On October 28, the Senate Commerce, Science, and Transportation Committee held a hearing on the dangers of dietary supplements and the effectiveness of the Dietary Supplements Health and Education Act (DSHEA)(P.L. 103-417).
In his opening statement, Chair John McCain (R-AZ) explained that the intent of DSHEA “was to alleviate certain unnecessary pre-market approval regulations on vitamins, minerals, and herbs, which were considered safe supplements to the human diet.” He added, “While it is true that DSHEA has succeeded in freeing many safe and useful supplements from unnecessary regulation, it is equally true that the Act appears to have provided a safe haven for substances that many experts believe pose potentially serious health risks.”
Throughout the hearing, Sen. McCain blamed the Food and Drug Administration (FDA) for the recent health crises caused by dietary supplements, in particular the deaths and serious illnesses associated with Ephedra. He directed his comments towards FDA Associate Commissioner for Regulatory Affairs, John Taylor. “But the thing that bothers me about this process is that, if [a harmful steroid] comes on the market or as it becomes used by a large number of people, then it comes to your attention, then you analyze it, and then you decide it should be banned. We’re always playing catch up here,” he stated.
Mr. Taylor defended his agency’s actions and argued that, “under [DSHEA], the regulatory framework for dietary supplements is primarily a post-market program, as is the case for foods…when false, misleading claims endanger the public health and undermine the goals of the FDA, we take action to ensure that consumers have access to truthful, non-misleading health information. FDA’s enforcement focus gives highest priority to products that have a potential for causing serious adverse affects or where there is a risk of injury or death.”
Testifying on behalf of the Federal Trade Commission (FTC), Howard Beales explained that the mission of the FTC is “to prevent unfair competition and to protect consumers from unfair or deceptive acts in the market place. As part of this mission, the Commission has a longstanding and active program to combat fraudulent and deceptive advertising claims about the benefits and safety of health-related products, including dietary supplements.” Mr. Beales showed a clip from a “Coral Calcium” infomercial claiming that the product can cure cancer, multiple sclerosis, and a number of other diseases and conditions. A successful joint initiative between the FDA and the FTC resulted in federal court actions, FDA product seizures, and temporary restraining orders and asset freezes against the marketers of the product. Mr. Beales also noted that the weight loss industry “appears to be one area for which the Commission must consider other approaches, and enlist new partners, to augment traditional law enforcement.” He argued that the media should play a significant role in combating deception in weight loss products advertising.
Terry Madden of the United States Anti-Doping Agency summarized a report on the effects of steroids on East German athletes under the former Soviet Union. “The documented side affects of steroid and steroid precursors among these East Germans athletes, particularly women athletes, are severe and include affects on the liver and reproductive system, susceptibility to cancers, and permanent masculinization of women,” he stated. Mr. Madden also noted that, “under the current regulatory scheme, a manufacturer is not required to test its steroid precursor product for either side affects or purity prior to putting it on the shelf. This is of particular concern when women and adolescents are considered.” Finally he pointed out that, in the United States, a high percentage of dietary supplements that contain steroids are mislabeled as being steroid-free.
Defending the FDA, David Seckman of the National Nutritional Foods Association stated, “In fact, the enactment of DSHEA provided the FDA, the primary agency that regulates supplements, with increased enforcement powers by establishing new labeling and potency standards.” Nonetheless, he went on to add that, “for a number of reasons, this law has never been fully implemented or adequately enforced.”
Dr. Arthur Grollman, a professor of Pharmacological Sciences and Medicine in New York, outlined a number of suggestions to protect consumers from the hazards of dietary supplements: 1) the address and telephone numbers of all companies manufacturing dietary supplements should be registered with the FDA; 2) manufacturers should provide evidence of good manufacturing practices, and the FDA should be given the authority to inspect manufacturers’ records; 3) Congress should require manufacturers to report all adverse effects to the FDA; 4) the burden of proof for demonstrating that a dietary supplement does not present a “significant or unreasonable risk of illness or injury under conditions of recommended use, as suggested on the label,” should be placed on the manufacturer; 5) dietary supplements should carry labels containing a list of ingredients that clearly and unambiguously identifies herbs by their botanical and common names; and 6) the Department of Health and Human Services should organize expert panels to review the safety of all dietary supplements.
