Legal Compliance

Who Really Needs DSHEA?

June 26, 2006

5 Min Read

Who Really Needs DSHEA?

by A. Wes Siegner

Have you ever thought about marketing some or all of your dietary supplement products as conventional foods? If not, perhaps you should. For the right products, there are now definite advantages to this strategy. If legislation requiring reporting of serious adverse events for dietary supplements is finally passed this year, the advantages of a food strategy may become too good to pass up for a much larger number of products currently marketed as dietary supplements. Given current regulatory, trade association and legislative trends, the high water mark for the protections afforded by the Dietary Supplement Health and Education Act of 1994 (DSHEA) appears to have passed, and the best strategy for future marketing of dietary supplements may be to switch these products to the conventional food category.

DSHEA was in large part a result of serious overreaching and misapplication of the food additive provisions of the Federal Food, Drug and Cosmetic (FDC) Act by the Food and Drug Administration (FDA). DSHEA put an end to an FDA-created pre-approval system for dietary supplements, which FDA had applied to make sure that no dietary supplements, other than standard vitamins and minerals, ever reached the market.

More than a decade after the passage of DSHEA, FDA, as expected, is making significant inroads into the protections that DSHEA affords to dietary supplements. These include:

The creation of a new risk/benefit safety standard for dietary supplements, which, if applied in the manner FDA used to ban ephedra, is a much stricter standard than that applied to conventional foods; and
The refinement of the new dietary ingredient (NDI) notification process to create standards that appear to parallel the requirements for food additive approvals.

Curiously, industry trade associations have largely failed to perform their historic function of resisting FDAs inevitable tendency to broaden its authority over dietary supplements. Instead, these associations have largely supported the creation and application of the risk/benefit standard. Recently, these same associations have gone so far as to propose and back the creation of a significant new authority that even FDA has not requestedmandatory provisions for the investigation, recordkeeping and reporting of all serious adverse events.

Despite the peculiar behavior of the trade associations, the industrys public perception woes are due mainly to the failures of FDA and Congress. FDA has refused to enforce pre-DSHEA labeling requirements and to implement DSHEA. FDAs inaction can be attributed to the failure of Congress to fund necessary programs, as well as a stubborn FDA desire to see DSHEA fail.

Twelve years have elapsed since Congress authorized FDA to issue GMP (good manufacturing practice) regulations for dietary supplements, and these regulations have yet to be published in final form. FDA inspections of dietary supplement manufacturing facilities are very rare at best, and this general lack of oversight has been combined with the termination of enforcement programs for other essential FDC Act provisions, such as those needed to assure that dietary supplements truthfully state their contents on the product label to permit consumers to determine what they are buying.

And what has Congress done? Years of under-funding of FDAs enforcement of existing dietary supplement requirements will be exacerbated by planned funding cuts this year, causing FDA to further reduce its already anemic enforcement programs. Is there any wonder that consumers regard dietary supplements with increasing skepticism?

Companies that once would have sought advice on how to enter the dietary supplement market are, not surprisingly, giving more consideration to marketing their products as conventional foods, medical foods or even as drugs. The advantages of a conventional or medical food strategy are significant:

No need to comply with the increasingly problematic NDI notification process, or notify FDA of structure/function claims;
- No need to worry about a poorly-defined and more restrictive risk/benefit safety standard;
- No concerns about the possible need to comply with costly adverse event investigation, recordkeeping and submission requirements;
- A much larger, more focused and better organized trade association lobby, which recently backed passage of the National Uniformity for Food Act in the House of Representatives, after dietary supplements were excluded from the legislation (which would exempt food products from a wide array of inconsistent and troublesome state labeling requirements such as Prop 65);
- The ability to market products with essentially the same structure/function claims and FDA-approved health claims available to dietary supplements, as well as medical food claims that permit labels to include specific reference to disease;
- A well-defined, FDA-accepted and largely manufacturercontrolled process for establishing generally recognized as safe (GRAS) status for food ingredients;
For single ingredient foods, no need to worry about GRAS status or NDI issues; and
No real concern over bad press connected with the market category as a whole.

Many dietary supplement ingredients already meet the GRAS standard for food safety, which is the primary barrier to marketing dietary supplements as conventional foods. Others could easily meet this well-defined standard with organized industry support for appropriate safety testing and expert GRAS panel review.

There is no doubt that DSHEA has served a valuable function by promoting an enormous increase in the amount of useful healthrelated information that dietary supplement labeling now conveys to consumers. However, the better-organized food industry has largely captured the same benefits that DSHEA provided for dietary supplements, while avoiding the negative press. If the adverse event reporting legislation passes, further burdening and stigmatizing the dietary supplement industry, many more companies will be asking or should be askingwouldnt it be easier to switch than fight?

Wes Siegner is a director in the law firm Hyman, Phelps & McNamara, P.C, with principal offices located in Washington, D.C. The firm specializes in advising clients on compliance with FDA and FTC laws as they relate to the dietary supplement industry and other FDA-regulated industries.

Editors Note: INSIDER welcomes industry commentary and letters to the editor. Direct your comments to Heather Granato, group editor, 3300 N. Central Ave., Ste. 300, Phoenix, AZ 85012, FAX (480) 990-0819, [email protected]. Letters may be edited for content or clarity and do not necessarily represent the views of Virgo Publishing or INSIDER.

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