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FDA, FTC act to remove “homeopathic” HCG weight loss products from the market

Joint action is first step in halting sale of the products.

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.

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. Read more

               

New Alternative to Botox Approved

Aside from plastic surgery, Botox has been the best anti-aging weapon up until now. However, that’s about to change as a new Botox alternative called LAVIV has been approved by the FDA. Learn more about this promising alternative that uses your own cells to help you look and feel younger.

Loved or, on the contrary, ridiculed Botox injections were the best alternative for those whose who wanted to restore the youth of their skin without going under the knife in the name of beauty. The idea of willingly injecting toxins in your body has repelled many who would have considered a surgery free alternative.

Thankfully, a very similar procedure that does not involve the injection of Botulinum toxin has already been approved by the FDA. Called LAVIV, the new anti-aging method relies on the use of fibroblasts, the cells that produce collagen, elastin and hyaluronic acid in order to provide a good skin firming result. Read more

               

FDA approves Botox for loss of bladder control

U.S. drug regulators approved Allergan’s Botox for treating a specific kind of overactive bladder on Wednesday, setting the stage for wider use of the popular wrinkle treatment in those with bladder problems.The U.S. Food and Drug Administration said Botox can be injected into the bladder to treat those who lose bladder control because of damage to the nervous system, through conditions such as multiple sclerosis or spinal cord injury. Read more

               

FDA OKs Xeomin for frown lines

The Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA, Merz Aesthetics) for temporary improvement of moderate to severe glabellar lines, Medscape Today reports.

According to a Merz statement, the approval is based on the results of two multicenter U.S. clinical trials involving 547 healthy adults. In both studies, Xeomin injections significantly improved the appearance of glabellar lines in 30 days when compared with placebo. Headache was the most common adverse reaction observed.

Under the brand name Bocouture, Xeomin is already approved in 14 European countries including Germany, the United Kingdom, France, Italy and Spain. It was FDA-approved in 2010 for the treatment of cervical dystonia and blepharospasm.

Xeomin will be available nationwide in the spring of 2012, Merz officials said.

Source:  July 27, 2011 by Bill Gillette for the Dermatology Times E-News at http://dermatologytimes.modernmedicine.com/dermatologytimes/article/articleDetail.jsp?id=732599&sk=74a2a9fe9b65554292446866052d368f

               

Allergan Receives FDA Approval for First-of-Its-Kind, Fully in vitro, Cell-Based Assay for BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA)

–Represents R&D Breakthrough in Commitment to Animal-Free Stability and Potency Testing for BOTOX® and BOTOX® Cosmetic–

 

IRVINE, Calif.–(BUSINESS WIRE)– Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved a fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic. The newly approved assay will be implemented immediately for release of product for sale in the United States. Allergan estimates that use of the new assay will reduce the use of animal-based assay testing for BOTOX® and BOTOX® Cosmetic by up to 95 percent or more over the next three years, as other regulatory agencies around the world approve this new assay. The new assay is the first to be developed and approved for any botulinum neurotoxin currently available worldwide, and is specifically applicable to Allergan’s botulinum toxin type A product. Read more

               

New Sunscreen Rules from FDA

Sunscreen labels will carry a “broad spectrum” label to show they offer some protection against UVA radiation as well as UVB radiation, according to a long-awaited new rule from the FDA.

The old “SPF” designation still will show how well a product protects against UVB, although the highest SPF level a product can claim will be “50+.”

The “broad spectrum” designation carries a lot less information than a zero-to-four-star system the FDA originally proposed for UVA protection. But the FDA did hold firm on insisting that sunscreens claiming swim/sweat protection say how many minutes such protection lasts.

“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well informed on which products offer the greatest benefit,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. Read more

               

FDA Panel Backs Approval of Restylane for Lip Augmentation

Dermatologists may not have to use Restylane off label for lip augmentation any longer. On April 27, a Food and Drug Administration panel voted 6-0 with 1 abstention that benefits outweigh risks for using the filler as a submucosal injection for lip augmentation.

The panel also voted 6-0 with 1 abstention that the filler is safe and effective for the expanded indication.

Restylane (Medicis Aesthetics) is a hyaluronic acid gel generated by Streptococcus bacteria, chemically crosslinked with 1,4 butanediol diglycidyl ether. The filler was first approved in 2005 for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

Medicis recently conducted a clinical study (MA-1399-15) to evaluate the safety and effectiveness of the filler in the augmentation of soft tissue fullness of the lips. The study included 135 patients, who received lip augmentation with Restylane, and 45 patients with no treatment. The mean volume of filler was 2.9 cc per patient, with a range of 0.6-5.6 cc per patient. At 8 weeks, 92% of patients who received Restylane were considered responders. Read more

               

Cutera gets FDA nod for device to treat fungal nails

Cutera Inc , which makes lasers for medical and aesthetic use, said U.S. health regulators approved its device to treat fungal nail infections, sending its shares up 6 percent in extended trade.

Cutera’s GenesisPlus laser will now be used by physicians to treat nail fungus that often causes the toenails to become discolored, thickened and separated from the nail bed.

“A significant number of affected patients are dissatisfied with the current treatment options, including topical therapies and oral medications,” said Chief Executive Kevin Connors. Read more

               

[Homeopathic] hCG weight-loss products are fraudulent, FDA says

A popular type of weight-loss products, heavily promoted on the Internet, is fraudulent and illegal, Food and Drug Administration officials say.

HCG weight-loss products that promise dramatic results and claim to be homeopathic are sold as drops, pellets and sprays on the Web, in drugstores and at General Nutrition Centers. They are supposed to be used in combination with a very low-calorie diet of 500 calories a day.

Many of the labels indicate the products contain HCG, or human chorionic gonadotropin, a hormone made by the placenta during pregnancy. The hormone itself is approved as a prescription treatment for infertility and other conditions.

There is no evidence the oral over-the-counter products are effective for weight loss, says Elizabeth Miller, FDA’s leader for the Internet and health fraud team. While they may not be dangerous, they’re at least “economic fraud,” she says.

Because the products do not seem to be “a serious direct health hazard or a serious indirect health hazard,” they have been a lower priority for FDA action than other products. Still, Miller says, “they could be subject to enforcement at any time.”

One of the issues is the homeopathic label. Homeopathy is an alternative medicine practice of using very small or diluted preparations of medicines or remedies to treat a condition. Miller says, “We are aware of HCG products that claim to be homeopathic, but it is not recognized in the Homeopathic Pharmacopoeia.” Therefore, these products “are not recognized by the FDA as homeopathic drugs, so they are unapproved drugs and are illegal,” she says.

Miller says HCG began being used for weight loss in the 1950s when a British physician had a theory that it could help people on a near-starvation diet not feel hungry. “Since then, a lot of research and clinical trials debunked that theory.”

Samuel Klein of Washington University School of Medicine in St. Louis agrees: “Data from most randomized controlled trials show that HCG is no better than placebo in achieving weight loss or reducing hunger.”

Stephen Barrett, a retired psychiatrist who operates quackwatch.org, says, “The bottom line is there is no reason to think the product works.”

Even experts in the supplement industry say the products aren’t legal and don’t work. Andrew Shao of the Council for Responsible Nutrition, an industry group, says HCG is “not considered a legal dietary ingredient and therefore cannot be sold as a dietary supplement. I am not aware of any scientific evidence that supports its use when taken orally.”

Because HCG is a peptide hormone, it would be broken down by the stomach and rendered ineffective, he says. He says the products are mostly sold over the Internet, so it’s difficult to track sales.

Kevin Wright, president of HCG Platinum, says his company made HCG products until about two months ago; it stopped because it found a formula that doesn’t use the hormone. Some bottles of the HCG formula are still on store shelves, selling for about $70 an ounce.

Read More at http://www.usatoday.com/yourlife/fitness/weight-loss-challenge/2011-01-24-hcgdiet24_ST_N.htm

Source:  By Nanci Hellmich, for USA TODAY

               

FDA Says No — At Least for Now — to Arena’s Weight-Loss Pill - lorcaserin

Arena Pharmaceuticals said early Saturday morning that the FDA won’t approve the company’s weight-loss drug lorcaserin without further data to support the drug’s efficacy and safety.

That wasn’t a terribly big surprise, given that an outside FDA advisory panel last month voted not to recommend approval. The FDA has questions about the possibility of a higher incidence of tumors in rats dosed with the drug, Arena said in a press release. And the agency wants to see data on how well the drug works in diabetic patients. “We will work with the FDA to address the issues with our [application] as soon as possible,” Arena President and CEO Jack Lief said in a statement.

But as the WSJ reports, satisfying the FDA may take more clinical trials, and those take time and money. The WSJ also reports that the company’s development partner for lorcaserin, Japan’s Eisai, said it “remains committed to working with Arena” but didn’t elaborate on what its options for the partnership are from here on out.

Meantime, the FDA is due to issue a decision on another weight-loss drug — Qnexa, made by Vivus — later this week. In July, an FDA advisory panel voted not to recommend approval of the drug, citing a need for longer-term data to assuage safety concerns. Yet another experimental diet drug, Orexigen’s Contrave, is scheduled for consideration by the panel on Dec. 7, with a decision due by the end of January. Read more

               

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