Industry coalition fights to protect DSHEA

The creation of the coalition is also intended to enhance the industry's presence and influence in achieving favorable public policies on Capitol Hill.

The Dietary Supplements Health and Education Act (DSHEA) created a separate category for supplements, making them distinct from both foods and drugs. Now in existence for ten years, it is under increasing threat from legislators who are looking to increase federal regulation of the products, with some of the bills introduced in recent months proposing adverse event reporting and registration of all supplement products.

The new coalition, which already has the support of companies such as Nutraceutical, Herbalife International and General Nutrition Companies, will be a non-profit organization comprised of major suppliers of dietary supplement products and services as well as leading industry trade associations and other supporters.

Funding will be achieved through donations and personal visits with legislators and their staff providing members of Congress with an analysis of existing and future legislation.

David Seckman, chief executive officer of the coalition, said: "If we don't stop harmful legislation and change the negative climate in Congress about our industry, the consequences will severely impact the access and affordability of all dietary supplements."​

"The coalition's primary aim will be to educate current legislators and staff about the origin, effectiveness and numerous benefits that DSHEA and dietary supplements provide to the American public."​

Seckman added: "Only 50 per cent of current members of the US House and Senate were in office when the DSHEA was passed ten years ago, and there has been an 80 per cent turnover in legislative staff."​

One of the primary strategies of the coalition is to educate dietary supplement retailers to the threats to the DSHEA and motivate them to take action. A consumer web portal has been developed so consumers can make comments to Congress and the media. DSHEA's website contains resources for legislators, staff, the media and retailers. Seckman explains that this is just one part of an overall plan.

"We plan to reignite grassroots passion and utilize a variety of ways to keep our grassroots activists in meaningful contact with their legislators."​

"When DSHEA was making its way through Congress in the early 90s, there was a huge outpouring of grassroots support. In fact, this grassroots effort generated more mail and phone calls to legislators than any other topic since the Vietnam War."​

The coalition has already submitted a citizen petition to the Food and Drug Administration that challenges the agency's recent interpretation of the statutory definition of 'dietary supplement'.

They have also held a series of meetings on Capitol Hill to protectthe supplement DHEA (dehydroepiandrosterone) used by many older Americans and threatened by legislation under the Anabolic Steroid Act currently under consideration in both the House and Senate.

Before DSHEA, the Food and Drug Administration (FDA) regulated dietary supplements as foods, ensuring they were safe and wholesome, and their labeling was not misleading. An important facet of ensuring safety was FDA's evaluation of the safety of all new ingredients, including those used in dietary supplements.

However, with DSHEA Congress amended the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include provisions that applied to dietary supplements and dietary ingredients.

Currently they are no longer subject to premarket safety evaluations required for other new food ingredients or for new uses of old food ingredients. However, they must meet the requirements of other safety provisions.