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