FDA issues warning letter to Zarbee's for making treatment claims regarding its supplement products

SILVER SPRING, Md. — The Food and Drug Administration in late June issued a warning letter to Zarbee's for making therapeutic claims regarding a dietary supplement product. "The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease," the agency wrote. "[I]ntroducing or delivering these products for introduction into interstate commerce for such uses violates the Act."

 

Examples of some of the treatment claims made by Zarbees include that its Zarbee’s Naturals Children’s Cough Syrup-Grape “calms coughs.”

 

The agency also found fault with Zarbee's customer testimonials on its site, and criticized the company for "liking" testimonials on its Facebook page. "Zarbees 'liked' the following comment made on Feb. 11, 2014," the agency wrote, regarding the company's children’s Sleep remedy. "[Customer:] 'I received the free sample … and … gave it to my daughter … I could not believe how well it worked! She was recently diagnosed with ADHD and put on medication … causing insomnia.'"

 

Zarbee's has until mid-July to respond to the FDA warning letter. "Failure to promptly correct these violations may result in legal action without further notice, including seizure and/or injunction," the agency warned.