Notice2024-10936
Program Policy and Procedures Manual Guide 1240.3605 Regulating Animal Foods With Drug Claims; Withdrawal
Primary source
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Published
May 20, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 98 (Monday, May 20, 2024)</title>
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[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Notices]
[Pages 43857-43858]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#fa919f969683d496958f8c939f889fba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="472c222b2b3e692b2832312e22352207212326692f2f3469202831">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#c4a5aaada9a5a8a2ababa0e9b4b6a1a9a5b6afa1b084a2a0a5eaacacb7eaa3abb2"><span class="__cf_email__" data-cfemail="35545b5c585459535a5a51184547505854475e5041755351541b5d5d461b525a43">[email protected]</span></a>.
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
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