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UNPA is deeply concerned that the story contains misinformation about the laws regulating dietary supplements, particularly in light of the tragic deaths of U.S. service members.
May 20, 2015
4 Min Read
The United Natural Products Alliance (UNPA) has issued the following response to the inaccurate and misleading reporting contained in the May 19 airing of a segment on HBO’s “Real Sports.”
UNPA is deeply concerned that the story contains misinformation about the laws regulating dietary supplements, particularly in light of the tragic deaths of U.S. service members. This irresponsible reporting is a glaring disservice to the public.
First and foremost, dietary supplements are subject to a host of regulations as promulgated by the Food and Drug Administration (FDA) under the Code of Federal Regulations, Title 21, of the Food, Drug and Cosmetic Act. Simply stated, it is a regulated industry.
FDA has found on more than one occasion that an ingredient in the products in question, 1,3-dimethylamylamine, commonly known as DMAA, is not a legal dietary ingredient and is not allowed to be sold as a dietary supplement, which is why FDA removed DMAA from the market.
To suggest that enactment of the Dietary Supplement Health and Education Act (DSHEA), the law that regulates dietary supplements, passed by unanimous consent of both the House and Senate in 1994, allowed the marketing of such products is either an intentional misrepresentation or a complete misunderstanding of the law. Either way, HBO is incorrect.
FDA has previously acted against a number of companies selling DMAA because the agency found that they were not legally on the market.
In May 2013, UNPA created a “no sale” policy of DMAA as a condition of membership in support of FDA’s enforcement action and to underscore that DMAA, a synthetic chemical, is not a dietary supplement.
UNPA believes that 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 review of the record tells a different story than the one told by HBO. Specifically:
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.
“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, who has tirelessly worked to assure continued access to safe and beneficial products. 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,” he added. “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.”
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