Second session: update on dietary supplement legislation

As I write this, the remaining days of the second session of the 108th US Congress are dwindling before the election recess, and time is running out for action on bills that would affect the regulation of dietary supplements. (Bills that have not been acted on in a given session of Congress do not carry over to the following session and need to be reintroduced.) By the time you read this, one or more of these bills may have passed, and in my next column, I will provide a recap of what happened as the 108th Congress wrapped up its final session.

Andro Action?

One bill that stands a better-than-average chance of passage this year is the Anabolic Steroid Control Act of 2004, S. 2195. This Senate bill would effectively prohibit the sale of certain steroid hormone precursors, such as androstenedione, by adding them to the list of controlled substances. Even though the Food and Drug Administration (FDA) has recently determined that andro is not a legal dietary supplement, the controversy continues--and it is damaging the industry, the agency and the athletes who could be banned from competition for using such products. This legislation would end the controversy.

S. 2195 also contains a provision that exempts the dietary ingredient DHEA--a prohormone will little or no potential for abuse as a performance-enhancing ingredient, but with demonstrated value in supporting normal hormone levels during aging. A similar bill to S. 2195, H.R. 3866, which was passed by the House of Representatives this past spring, also contains a DHEA exemption. Both of these bills are supported by the leading dietary supplement trade associations, including mine.

Adverse Event Reporting

Another relatively late-breaking legislative development concerns disclosure to the government of adverse experiences related to the use of dietary supplements. As background, under current federal regulations, dietary supplement manufacturers are encouraged--but not required--to tell the FDA if they learn about a negative experience that could potentially be connected to the use of one of their products. Manufacturers of over-the-counter drags also are not required to report adverse events unless their product was originally available only by prescription. Only prescription drug manufacturers must report any adverse experiences associated with the use of any of their products.

While the Senate was considering the Department of Defense spending bill just before Congress adjourned in August, Sen. Richard Durbin (D-Ill.) attempted to attach an amendment to the legislation that would have required dietary supplement manufacturers who sold their products on military bases to report adverse events. Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) argued that legislation concerning the reporting of adverse events was a broader issue that should not be limited only to the armed services, and they introduced their own amendment.

Although Durbin is one of the Senate's most outspoken critics of dietary supplements, and Hatch and Harkin are strong proponents, the three senators agreed to withdraw their respective amendments and collaboratively draft new legislation. This legislation was still being drafted at the time of this writing. However, the key component of this bill, if introduced, will mandate that manufacturers of both dietary supplements and over-the-counter drugs report to the government any serious adverse experiences associated with their products.

The dietary supplement industry as a whole is supportive of this effort and looks forward to seeing such legislation.

DSHEA Turns 10

It was l0 years ago in October that the Dietary Supplement Health and Education Act (DSHEA) was signed into law. And although the merits of the law have been debated at various times since its passage, it was only last year that legislative attempts to change DSHEA began. In that regard, DSHEA is not unusual. Bills are often revisited several years after they were enacted to determine how effective they've been and whether change is needed. The effectiveness of any law is tied to a variety of factors. Bills tend to be broadly written to allow for flexibility in their enactment, but this can also lead to confusion, about the exact intent of Congress. In addition, the agency charged with implementing and enforcing a law may not have the will or the wherewithal to carry out its duties.

In DSHEA's case, its supporters in both Congress and the industry believe that it's a good law that has never been fully implemented the way Congress intended. I believe many of the criticisms that DSHEA has endured stem from the fact that the FDA has been slow to carry out certain provisions of the law--such as introducing a good manufacturing practices regulation--and to use its power to remove products from the market, as happened earlier this year in the eases of ephedra and androstenedione.

To ensure that the law itself, if not the spirit of it, remains intact, several dietary supplement manufacturers and trade associations have banded together to create the Coalition to Preserve DSHEA. This group, which I am fortunate enough to head, is dedicated to educating members of Congress about the important benefits that DSHEA has provided to the health of all Americans.