Getting tough" proposed law will benefit supplement users

Last summer, Senator Orrin Hatch (R-Utah) and Senator Tom Harkin (D-Iowa) introduced legislation to increase funding in an effort to enable the US Food and Drug Administration (FDA) to completely implement the Dietary Supplement Health and Education Act (DSHEA), a bill they co-authored in 1994. The DSHEA Full Implementation and Enforcement Act (S. 1538) would provide the FDA with the money it needs to ensure the original law is carried out as Congress intended. It would also up the budget for the National Institutes of Health's Office of Dietary Supplements, which was treated to expand research and provide information on dietary supplements.

The FDA has often been criticized by members of Congress for inaction when it comes to enforcement of dietary supplement regulations. Passage of this legislation would take away the agency's ability to plead lack of resources when it comes to implementing law, and would, I hope, encourage the FDA to act when appropriate.

The DSHEA Full Implementation and Enforcement Act would appropriate a total of $205 million to the FDA over the next 5 years, beginning in 2004 with $20 million and increasing annually. This funding, which is specifically earmarked for implementation of DSHEA, would more than double the amount appropriated in 2003 for the same purpose. The bill also requires the FDA to submit a written report to Congress each year detailing how the agency is using its resources to regulate supplements.

We think this bill is a win for both the dietary supplement industry and consumers because it helps to eliminate the bad apples who've tarnished the industry's reputation. Part of this tarnishing comes from the controversy surrounding an herb called ephedra. This popular herb, commonly used for weight loss, is probably in the news more than it is out, and usually not in a good way. Ephedra, or mahuang as it is often called, has been continually questioned for its safety and efficacy over the past few years. As I reported 3 months ago (BN, July 2003), the FDA is weighing the evidence for and against ephedra and will issue a determination on whether or not it presents a hazard to public health.

It has become commonplace in Washington recently for lawmakers to use the ephedra controversy as a tool to begin dismantling DSHEA. In the past year, we've seen several hearings in both the House and Senate that have used ephedra as a springboard to attack this law. Rather than being treated as a unique case, ephedra is being used to raise a whole host of larger concerns about supplements--whether such concerns are justified or not.

This became crystal clear in two hearings held by a subcommittee of the powerful House Energy and Commerce Committee. More than 20 representatives from industry, government, academia, professional sports leagues and the families of those claimed to have been harmed by ephedra testified. Nearly all committee members, in comments and in sometimes relentless questioning, made it clear that they favored an immediate ban on ephedra and the swift enactment of legislation that would expand the power of the FDA to regulate dietary supplements. While the FDA commissioner did not advocate a change to DSHEA at that time, he did say that the agency's criteria for banning a product is vague under that law.

Although several committee members noted that the FDA was negligent in regulating ephedra, many nevertheless feel the agency's powers need to be expanded. One committee member is in favor of giving the FDA greater regulatory power so it won't have any excuses for not acting. Look for legislation to be introduced in regard to DSHEA from members of the committee this fall.

Perhaps a more immediate threat to dietary supplement law is a Senate bill I reported on in July. This legislation, the Dietary Supplement Safety Act of 2003 (S. 722), is being positioned as primarily addressing the ephedra issue. A press release from the bill's sponsor, Senator Richard Durbin (D-Illinois), mentions ephedra no less than 18 times, including the headline. And how many times do you think ephedra appears in the actual bill the press release describes? The answer is zero, which is why we're concerned about this bill--and why you should be too.

The reality is that Durbin's bill would provide no more safeguards than the current law already does. But, because it is written so broadly, it would subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is both unwarranted and unnecessary--the end result of which could be the removal of hundreds of safe and effective dietary supplements from store shelves.

If these initiatives concern you, please take the time to learn more about this legislation by visiting the Advocacy Action Center on NNFA's Web site at www.nnfa.org.

If you agree that this bill might have a negative impact on an otherwise innocuous industry, please take the time to email your senator a letter. With any luck, by the time you read this, it won't be too late to act. After all, the legislative process isn't exactly known for its speed. Let's hope that's the case here.