Last week, the FDA and FTC issued a press release which announced that seven companies which manufacture over-the-counter weight loss products containing human chorionic gonadotrpin have been asked to stop selling and marketing the unapproved drugs.
'Tis the season for massive holiday meals and treats, and as a result, weight gain for the majority of Americans who indulge during these festive months. Usually, this trend transitions into strict dieting shortly after January 1st, but a recent move by the US Food and Drug Administration (FDA) along with the Federal Trade Commission (FTC) may have some dieters in uproar.
On December 6th, 2011, the FDA and FTC issued a press release which announced that seven companies which manufacture over-the-counter weight loss products containing human chorionic gonadotrpin (HCG) have been asked to stop selling and marketing the unapproved drugs.
HCG is a hormone that is produced in women’s placentas; it is FDA-approved, but only as a prescription injection drug to treat certain cases of infertility and types of male hormone imbalances.
According to some studies, however, HCG absorbs excessive fat tissue, and many companies have come to market the hormone as a weight loss drug which can decrease appetite and speed-up metabolism. These products are not approved for weight loss, but versions of these drugs claiming to contain the hormone are sold under homeopathic labels.
"Almost more than any other [market], the weight loss industry is fad driven," reported Richard Cleland, assistant director of the division of advertising practices at the FTC. "Also, unfortunately it is fraud driven."
According to Elizabeth Miller, acting director of the Division of Non Prescription Products and Health Fraud at the FDA, there is no certainty that these homeopathic products even contain HCG; if they do, it may only be present in miniscule levels.
"Whether they contain it or not, they are illegal and unapproved drugs," Miller said.
Further, Miller stated that no studies have linked a particular product containing HCG to additional weight loss when coupled with a low-calorie diet. These drugs are advertised to work speedily when paired with a low-calorie diet, but the FDA has said that a very low calorie diet can lead to the formation of gall stones, electrolyte imbalances, and even heart arrhythmia, whether HCG is taken or not.
According to the FDA website, the firms which have received warning letters "may face enforcement action, possible legal penalties, or criminal prosecution” if they do not respong to the FDA and the FTC within 15 days stating the steps they have taken to correct their violation.
The companies which have been warned to stop manufacturing and marketing the products include Nutri-Fusion Systems LLC, Natural Medical Supply, HCG Platinum, LLC, theorginalhcgdrops.com, HCG Diet Direct, LLC, and Hcg-miracleweightloss.com.
Gary Arbuckle, co-founder of theorginalhcgdrops.com, reported that his company does not intend to shut down, even though it exclusively produces and sells HCG drops.
"We're looking at making some changes that [the letter] calls attention to," reported Arbuckle. "Obviously our mission to help people with weight loss will be different. It's not going to end."
Arbuckle would not state how much HCG his product contains, or what changes will be made to them.
Cleland reported that the majority of these products are marketed through the Internet, to which roughly 8 million people per year fall victim to consumer fraud.
While most of the dieters who take HCG do so by purchasing homeopathic versions of HCG, there are certain physicians who acknowledge the weight-loss benefits of the hormone and use the pharmaceutical grade HCG injection off-label to help patients with weight problems.
Dr. Sherri Emma, a weight loss physician based in Brick, NJ, stated that the difference between dieting solo and dieting with HCG is in how the weight is lost. "HCG spares the muscle tissue but gets rid of the fat," Emma reported.
Emma treats almost 100 patients per week with the diet program, but while she is an advocate of the drug for weight loss, she also said that she is happy that the FDA has cracked down on homeopathic versions of HCG. Oral consumption, she said, of trace amounts of HCG does not absorb into the body, and therefore does not provide the consumer with the same results as injections of the hormone.
"I understand that this diet is becoming very popular, so I feel a sense of responsibility that people are educated and not doing things on their own," said Emma.
Despite Emma’s enthusiasm for HCG as a weight loss treatment, however, the FDA maintains that HCG is not an appropriate for such a use.