Earlier this week, the U.S. Senate Committee on Commerce, Science and Transportation held hearings regarding availability of dietary supplements, the marketing practices of the industry and the effectiveness of DSHEA (Dietary Supplement Health and Education Act) to protect consumers.
Chairman of the committee Senator McCain (R-AZ), presiding over the hearing, called a witness list which included representatives from FDA, FTC, the United States Anti-Doping Agency, David Seckman from the NNFA (National Nutritional Foods Association), Dr. Arthur Grollman, Distinguished Professor, Pharmacological Sciences and Medicine, State University of New York at Stony Brook and Mr. Charles Bell of the consumers Union.
In his introductory remarks, the Chairman noted that supplements are often promoted with questionable marketing practices and focused on potential adverse health risks. He observed that DSHEA had been effective in reducing unneccessary regulatory burden on supplements but may at the same time, have provided a safe haven for substances with health risks.
Specifically referred to were heavy use of supplements among teenagers and school sports teams and the fact that steroid precursors 'interfere with normal growth and bone development, cause hormonal imbalances, liver and kidney damage, and an increased risk of certain types of cancer.' Chairman McCain noted that he feared a health care crisis in the future due to current supplement use.
Mr. John M. Taylor, testifying on behalf of the FDA, commented on current enforcement issues and programs in concert with FTC, and Mr. Howard Beales, Director of the Bureau of Consumer Protection, Federal Trade Commission observed that 'unfounded or exaggerated claims for dietary supplements have proliferated.' He listed weight loss advertising and Internet health scams specifically, and noted the voluntary compliance to his enforcement actions, as well as the dietary supplement industry response (through the trade associations' support and impact through strong public pronouncements) against unfounded claims.
Speaking about weight loss advertising, Mr. Taylor also observed that even the most active enforcement would not totally clean up the deception, and suggested other approaches and measures might be required.
Mr. Seckman, Executive Director and CEO of NNFA, described enforcement and regulatory powers under DSHEA and noted that the 'law has never been fully implemented or adequately enforced', specifically listing GMP's, FDA's lack of response on performance enhancing products, ephedra and adverse event data. He urged the commission to 'Stop seeking legislative solutions to regulatory problems when it comes to DSHEA. Changing DSHEA to give the FDA increased authority when it has not fully applied its current powers will simply perpetuate the current situation. '
Dr. Grollman dealt specifically with safety and toxicology focusing on the lack of standardization, adulteration, herb-drug interactions, and a lack of adverse event reporting.
He observed that 'consumers are provided with more information about the composition and nutritional value of a loaf of bread than about the ingredients and potential hazards of botanical medicines.' Citing adverse event data and several 'reviews', Dr. Grollman used the ephedra example to illustrate how DSHEA hindered FDA and suggested several recommendations, including urging support for Bill S.722.
Mr. Bell commented that his concerns included the fact that new dietary supplement products can be introduced overnight that contain novel, untested ingredients and obseerved that manufacturers have suppressed safety information, DSHEA contains loopholes which allow for marketing of products such as steroid 'equivalents' and concluded that post-marketing surveillance is inadequate and ephedra should be banned.