Synthetic Ephedrine Found In 10 Marketed Supplements – Public Citizen
This article was originally published in The Tan Sheet
Executive Summary
Ten dietary supplements containing synthetic ephedrine should be seized, Public Citizen urges HHS Secretary Tommy Thompson in a Jan. 31 letter
|
Ten dietary supplements containing synthetic ephedrine should be seized, Public Citizen urges HHS Secretary Tommy Thompson in a Jan. 31 letter. The products, currently being sold over the Internet, are positioned as containing "pharmaceutical grade" ingredients and therefore cannot be marketed as supplements, the consumer watchdog group states. "Given that the FDA has determined that synthetic drugs are not legitimate ingredients for dietary supplements, and since ephedrine HCl and [phenylpropanolamine] are defined as drugs, these products should also be seized on the basis of being unapproved drugs," the group adds. In addition, Public Citizen notes the majority of the products contain both caffeine and ephedrine alkaloids. "Scientific literature shows that the combination of ephedrine and caffeine at individually sub-threshold quantities are synergistically able to produce an effect that is similar to that of amphetamine, an illegal drug." The products/manufacturers cited in the letter are: Ephedrine 25 and Hollywood Cuts (Scientifically Advanced Nutrition); Adrenalin (Genapharm); Ephedrol (Thermal Plus); Overdrive (7th Millenium Nutrition); Lipodryl II (Thermolife); Phenylkinetics (21st Century Nutritionals); Metaburn Extreme (Metabolic Response Modifiers); Alphadrine (Pro-Muscle); and Adipokinetics (Syntrax). Online sale of the products is "cause for added concern," Public Citizen states, due to the accessibility to minors. For example, marketing materials for Hollywood Cuts claims the product's ingredient, "IR, 2S Norephedrine [PPA], is a close cousin to the pharmaceutical 'amphetamine,'" the letter notes. Public Citizen points to FDA's Oct. 31 seizure of E'Ola's synthetic ephedrine product, AMP II Pro Drops , as precedent for similar actions against the nine companies (1 (Also see "E’Ola Ephedrine HCl Product Seized, FDA Complaint Alleges Item To Be Drug" - Pink Sheet, 5 Nov, 2001.), p. 5). The consumer group and University of Arizona's Raymond Woosley, MD/PhD, petitioned FDA last September to ban all ephedrine alkaloid products, citing poison control center data that showed a doubling of related adverse events between 1997 and 1999 (2 (Also see "Ephedrine Alkaloid AERs Nearly Double Over Two Years - AAPCC Data" - Pink Sheet, 10 Sep, 2001.), p. 3). |