- October 18, 2022
- 10:00 AM ET
- Organized By:
On This Page:
- Listening Session Information
- Requests for Oral Presentations
- Submitting Electronic or Written Comments
- Recording and Transcript
On Tuesday, October 18, 2022, the FDA’s Center for Veterinary Medicine (CVM) will host a virtual listening session on the Agency’s regulation of animal foods with certain types of claims such as claims about environmental benefits (e.g., reduced greenhouse emissions), production (e.g., growth promotion, feed efficiency), and effects on the animal microbiome. The listening session will be an opportunity for the public and stakeholders to share information on this topic with the FDA.
During Q1 of calendar year 2023, CVM intends to provide the public with additional opportunities to share input on other animal food-related topics such as the FDA’s role in the AAFCO ingredient definition process. As details for these opportunities are finalized, the FDA will publicize them by posting information on its website.
The FDA regulates both food and drugs for animals. Depending on characteristics of the product, how a product for animals is intended to be used, and what the product claims to do, the product could meet the legal definition of a food, a drug, or occasionally, both a food and a drug.
CVM Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods With Drug Claims, published in 1998, states that the FDA will usually regulate nutritional ingredients or products with claims describing an intended effect on the structure or function of an animal’s body (structure/function claims) as animal food. The PPM also states that the FDA will usually regulate nutritional ingredients or products with production claims and non-nutritive ingredients or products with structure/function claims as animal drugs. The FDA is reviewing this existing policy to evaluate how it could be updated to reflect evolving scientific knowledge and promote innovation.
Listening Session Information
The virtual listening session is an opportunity for stakeholders – consumers, industry, interest groups, academia, and others – to share information and feedback that they feel the FDA should consider as it reviews the way it regulates animal foods with certain claims.
The FDA is focusing the scope of this request on animal foods with certain types of claims such as claims for environmental benefits, production, and effects on the animal microbiome. Some animal food products with these types of claims are currently regulated as animal drugs, but changes to the FDA’s existing policy could potentially allow these products to be regulated as animal food while maintaining safety and consistency with current laws and regulations.
The FDA is specifically interested in receiving public comments on its existing policy, PPM 1240.3605, Regulating Animal Foods with Drug Claims, to address the following questions:
- How could the FDA modernize or improve this policy?
- What challenges are presented by this policy?
- What additional types of claims or ingredients should the FDA consider in its review of this policy?
Registered participants will receive an email reminder about the event one day before the virtual listening session. If adjustments are needed to reflect the speaker lineup as it occurred during the listening session, a revised, final agenda will be posted after the event.
As of October 11, registration for the listening session has closed. After the event takes place, FDA will post a recording on this web page. If you have comments about the regulation of animal foods with certain types of claims that you want to share with the FDA, please submit them to the docket (FDA-2022-N-2015) via https://www.regulations.gov by November 17, 2022.
Requests for Oral Presentations
On the registration form, you may indicate if you wish to make an oral presentation about regulation of animal foods with certain types of claims during the listening session. The FDA will do its best to accommodate all requests to make oral presentations. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate. If you want to present but know you will be unable to participate live during the event or if you have other questions, please email AnimalFoodClaims2022@fda.hhs.gov. All requests to make oral presentations must have been received by September 20, 2022, at 11:59 p.m. ET.
Based on the number of presentation requests, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and we will notify participants shortly after September 27, 2022, with instructions and a deadline for submitting presentation materials.
No commercial or promotional material will be permitted to be presented or discussed during the listening session.
Submitting Electronic or Written Comments
The FDA is accepting electronic or written comments on this topic until November 17, 2022.
To electronically submit comments to the docket, visit https://www.regulations.gov and type FDA-2022- N-2015 in the search box. For assistance in submitting electronic comments, please see regulations.gov/help. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015.
For access to the docket to read the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, FDA-2022-N-2015, into the “Search” box and follow the prompts.
Recording and Transcript
To view the recording and transcript of the listening session, please visit the following links:
- FDA Virtual Listening Session on the Regulation of Animal Foods with Certain Types of Claims Recording
- FDA Virtual Listening Session on the Regulation of Animal Foods with Certain Types of Claims Transcript
|Agenda - FDA Virtual Listening Session on the Regulation of Animal Foods with Certain Types of Claims||pdf (107.41 KB)|