The US Federal Trade Commission (FTC) and the Food and Drug Administration (FDA), working with government agencies in Mexico and Canada, have launched a drive to stop deceptive Internet advertisements and sales of products misrepresented as cures or treatments for diabetes. The ongoing joint campaign has so far included approximately 180 warning letters and other advisories sent to online outlets in the three countries.
"We will continue working with our partners in the U.S. and internationally to make sure scammers have no place to hide," said Lydia Parnes, Director of FTC’s Bureau of Consumer Protection. "The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases. Our advice to consumers: ‘Be smart, be skeptical’ when evaluating health claims online."
"We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars," said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs. "Diabetes requires effective treatments and aggressive management, not bogus and unproven products."
The joint diabetes initiative to stop commercial sale of fraudulent therapies originated with a Web surf for "hidden traps" by the International Consumer Protection and Enforcement Network (ICPEN), an organization of law enforcement authorities, members of the Mexico, United States, and Canada Health Fraud Working Group (MUCH), and the attorneys general offices of Alaska, Michigan, Ohio, Virginia, and Wisconsin. MUCH, which consists of regulatory officials from health, consumer and competition protection agencies in the three North American countries, had previously conducted a campaign against fraudulent weight-loss products.
Using the results of the Internet sweep, FTC sent warning letters for deceptive ads to 84 domestic and 7 Canadian Web sites targeting U.S. consumers, and referred an additional 21 sites to foreign governments. About a quarter of the firms have already changed their claims or removed their pages from the Internet, and several others are in contact with FTC.
On October 19, FDA announced it has issued warning letters to 24 firms marketing dietary supplement products with claims to treat, cure, prevent or mitigate diabetes (see link to Warning Letters at http://www.cfsan.fda.gov/~dms/dialist.html ). The FDA letters warn firms that failure to promptly correct the violations may result in enforcement action without further notice, which may include seizure of violative products and/or injunctions against the manufacturers and distributors.
FTC is also announcing today a new consumer education campaign to teach consumers how to avoid phony diabetes cures. The materials encourage consumers to "Be smart, be skeptical!" and will be available in English, Spanish, and French. One component is a "teaser" Web site available at http://wemarket4u.net/glucobate/index.html.
At first glance, the site appears to be advertising a cure for diabetes called Glucobate, but when consumers click for more information on ordering the product, it reveals information about avoiding ads for phony cure-alls in the future. The new education materials, including a bookmark and consumer alert, are being introduced in time for Diabetes Awareness Month in November. The American Dietetic Association has agreed to help disseminate the information.
FDA has developed a strategy to focus its enforcement efforts in the area of dietary supplements, and today’s announcement is one important action under that strategy. The strategy was designed to address illegal dietary supplement ingredients and ensure integrity and truthful labeling of dietary supplements. One emphasis is on claims aimed at patients with serious diseases such as cancer and diabetes. Within the last twelve months, the agency has sent more than 100 warning letters and other advisories to Internet firms and has seized products at one firm.
On October 13, 2006, the U.S. Food and Drug Administration (FDA) alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. These test strips are used by people with diabetes to measure their blood glucose. Today’s announcement provides two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.
The counterfeit test strips are:
The counterfeit test strips potentially could give incorrect blood glucose values–either too high or too low–which might result in a patient taking either too much or too little insulin and lead to serious injury or death. LifeScan alerted FDA of the counterfeit test strips. The FDA continues to investigate the matter, including whether there have been any adverse events associated with this counterfeit product.
Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact Lifescan, Inc. at 1-866-621-4855. Consumers who have discarded the outer box or do not know the lot number of their test strips should stop using those test strips and replace them.
The counterfeit test strips were distributed to pharmacies and stores nationwide by various distributors.
How to Identify
For complete information on how to identify the counterfeit test strips, please check Lifescan’s web site at http://www.lifescan.com/compan.....unterfeit/.
The following characteristics may help to identify the counterfeit test strips.
Counterfeit One Touch Basic/Profile Test Strips, lot numbers 272894A, 2619932, and 2606340
Counterfeit One Touch Basic/Profile Test Strips, lot number 2615211
Counterfeit One Touch Ultra Test Strips, lot numbers 2691191 and 2691261
On October 13, 2006, LifeScan alerted the public via a press release and notified pharmacists, distributors, and wholesalers through a letter. In its letter, the company advised customers to contact their original source of supply for restitution. For more information, visit: http://www.Lifescan.com.
On October 13, 2006, FDA alerted its Counterfeit Alert Network partners, a coalition of healthcare professional, consumer and trade associations, who have agreed to further disseminate this important information in a timely and effective manner. For more information about this and other counterfeit products, visit: http://www.fda.gov/counterfeit/.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or through the MedWatch Web site at http://www.fda.gov/medwatch.