The dietary supplement industry is among the world's fastest growing economic sectors. Consumer spending for its products nearly doubled from 1994 to 2000, and it continues to grow more than 10 percent a year. Some of these products are widely recognized as beneficial. Others, however, are ineffective, potentially dangerous, or marketed using fraudulent claims, and there is an increasing risk that consumers will substitute them for effective medications, delaying proven therapy and risking injury.
Against this background, in 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA) to ensure consumers' access to legitimate dietary supplements while providing FDA with authority to protect the public against supplements that pose safety concerns or bear false or misleading labeling. Under DSHEA, a dietary supplement firm must ensure that its products are safe and that statements about them are not false or misleading. Permissible assertions include health claims authorized by FDA; statements about a supplement's use to prevent classic nutrient deficiency diseases (e.g., scurvy); and substantiated claims about the supplement's effects on the structure or function of the body.
FDA is committed to enforcing DSHEA. In fiscal year 2002, FDA took numerous actions to protect the health of consumers and to help ensure a level field for legitimate dietary supplement manufacturers and marketers. Following are highlights of the measures FDA took last year:
FDA coordinated many of its efforts with other state and federal law enforcement agencies. FDA also used its Web site to provide truthful and reliable dietary supplement information for consumers and to provide industry with guidance on permissible practices under DSHEA.
Looking ahead, FDA will intensify its work to meet the goal set by its January 2000 dietary supplement enforcement program: to have a "regulatory program that fully implements [DSHEA], thereby providing consumers with a high level of confidence in . . . dietary supplements." A key part of this program will be enforcement action ranging from seizures and injunctions to, where appropriate, criminal prosecutions. Based on its experience in this area, FDA has targeted certain "problem" products for close attention, including treatments for life-threatening diseases, treatments for diseases that afflict children (e.g., autism and behavioral disorders), weight loss products, and supplements marketed to smokers and drinkers. FDA will not tolerate fraudulent schemes that deceive or endanger the public.
Technology will play a critical role in FDA's future efforts. A newly modeled adverse event reporting system called "CAERS" will provide a single system to track and analyze all adverse event reports involving dietary supplements. CAERS will increase efficiency, speed processing time, and provide medical review for all serious adverse event reports. FDA will also continue to use its Web site and other means to provide industry guidance and critical information for consumers.
Finally, FDA will strengthen its ties to domestic and foreign law enforcement agencies. FDA has a long history of working with the Federal Trade Commission against health care fraud. This partnership has been an unqualified success. FDA will build similar relationships with other law enforcement entities. This is especially important because of the challenges posed by the Internet. Bad actors can now run scams from virtually anywhere, including outside the United States. In fighting these scams, FDA must work with other federal, state, and foreign law enforcement agencies.
Whatever challenges the future brings, FDA remains committed to ensuring consumer access to dietary supplements, while protecting consumers from harmful products and false or misleading claims.
Dietary Supplement Enforcement Report
Press Release: "FDA Announces Initiative to Provide Better Health Information for Consumers"
Press Release | FDA Home Page | Search | A-Z Index | Site Map | Contact FDA