In a warning letter to Zarbee’s, Inc., the Food and Drug Administration recently cautioned the dietary supplement maker that its social media activity ran afoul of the Food, Drug and Cosmetic Act.
Zarbee’s offers six products for sale on its Web site and on social media pages, including “Zarbee’s Natural Children’s Cough Syrup” and “Zarbee’s Naturals Seasonal Relief.” According to the FDA, the company advertised that the products are intended for use as drugs, despite not being approved as such by the agency.
According to the FDA, the company posted testimonials on its Web site that “recommend[ed] or describ[ed] the use of [its] products for the cure, mitigation, treatment, or prevention of disease,” citing an example stating: “I feel much safer taking these tablets, compared with prescription or OTC sleeping pills, because melatonin & L-theanine are natural substances.” Zarbee’s social media activity included posts like “RT@MomCentral Have you tried #ZarbeesCough for cold and cough relief?”
A social media user posted: “I received your…Zarbee’s Naturals Children’s Sleep Product. I have a daughter…born with cerebral palsy and she suffers from Complex Regional Pain Syndrome…[s]he took the samples you sent and slept through the night…best sleep she has had in years.” In response, Zarbee’s commented “Mary, Thank you for writing this!!! We love to hear that we have helped people.”
The FDA cited the comments and “likes” as evidence that Zarbee’s promoted its products for use as drugs, even though none of them has been approved for such use. The agency requested a response within 15 days with documentation that Zarbee’s has undertaken efforts to correct its mistakes.
To read the FDA’s letter to Zarbee’s, click here.
Why it matters: The FDA said Zarbee’s was effectively “recommending or describing” its products as a cure or treatment that eases a condition based on its social media activity, including tweets, the use of testimonials on its Web site, and by “liking” or commenting favorably about posts made by consumers. The agency has sent previous letters about social media activity to drug companies, including one earlier this year addressing a drug’s “false and misleading” page. To help guide pharmaceutical companies and drug manufacturers, the FDA released draft social media guidance last month.