Guidance for Industry on Street Drug Alternatives; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.