A few weeks ago, we ran an article titled, "Beyond the Bed: Adding Dietary Supplements to Retail Mix Boosts Salon Profits." In it, Ike Blackmon, executive director of Creative Bioscience, shared information about indoor tanning salons that are starting to offer dietary supplements to beef up their retail sales.
This week I received a press release announcing that the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) had issued seven Warning Letters to companies marketing over-the counter (OTC) human chorionic gonadotropin (hCG) products labeled as “homeopathic” for weight loss. That release appears in full at the end of my blog.
I asked Blackmon to comment on the FDA and FTC warnings because some of his company's products use hCG. However, there is a clear distinction between Creative Bioscience and the products and claims made by the companies that received warnings.
"In light of the recent FDA and FTC report, Creative Bioscience would like to make a couple of important distinctions," Blackmon shares. "You may have noticed that of the seven companies mentioned in the warning letter, Creative Bioscience was not named. Creative Bioscience’s hCG products are not homeopathic remedies, as the targeted companies’ products claim to be. Our products do not contain hormones of any kind. We are in full compliance with the FDA, FTC and all government regulations. We are in regular communication with the FDA and always strive to meet their requirements.
"As for making unsupported claims, Creative Bioscience has never and will never fabricate information about our products or the results they produce. Our testimonials are all 100 percent real and come from satisfied customers who have used our products to achieve their weight-loss goals."
Bottom line: salons that carry dietary supplement products such as those from Creative Bioscience needn't be concerned about this latest news. However, if the salon carries hCG weight-loss products labeled as "homeopathic," there could be trouble. Read the full release below for more details.
The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss. As per the FDA website, the companies impacted include:
• Nutri Fusion Systems Inc.
• Natural Medical Supply LLC DBA HCG Complete Diet
• HCG Platinum LLC
• Theoriginalhcgdrogs.com
• HCG Diet Direct LLC
• Hcg-miracleweightloss.com
Human chorionic gonadotropin (hCG) is a hormone produced by the human placenta and found in the urine of pregnant women. hCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions.
The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved hCG drug products for weight loss.
The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets and sprays.
The labeling for the “homeopathic” hCG products states that each product should be taken in conjunction with a very low-calorie diet. There is no substantial evidence hCG increases weight loss beyond that resulting from the recommended caloric restriction. Consumers on a very low-calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance and heart arrhythmias.
“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” says Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low-calorie diet should only be used under proper medical supervision.”
“Deceptive advertising about weight-loss products is one of the most prevalent types of fraud,” states David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”
According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA's voluntary reporting program, by calling 800.FDA.1088, or electronically via the FDA's site, www.fda.gov.
