FDA siezes more than $1.3 million in LG Sciences’ dietary supplements
ROCKVILLE, Md. In a move that may show Congress and public that the Food and Drug Administration is already effectively regulating both dietary supplements and the potential contamination of those supplements with steroids, the FDA last week seized more than $1.3 million in dietary supplements from LG Sciences of Brighton, Mich. because the products contained unapproved ingredients. The specific ingredients were not identified by the agency.
Labeled as dietary supplements, the products are marketed for use by body builders . under the brand names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”
“The FDA takes seriously its responsibility to protect Americans from unsafe dietary supplements,” stated Margaret Glavin, FDA’s associate commissioner of the Office of Regulatory Affairs. “[Last week’s] action shows FDA’s commitment to protecting consumers from potentially harmful products.”
“Working with the FDA, we are taking prompt civil action to protect the public health by seizing these illegal products and forestalling their shipment into the stream of commerce in any manner that could create harm to the public,” stated U.S. Attorney Stephen Murphy.
The FDA has not received scientific information on the safety of the seized products and cannot determine, at this time, whether they represent a hazard to consumers, the agency reported.
In March 2006, the FDA warned Legal Gear (the predecessor of LG Sciences) to cease distribution of a different product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids.
NAD supports some PinnoThin claims
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Thursday announced that Lipid Nutrition B.V. North America has provided sufficient support for certain advertising claims made for the company’s PinnoThin dietary supplement.
NAD has recommended, however, that certain claims be modified or discontinued.
Following its review of a random double-blind study provided by Lipid Nutrition, NAD determined that the advertiser did not have a reasonable basis for its claim that it has “clinically proven” that PinnoThin promotes the feeling of satiety, suppresses the desire to eat or provides control over one’s appetite. However, NAD did determine that the advertiser could support a more limited claim that PinnoThin “may help to” promote a feeling of fullness, reduce prospective food intake, suppress the desire to eat, provide control over one’s appetite or increase the release of GLP-1 (a hormone).
NAD noted that the advertising in question is directed to other marketers and manufacturers of dietary supplements, rather than consumers. NAD noted that it is mindful that businesses purchasing PinnoThin from Lipid Nutrition will likely be relying on Lipid Nutrition’s claims in determining what advertising claims can be supported for products containing this ingredient in future consumer-directed advertising.
Lipid Nutrition told NAD that PinnoThin is refined pine nut oil derived from pine nuts mainly of the Korean pine tree. The oil of Korean pine nuts is especially rich in very long chain fatty acids, such as pinolenic acid. According to the advertiser, a large body of scientific evidence demonstrates that long chain fatty acids stimulate the release of the hormones cholecystokinin (CCK) and glucagon-like peptide 1 (GPL-1), promoting a feeling of fullness or satiety.
The company, in its advertiser’s statement, noted that it disagreed with certain of NAD’s conclusions. “Nonetheless, Lipid Nutrition will take the NAD’s conclusions and recommendations into account when developing future advertising,” the company stated.
FDA approves Mark of Fitness’ RevitaLeg massager
NORTH BRUNSWICK, N.J. Mark of Fitness received approval from the Food and Drug Administration for its RevitaLeg portable compression massager for the temporary relief from muscle aches and pains and the promotion of an increase in circulation.
Mark of Fitness touted the product’s portability—it’s no bigger than a soda can—and suggested that air travelers may be a key demographic, because long flights can lead to the development of deep vein thrombosis. According to the World Health Organization, traveling by plane, bus or train for four hours or more doubles the risk of developing DVT.
RevitaLeg will begin shipping in May, and will be sold through home care dealers, retail pharmacies, specialty stores and online. The suggested retail price is $149, and the product may be qualified for reimbursement under certain health plans and for specific conditions, the company stated.