In May of last year, the Food and Drug Administration sent a Warning Letter to General Mills about a box of Cheerios. The problem? The FDA read the Cheerios box and didn't like what they saw when it came to viewing some language with respect to the consumption of soluble fiber might lower cholesterol. Here is what they said:
"Based on claims made on your product's label (the box), we have determined that your Cheerios Toasted Whole Wheat Grain Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease."
Food is, for the most part, regulated by the United States Department of Agriculture (USDA), but in relation to health claims, the FDA can, and obviously does become involved. The FDA has laid out guidelines for how and when a health claim can be made about particular foods. Here, while the FDA does allow a health claim related to the consumption of soluble fiber, the parameters for doing so are very strictly interpreted by the agency.
The FDA regulates the labeling of drugs. It also regulates the marketing of drugs, i.e., advertising and when the FDA considers that a food is being marketed as a drug, it can presumably act not only with respect to the label (the food package), but advertising for the product as well, if it contains the same claims.
But the Federal Trade Commission also regulates advertising. And in a different matter, the FTC recently expanded an existing order related to claims made by Kellogg's related to immunity boosting language used in advertising for Rice Krispies (Snap, Crackle and Drop – the immunity claim, anyway). The FTC is now proscribing the company from making any health claims unless backed by scientific evidence. While in the Cheerio's case, the FDA focused on specific claims being made on the label, the FTC in the Kellogg's case was focused on a general claim for the product to "boost immunity".
The two actions may seem similar, but are very different. But this tale of the two cereals is a good cautionary lesson for communicators. One might crave very singular and simple black and white instructions on how to proceed when a health claim is concerned. But the fact is that health claims can be a very complicated business and that everyone working with a product making one has to look at the issue from several different angles and perspectives – particularly those of the FDA AND the FTC. And in the words of an FDA spokesperson on this issue – "every situation is different" which makes it difficult to "describe a perfect algorithm".
