[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.529]

[Page 30-31]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
Sec. 310.529  Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.

    (a) Thiamine hydrochloride (vitamin B-1) has been marketed as an 
ingredient in over-the-counter (OTC) drug products for oral use as an 
insect repellent (an orally administered drug product intended to keep 
insects away). There is a lack of adequate data to establish the 
effectiveness of this, or any other ingredient for OTC oral use as an 
insect repellent. Labeling claims for OTC orally administered insect 
repellent drug products are either false, misleading, or unsupported by 
scientific data. The following claims are examples of some that have 
been made for orally administered OTC insect repellent drug products: 
``Oral mosquito repellent,'' ``mosquitos avoid you,'' ``bugs stay 
away,'' ``keep mosquitos away for 12 to 24 hours,'' and ``the newest way 
to fight mosquitos.'' Therefore, any drug product containing ingredients 
offered for oral use as an insect repellent cannot be generally 
recognized as safe and effective.
    (b) Any OTC drug product that is labeled, represented, or promoted 
for oral use as an insect repellent is regarded as a new drug within the 
meaning of section 201(p) of the Federal Food, Drug and Cosmetic Act for 
which an approved new drug application under section 505 of the act and 
part 314 of this chapter is required for marketing. In the absence of an 
approved new drug application, such product is also misbranded under 
section 502 of the act.
    (c) Clinical investigations designed to obtain evidence that any 
drug product labeled, represented, or promoted OTC for oral use as an 
insect repellent is safe and effective for the purpose intended must 
comply with the requirements and procedures governing the use of 
investigational new drugs set forth in part 312 of this chapter.
    (d) Any such drug product in interstate commerce after December 17, 
1985, that is not in compliance with

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this section is subject to regulatory action.

[40 FR 25171, June 17, 1985, as amended at 55 FR 11579, Mar. 29, 1990]