Council For Responsible Nutrition names new members
WASHINGTON The Council for Responsible Nutrition last week added four members to its roster — ingredient manufacturer Ashland Aqualon Functional Ingredients, functional foods supplier Celsius, dietary supplement developer Nutrition 21 and eye supplement marketer ZeaVision.
FDA declines to approve Qnexa
MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.
The company said Thursday that it received a complete response letter from the FDA for Qnexa (phentermine and topiramate) controlled-release capsules. The agency said the application can’t be approved in its current form and asked for additional study data. The FDA issues a complete response letter to indicate that it has completed review of an application, but questions remain that preclude final approval.
The prospects for the drug’s approval didn’t look good even before Vivus submitted its application, despite the drug showing some promise in clinical trials. In July, an FDA advisory committee voted 10-6 against recommending approval for Qnexa, citing such possible side effects as psychiatric problems and birth defects. Though an advisory committee’s vote does not determine whether the agency will approve a drug, its vote is taken into consideration.
NAD to Bell Lifestyle: Discontinue ad claims for dietary supplement
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Thursday recommended that Bell Lifestyle Products discontinue certain claims for its dietary supplement Bell Shark Cartilage #1.
NAD, the advertising industry’s self-regulatory forum, reviewed advertising claims for the product following a challenge by the Council for Responsible Nutrition. Claims at stake included that the product addressed osteoarthritis, rheumatoid arthritis, sciatica, neck and back pain, and carpal tunnel syndrome. Additionally, Bell Lifestyle promised users they would be “pain free in two weeks” and that its dietary supplement product was cheaper and more efficacious than prescription remedies.
“Synthetic drugs for rheumatoid arthritis may run to $10,000 a year (we have documented cases) and may not be as effective as Bell Shark Cartilage #1, and may as well have severe side effects that have to be treated additionally with different synthetic drugs. Bell Shark Cartilage #1 costs less than $100 and has virtually no side effects,” the company claimed in its advertising.
Bell Lifestyle reported to NAD that its product contains significant concentrations of chondroitin sulfate and glucosamine, and that the company relied on scientific research to establish the presence and availability of chondroitin sulfate and glucosamine in shark cartilage and substantiate the health benefits to consumers from taking those ingredients in a dietary supplement. However, according to regulations passed under the Dietary Supplement Health and Education Act of 1994, manufacturers may not make any disease-state claims, including pain relief, with regard to any dietary supplement, including glucosamine and chondroitin.
At the outset of the NAD’s investigation, Bell Lifestyle asserted that it had discontinued certain claims, including all claims and testimonials referencing treatment of a specific disease, claims comparing the relative efficacy of Bell Shark Cartilage #1 with synthetic drugs, the performance claims referencing the absolute number of users helped by Bell Shark Cartilage #1, claims that reference a specific percentage efficacy and testimonials referencing alleviation of serious rheumatoid arthritis symptoms and the statements of the consumers who wrote that they avoided surgery after using Bell Shark Cartilage #1.
Following its review, the NAD determined that it was not clear how much glucosamine is contained in the advertiser’s product. The NAD noted that the advertiser acknowledged that it had not tested and established the amount of glucosamine in its shark cartilage product and noted, as well, the advertiser’s assertion that “Bell Lifestyle is currently undertaking a chemical analysis of Bell Shark Cartilage to verify the presence of glucosamine and chondroitin sulfate in the concentrations found in chemical analyses by others.” The NAD concluded that the evidence in the record was insufficient to support joint health claims for the product and recommended that the claims be discontinued.
The company, in its advertiser’s statement, said it “accepts the NAD’s decision and, pending verification of the product contents, will discontinue its joint health benefit claims, including performance claims referencing treatment of disease and efficacy of the product in absolute terms and in comparison to medical treatments.”