Posted March 8, 2012

Supplement Maker Warned About Cancer Claims

FDA issued a letter to Royal Domains (dated January 6, 2012) warning that their Nature's Pearl Premium Muscadine Grape Seed dietary supplement is being promoted as a drug and as such is misbranded.

The product website makes therapeutic drug claims that Nature's Pearl Premium Muscadine Grape Seed can be used to prevent cancer, diabetes and other health conditions which require medical treatment. Videos posted on the website include the company president describing therapeutic drug uses for the product. Under US regulations, dietary supplements may not make claims to treat, cure or prevent illness.

FDA warned that drug claims are not permitted for products marketed as dietary supplements and gave the company 60 days to respond to the warning.

For information about extracts of grape seed see the encyclopedia article on OPCs in ConsumerLab.com’s Encyclopedia.

The Warning Letter is available on the FDA website using the link below.