On October 29, the FDA sent a warning letter to Procter & Gamble concering their sale of combination over the counter (OTC) drug/dietary supplement products. Without making your eyes glaze over, the problem with this is that drugs must be approved by the FDA before they can be sold. Dietary supplements do not.
The FDA's position is that when a dietary supplement is combined with a drug and sold together as a single product, the combination renders the entire product a drug. And since the dietary supplement portion of the product has not been tested and proven as safe when used in combination with the drug part, the product cannot be sold in its entirely unless and until the entire product has been approved.
Like the FDA/FTC letter to Dr. Weil from earlier this month, and the suspension of the Smart Choices labeling program, this action highlights that the FDA is stepping up its enforcement of existing law. Overall, this is a good thing, especially considering the fact that several new bills in Congress would change the way the FDA is required to perform its duties as regulator.
It's generally a good idea to enforce the laws already on the books before you have to starting enforcing new ones.
