FDA warns companies to stop making MRSA claims for over-the-counter products
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued four warning letters to companies that manufacture and market over-the-counter drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, or MRSA.
Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents. In addition, the labeling of some of the firms’ hand-sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus. The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.
"MRSA is a serious public health threat," stated Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "The FDA cannot allow companies to mislead consumers by making unproven prevention claims."
The FDA warning letters were sent to the following firms:
Tec Labs for StaphAseptic first-aid antiseptic/pain-relieving gel;
JD Nelson and Associates for Safe4Hours hand-sanitizing lotion and Safe4Hours first-aid antiseptic skin protectant;
Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor’s antiseptic gel; and
Oh So Clean, doing business as CleanWell Co., for CleanWell all-natural foaming hand sanitizer, CleanWell all-natural hand sanitizer, CleanWell all-natural hand sanitizing wipes and CleanWell all-natural antibacterial foaming hand soap.
The warning letters explain that the companies are marketing these products in violation of federal law.
The companies have 15 days to correct the violations cited in the warning letters. Failure to do so may result in legal action, including seizure and injunction, the agency stated.
Performance Health receives APMA seal of acceptance for heel pain treatment
AKRON, Ohio — The American Podiatric Medical Association has awarded the APMA seal of acceptance to Performance Health’s Thera-Band First Step to Foot Relief, a first-line treatment plan for heel pain.
The seal is awarded to a product after the Committee on Podiatric Seals, a standing committee of the American Podiatric Medical Association, scientifically evaluates and determines whether the product allows normal foot function and promotes quality foot health.
The First Step to Foot Relief provides the podiatrist with an at-home treatment plan that enhances his or her in-clinic service with professional tools and an easy-to-follow program. The product was developed under the direction of practicing podiatrists, physical therapists and chiropractors to address heel pain.
“[More than] 2 million Americans suffer from heel pain, the most common ailment seen in podiatry today,” stated Elizabeth DeFranco, podiatry marketing manager at Performance Health. “Our new First Step to Foot Relief provides a podiatrist with guided options to improve [his or her] patient’s well-being and to enhance [his or her] level of service for patients with heel pain."
Performance Health also announced that its Biofreeze pain reliever external analgesic was recognized by the APMA seal of approval.
Astroglide introduces new personal massager
VISTA, Calif. — Astroglide on Wednesday launched its new personal massager device, the AstroglideVibe.
A durable waterproof device, the travel-sized AstroglideVibe offers multiple speeds and requires only one AA-sized battery.
The product sells for $13.99 on CVS.com.