No. This has always been the law of the Food, Drug and Cosmetic Act. With some exceptions, how a product is classified is based on how it's marketed. If you make health claims, you're a drug. If you don't, you're not. Simple as that.
The FDA is stepping over the line in many areas recently but not in this area. That can be blamed on congress as much as obummer.
Concur - it’s an abuse but it all revolves around how they label the product. If they claim it does something that falls under the definition of a medical device or a drug then prior to the marketing it must be approved by the FDA. If I woul them I’d do a quick recall of all the newly marked packages and repackage without the claim - it would be a lot easier and would eliminate the FDAs requirement that they get drug approval. Again I don’t agree they should be but that is how they regs have been interpreted for years. sigh....
Concur - it’s an abuse but it all revolves around how they label the product. If they claim it does something that falls under the definition of a medical device or a drug then prior to the marketing it must be approved by the FDA. If I woul them I’d do a quick recall of all the newly marked packages and repackage without the claim - it would be a lot easier and would eliminate the FDAs requirement that they get drug approval. Again I don’t agree they should be but that is how they regs have been interpreted for years. sigh....being in the food industry Diamond knows the FDAs regs well enough that their quality/compliance people should have stopped this before it went out - someone will be out of a job...