This comes a bit late, but still is worthy of discussion: Cheerios, which has been making health claims as to the effect of their cereal on cholesterol, were issued a warning letter by the FDA. You can read the text of the letter here. The FDA also gives a sort of rule-of-thumb guide to the incident with a short Q&A webpage here.
What got General Mills in trouble? Not the claim that their cereal lowers cholesterol – the claim that it does so with specific results. By naming specific percentages, according to the FDA, it promotes the breakfast cereal as a drug and would have to be labeled as such.
After reading carefully the FDA’s standards on aromatherapy last year, I decided to withdraw my entire aromatherapy line. The way it is phrased, and the example, made me realize that even suggesting a fragrance formula could do something as seemingly innocuous as reduce stress could get me in trouble – and if the FDA wanted to, they could claim that having suchandsuch chemical that is commonly believed to do (fill in the blank) would be enough to merit pharmaceutical testing:
“A claim that a perfume’s aroma makes a person feel more attractive, in general, is a cosmetic claim not requiring FDA approval before a product is sold. But if someone tries to market a scent suggesting effectiveness as an aid in quitting smoking, as a sleeping aid, or to treat or prevent any other condition or disease, or otherwise affect the body’s structure or function, such a claim may cause the product to be regulated as a drug, requiring premarket approval. The agency will make judgments on a case-by-case basis.”
I don’t know whether going after Cheerios was erroneous – certainly guaranteeing it would lower cholesterol bordered on irresponsible marketing, since not everyone could get that result – there are too many types of metabolism and body chemistries out there to make such a claim. It’s a serious message, either way: the FDA isn’t messing around. Mind your labels and your p’s and q’s.
