[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: 21CFR310.527]

[Page 29]
 
                        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. 310.527  Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.

    (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, 
biotin and all other B-vitamins, dexpanthenol, estradiol and other 
topical hormones, jojoba oil, lanolin, nucleic acids, polysorbate 20, 
polysorbate 60, sulfanilamide, sulfur 1 percent on carbon in a fraction 
of paraffinic hydrocarbons, tetracaine hydrochloride, urea, and wheat 
germ oil have been marketed as ingredients in OTC drug products for 
external use as hair growers or for hair loss prevention. There is a 
lack of adequate data to establish general recognition of the safety and 
effectiveness of these or any other ingredients intended for OTC 
external use as a hair grower or for hair loss prevention. Based on 
evidence currently available, all labeling claims for OTC hair grower 
and hair loss prevention drug products for external use are either 
false, misleading, or unsupported by scientific data. Therefore, any OTC 
drug product for external use containing an ingredient offered for use 
as a hair grower or for hair loss prevention cannot be considered 
generally recognized as safe and effective for its intended use.
    (b) Any OTC drug product that is labeled, represented, or promoted 
for external use as a hair grower or for hair loss prevention is 
regarded as a new drug within the meaning of section 201(p) of the 
Federal Food, Drug, and Cosmetic Act (the 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 for OTC external use as a 
hair grower or for hair loss prevention 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) After January 8, 1990, any such OTC drug product initially 
introduced or initially delivered for introduction into interstate 
commerce that is not in compliance with this section is subject to 
regulatory action.

[54 FR 28777, July 7, 1989]