Guidance for Industry

Street Drug Alternatives

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

March 2000

Compliance
Guidance for Industry

Street Drug Alternatives

Additional copies of this Guidance are available from:

 Office of Training and Communications

 Division of Communications Management

Drug Information Branch, HFD-210

Center for Drug Evaluation and Research

Food and Drug Administration

 5600 Fishers Lane, Rockville, MD 20857

(Phone 301-827-4573)

Internet: http://www.fda.gov/cder/guidance/index.htm.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

March 2000

Compliance
Guidance for Industry1

Street Drug Alternatives

I. INTRODUCTION

This guidance is intended for those persons who are manufacturing, marketing, or

distributing alternatives to illicit street drugs. 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 Federal Food, Drug, and Cosmetic Act

(the Act). Such violations may result in regulatory action, including seizure and

injunction.

II. BACKGROUND

The Agency has become aware of the proliferation of various products that are being

manufactured, marketed, or distributed as alternatives to illicit street drugs (street drug

alternatives). FDA is concerned that these products are being abused by individuals,

including minors, and pose a potential threat to the public health.

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. Many of these products are promoted on the

Internet and in counterculture magazines as alternatives to illicit street drugs such as

MDMA (4-methyl-2, dimethoxyamphetamine), a methamphetamine analogue, also

known as ecstasy, XTC, and X. Other examples of products whose names imply street

drug alternative use are e-Ludes, Hextacy, and Herbal Koke.

These products are intended to be used for recreational purposes to effect psychological

states (e.g., to get high, to promote euphoria, or to induce hallucinations) and have

potential for abuse. FDA considers these street drug alternatives to be unapproved new

drugs and misbranded drugs under sections 505 and 502 of the Act.

 1

This guidance has been prepared by the Office of Compliance, Division of Labeling and

Nonprescription Drug Compliance, in the Center for Drug Evaluation and Research (CDER), Food and

Drug Administration. This 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.
FDA is also aware that some of these street drug alternatives are being marketed as

dietary supplements. FDA does not consider street drug alternatives to be dietary

supplements. The term dietary supplement as defined in section 201(ff) of the Act

means, inter alia, a product "intended to supplement the diet." While the Act does not

elaborate on the meaning of this phrase, many congressional findings, set forth in the

Dietary Supplement Health and Education Act of 1994, suggest that dietary supplements

are intended to be used to augment the diet to promote health and reduce the risk of

disease. FDA does not believe that street drug alternatives are intended to be used to

augment the diet to promote health or reduce the risk of disease. Moreover, FDA

considers the diet to be composed of usual food and drink that may be designed to meet

specific nutritional requirements. Illicit street drugs are not food or drink, and neither

they, nor alternative street drugs, can be said to supplement the diet. Rather, these

products are intended to be used for recreational purposes to effect psychological states

(e.g., to get high, to promote euphoria, or to induce hallucinations). Accordingly, street

drug alternatives are not intended to supplement the diet and are not dietary supplements.

This position is consistent with that set forth at 62 Fed. Reg. 30678, 30699-700 (June 4,

1997).

III. POLICY

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

Federal Food, Drug, and Cosmetic Act. Such violations may result in regulatory action,

including seizure and injunction