Posted 09 July 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has issued a rare Warning Letter chiding a company for, among other reasons, improperly "liking" certain unapproved claims about its product on Facebook.
The letter, sent to Utah-based dietary supplement manufacturer Zarbee's, is primarily focused on the company's marketing claims, which FDA says cause the company's products to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act).
Under federal law, dietary supplements cannot claim that they treat or cure a specific disease or condition. If they do, they are treated instead as drugs, and subject to FDA's pharmaceutical regulations.
Unusually, FDA's letter takes aim at the company for less conventional disease claims, such as that its products "calm coughs," offer "proven congestion relief," and relieve patients of "itching and redness" caused by seasonal allergies.
FDA has traditionally gone after companies for more egregious disease claims, such as that a dietary supplement treats Alzheimer's disease. However, it has cited companies for claims about coughing, though usually in conjunction with claims about efficacy in treating bronchitis.
FDA Doesn't ‘Like’ a Company's Likes
But the letter is perhaps more remarkable for its attention to the company's social media accounts on Twitter and Facebook—the first company to be cited for its use of either website in more than 11 months.
And for just the second time ever, FDA has cited the company for "liking" several claims posted to its Facebook page by third-party users of the website.
FDA cited Zarbees for liking six Facebook comments attesting to the efficacy of its products to treat insomnia, bronchitis, pneumonia, colds, congestion and allergy relief.
One comment cited by FDA read: “I’ve been battling either bronchitis or pneumonia for the last 18 days and have tried everything…your Children’s Cough Syrup and mucus relief got rid of…my hoarsness [sic]…[m]y throat and chest are beginning to feel so much better…."
FDA said that these comments constituted "evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease."
FDA said it considered the company's "likes" to be equivalent to endorsements or promotions.
As first reported by Regulatory Focus, FDA first cited a company for improperly "liking" a status in February 2013, when it cited AMARC Enterprises in a Warning Letter.
FDA also cited Zarbee’s for its problems on Twitter, though for more conventional issues.
The company tweeted out at least two claims:
- “Try @Zarbees #naturalremedies for Cold and Cough Season…”
- “RT@MomCentral Have you tried #ZarbeesCough for cold and cough relief?”
FDA said both of these tweets indicated that the products are, in fact, drugs and not dietary supplements.
FDA Warning Letter to Zarbee’s
Earlier Warning Letter to AMARC