FDA bans "Cocaine" (Street Drug Alternatives)

http://www.fda.gov/foi/warning_letters/b6312d.htm

WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED April 4, 2007 James KirbySenior Partner/FounderRedux Beverages, LLC41605 Elm Street, #6Murrieta, CA 92562

Dear Mr. Kirby:

The Food and Drug Administration conducted an inspection of your firm, Drink Reboot, on February 14, 2007. This letter concerns your firm's marketing of the product "Cocaine" as a dietary supplement on your website, http://www.drinkcocaine.co/. According to information on your website, Cocaine is marketed as an alternative to an illicit street drug, and certain ingredients contained therein are intended to prevent, treat, or cure disease conditions.As explained in greater detail below, dietary supplements are products that e intended to supplement the diet . Street drug alternatives, i.e., products that claim to mimic he effects of recreational drugs, are not intended to supplement the diet and, as a result, cannot lawfully be marketed as dietary supplements.In addition, a dietary supplement may not bear claims that it prevents or treats a disease, except for authorized health claims about reducing the risk of a disease. Other disease prevention and treatment claims render the product a drug subject to the drug requirements of the Food, Drug, and Cosmetic Act (Act).The following statements that are noted on your product container or on your website demonstrate that your product is intended as an alternative to an illicit street drug:"The Legal Alternative"The product name is "Cocaine," and the letters in the product name appear to be spelled out in a white granular substance that resembles cocaine powder."Speed in a Can""Liquid Cocaine""Cocaine - Instant Rush.""The question you have to ask yourself is: "Can I handle the rush?"This beverage should be consumed by responsible adults. Failure to adhere to this warning may result in excess excitement, stamina, . . . and possible feeling of euphoria."The following statements on your website about an ingredient of "Cocaine" demonstrate that your product is intended to treat or prevent certain diseases:*"Inositol -... reduces cholesterol in the blood; it helps prevent hardening of the arteries, and may protect nerve fibers from excess glucose damage. Inositol has a natural calming effect and may be used in the treatment of anxiety, depression, and obsessive-compulsive disorder without the side effects of prescription medications."Street Drug AlternativesFDA has become aware of the proliferation of various diet supplement products that are being manufactured, marketed, or distributed as alternatives to illicit street drugs. Street drug alternatives are not intended to supplement the diet. 21 U.S.C. 321(ff). Accordingly, street drug alternatives do not qualify as dietary supplements. See United States v. Undetermined Quantities of Articles of Drugs, 145 F. Supp. 2d 692 (D. Md. 2001). In March of 2000, FDA made available a guidance for industry on street drug alternatives. This document contains additional information and is available at http://www.fda.gov/cder/guidance/index.htmDisease ClaimsYour product, Cocaine, is a drug, as defined by Section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, 21 U.S.C. §§ 321(g), 321(ff), and 343(r)(6). Moreover, this product is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under Sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Cocaine without an approved application violates these provisions of the Act.Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use this product safely for its intended uses. Thus, Cocaine's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.Please address your written response to the attention of:Pamela B. SchweikertDirector, Compliance BranchUnited States Food and Drug Administration19701 FairchildIrvine, CA 92612-2506If you have any questions about the content of this letter please contact Mr. John J. Stamp at (949) 608-4464.Sincerely yours,/S/Alonza E. CruseDistrict DirectorCc: California Board of Pharmacy1625 N, Market Blvd.Suite N219Sacramento, CA 95834

http://www.fda.gov/cder/guidance/3602fnl.htm
Guidance for Industry
Street Drug Alternatives
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)March 2000Compliance
[Acrobat Version of this Document]
Additional copies of this Guidance are available from:Office of Training and CommunicationsDivision of Communications ManagementDrug Information Branch, HFD-210Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers Lane, Rockville, MD 20857(Phone 301-827-4573)

Guidance for Industry
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.
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