[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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