Cholestin is made from a pulverized strain of rice fermented with red yeast. After fermentation it is ground up into a brick-colored powder and encapsulated. The rice is imported from China, where it has been used for more than 2,000 years as an herbal remedy and a food. The FDA said that it intended to pursue the case despite the latest ruling. This act allowed for products to be marketed as dietary supplements as long as there are no medicinal claims.
All products still have to be safe.
Dietary supplements are here to stay. Each week a highlight of what is going on at FDA is shared to assure that new information is expeditiously made available. It is clear to those of us in Clinical Research that until a product is actually marketed, there is no way through the NDA approval process to assure that a product's benefit to risk ratio will be acceptable. While not a perfect system, MedWatch has again proven to be a valuable tool in the monitoring of drug safety. The following summarizes the most recent successes of the MedWatch program.