[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Notices]
[Pages 43857-43858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2015]


Program Policy and Procedures Manual Guide 1240.3605 Regulating 
Animal Foods With Drug Claims; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the withdrawal of the Center for Veterinary Medicine's 
(CVM's) Program Policy and Procedures Manual Guide (PPM) 1240.3605 
Regulating Animal Foods with Drug Claims. This 1998 document presented 
guidance to CVM staff for the regulation of animal food that may have 
intended uses that result in the products also being drugs. FDA is 
withdrawing PPM 1240.3605 after determining that it no longer reflects 
Agency current thinking.

FOR FURTHER INFORMATION CONTACT: Kelly A. Louviere, Center for 
Veterinary Medicine (HFV-200), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5815, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of CVM's 
PPM 1240.3605 Regulating Animal Foods with Drug Claims. This 1998 
document presented guidance to CVM staff for the regulation of animal 
food that may have intended uses that result in the products being 
drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(g)).
    In 2021, CVM initiated a review of PPM 1240.3605, spurred by 
stakeholder interest, including industry and government (e.g., 
Congressional) stakeholders. Congress requested FDA ``review [PPM] 
1240.3605 for solutions on how ingredient claims for animal production, 
animal well-being, food safety and the environment can be regulated as 
animal food.'' In making this request, Congress expressed concern that 
PPM 1240.3605 had not been updated since 1998 and had not kept pace 
with science (H. Rep. No. 117-82 at 91 (2022)).
    On October 18, 2022, CVM held a virtual listening session to gather 
information and stakeholder feedback to be considered during our review 
of the regulation of animal food with certain types of claims, such as 
claims about environmental benefits (e.g., reduced greenhouse gas 
emissions), production

[[Page 43858]]

(e.g., growth promotion, feed efficiency), and effects on the animal 
microbiome. We specifically asked for feedback on how we could 
modernize or improve PPM 1240.3605, what challenges were presented by 
this PPM, and what additional types of claims or ingredients CVM should 
consider during its review of the policy. Many stakeholders requested 
that we update our PPM to provide for a larger set of ingredients that 
can be safely used in animal food to be treated other than as drugs and 
to encourage innovation that supports human and animal health, promotes 
sustainable animal production, and provides benefits to the 
environment.
    After a thorough review of PPM 1240.3605, and careful consideration 
of stakeholder feedback, FDA has determined that PPM 1240.3605 no 
longer reflects Agency current thinking and is therefore withdrawing 
the PPM.
    FDA encourages firms developing animal food, nutritional 
ingredients, or non-nutritive ingredients with intended uses that could 
make them a drug, including substances that are for use in animal food 
and are intended to affect the structure or any function of the 
animal's body, to contact the Agency early in the product development 
process. To contact FDA's Center for Veterinary Medicine about an 
animal food substance intended to have the effects described above, 
please email [email protected].
    FDA intends to issue guidance to clarify our current thinking on 
the regulation of certain substances that are for use in animal food 
and are intended to affect the structure or any function of an animal's 
body.

    Dated: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10936 Filed 5-17-24; 8:45 am]
BILLING CODE 4164-01-P