Gregory P. Availability of DMAA Supplements Despite US Food and Drug Administration Action. JAMA Intern Med. 2013;173(2):164-165. doi:10.1001/2013.jamainternmed.724
Author Affiliations: Natural Medicines Comprehensive Database, Stockton, California, and Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, Nebraska.
The stimulant DMAA, also known as 1,3-dimethylamylamine, has been the subject of much controversy.1 In the United States, it is currently marketed as a dietary supplement, primarily in products promoted as a preworkout supplement for boosting strength, energy, and power. Two of the most prominent supplements containing DMAA are “Jack3d” and “OxyELITE Pro” (USP Labs) However, there are over 250 commercial dietary supplements containing DMAA on the market.2
As has been reported elsewhere,1 DMAA supplements are immensely popular among consumers. However, there is great concern among health professionals and regulators for several reasons. First, it is unlikely that DMAA is truly of natural origin. Therefore, its marketing as a dietary supplement may be illegitimate. Second, there are significant safety concerns. To date, there have been over 40 reports of serious adverse events, including at least 2 reports of death.2,3
On April 27, 2012, the US Food and Drug Administration (FDA) sent warning letters to 10 manufacturers of 16 products containing DMAA. The warning indicated that the products were considered adulterated because DMAA is considered a new dietary ingredient(NDI).3 NDIs require the manufacturer to submit some documentation demonstrating the expectation of safety. Without such document, the FDA considered the products to be adulterated, unapproved drugs.
It came to my attention on May 17, 2012, that some of these products were still available for sale through online retailers. As a result, I conducted a systematic survey of online retailers to determine the extent of availability of these illegal products.
On May 17, 2012, I conducted an online survey using Google Search and Google Shopping. For each of 16 products identified by the FDA (Table), I searched Google using the product brand name. I searched using the product name in isolation as well as combined with the manufacturer's name. For each product searched I reviewed the product manufacturer's website to determine if the product was still available for sale directly by the manufacturer. I also conducted a search in Google Shopping to determine if the product was still available through other online retailers.
Of the DMAA-containing products searched, all 16 were still available for sale through online retailers (Table). Six of the 16 products were still for sale directly from the manufacturer's website as well as from an independent retailer.
In many cases, the illegal DMAA-containing products were readily available through major online retailers. For example, 12 of the 16 products were available for sale through General Nutrition Centers (www.gnc.com). Eight of the 16 products were available through Drugstore.com. None of the websites reviewed provided any information about the products being illegal, adulterated, or otherwise not permitted for sale.
The FDA's action to identify and warn manufacturers of DMAA-containing products is a step in the right direction. However, despite this warning, all of the products in question are still readily available. This suggests that the FDA's warning process may do little to nothing to stem the significant public health risk posed by this potentially dangerous ingredient.
Correspondence: Dr Gregory, School of Pharmacy and Health Professions, Creighton University, 2500 California Plaza, Omaha, NE 68178 (email@example.com).
Published Online: December 3, 2012. doi:10.1001/2013.jamainternmed.724
Conflict of Interest Disclosures: None reported.