U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CPG Sec. 642.100 *Drugs for Odor Control and Conception in Pet Animals*
  1. Search for FDA Guidance Documents

COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 642.100 *Drugs for Odor Control and Conception in Pet Animals* March 1995

Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs

BACKGROUND:

The Center for Veterinary Medicine (CVM) is aware of products on the market intended for use primarily in companion animals, such as dogs and cats and other small animals, for the control of body odors. Labeling representations range from the complete control of breath and body odors generally, to the masking or prevention of estrus odors, and to direct claims for prevention of mating or conception. Chlorophyll, antibiotics such as chlortetracycline, and other drugs, have been included as active ingredients.

We believe that products, including products with known drug properties such as antibiotics, intended for systemic use in animals to prevent body odors or conception are drugs because they meet the definition in 201(g)(1)(C) and/or 201(g)(1)(A). In the absence of expert recognition, supported by scientific data establishing that any of these claims are valid, the products are new animal drugs. <>Topically applied products that contain ingredients with known drug properties, such as antibiotics, may be new animal drugs for the same reason when indicated for the control of odor or conception.

On the other hand, CVM believes that topically applied chlorophyll-based products intended merely to mask or control odors constitute animal cosmetics (grooming aids) which are not regulated by the statute since the definition of cosmetics in Section 201(i) pertains only to human use products.

POLICY:

Chlorophyll-based products for systemic use constitute a low order of regulatory priority, provided that claims are limited to masking, suppressing, or controlling body odor in animals, and safety concerns are not involved. CVM places a higher priority on regulatory action under Section 501(a)(5) against systemic chlorophyll products where the labeling contains direct claims for contraceptive use.

Antibiotics or other drug components promoted for suppression, masking or control of animal body odor also have a higher priority for regulatory action under Section 501(a)(5). <>

REGULATORY ACTION GUIDANCE:

Regulatory action against chlorophyll-based animal drugs labeled merely for the masking, suppression, or control of animal body odors has a low regulatory priority. However, new animal drug charges may be recommended against such products where the labeling contains direct representation to prevent conception. Other unsubstantiated claims should be reviewed by the Center before regulatory action is recommended.

Regulatory action, based on Section 501(a)(5), will be considered where antibiotics, or any drug components other than chlorophyll, are distributed with indications for use for the masking, suppression, or control of animal body odors.

*Material between asterisks is new or revised*
<> Indicates material has been deleted

Issued: 7/13/76
Revised: 12/19/89, 3/95


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002