A recent Warning Letter to an online retailer of dietary supplements once again illustrates that the US Food and Drug Administration (FDA) is paying attention-close attention-to promotional terms, even if they're not readable by humans.
The Federal Food, Drug and Cosmetic Act (FD&C Act) has long regulated the use of specific marketing claims for products regulated by the US Food and Drug Administration (FDA), including pharmaceuticals, medical devices, biologics and food supplements.
The core of those regulations stipulates that a product is misbranded if it makes claims for which it was not approved, or which it is unable to make because of its very definition. A dietary supplement, for example, could not claim to cure Alzheimer's disease because that would make it, by definition, a drug. Conversely, even if a drug was approved, its claims must remain on-label-that is, marketed only using the explicit claims approved by FDA.
These definitions have remained relatively uniform for decades, save for the introduction of medical devices in the 1970s and the loosening of restrictions on dietary supplements in the 1990s.
But with the rise of Internet-enabled communication and search engine capabilities, regulators are now facing a new, more difficult-to-uncover problem related to illicit promotion: metadata.
Metatags are unreadable to a person casually browsing a website, and are instead embedded into the code of the website for the purpose of allowing search engines to find a website more easily. For example, Regulatory Focus might use the metatags "regulatory news" or "regulatory intelligence" under the theory that if people are searching for those terms, a search engine would be more likely to link them to Focus.
In practice, however, sites sometimes use those terms for unscrupulous reasons, such as making it more likely that you'll stumble upon a website and buy their products.
As two letters sent by FDA in 2013 illustrate, dietary supplement manufacturers are sometimes among those trying to associate disease-specific metatags-diabetes, cancer, Alzheimer's, etc-with their respective products, despite supplements being banned from making disease-specific health claims.
In both letters (1) (2), FDA maintained that because the metatags were associated with specific products, those metatags constituted marketing claims regulated by FDA. Outside of the two 2013 letters, metatags have only been mentioned one another time, in a 2008 Warning Letter to a dietary supplement retailer.
New Warning Letter
But as of 14 January 2014, a fourth Warning Letter mentioning metatags has emerged, again sent to a marketer of dietary supplements who used the tags to steer unwitting consumers toward its website.
FDA's letter to Prestige Chinese Teas Company claims that several of the company's products are in violation of the FD&C Act in that they make claims that are restricted to pharmaceutical products. Those products claimed to reduce cholesterol, regulators wrote.
But just as troubling as the claims were the manner in which the company marketed them through its website, FDA wrote.
"[T]hese claims are supplemented by the metatags you use to bring consumers to your website through Internet searches," it said.
Specific examples found by FDA included the following keywords:
"cholesterol reducing tea … green tea cholesterol, cholesterol reduce, lowering cholesterol, cholesterol reducing, lowering cholesterol naturally, diet lowering cholesterol, lowering cholesterol levels, cholesterol tea, triglycerides levels"
Those claims-in addition to a lengthy list of other alleged infractions by Prestige-were sufficient enough for FDA to call the products misbranded and demand that the company cease its purportedly violative actions within 15 days of receipt of the Warning Letter.
Warning Letter to Prestige Chinese Teas Company