[Federal Register Volume 65, Number 64 (Monday, April 3, 2000)]
[Notices]
[Page 17512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1119]


Guidance for Industry on Street Drug Alternatives; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Street Drug 
Alternatives.'' The guidance is intended to inform industry and the 
public that FDA considers any product that is promoted as a street drug 
alternative to be an unapproved new drug and a misbranded drug in 
violation of two sections of the Federal Food, Drug, and Cosmetic Act 
(the act). Such violations may result in regulatory action, including 
seizure and injunction.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written 
requests for single copies of this guidance to the Drug Information 
Branch (HFD-210), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  William Nychis, Center for Drug 
Evaluation and Research (HFD-310), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7363.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Street Drug Alternatives.'' FDA is 
issuing this guidance in response to the proliferation of various 
products that are being manufactured, marketed, or distributed as 
alternatives to illicit street drugs. FDA is concerned that these 
products are being abused by individuals, including minors, and pose a 
potential threat to the public health.
    These street drug alternatives are generally labeled as containing 
botanicals, and some are also labeled as containing other ingredients, 
such as vitamins, minerals, or amino acids. They are marketed under a 
variety of brand names with claims implying that these products mimic 
the effects of controlled substances. These products are intended to be 
used for recreational purposes to effect psychological states.
    This guidance is intended to inform industry and the public that 
FDA considers any product that is promoted as a street drug alternative 
to be an unapproved new drug and a misbranded drug in violation of 
sections 505 and 502 of the act (21 U.S.C. 355 and 352). Such 
violations may result in regulatory action, including seizure and 
injunction.
    Moreover, FDA is also aware that some of these street drug 
alternatives are being promoted as dietary supplements. FDA does not 
consider street drug alternatives to be dietary supplements because 
they are not intended to supplement the diet.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The guidance is 
being implemented immediately without prior public comment because of 
the potential hazard to the public health. The guidance represents the 
agency's current thinking on street drug alternatives. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute, 
regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 28, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-8110 Filed 3-31-00; 8:45 am]
BILLING CODE 4160-01-F