Enforcement Activities Part of Joint FDA/FTC Crackdown on Unsubstantiated Claims for Dietary Supplements and Other Health-Related Advertising Fraud
FTC Chairman Muris Applauds FDA’s Consumer Health Information Initiative
The Federal Trade Commission today announced the results of its most recent efforts to crack down on unfounded claims about the benefits and safety of dietary supplements and other health-related products. Since December 2002, the Commission has filed or settled 17 enforcement actions against parties engaged in false or misleading advertising of dietary supplements and other products deceptively marketed for their purported ability to treat or cure a wide variety of health conditions. The FTC estimates these actions target products with a total of more than $1 billion in consumer sales. The cases are part of a joint effort by the Food and Drug Administration (FDA) and the FTC to crackdown on deceptive health claims for dietary supplements. Separate enforcement actions have been taken by the FDA against additional supplement products.
The enforcement efforts reflect the FTC’s ongoing commitment to work with the FDA to implement the Consumer Health Information for Better Nutrition initiative, which was announced by FDA Commissioner McClellan on December 18, 2002. That initiative has two principal goals: 1) to enhance the ability of food companies to provide accurate, science-based information to consumers about important developments in nutrition and health; and 2) to preserve the value of nutrition/health information by stepping up enforcement against false or misleading claims for dietary supplements and other health products. The staffs of the two agencies have been working closely together since December to achieve both goals.
“The level of coordination and the volume of enforcement activity by both agencies in the past several months is unprecedented,” said FTC Chairman Timothy J. Muris. “The FTC and FDA have always worked closely to combat health fraud in the dietary supplement market, on the Internet, and elsewhere,” explained Chairman Muris. “Since December this enforcement effort has been further enhanced by the creation of a joint staff task force on dietary supplement marketing. Staff of both agencies have been meeting regularly to identify fraudulent health marketing, share information about enforcement targets, and to attack fraud using the strongest and most effective tools available to each agency,” he added. In some instances, the FTC has sought ex parte temporary restraining orders to stop the challenged claims immediately, and it has obtained asset freezes to preserve ill-gotten profits for consumer redress programs. Similarly, the FDA has seized more than 10 million dollars worth of improperly labeled supplements, issued recalls for a number of products or promotions presenting safety concerns, and banned the import of hundreds of supplement products into the U.S.
The task force activities include joint FTC federal court actions/FDA product seizures in two cases: one involving Seasilver USA for Internet marketing of a multi-ingredient supplement purported to treat or cure cancer, AIDS, diabetes and 650 other diseases; and the other against Kevin Trudeau, Robert Barefoot, and others for their heavily aired national infomercials touting Coral Calcium Supreme to treat or cure cancer, multiple sclerosis, heart disease, and other serious ailments. In addition, the FDA provided invaluable technical and scientific support to the FTC in its investigation and recent action against Glenn Braswell and his company, Gero Vita, for a massive direct marketing campaign involving a myriad of supplements sold to treat everything from asthma, emphysema, diabetes, and Alzheimer’s, to weight loss and aging, through publications such as the “Journal of Longevity.” In addition to bringing joint actions, the FTC and the FDA have individually pursued numerous other cases against health fraud with support from their sister agency.
Both agencies have also issued a combined total of more than 200 warning letters, cyber letters and e-mail advisories to various companies marketing dangerous or fraudulent health products over the Internet and by other means since December 2002. The agencies use these letters to advise marketers that they appear to be making false or unsubstantiated claims in violation of the law and to warn them that formal legal action may result if they continue to deceive consumers. The warning letters have been directed, for instance, at recent waves of fraudulent marketing preying on consumers’ fears about biological, chemical, and nuclear terrorism threats and the SARS epidemic. Others have targeted fraudulent marketing in specific supplement product categories like coral calcium and ephedra. The agencies are closely monitoring compliance with these letters and advisories.
A complete listing of FTC enforcement activities involving dietary supplements and health fraud from December 2002 to July 2003 is accessible on the FTC’s Web site in the links to related documents. Additional information on individual FTC cases can be accessed by clicking on the case name. A link to the FDA’s “Dietary Supplement Enforcement Report June 2003” is also provided in the related documents and is available directly on the FDA’s Web site at www.fda.gov.
In a statement released today, FTC Chairman Muris also applauded the FDA’s progress toward implementing the initiative’s other goal of promoting more complete, more timely, and more reliable information about diet and health in food labeling. The FTC staff has participated in an FDA task force to develop an approach to facilitate the review and approval of new health claims for food labeling. The FDA today issued a report on the efforts of the task force along with guidance documents detailing the new review and approval process. “I am very excited about the new access that this initiative will give consumers to important diet and health information,” said Muris. “I am also confident that, when food companies are permitted to promote the health benefits of their foods, they will be motivated to develop healthier food products. Better nutrition information means not only better choices for consumers but also more choices.”
The FTC will continue to work with the FDA in implementing the new policies for health claims in food labeling. In particular, the FTC staff will provide assistance to the FDA on implementation of its proposed consumer research agenda, to examine how best to communicate emerging diet and health information.
The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1 877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.