89 FR 98 pgs. 43857-43858 - Program Policy and Procedures Manual Guide 1240.3605 Regulating Animal Foods With Drug Claims; Withdrawal
Type: NOTICEVolume: 89Number: 98Pages: 43857 - 43858
Pages: 43857, 43858Docket number: [Docket No. FDA-2022-N-2015]
FR document: [FR Doc. 2024-10936 Filed 5-17-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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, kelly.louviere@fda.hhs.gov.
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)).
[top] 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
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 animalfood-premarket@fda.hhs.gov.
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]
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