There are over 8000 unregulated dietary supplements on the market, untested and ostensibly safe for use. According to a 2011 study released by the FDA, more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40% between 1988 and 1994.
On April 11, 2013, the FDA issued a warning about supplements containing DMAA, dimethylamylamine, a stimulant. The warning came in advance of a story aired on NBC’s Rock City, about a young soldier who died of a heart attack as a result of using Jack3d, a product that contains DMAA.
DMAA is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.
DMAA provides ‘that little edge’ to make workouts better. The product in question, Jack3d (pronounced Jacked) is manufactured by USP Labs. There is no law prohibiting it and no legislation that gives the FDA authority to do more than issue a strong statement about the dangers of dietary supplements containing DMAA.
In a written statement to NBC News, Michael Petruzzello, on behalf of USP Labs, writes, “DMAA is a safe and lawful dietary ingredient. We stand by the scientific evidence presented and believe there is no reason to withdraw it from the market.”
GNC is one of the nutritional stores that sells Jack3d. They do not feel responsible for ‘policing’ the items they sell. In a statement to Rock Center they said they rely on the manufacturers to make sure drugs are in compliance with the law and safe for humans to take.
A US law passed in 1994 declared dietary supplements exempt from pre-market FDA approval. The FDA’s warning last week stated, “FDA's authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don't voluntarily comply.”
For now, the FDA can only issue a warning. And GNC will keep Jack3d on its shelves because USP Labs says their product is safe. USP Labs and other manufacturers of dietary supplement remain free of the kind of scrutiny drug makers must go through. The burden rests on these businesses, the ones manufacturing and profiting from the production of these so-called ‘safe’ dietary supplements, to respond appropriately. In the absence of legal oversight, it’s left to businesses like GNC and USP Labs to weight the considerations of human life versus making a profit.
Bottom line: we have hundreds of manufacturers, supported by big box businesses like GNC, producing and selling unregulated dietary supplements to consumers. DMAA, the ingredient in Jack3d, is banned in nine countries across the world, including Canada. Yet, you or I can walk into a store and buy a product that has already been connected with the illness or death of 86 individuals.
There has to be a balance between neglect, overreaching government regulations and judicious oversight. We should, however, expect more when it comes to the safety of American citizens – our families, our friends, our loved ones.
For more on the hazards of DMAA, see a previous article this writer published a year ago at: /defective-and-dangerous-products/dmaawhat-is-it-and-why-hasnt-it-been-banned-in-the-us.aspx?googleid=300874 or visit http://www.michiehamlett.com.