[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.52]

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                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
              Subpart C--Animal Drug Labeling Requirements
 
Sec.  500.52  Use of terms such as ``tonic'', ``tone'', ``toner'', or ``conditioner'' in the labeling of preparations intended for use in or on animals.

    (a) The use of terms such as tonic, tone, toner, and similar terms 
in the labeling of a product intended for use in or on animals implies 
that such product is capable of a therapeutic effect(s) and causes such 
a product to be a drug within the meaning of section 201(g) of the 
Federal Food, Drug, and Cosmetic Act. The unqualified use of such terms 
in a product's labeling fails to provide adequate directions and 
indications for use of such product and causes it to be misbranded 
within the meaning of section 502(a) and (f)(1) of the act. The terms 
tonic, tone, toner, and similar terms may be used in labeling only when 
appropriately qualified so as to fully inform the user regarding the 
intended use(s) of the product.
    (b) The unqualified use of the term conditioner and similar terms in 
the labeling of a product intended for use in or on animals implies that 
such product is capable of a therapeutic effect(s) and causes such a 
product to be a drug within the meaning of section 201(g) of the act. 
The unqualified use of such terms in a product's labeling fails to 
provide adequate directions and indications for use of such product and 
causes it to be misbranded within the meaning of section 502(a) and 
(f)(1) of the act. The term conditioner and similar terms may be used in 
labeling only when appropriately qualified so as to fully inform the 
user regarding the intended use(s) of the product. A product labeled as 
a ``conditioner'' or with a similar term can be either a food or drug 
depending upon the manner in

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which the term is qualified in the labeling to reflect the product's 
intended use.
    (c) An article so qualified as to be represented as a drug must be 
the subject of an approved new animal drug application unless the use of 
the article under the conditions set forth in its labeling is generally 
recognized as safe and effective among experts qualified by scientific 
training and experience to evaluate the safety and effectiveness of 
animal drugs.