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January/February 2004 Alternative Health
Our Access to Vitamins and Supplements at a Crossroads - Again

by G. Diane Corsaro

There is currently a Bill before the Senate that could again pose a threat to the availability of your vitamin, herb and mineral supplements in the future. This Bill – S.722 – would enable the FDA to completely remove a supplement from the market with just a single complaint about it. Known as the ‘Dietary Supplement Safety Act of 2003", S.722 will require supplement manufacturers to report to the FDA within 15 days any "serious adverse experience" submitted by a consumer "without regard to whether the event is known to be causally related to the dietary supplement" (Sec. 416.a.1. of S.722, italics added), thoroughly investigate the experience, possibly do post market surveillance on the supplement for 3 years or more, research and submit data demonstrating that the dietary supplement (or ingredient) is safe….all of this at the manufacturer’s own expense.

At the same time, S.722 allocates $10 Million (annually) to the FDA to issue and follow up on these requirements, and ultimately issue a determination that the supplement in question is safe and approved, or unsafe and disapproved for future marketing.

Some of the concerns about this scenario are:

• Small and medium-sized supplement manufacturers (currently comprising about 98% of the market) may not survive the additional costs of adhering to the requirements imposed by S.722 - especially when added to the costs of the FDA’s new proposed GMPs (Good Manufacturing Practices). This could leave only the larger manufacturing firms, many of whom are owned by large conglomerates or pharmaceutical companies.
• It could create an arena that might foster abuse somewhere down the line, should a complaint (from any source, for any reason) be false. The procedures outlined above would be required from just this one complaint, and the subsequent burden of initial investigation and proof of product safety would fall completely to the manufacturer (at a possible cost of tens of thousands of dollars for lawyers and scientific consultants. S.722 not only fails to provide any checks and balances in this regard, but actually includes a clause that waives a requirement that the FDA conduct their own investigation of the incident if the patient (or next of kin) indicates an unwillingness to cooperate.
• The gains afforded to both the nutritional supplement industry and consumer choice in 1994 by the Dietary Supplement Health and Education Act (DSHEA) may be reversed. Under the (current) law, the FDA has the burden of proof that a dietary supplement is unsafe before removing it from the market, and only when a complaint of injury is reasonably traceable to the product is the manufacturer involved. According to John Emord, a Constitutional rights attorney (in an interview in Whole Foods Magazine, October, 2003), "The present law ensures (italics added) that the FDA will not act on every complaint, but can exercise discretion to determine which complaints are genuine and present credible evidence of harm." Section 2(13) of DSHEA itself states, "although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers." It is feared that S.722 will do just that.
• A "trickle-down" effect to the consumer would likely be an increase in cost of supplements, a decrease in new product research and availability, and an overall decrease in the number and kinds of supplements available.

Although according to Jonathan Emord, the number of deaths attributed to pharmaceutical drugs per year is over 1,400, while the number of deaths attributed to dietary supplements is about 12, there is no policy exactly like this in place for the pharmaceutical industry. And, by contrast to S.722’s requirement that a supplement manufacturer report any "…serious adverse experience…without regard to whether the event is known to be causually related to the dietary supplement," the FDA’s proposed New Safety Reporting Requirements for pharmaceuticals requires "…expedited reporting of …suspected adverse drug reactions…unless the company is sure that the product did not cause the reaction." (italics added)

In a more enlightened vein, there is another Senate Bill known as the ‘DSHEA Full Implementation and Enforcement Act’ - (S.1538) - that would increase funding to the FDA to more fully implement the Office of Dietary Supplements’ research on dietary supplements. This Act would allocate $205 million over the next five years for this endeavor. While it is a step in the right direction, efficient use of the FDA’s resources will, according to Emord, depend more on a redirection of the FDA’s efforts (which it is hoped that the new FDA Commissioner, Mark McClellan will accomplish).

Both Houses of Congress are recessing for the Holidays but, according to Kim Smith at the NNFA (National Nutritional Foods Association), the high profile of these Bills (further increased by co-sponsorship on the part of Senator Hillary Clinton and Senator Diane Feinstein) will probably bring them to the floor early, once sessions have reconvened in January, 2004. To let your representatives know how you feel, please call your Senators - in Oregon, they are Gordon Smith ®, (202) 224-3753 (Fax: 202-228-3997) and Ron Wyden (D), (202) 224-5244 (Fax: 202-228-2717). For further information, contact the NNFA at www.nnfa.org or 1-800-966-6632 (Fax: 949-622-6266)

Contact G. Diane Corsaro at 503-574-2960