever known a child with a
serious food allergy knows how dire a reaction can be.
Over a year ago, the FDA issued a request for information about
requiring the sesame allergen label and since then has only taken
limited action to address this issue through draft guidance that would
allow manufacturers to voluntarily list sesame as an ingredient.
The FDA needs to do more to help curb the risks these children face
and the FASTER Act will help the FDA do just that. I urge all my
colleagues to support this bill.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 2117, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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