For the second time in recent months, a Warning Letter sent by the US Food and Drug Administration (FDA) has cited a company's improper use of metadata on its website to bring people to the site through search engines, potentially signaling the agency's increased attention on their use.

Background

In February 2013, FDA sent a Warning Letter to Medical Doctors Research, a Florida-based researcher and manufacturer of nutritional supplements. MDR's website, FDA explained, had search capabilities on its website that allowed a user 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.

As Regulatory Focus noted at the time, the wording of FDA's Warning Letter raised 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 Federal Food, Drug and Cosmetic Act (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 for them to be deemed misbranded.

A Second Letter-the Start of a Trend?

Now that logic seems to be bearing fruit, as a subsequent letter to California-based Nature's Health Supply, Inc has resulted in similar contentions from FDA.

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.

As FDA explains in the letter, NHS's websites (it maintains five of them) use metatags, including:

• "diabetes"
• "diabetes natural treatment"
• "diabetes herbs"
• "natural diabetes cure"
• "natural diabetes treatment"
• "benign prostatic hypertrophy"
• "Controlling Cholesterol"
• "natural cholesterol cure"
• "cancer therapy"
• "natural cancer treatment"
• "cancer"

Because these tags are associated with these products, they constitute marketing claims, the letter implies.

"Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]," FDA wrote. "New drugs may not be legally marketed in the US without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective."

However, the letter stops short of explicitly stating why the metatags themselves are improper, noting only that they "supplement" earlier claims which the agency also flagged as being unapproved and acting to misbrand the product.

Additional Details

Past Warning Letters have also cited the meta-tagging issue in a similar way, such as a 2008 letter to a company called Nutrition 2000, whose website was found to be tagged with terms like "bladder cancer" and "bone cancer." In that case, FDA again used the terms "supplemented," implying that the terms were improper, but falling short of explicitly stating so.

One interesting trend is that none of the letters thus far have come from FDA's main offices. The search engine letter to MDR came from FDA's Florida district office, while the NHS letter came from the Los Angeles office and the Nutrition 2000 letter from the New Orleans office.

Warning Letter to NHS