FDA panel recommends stricter labeling for eye care products
GAITHERSBURG, Md. A Food and Drug Administration advisory panel on June 10 recommended there be stricter labeling and testing for contact lenses and cleaning solutions, following a meeting of the Ophthalmic Device Panel of the Medical Devices Advisory Committee.
The meeting was called by the FDA, in part, because of the number of product recalls associated with contact lens cleaning solutions in the past few years.
Specifically, the advisory committee suggested stronger label warnings that would identify potential infections that can lead to blindness, for example, as a possible consequence of not following product instructions.
Panelists also recommended the agency require pre-approval testing of the efficacy of lens solutions against Acanthamoeba keratitis, a parasite involved in one of the outbreaks.
Next Pharmaceuticals announces positive Flavoxine results
SALINAS, Calif. Next Pharmaceuticals announced Thursday the results of their small-sample clinical trial, which found that its supplement Flavoxine significantly reduced LDL-cholesterol and triglycerides, and also decreased blood pressure and fasting blood glucose.
The study also found that Flavoxine increased HDL-cholesterol, and may be helpful in weight reduction.
“Flavoxine is the result of Next Pharmaceuticals devoting many years to finding a natural formula for heart health that would have multiple benefits,” stated Charles Kosmont, chief executive officer of Next Pharmaceuticals. “We are very satisfied with the results of this study and the benefits Flavoxine will provide to people who prefer a safe and effective natural approach to their heart health.”
The study was recently published in Nutrition Journal, an open access, peer-reviewed, online journal. The published clinical trial is also available at PubMed and archived in PubMed Central.
The 8-week, placebo-controlled study was conducted with four groups, comparing the effects of Flavoxine to placebo in overweight and normal weight. The subjects were given Flavoxine (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel) or a matching placebo.
Eighty subjects were enrolled and 45 subjects completed the study.
NPF applauds FDA for targeting false cancer-cure claims
WASHINGTON The Natural Products Foundation on Thursday commended the Food and Drug Administration for cracking down on bogus cancer cure claims made by distributors of dietary supplement products.
“While I can’t comment on a particular case, I can say that we’ve always urged full enforcement of the law in regard to dietary supplements and other natural products,” stated Tracy Taylor, executive director of the foundation. “So if someone is making illegal claims, the FDA or the FTC needs to take action and the Natural Products Foundation is in full support,” she said. “I think it’s important to note from a broader perspective that the fact the FDA, or the FTC, for that matter, can exercise enforcement power is further evidence that the law—the Dietary Supplement Health and Education Act—is working.”
Taylor noted that NPF is committed to truth in advertising and has several educational initiatives in place to ensure its members do not cross the line, she said. “Our goal is to make sure that these claims never get into print or on the Internet in the first place,” she said. To help augment the prevention of such claims, the foundation fields complaints from consumers and others about dietary supplement advertising “that crosses the legal line.”
“If a complaint is found to have merit by our legal review panel, we will take action, including potentially bringing the complaint to the appropriate regulatory agency,” Taylor said.