Proposed Rule2025-14339
Spoonbill Foundation; Filing of Food Additive Petition
Primary source
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Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by the Spoonbill Foundation, proposing that we amend our food additive regulations to provide for the safe use of 4'-phosphopantetheine (4'-PPT) as a nutrient in medical food.
Full Text
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<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Proposed Rules]
[Page 35645]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14339]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2025-F-2137]
Spoonbill Foundation; Filing of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of petition.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a food additive petition, submitted by the Spoonbill
Foundation, proposing that we amend our food additive regulations to
provide for the safe use of 4'-phosphopantetheine (4'-PPT) as a
nutrient in medical food.
DATES: The food additive petition was filed on July 3, 2025.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Marissa Santos, Human Foods Program,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-8160.
SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that
we have filed a food additive petition (FAP 5A4842), submitted on
behalf of Spoonbill Foundation by Immix Law Group, 500 NW Naito Pkwy,
Unit G, Portland, OR 97209. The petition proposes that we amend our
food additive regulations in part 172 (21 CFR 172), ``Food Additives
Permitted For Direct Addition to Food For Human Consumption,'' to
provide for the safe use of 4'-PPT as a nutrient in medical food.
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(k) because granting of this petition would
become effective ``for substances added directly to food that are
intended to remain in food through ingestion by consumers and are not
intended to replace macronutrients in food.'' In addition, the
petitioner has stated that, to their knowledge, no extraordinary
circumstances exist. If FDA determines a categorical exclusion applies,
neither an environmental assessment nor an environmental impact
statement is required. If FDA determines a categorical exclusion does
not apply, we will request an environmental assessment and make it
available for public inspection.
Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14339 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-P
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