By Loren Israelsen, Executive Director of the Utah Natural Products Alliance
2006 could prove a crucial year in the development of the dietary supplement industry. How the industry deals with a range of critical public policy issues will have major ramifications both for consumer confidence in natural products and for the industry’s relationship with Congress. Fortunately, there are pathways for success that will produce positive results for both consumers and industry.
One important pathway is a proposal now being considered in Congress, spearheaded by Senator Orrin Hatch and a bipartisan coalition of his colleagues in the United States Senate. This plan would require dietary supplement manufacturers to report any serious adverse events, such as a hospitalization or persistent or significant disability related to the consumption of dietary supplements, to the Food and Drug Administration (FDA).
Dietary supplements have a very safe track record, so these serious adverse reactions are few and far between. And many responsible natural products manufacturers already voluntarily report them to the FDA. However, some do not. And that should change.
Such a commonsense change would provide better early warning signals in the rare event a serious adverse event occurs. It could more rapidly identify a batch of products that have been adulterated or tampered with. This is even more pressing today in the face of the growing threat of bioterrorism, a concern to the food industry as a whole.
Such a change will increase consumer confidence in the safety of their supplements and help companies more rapidly identify and correct a problem. It will assure consumers that serious adverse events are rare, and that problems will be promptly investigated. And a strong national reporting system will mean that companies won’t have to deal with duplicative or widely varying state or local requirements. States like New York and California have already signaled their interest in such new requirements.
The Utah Natural Products Alliance and most of the major dietary supplement trade associations support a responsibly crafted national mandatory reporting system. However, some in our industry disagree. They argue that it will lead to a flood of bogus complaints created by competing companies hoping to embarrass their rivals. They argue that these complaints will drive a wave of lawsuits that will put companies out of business. There is little evidence to back up these claims. Senator Hatch’s proposal would make it a crime to knowingly submit a bogus complaint. And it has other protections to discourage misuse of a serious adverse event report by suit-happy lawyers.
Of course, we need to be vigilant to assure that final legislation approved by Congress stays within the commonsense parameters set out by Senator Hatch and his colleagues. And we need to be ever watchful to make certain that the FDA fairly implements the new law.
But taking the path of opposition to mandatory reporting of serious adverse events will strike a blow against consumer confidence and will reduce Capitol Hill’s confidence in the dietary supplement industry’s commitment to safety and quality. And it will strengthen the hand of those in Congress who would like to repeal or fundamentally alter the regulatory framework of the Dietary Supplement Health and Education Act.
A commonsense mandatory serious adverse events reporting system for supplements is one change under consideration in Washington that truly is a win-win. Passage of the bipartisan proposal al would be a victory for consumers and industry.
Utah Natural Products Alliance
| About Loren Israelsen|
Loren Israelsen is Executive Director of the Utah Natural Products Alliance (UNPA), a trade association of dietary supplement companies committed to safety, science and quality. UNPA was founded in 1991 with the mission to create a new legislative model for the regulation of dietary supplements. This was realized by passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. Since then, UNPA has worked closely with Congress, FDA and allied trade associations to assure full and proper implementation of DSHEA.
Mr. Israelsen has been deeply involved in the commercial and regulatory issues facing the global dietary supplement industry since 1982. He has served as vice president/general counsel to the American Herbal Products Association, co-founder and counsel to the European American Phytomedicine Coalition (EAPC), industry liaison to FDA’s Expert Advisory Committee on Ephedra, issue manager for dietary supplements for the Transatlantic Business Dialogue (TABD), a founding member and executive board member of the International Alliance of Dietary Supplement Associations (IADSA), industry advisor to the Office of Dietary Supplements (ODS), and an expert panel member to IFT’s Functional Food Report published in 2005.