;   Medical Translation Insight: Cereal maker learns that "labeling" is a broad term - ForeignExchange Translations

Cheerios learns that labeling is a broad termFDA recently issued a warning letter to General Mills, makers of Cheerios(R) breakfast cereal. The warning letter raps The Mills on the knuckles for illegally marketing their new "drug," commonly known as Cheerios(R) Toasted Whole Grain Oat Cereal.

What, Cheerios(R) is a drug?

Yes, because according to the Federal Food, Drug, and Cosmetic Act, a "drug" includes "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals..." That's relevant because the product label stated that you can lower your cholesterol 4% in six weeks.

Interestingly, the claim referenced by FDA did not appear on the Cheerios(R) box, but rather appeared a General Mills web site, www.wholegrainnation.com. According to the FD&C Act, "[t]he term 'labeling' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article". Because General Mills' claims appeared on a web site featured on the Cheerios(R) box, the FDA considered the content on the web site as part of the labeling.

Warning letters are no laughing matter, and historically, regulators and courts have taken an expansive view of what is included in a product's labeling.

And it's not just nutritional products that are impacted. The latest version of the Medical Device Directive 2007/47/EC broadened the definition of "medical device" to include software that is intended for diagnostic or therapeutic purposes. This means many medical device manufacturers are rushing to localize software so that their products can retain the CE Mark.

In a statement, General Mills said "the dispute with the FDA is more about language than science".

Now, where is the milk to add to my breakfast drug cocktail?


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