Light BioScience receives OTC clearance for wrinkle treatment
VIRGINIA BEACH, Va. Light BioScience on Monday became the first company to receive a 510(k) over-the-counter clearance from the Food and Drug Administration for the treatment of periorbital wrinkles (wrinkles around the eye).
“This clearance paves the way for future development of a new anti-aging device to deliver the GentleWaves LED Photomodulation technology directly to the consumer marketplace without a prescription,” the company stated. “This … marks a significant milestone for our company as we continue to demonstrate our leadership in light-based science and break new ground in the medical professional and home-use markets,” stated Rick Krupnick, Light BioScience chief executive officer. “The opportunity to develop the first FDA-cleared at-home, light-based device to treat wrinkles is just the first step in making this exciting technology more accessible to the public.”
According to the company, GentleWaves has been scientifically proven to reduce the appearance of fine lines and wrinkles through the use of a patented system of pulsating amber-colored LEDs. These LEDs are specifically coded to stimulate collagen production while slowing down collagen breakdown, the company said.
Currently, Light BioScience is investigating the use of light therapy as a treatment for wound healing, radiation dermatitis, acne, thinning hair and ophthalmic disorders.
“Our on-going research reveals that the platform GentleWaves technology has the potential to treat or prevent a wide variety of medical conditions,” Krupnick said.
Products can’t claim effectiveness against diseases, FDA says
ROCKVILLE, Md. The Food and Drug Administration on Friday announced that Brownwood Acres Foods, Cherry Capital Services—doing business as Flavonoid Sciences—and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.
The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as “Chemicals found in Cherries may help fight diabetes.” The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products’ label and labeling comply with the law, the FDA stated.
“The FDA will not tolerate unsubstantiated health claims that may mislead consumers,” stated Margaret O’K. Glavin, associate commissioner for regulatory affairs. “The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers.”
Brownwood Acres Foods and Cherry Capital Services manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine and salmon oil capsules.
The decree was signed by Judge Paul Maloney on Feb. 19 in the U.S. District Court for the Western District of Michigan.
Study indicates that taking multiple NSAIDs may lead to poorer health
DURHAM, N.C. A new study released recently stated that patients taking more than one nonsteroidal anti-inflammatory drug may have poorer health quality. NSAIDs are available with or without a prescription and that is one of the problems according to the study.
These drugs are widely available, and patients may take both prescription and over-the-counter NSAIDs at the same time, either because they need more pain relief or because they don’t realize the products belong to the same class of drugs, said the study authors, who added that doctors may not know their patients are taking more than one NSAID.
The researchers, led by Stacey Kovac of Durham VA Medical Center and Duke University, found that 26 percent of the patients reported taking at least two NSAIDs (prescription, OTC or both) during the previous month, during the study, which took place from February 2002 until August 2002. These dual users scored lower than others on the physical component of a questionnaire designed to evaluate physical and mental health.
The authors suggest that physicians should keep a complete list of a patient’s medication to help identify which ones are taking more than one NSAID. Also, the researchers conclude their study by saying that, “Adequate pain management may have the potential to reduce dual use, improve patient symptoms, including physical functioning, and reduce patient safety problems.”