Spa Regulations Coming to Mass.
The Massachusetts Board of Registration in Medicine will issue a report next month outlining potential regulatory and statutory changes, and new policies and guidelines for medical spas, according to a board spokesman. The report will be the culmination of a year's worth of work by a medical spa task force. In 2006, the state legislature directed the board to look into how medical spas are monitored and regulated. Massachusetts may be the first state to have taken a comprehensive look at spas. Other state medical boards are eagerly awaiting the task force report, according to the board spokesman. When it is completed, the report will be posted at
www.massmedboard.org/public/med_spa.shtm
Mesotherapy Chain Closes
Fig., a St. Louis-based chain of spas offering mesotherapy, closed 17 of its 18 facilities in mid-December. Only an independently owned and operated center in Costa Mesa, Calif., remains open. According to the chain, formerly known as Advanced LipoDissolve, they had received an eight-figure influx of capital in September from the Larchmont, N.Y., office of Bessemer Venture Partners. At press time, postings on Fig.'s Web site reported that executives planned to file for bankruptcy and eventually reorganize.
FDA Investigating Tattoo Ink
The Food and Drug Administration is investigating the safety of inks and dyes used in tattooing and permanent makeup. In an article written for consumers and posted on FDA's Web site in December, agency officials said that continuing reports of reactions to ink prompted the launch of a study. The agency's National Center for Toxicological Research now is looking into the chemical composition of inks and how they are metabolized, short- and long-term safety of pigments used in tattoo inks, and how inks might change when the body is exposed to light. Some research has already shown that some pigment migrates to the lymph nodes, according to the FDA. The article can be found at
www.fda.gov/consumer/features/tattoos120607.html
Warning on Bioidentical Hormones
The FDA is warning seven pharmacy operations that their claims regarding bioidentical hormone therapy (HT) products are not supported by medical evidence and are considered false and misleading. The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. Compounded drugs are not reviewed by the FDA for safety and effectiveness; in addition, no drug product containing estriol has been approved by the FDA. The agency said the pharmacy operations improperly claim that these drugs are superior to FDA-approved HT drugs and prevent or treat diseases, including Alzheimer's disease, stroke, and cancer. More information is available at
www.fda.gov/cder/pharmcomp/default.htm
Minn. Mercury Ban Goes Into Effect
A Minnesota ban on the use of mercury in over-the-counter pharmaceuticals, cosmetics, toiletries, fragrances, and a host of other household and medical products, including thermometers and barometers, went into effect on Jan. 1. The law, signed last May by Gov. Tim Pawlenty, a Republican, is aimed at reducing mercury exposure. Mercury is often added to cosmetics as a preservative. Retailers who knowingly sell cosmetics that contain mercury are liable for fines of up to $700, and manufacturers could be penalized as much as $10,000 for failing to disclose mercury on any product label.
Tanner Subtypes Identified
Physicians can more effectively target messages about the risks of indoor tanning if they first determine a tanner's behavior pattern, researchers from East Tennessee State University and Pennsylvania State University have found. They identified four tanning subtypes: special event, spontaneous or mood, mixed, and regular year-round tanning. They drew their conclusions from a sample of 168 women randomly selected from a larger study of indoor tanning behavior among female students at East Tennessee State. Participants were asked to assess their tanning frequency during the previous 3, 6, and 12 months, and to project their intentions over the next year. The researchers found statistically significant differences among participants in attitudes, social norms, partner preference, and belief that tanning relieves stress, and on four tanning dependence scales. Event tanners (53% of the sample) tanned the least, and scored lowest on attitudes, social norms, and tanning dependence measures; year-round tanners (12%) scored highest and started earliest. The study was funded by grants from the American Cancer Society and the National Cancer Institute. It was published in the December issue of the Archives of Dermatology.
Scant Number of New Approvals
The FDA approved only 17 new chemical entities (NCEs) in 2007, the lowest number since 2002. This comes on the heels of 2 previous years with only 18 NCE approvals each. NCEs are unique products. Those approved in 2007 included two HIV therapies; four oncology products; two antihypertensives; one antibiotic; and one NME each to treat Parkinson's disease, pulmonary hypertension, impetigo, acromegaly, attention-deficit hyperactivity disorder, and phenylketonuria. An imaging agent and injection to prevent blood volume loss during surgery also were approved, as were a handful of biologics, an influenza vaccine, and an avian flu vaccine.