Bitter pill: proposed supplement regulations hard to swallow - DC updates: David Seckman, CEO of the National Nutritional Foods Association, writes about political issues affecting consumers

Better Nutrition, July, 2003 by David Seckman

You might think conventional wisdom would dictate that any issue not directly connected to the war with Iraq, its aftermath and by-product concerns about homeland security would have been placed on the government's equivalent of the back burner over the past few months. But these are decidedly unconventional times. Given that fact, I note that Washington, DC, has recently become a regulatory and legislative hotbed of activity in regard to the natural products industry.

From a regulatory perspective, two proposed rules were issued that will have a major impact on consumers of dietary supplements. One of the regulations concerns manufacturing standards for dietary supplements, and the other suggests warning labels for products containing the herb ephedra.

the "safety" act

Legislatively, the National Organic Program survived a stealth attack that would have lowered its standards, and a bill was introduced that could significantly alter the Dietary Supplement Health and Education Act (DSHEA) of 1994.

A surface reading of the Dietary Supplement Safety Act of 2003 (S. 722), introduced by Senator Richard Durbin (D-Ill.), might lead you to believe that it only applies to certain types of supplements. However, bills are usually broadly written and thus subject to interpretation. Using a shotgun approach like this may ensure that you hit the target you're aiming for, but you're also likely to hit everything else in the near vicinity.

So even though this bill targets stimulants and certain performance-enhancing products for additional regulation, nearly all vitamins, minerals, herbal products and other supplements could be subjected to a level of scrutiny that we believe is both unwarranted and unnecessary.

Under this proposed legislation, any dietary supplement that receives even one complaint could be removed from the marketplace, regardless of whether the product had been used under conditions cautioned against on the label.

Products that have been used safely for hundreds or thousands of years would be subject to clinical evaluation using standards that are at the discretion of the Food and Drag Administration (FDA).

This bill's title may wrongly lead some to conclude that dietary supplements are unsafe. But by almost every measure, dietary supplements have a safety record that surpasses conventional foods and over-the-counter and prescription drugs.

We believe DSHEA, which currently governs dietary-supplements and grants the FDA the authority to act against products that prove to be unsafe, should not be dismantled, but more fully enforced.

keeping the bar high

A provision was added to the 2003 budget bill allowing meat, poultry and dairy products to be labeled "organic" even if the livestock from which these products were derived were given non-organic feed.

The addition of this provision was apparently an attempt by farmers to circumvent paying the potentially higher costs of organic feed. The National Organic Standards program, which went into effect last October, requires that livestock be given 100 percent organic feed in order to be labeled as such.

But less than two months after this provision was added, it was repealed due to pressure from the organics industry, demonstrating the effectiveness of a swift response.

ephedra redux

In conjunction with the release of a new review of ephedra's efficacy and safety, a proposed regulation from the US Department of Health & Human Services (HHS) asked for public comment regarding the potential addition of warning labels to products containing the herb. The FDA also asked what additional legislative authority it might need to effectively address this issue.

We find this troubling because any change in the FDA's authority would come as a result of amending DSHEA and could apply to all supplements, not just ephedra.

You should find this troubling for the very reasons I mentioned in opposing S. 722--legislation targeting ephedra could be used to remove other supplements from health food store shelves. The comment period for this proposal has closed, and HHS is expected to release a final rule in the next few months.

setting standards

More than 9 years after DSHEA gave the FDA the authority to establish manufacturing standards for supplements--and with encouragement from the industry--the agency has issued a proposal. Under the role, "Manufacturers would be required to evaluate the identity, purity, quality, strength and composition of their dietary ingredients and dietary supplements."

Among the items covered in this regulation are quality control and testing of raw materials and finished products--as well as requirements for maintaining records and handling complaints. This proposal is likely to draw comments, which the FDA will need to consider before issuing a final regulation.

In the meantime, we'll keep you informed on all pending legislation that may affect your access to dietary supplements. Plus, you can visit the NNFA Web site at www.nnfa.org for current updates.

David Seckman urges full enforcement of current supplement laws.