Inspections, Compliance, Enforcement, and Criminal Investigations
Stardust Industries 31-Mar-03
Public Health Service
|Rockville, MD 20857|
March 31, 2003
VIA FEDERAL EXPRESS
9018 Balboa Blvd.
Northridge, California 91325
Ref. No: 03-HFD-312-11
This letter is written in reference to your firm?s marketing of various products that are promoted on your Internet web site, www.stardustdrugs.com, as alternatives to illicit street drugs. Some of these products purport to contain sources of ephedrine (i.e.,ephedra, ma huang, or sida cordifolia).
Your Internet web site, from which these products may be ordered, promotes these products with brand names and claims, indicating that they are intended to be used as street drug alternatives, and lists ingredients of these products, as follows:
Opening text of web site
?Looking for a Safe high? ? The following list is meant as a general guide to our products and their similarity in effect to several illegal drugs . . . Stardust safe and legal alternatives for the party lifestyle.?
?Cocaine . . . THE SAFE & LEGAL STARDUST ALTERNATIVE: Herbal Ecstasy, Legal Speed?
?Ice . . . Also known as: . . . Methamphetamine . . . THE SAFE & LEGAL STARDUST ALTERNATIVE: Herbal Ecstasy, Legal Speed?
?Hallucinogens . . . THE SAFE & LEGAL STARDUST ALTERNATIVE: Herbal Ecstasy . . .?
Herbal Ecstacy 30 pills
?The standard for all herbal ecstacy pills gives you a rush of both pleasure and energy. This 30 dose bottle will provide you with hours of bliss and charge for any activity (try it with sex for a wild ride!!) Active Ingredients: sida cordifolia, Stardust XTC blends?
Legal Speed capsules
??The name says it all. Get legal speed now. Active Ingredients: Sida Cordifolia?
". . . this is the strongest, best herbal ecstasy available. . . . ?This product will rock your world!! Try and be hooked? ?best herbal ecstacy alternative on the Market today?, users insist TRIP2NIGHT is 10 times better than any other Herbal Ecstacy they?ve ever experienced. You will be amazed at how much it feels like the real thing? *Warning* Trip2Night contain [sic] Ephedra . . . Active Ingredients: Ma Huang, Guarana, 5-HTP, Bioperine, Indian Bromine, Cinnamon, Cola Nut, Niacin and Fo Ti.?
Road Runner capsules
?Road Runner Super is the most effective and carefully designed legal stimulant available . . . gives an overall stimulation of the body, mind and spirit, that won?t let you down. The main active ingredient is our Sida extract, which gives an amphetamine like stimulation, giving massive rushes and tingling of the skin and hair . . . Active Ingredients: Sida cordifolia, GINSENG (Eleutherococcus senticosus), GUARANA (Paullinia cupana), L-PHENYLANALINE (L-Phe), GAMMA AMINO BUTYRIC ACID (GABA)?
Bliss Ecstasy (Bliss Extra) capsules
?The key ingredient in Bliss Extra is the Aserone contained in its Calamus extract. Aserone is converted into TMA-2, which is the basic building block from which most modem amphetamines were originally derived. The Ecstasy like hallucinogenic properties of the Aserone, together with the stimulating properties of the Sida extract, makes [sic] Bliss Extra the first true Ecstasy alternative Active Ingredients: CALAMUS [Acoru calamus], GINSENG (Eleutherococcus senticosus), L-PHENYLANALINE (L-Phe), GABA [Gamma Amino Butyric Acid], Sida cordifolia?
FDA is aware that some street drug alternatives are being marketed as dietary supplements. 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. Accordingly, street drug alternatives are not intended to supplement the diet and are not dietary supplements. 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.htm.
Based on the claims cited, the products discussed above are ?drugs? as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act). Moreover, they are also ?new drugs? (Section 201(p) of the Act) because there is no evidence that these products are generally recognized as safe and effective for their intended uses. Under Section 505 of the Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug. Since these products are not the subjects of approved NDAs, they may not be marketed in the United States and their continued marketing violates Section 505 of the Act.
This letter is not intended to be an all-inclusive review of your Internet web site or all of your firm?s labeling and products, and it is not intended to be an all-inclusive list of violations concerning your firm and its products. You are responsible for ensuring that all products marketed by your firm are in compliance with applicable United States laws.
We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug, and Cosmetic Act provides for seizure of illegal products and for an injunction against the manufacturer and/or distributor of illegal products.
You must notify this office in writing within fifteen (15) working days of your receipt of this letter as to the specific actions you have taken lo correct the stated violations. You should also include an explanation of each step you have taken 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. Further, if your firm does not manufacture the product, your reply should also 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 manufacturing firm.
Address your reply to the Food and Drug Administration, Division of New Drugs and Labeling Compliance, 5600 Fishers Lane, (HFD-310 / MM2 / Rm. 328), Rockville, MD 20857. Attention; Dr. Linda Silvers.
David J. Horowitz, Esq.
Office of Compliance