Zarbee’s is just another dietary supplement manufacturer; take a look at its website and you see a very mom-friendly layout with smiling cartoon bees and grass-green borders. It doesn’t look like your typical drug supplement e-sales website, but it is. Zarbee’s has a thriving Facebook community of over 500,000 likes. The company has captured the so-called “Mommy Bloggers” market, offering free samples and sponsoring contests, all designed to sell its safe and natural products.
Recently, the FDA sent Zarbee’s a letter warning it against promoting its products in violation of the Federal Food, Drug and Cosmetic Act—all because of Facebook “Likes”. It’s fairly unheard of for the FDA to go after companies based on Twitter and Facebook content so the story captured national attention.
Zarbee’s statements or “Likes”, in this case, are not the typical over-the-top dietary supplement claim. It is not claiming to cure diseases or help you lose 10 pounds in one week. According to the Regulatory Affairs Professionals Society, RAPS, the “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 the 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…”
The 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.” That is a “no-no” for a dietary supplement. (RAPS.org, 7/9/14)
Zarbee’s was using third-party endorsements to validate its products. Mothers recommending medications to other mothers is powerful, and in the world of Mommy blogging, getting in front of that audience is invaluable marketing. According to the company’s Facebook page, there are over 40,000 doctors promoting its ‘natural’ cough syrup and sleep aids. These products are sold in over 55,000 stores across the country, including Walmart, Target and online. We’re talking big business here.
If you read the FDA’s warning letter, it’s clear that Zarbee’s is promoting its dietary supplements as drugs. This is one of the claims posted on Facebook on February 6, 2014: “Dark honey [an ingredient used in “Zarbee’s Naturals Children’s Cough Syrup+Mucus Relief” and “Zarbee’s Naturals Children’s Cough Syrup”]…is clinically proven to calm coughs and sore throats in children…”.
It is reassuring to know that the FDA is paying attention to the social media claims of dietary supplement manufacturers. (Further evidence of the power of social media, incidentally). In December 2011, the FDA cited another company, AMARC, for testimonials about a product, Poly-MVA, which supposedly cured a man of his multiple myeloma. The FDA notified AMARC that it was in violation of the Federal Drug & Cosmetic Act calling the Facebook “Likes” evidence of drug endorsements.
We will be watching carefully to see how closely the FDA continues to monitor social media as part of its regulatory oversight. This is likely only the beginning. Some people may say that this is going too far, but if the FDA’s mandate is to protect the health of Americans, it has to take an all-encompassing approach to monitoring and regulating the industry. With social media playing such a vital role in everyday life, it was inevitable that a regulatory agency would slap the wrist of a business using the medium a little too enthusiastically.