New York, NY—HBO’s airing of Real Sports with Bryant Gumbel on May 20 has caused a stir in the natural products industry for mischaracterizing the dietary supplements industry.
The 16-minute segment called “In Harm’s Way” implied that no one is looking out for the military personnel who take “dangerous workout supplements” to stay in shape and that the supplements industry is underregulated.
In an interview with journalist Soledad O’Brien, Pieter Cohen, M.D., from Harvard University, said, “We’ve seen products sold on our military bases that do harm our troops and that’s beyond unacceptable.”
This reference was to two soldiers who died from heart attacks after taking a DMAA, Jack3d, which was bought at a GNC located on military base in 2011. Legitmate members of the supplements industry have since stopped selling DMAA; this ingredient is regarded as illegal for sale as a supplement due to lack of safety data and potential health risks.
O’Brien pointed her finger at the Dietary Supplement Health and Education Act of 1994 (DSHEA) as allowing supplements to be marketed without human testing or approval from the U.S. Food and Drug Administration. Several interviewees voiced the opinion that the industry is completely unregulated.
Moreover, Anne Weismann, chief counsel for the Citizens for Responsibility and Ethics, made the case the Senator Orrin Hatch (R-UT), a staunch supporter and original sponsor of DSHEA, receives substantial monetary donations from the supplements industry. O’Brien accused him of protecting the supplements industry in exchange for financial support to the detriment of troops (and the public). Stated Weismann, “Hatch has never stopped fighting to limit regulation over the supplement industry,” according to the Salt Lake City Tribune.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), felt the coverage was inaccurate and one-sided. He stated 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.”
CRN and other industry groups also were very concerned about the misinformation presented in the piece. “This irresponsible reporting is a glaring disservice to the public,” said the United Natural Products Alliance.
The trade associations pointed out that DMAA is illegal for sale and underscored the many ways that DSHEA and FDA regulates this industry.
To O’Brien’s accusations of Hatch, UNPA stated, “there is no evidence that Sen. Orrin Hatch has ever supported the sale of any unsafe dietary supplement. To the contrary, Sen. Hatch has led efforts to assure the full enforcement of the law and to secure adequate funding to do so.”
A UNPA press release provides "a review of the record" that "tells a different story than the one told by HBO.":
- DSHEA grants FDA authority to remove any dietary ingredients or dietary supplement products deemed to be unsafe. Sen. Hatch has repeatedly noted this, including, as an example, when he co-sponsored the Anabolic Steroid Control Act (S. 1780 and S. 1538). This legislation, which was enacted into law in 2004, defined a long list of anabolic steroids as drugs and not dietary supplements.
- Hatch has never stopped working to have FDA enforce the law and has repeatedly fought for additional funds for FDA to enforce it. He co-authored the “DSHEA Full Implementation and Enforcement Act of 2010,” a proposed amendment to provide FDA with additional resources; direct FDA to inspect facilities to ensure compliance with the new dietary supplement good manufacturing practice regulations; allow it to use the authority under DSHEA to protect the public from unsafe dietary supplements; and ensure that claims made for dietary supplements are truthful, non-misleading and substantiated.
- In remarks in support of the above amendment, he said: “When we drafted DSHEA, ensuring the safety of products was at the forefront of our efforts. The law gives the FDA abundant tools to remove products that are unsafe from the market. … There is no excuse for a supplement manufacturer to market products that are unsafe or inaccurately labeled or that make outlandish claims.”
- In the same floor statement, Hatch pointed to the real issue when he said: “It is impossible for this law to protect consumers if it is not enforced.”
- Hatch also co-sponsored the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, a law requiring mandatory reporting of serious adverse events for dietary supplements and OTC drugs.
- In 2014, he co-sponsored the Designer Anabolic Steroid Control Act of 2014 that protects consumers from potentially dangerous anabolic steroids that are often falsely marketed as dietary supplements. This legislation was signed into law in December 2014.
“Regrettably, HBO has chosen to misinform its viewers on the regulation and safety record of supplements,” stated Loren Israelsen, president of UNPA. “And while we agree that rogue players and products do exist, this is not because of DSHEA or Sen. Hatch, who has consistently worked to preserve the rights of consumers to access safe dietary supplements.”
In other news, Senators Hatch and Martin Heinrich (D-NM) sent a letter to U.S. Attorney General Loretta Lynch showing their support for taking strong measures against manufactures who sell illegal "dietary supplements" containing anabolic steroids or active pharmaceutical ingredients.
The pair even stated the low number of criminal convictions is not deterring "would-be criminaks." The letter states, "Much more could be done. Illicit behavior that puts the public health at risk warrants a full criminal investigation, and if appropriate, criminal charges should be aggressively pursued to punish wrongdoers appropriately while deterring those contemplating engaging in similar conduct."
Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association commended the pair for taking this action and agreed that "FDA should enforce the laws currently on the books to prevent criminals from tainting our industry."
Published in WholeFoods Magazine, July 2015 (online May 20, 2015)