WASHINGTONAs the natural products industry continues to debate the provisions of Sen. John McCains Dietary Supplement Safety Act, the senator issued a floor statement clarifying what he considers to be misinterpretations of the bill. In fact, he noted, opponents to this bill and their well-paid Washington lobbyists have spread false statements and rumors about the legislation, which is really a disservice to consumers, and instead proudly boast that they remain largely untouchable by the FDA.

However, industry organizations including the Council for Responsible Nutrition (CRN) and the Alliance for Natural Health (ANH) suggested McCain (R-Ariz.) was overlooking key aspects of the current regulatory structure and how the bill would change FDAs ability to oversee dietary supplements. In fact, CRN noted, There are onerous provisions in the bill that do, in fact, fundamentally alter the regulatory structure and limit consumer access.

In McCains statement, he noted his bill would require dietary supplements to list all ingredients on packaging, mandate that manufacturers register with FDA, and provide FDA with mandatory recall authority for dietary supplements it determines are hazardous to human health. Among what he considers falsehoods from the bills opponents are that it would limit consumers ability to purchase dietary supplements, and would establish a new regulatory structure for dietary supplements at FDA.

However, ANH pointed out the bill would remove the current structure under which dietary ingredients that were on the market prior to the passage of the Dietary Supplement Health and Education Act (DSHEA) were grandfathered, instead mandating FDA keep a list of acceptable ingredients for such products. ANH stated, What supplements would be legal to sell if this bill passes? Only those supplements included on [a] listprepared, published, and maintained by the [FDA]. In other words, traditional (pre-1994) supplements would no longer be protected. The FDA would have arbitrary power to choose permitted supplements and (importantly) supplement doses.

In a letter to McCain, Steve Mister, CRNs president and CEO, echoed those concerns about the change in the New Dietary Ingredient (NDI) provisions of federal law. Accordingly, dietary ingredients with a long history of safe use and wide consumer acceptance would have to petition FDA to get on the list, and unless and until FDA grants that approval, these products would be withdrawn from the market. That regulatory regime would turn a basic tenet of [DSHEA]namely, that dietary supplements with a history of safe use should be accessible to consumers unless FDA determines that they are not safeon its head.

McCain stated he introduced the bill to protect Americans who take a dietary supplement, because he claimed there are thousands of hospitalizations and doctors visits linked to adverse reactions from such products, not to mention deaths from their use. The disclosure of ingredients on a dietary supplement can save lives; and therefore, it should be mandatory, he said. However, as current law stands, any product that does not list all ingredients on its label is in violation of the law and is an illegal and misbranded product. As Mister pointed out, If the label does not provide ... the identity and quantity of ingredients, then the product is misbranded and its manufacturer is subject to both civil and criminal penalties.

Mister added the association supports certain aspects of the McCain bill, including annual registration of facilities with FDA and giving the agency mandatory recall authority over all of the products it regulates; however, it has dire concerns with other aspects. He said, We respectfully disagree that your legislation, as introduced would not seek to limit consumers ability to purchase dietary supplements, and that it would not establish a new regulatory structure for dietary supplements at FDA. ... It would be disingenous of CRN, as a representative of the industry, not to acknowledge the gravity of these concerns, even as we seek to work with you to devise solutions to the issue of products containing undisclosed steroids or other prohibited ingredients.