Dietary supplements containing 1,3-dimethylamine (DMAA) were readily available online, despite FDA warnings to their makers that they had failed to meet safety requirements, according to a researcher.
Sixteen DMAA-containing products, all manufactured by 10 companies that received FDA warning letters in April, were for sale through online retailers nearly a month later, including the companies’ own websites, reported Philip Gregory, PharmD, from Creighton University in Omaha, Neb., in a research letter in the Archives of Internal Medicine online.
“None of the websites reviewed provided any information about the products being illegal, adulterated, or otherwise not permitted for sale,” Gregory wrote.
DMAA is marketed as a natural stimulant in “products promoted as a pre-workout supplement for boosting strength, energy, and power,” Gregory explained.
A chemical analysis of DMAA published in Drug Testing and Analysis in July 2012 showed that the ingredient was entirely synthetic. Gregory noted products with DMAA were implicated as the cause of more than 40 adverse events, including at least two deaths.
The FDA issued warning letters to the following DMAA supplement makers on April 27, 2012:
- Exclusive Supplements
- Nutrex Research
- USP Labs
- Fahrenheit Nutrition
- SEI Pharmaceuticals
- Muscle Warfare
- Gaspari Nutrition
The warning letters “indicated that the products were considered adulterated [and unapproved] because DMAA is considered a new dietary ingredient,” which requires the manufacturer to submit documents to the agency demonstrating their product’s safety, Gregory explained.
The substance is “known to narrow blood vessels and arteries,” which can cause shortening of breath, myocardial infarction, or other cardiovascular events, the FDA noted in a statement following the warning.
Gregory conducted an online search on May 17, 2012 for the 16 products sold by the manufacturers mentioned in the warning letters. He searched by product name alone or in combination with the manufacturer’s name. He also reviewed the manufacturer’s website.
The primary endpoint was availability of the dietary supplement through the manufacturer’s or other online retailer’s website.
All 16 products were available through an online seller, including major retailers such as General Nutrition Centers and Drugstore.com. Six of the products could be ordered directly from the manufacturer’s website.
Gregory noted that the warning letters were a “step in the right direction,” but that the FDA’s warning process “may do little to nothing to stem the significant public health risk posed by this potentially dangerous ingredient.”
http://www.medpagetoday.com/PrimaryCare/ExerciseFitness/36232Social tagging: banned substances > cardiovascular > DMAA > doping > supplements