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.... ]
No, they should simply apply for review as an over the counter drug. I think all food companies should FLOOD the FDA with useless requests and drown those busybodies with paperwork.