116th CONGRESS 1st Session |
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.
April 8, 2019
Ms. Matsui introduced the following bill; which was referred to the Committee on Energy and Commerce
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Food Allergy Safety, Treatment, Education, and Research Act of 2019” or the “FASTER Act of 2019”.
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 after section 317T of such Act (42 U.S.C. 247b–22) the following new section:
“SEC. 317U. Collection of food allergy data.
“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
“(2) include such information within annual or other periodic reporting to the Congress and the public on other surveillance activities.”.
(1) MAJOR ALLERGEN DEFINITION.—Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3211(qq)(1)) is amended by striking “and soybeans” and inserting “soybeans, and sesame”.
(2) ADDITIONAL ALLERGENS.—Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3211(qq)(1)) 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 prevalence and severity of allergic reactions to the food ingredient.”.
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 treatments for patients with food allergies.”.
SEC. 4. Study on economic costs of food allergies.
The Director of the National Institutes of Health shall seek to enter into an arrangement with the National Academies of Sciences, Engineering, and Medicine (or if the National Academies decline to enter into an arrangement, another appropriate entity) to—
(1) study the economic costs of food allergies in the United States, both individually and for the food allergy population overall; and
(2) not later than 1 year after the date of enactment of this Act—
(A) complete such study;
(B) submit to the Congress a report on the results of such study; and
(C) publish such report.