The FDA often sends warning letters to companies for violating FDA regulation on how their products are marketed. For instance, if a company is advertising its product as a treatment for an ailment its not approved for, they’re going to hear from the FDA.
So is the case with a recent FDA warning letter to Zarbee’s Naturals, which the FDA scolded for not only claiming to treat conditions like coughs (supplements cannot make these claims, otherwise they would drugs and regulated as such), but for the company’s Facebook “likes” and tweets.
In the letter, the FDA takes issue with certain consumer comments on the Zarbee’s Facebook page that the company “liked” or commented on, which the FDA says is basically the same as endorsing that comment, and since several comments were about cures or uses that the supplements are not approved for, that’s a no-no. For example, the FDA writes:
The letter also points out tweets the FDA believes are also promotional for treatments not proven:
The issue with Zarbee’s is that it’s not a drug, and sending tweets or endorsing Facebook claims for specific treatments is inappropriate. “Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are ‘new drugs’,” the letter reads.
The Zarbee’s letter is evidence that the FDA is taking social media actions seriously. Last month the agency released two draft guidances for how the pharmaceutical and medical device industry should go about communicating over the Internet and social media. The FDA argues that the Internet has changed the way Americans get information about medical products and therefore manufacturers and their representatives need to know the FDA position on how to communicate about drugs and devices accurately.
“In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve,” Thomas Abrams, director of FDA’s Office of Prescription Drug Promotion wrote.
Social media allows manufacturers to interact with their consumers in a more active way, and in real-time. The first set of recommendations from the FDA says that both the risks and benefits of a given product need to be presented online, even with character restrictions. The FDA suggests the following format as an example tweet for a drug company “NoFocus” that is both accurate, not misleading, and provides both benefits and risks. The FDA also encourages hyperlinks for additional context.
In the FDA’s second guidance, they provide an outline for what they think is an appropriate way for manufacturers to correct what they believe to be inaccurate information about their product. For example, if a blogger is posts incorrect information about a drug, the manufacturer can respond online as long as it is specific and non-promotional.
Of course, some pharmaceutical companies find the FDA guidance overbearing. “If the FDA is going to require the same type of fine print that you see in a magazine ad to be in a tweet, then the FDA is essentially taking that tool away from patients who may want to hear from companies as well as healthcare professionals,” Jeffrey K. Francer, vice president and senior counsel with Pharmaceutical Research and Manufacturers of America told the publication GEN in an interview. “I assume that the FDA believes that its own tweets are truthful and not misleading. If they believe that, then why couldn’t a company use Twitter in the same way that the FDA is using Twitter?” Francer thinks the guidelines interfere with the First Amendment.
The FDA says that as with traditional media, it wants to ensure all messages on social media are honest and not misleading. And it’s clear they will regulate as such.