A strongly worded letter from the Health Research Group, dated January 31, 2002, admonished Department of Health and Human Services secretary Tommy Thompson that his “… Department has been grossly negligent in protecting Americans from what is clearly the most dangerous drug that masquerades as a food supplement, Ephedra. At least 10 products made by nine dietary supplement producers are now being sold on the Internet—products that illegally contain dangerous synthetic derivatives of...
A strongly worded letter from the Health Research Group, dated January 31, 2002, admonished Department of Health and Human Services secretary Tommy Thompson that his “… Department has been grossly negligent in protecting Americans from what is clearly the most dangerous drug that masquerades as a food supplement, Ephedra. At least 10 products made by nine dietary supplement producers are now being sold on the Internet—products that illegally contain dangerous synthetic derivatives of ephedra.” Secretary Thompson was specifically asked to order the seizure of these illegally marketed products.
A list of these producers and their products appear in the box on this page. The text of the letter is available on our web site at
www.citizen.org/publications/release.cfm?ID=7146. A hard copy of this document can be obtained by writing to us at 1600 20th Street, NW, Washington, DC 20009.
Ephedra is an herb that contains a number of substances that are chemically similar to the amphetamines (“speed” like substances) such as ephedrine and norephedrine (also known as phenylpropanolamine or PPA). Data from the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition’s Special Nutritionals Adverse Event Monitoring System shows that dietary supplements containing these chemicals are associated with more reports of death, heart attack, heart rhythm disturbances, high blood pressure, stroke and seizure than all other dietary supplements combined.
The Health Research Group petitioned the FDA on September 5, 2001 to ban the production and sale of dietary supplements containing ephedra and the chemicals derived from this herb. Prior to this, on October 19, 2000, we had also petitioned the FDA to ban all over-the-counter (OTC) uses of PPA. The FDA is now in the process of formally removing PPA from all prescription and OTC products.
On January 9, 2002, Canadian regulatory authorities announced the initiation of a voluntary recall of certain products containing Ephedra and ephedrine. This decision was reached after a risk assessment concluded that these products pose a serious health risk. Secretary Thompson should look north for guidance.
U.S. law is very clear on adding synthetic compounds to dietary supplements. The Food, Drug and Cosmetic Act expressly limits dietary supplements to ingredients that are concentrates, metabolites (breakdown products), constituents, or extracts of dietary substances.
Our letter concludes by informing Secretary Thompson that “Failure to act swiftly and decisively in this matter as required by law and to ban all ephedra alkaloids will result in a continuation of the harm and injury of dietary supplement consumers nationwide and will emphasize how fraudulent your concerns about food safety are.”
What You Can Do
You should not use any dietary supplements other than vitamins and minerals. Even supplement producers who do not lace their products with synthetic substances are not required to show that what they are selling is either safe or effective for any purpose.
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PRODUCT
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PRODUCER
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Adipokinetix
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Syntrax Innovations, Inc.
PO Box 1593
Cape Girardeau, MO 63702
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Adrenalin
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Genapharm
PO Box 2558
Ceder Park, TX 78641
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Alphadrine
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Pro-Muscle
Address not available
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Ephedrine 25
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Scientifically Advanced Nutrition, Corporation
4230 Del Rey Ave. # 458
Marina Del Rey, CA 90292
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Ephedrol
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Thermal Plus
900 Greenbank Rd. Suite 522
Nepean, Ontario K2J-4P6
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Hollywood Cuts
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Scientifically Advanced Nutrition, Corporation
4230 Del Rey Ave. # 458
Marina Del Rey, CA 90292
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Lipodryl II
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Thermolife
720 El Camino Real #101
Belmont, CA 94002
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Meta-Burn Extreme
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Metabolic Response Modifiers
236 Calle Pintoresco
San Clemente, CA 92673
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Overdrive
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7th Millennium Nutrition
P.O. Box 2206
Stow, OH 44224
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Phenylkinetics
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21st Century Nutritionals / Synergy Nutritionals
745 Hollywood Blvd. N.W.,
Ft. Walton Beach FL 32548
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