By Hank Schultz Nutra Ingredients USA
An HBO Real Sports segment about dietary supplement use in the US military implied that Sen. Orrin Hatch was complicit in the deaths of several US soldiers who collapsed with the banned ingredient DMAA in their systems.
DSHEA cast as root of problem
In the show which aired last night reporter Soledad O’Brien made the link via Hatch’s sponsorship of Dietary Supplements Health and Education Act (DSHEA), which was cast as an anything-goes hall pass for the dietary supplements industry, calling it the law that “shields the industry from regulation”. Other than making the Hatch-death link, which is new, the segment recycled tried-and-true criticisms of the industry, saying that it is insufficiently regulated and that products are not approved by FDA before going to market. It quoted industry critics such as Anne Weismann, chief counsel for the Citizens for Responsibility and Ethics in Washington, and Dr Pieter Cohen of the Harvard Medical School. The segment did not include any input from supplements industry representatives.
“In the world of supplements almost anything is possible, thanks to the law that governs the industry, or some might say, doesn’t govern the industry,” O’Brien said.
The video began with an emotional recounting of the death and US Army private Michael Sparling, who suffered cardiac arrest while on a training run. Sparling had been using the pre-workout supplement Jack3D which at that time contained DMAA, an ingredient that FDA has since removed from the market. O’Brien’s report did mention that a subsequent military review of Sparling’s death and the deaths of two other soldiers found that they could not be causally linked to the ingredient.
O’Brien’s report implied that Hatch’s activities on behalf of the industry enabled such companies to do business.
“Hatch has never stopped fighting to limit the regulation of the supplements industry,” she said.
Industry trade organizations were quick to respond to what they see as a distorted and one-sided report. Chief among their complaints is that the industry is in fact regulated, and Hatch in particular has worked to improve those regulations, including sponsoring the 2006 law that set up the adverse events reporting requirement for dietary supplements. Problems in the industry can be attributed to a lack of adequate enforcement, not deficiencies in the regulatory scheme, they say.
“Millions of consumers use dietary supplements daily and do so safely and with great benefit,” said UNPA President Loren Israelsen. “This is in large part due to the efforts of Sen. Hatch. Based on his record, we are surprised and disappointed that HBO missed the mark so badly.
“Regrettably, HBO has chosen to misinform its viewers on the regulation and safety record of supplements. And while we agree that rogue players and products do exist, this is not because of DSHEA or Sen. Hatch,” he said.
Steve Mister, CEO of the Council of Responsible Nutrition, said his organization was dismayed that O’Brien chose not to allow industry representatives to provide information that might have resulted in a more balanced report.
“We are disappointed that HBO ignored our requests to provide perspective from the mainstream, responsible dietary supplement industry as we would have confirmed our position that the products the segment focused on are being illegally marketed as dietary supplements in violation of the requirements for new ingredients.
“Further, we would have provided accurate information and a more balanced perspective of the numerous provisions in the law, added with the passage of DSHEA and beyond, that have given FDA more authority than it previously had to remove unsafe products from the market and ample tools to enforce the law. To that end, we are concerned that FDA has not always acted as swiftly as appropriate to remove from the market these kinds of questionable products, and we continue to urge for further resources, financial and otherwise, for FDA to more fully enforce the law,” Mister said.
O’Brien’s report hinged on the three US Army deaths that have been associated with DMAA and also told the story of a US Navy sailor who was taking an unspecified weight loss supplement and who later required a liver transplant. She cited 48 medical evacuations of military personnel from Iraq and Afghanistan, implying that these were the result of supplement use. She did not contrast these figures with any adverse events in the same period associated with the use in the military of prescription medications. If the adverse event record for these substances in the general population over the same time period is any guide, there must have been many hundreds if not thousands of adverse events among soldiers and sailors associated with prescription drugs.
“The use of supplements is rampant in the military. Few of the troops realize the risks but our research indicates they can be severe,” O’Brien said.
“Critics of dietary supplement regulation tend to focus on pre-market approval as the only option, ignoring the fact that pre-market approval is not a full-proof method to safety, nor is it a viable option for the vast majority of products in our industry that don’t receive the same patent protection and financial incentives as pharmaceutical products,” said CRN’s Mister. “Our industry is open to dialoguing with those who are serious—and realistic—about finding ways to avoid the kinds of tragedies shown in this segment in the future.”
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