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 is it 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, market 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.
The issue is one highlighted in a recent warning letter to Medical Doctors Research, a Florida-based researcher and manufacturer of nutritional supplements.
While FDA's warning letter, sent 29 January 2013, alleges a number of problems-a handful of supplements being marketed using unapproved claims and current good manufacturing practice deficiencies among them-they are perhaps less interesting than one sentence nestled unassumingly in the middle of the letter.
Evolution: Banned Search Term Associations?
MDR's website, FDA explained, has search capabilities on its website that allow you to search for a particular search term. The results of that term, it said, bring up products associated with it.
"Typing the key word 'cancer' or 'diabetes' into [MDR's] product search field located on [its] website" brings up a number of products, FDA observed.
Because those products are associated with that particular search term, the company is thus "implying [that its] products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases," FDA said.
An exploration of the company's website by Regulatory Focus finds that the search functions only turn up exact matches for a word. The search bar would turn up "disease," for example, but not "diseases," making it unlikely that the company was keyword-tagging its products.
But the wording of FDA's warning letter raises the distinct possibility that it considers such activities to be illegal under federal law.
FDA could have individually called out each of the products, making note of each claim used to promote them that fell afoul of the FD&C Act. But that's not what the letter says, instead saying that just the act of "implying" that the products are intended for an unapproved use would be enough to be deemed misbranded.
But enforcement of keyword association-sometimes found in the form of metadata used to optimize search engines-could prove difficult. Unlike visible words, metadata sits in the source code and HTML of a page, and is largely invisible to the untrained eye. Still other associations, such as those hard-coded into a search engine (as opposed to a static link), may be difficult to find without spending a considerable amount of time on a page.
Still, the warning letter indicates that regulatory officials are intent on targeting those associations when they're able to be found.
SEO-savvy regulatory folks might do well to ask themselves, in the classic words of Google, if they're "Feeling Lucky" enough to risk noncompliance.