A group known as the Coalition to Preserve DSHEA recently came together to enhance the industry’s presence and influence in achieving favorable public politics on Capitol Hill. The Coalition’s primary goals will be to protect the Dietary Supplement Health & Education Act (DSHEA) of 1994 and to cultivate a long-term base of support through education of members of Congress and their staff. The Coalition is a non-profit organization comprised of major suppliers of dietary supplement products and services, as well as leading trade associations and other supporters. Its activities, which are funded through donations, include personal visits with legislators and their staff to provide members of Congress with an analysis of existing and future legislation. Another important strategy of the Coalition is to reach out to dietary supplement retailers and consumers across the U.S. to educate them regarding the threats to DHSEA and motivate them to take action. Efforts are underway to develop a consumer website portal, so that consumers can express their opinions to Congress and the media, as well as a website of DSHEA resources for legislators and staff, the media and retailers.

In early May, the Coalition submitted a citizen petition to the FDA, which called for reconsideration of statements made in recent agency documents: first, that the term “dietary substance” refers only to ingredients commonly used in human food and drink; and second, that the statutory definition of “dietary supplement” excludes synthetic equiva­lents of specific constituents of botanical ingredients. In the petition, the Coalition said it believes these statements conflict with both the clear meaning of the statute DSHEA) and Congress’ intent to ensure consumer access to the broadest possible range of safe dietary supplement products. The Coalition also believes that these interpretations threaten new product introductions and subject to potential legal challenge significant existing industry products. Many small manufacturing and retail businesses, as well as larger established ingredient suppliers and manufacturers, would be adversely affected. “Congress explicitly intended that section 201(ff)(1)(E) of the FD&C Act not be limited to substances commonly used for human food or drink. In fact, the Senate Committee Report accompanying DSHEA reveals Congress’ explicit expectation that numerous substances would fall within the statutory definition of ‘dietary supplement’, even though they were not commonly used as human food or drink and were not vitamins, minerals, botanicals or amino acids,” the petition said. Two such substances that would be excluded from the market if FDA’s interpretation were to stand, include glucosamine sulfate and CoQ10. Further, the Coalition says that if FDA’s interpretation were correct, the only botanicals eligible for use in dietary supplements would be those commonly used for food. As a result, almost all botanical constituents would be removed from the market. In summation, the petition said, “Nowhere in the statutory definition of ‘dietary supplement’, or in any other provision of the FD&C Act dealing with dietary ingredients, is there any indication that Congress intended to restrict an ingredient category based on its natural or synthetic derivation.”