On March 24, the House Government Reform Subcommittee on Human Rights and Wellness examined dietary supplements and the Food and Drug Administration’s (FDA) implementation of the Dietary Supplements Health and Education Act (DSHEA) of 1994 (P.L. 103-417).
Chair Dan Burton (R-IN) explained that the legislation “ensures the safety of dietary supplements by requiring manufacturers to follow standards called ‘Good Manufacturing Practices’…Essentially, all ingredients in supplements sold in the United States must be previously approved by the FDA and listed on the bottle label, and distributors must follow strict guidelines on any claims that are made in regard to a particular product to provide consumers with the most accurate information on supplements. Additionally, if at any time the FDA decides that a particular product or dietary ingredient is detrimental to human health, it reserves the right to have those items removed.”
Sen. Richard Durbin (D-IL) testified before the subcommittee, expressing his concern that DSHEA does not go far enough to protect consumers. Contending that the average consumer of dietary supplements is a “guinea pig,” he argued that the FDA should test products before they are put on the market. Sen. Durbin also noted his sponsorship of the Dietary Supplement Safety Act of 2003 (S. 722), a bill to require reports on adverse experiences with dietary supplements. Such reporting is currently voluntary under DSHEA.
Director of the Center for Food Safety and Applied Nutrition at the FDA, Robert Brackett, summarized the FDA’s activities in regulating dietary supplements. He noted that the FDA published a proposed rule for dietary supplement current good manufacturing practices on March 13, 2003. The rule “would establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labeled to accurately reflect the active ingredients and other ingredients in the product.” Dr. Brackett said that the FDA is currently reviewing over 1,600 pages of comments and will publish a final rule once the evaluation is completed.
Dr. Brackett also discussed the enforcement activities of the FDA, which it shares with the Federal Trade Commission (FTC). “The FDA regulates the safety, manufacturing, and labeling of dietary supplements, while the FTC has primary responsibilities for regulating the advertising of these products,” he explained. “Over the last few years, the FDA and the FTC have worked well together to ensure that there is a seamless assertion of our jurisdiction over these products.” Dr. Brackett highlighted a number of recent enforcement activities, including action against the marketers of Coral Calcium Supreme, which was claimed to treat or cure cancer, multiple sclerosis, lupus, and heart disease. He stated, “In June, on FDA’s behalf, U.S. Marshals seized $2.6 million worth of Coral Calcium Supreme. In a separate action, FTC charged the marketers of Coral Calcium Supreme with making false and unsubstantiated claims that the product can treat or cure diseases.”
David Seckman of the National Nutritional Foods Association highlighted some of the benefits of taking dietary supplements. He cited a medical journal report that found: “Increased intake of vitamin E, folic acid and zinc could save $20 billion annually in hospital costs by reducing heart disease, birth defects and premature death.” Another study indicated that health care costs could be reduced by $1.6 billion annually if all seniors took a daily multivitamin.
Mr. Seckman did not feel that more legislation was required to regulate dietary supplements. He stated, “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.” He offered a number of suggestions to improve DSHEA: 1) Congress should give the FDA the resources to fully implement DSHEA; 2) the FDA should finalize the good manufacturing practices rule; and 3) Congress should stop looking for legislative solutions to regulatory problems in DSHEA.
Doug Rose, the father of a daughter with a genetic mutation, testified on the benefits of folic acid in preventing birth defects such as spina bifida and anencephaly. He explained that in the 1970s, the FDA permitted multivitamins and cold cereals to be fortified with 400 micrograms of folic acid. Since that time, “Americans who consumed these products had many fewer babies develop birth defects and they themselves have been reported to have less cancer and less cardiovascular disease,” he stated. Mr. Rose said that in 1992, the United States Public Health Service recommended that all women consume 400 micrograms of folic acid a day; in 1998, the Institute of Medicine clarified by recommending 400 micrograms of synthetic folic acid a day; and in 1998, the FDA required that 100 micrograms of synthetic folic acid be added to all “enriched” grain products.
Although the consumption of folic acid has prevented approximately 1,000 of the 4,000 cases of spina bifida and anencephaly that occur each year, Mr. Rose said that according to the March of Dimes, only 30 percent of American women of reproductive age consume enough folic acid. He suggested that the FDA should increase by 150 percent the concentration of folic acid currently required in enriched grain products. Mr. Rose also noted that Johnson and Johnson is working with the FDA to market oral contraceptives that include 400 micrograms of folic acid. He expressed his hope that the product “is on an expedited path as it could almost instantaneously result in 20 million American women consuming the recommended amount of folic acid.” Finally, Mr. Rose contended that it would cost $100 million for the Centers for Disease Control and Prevention (CDC) to implement a successful national folic acid education campaign, but pointed out that the CDC currently spends less than $10 million on such programs.
