The FDA told Natural Biology its resveratrol products were being marketed as a cure and therefore violated the Federal Food, Drug, and Cosmetic Act which controls such claims.
The product, called Vintage Resveratrol, was being promoted in a number of ways the FDA took issue with. These claims included:
· Anti-cancer, anti-viral and anti-inflammatory claims (by inhibiting cyclooxygenase-1 (COX-1))
· Improved insulin signaling for those with diabetes
· Improved fat metabolism
· Controls high blood pressure
· Inhibits blood clots
· Reduces risk of breast cancer
· Causes aptosis (death of cancer cells)
· Reduces the risk of prostate cancer
· Works as anti-depressant
The FDA said the product blatantly marketed itself as a cancer cure on the company website, including a section called ‘Health News and Research’, where reference was made to scientific papers.
One paper said resveratrol worked effectively against cancer during the three phases of the cancer process: initiation, promotion, and progression.
“For example, resveratrol displayedantimutagenic and antioxidant activity, providing greater protection against DNA damage than vitamins C, E, or beta-carotene. Resveratrol restored glutathione levels, considered by some as the most essential of antioxidants,” the company wrote of the product on the website.
The FDA took issue with another Natural Biology product called Nano HGH that contained L-arginine and a marine-sourced calcium.
In its letter to the company the FDA wrote: “Your products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are ‘new drugs’… Your products ‘Nano HGH’ and ‘Vintage Resveratrol’ are also misbranded within the meaning … of the Act, in that labeling for these drugs fails to bear adequate directions for use.”
The FDA added the list was not comprehensive as it had noticed other potential transgressions on the company’s website.
“The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter,” it said.
“It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.”
Resveratrol is a polyphenol typically found in red wine.