Posted July 11, 2014

Maker of Cough and Sleep "Remedies" Warned for Drug Claims

On June 27, 2014, the FDA issued a warning letter to Zarbee's, Inc. following a review of the company's website, Twitter account and Facebook page, which found statements made about certain products, including Zarbee's Naturals Children's Cough Syrup+Mucus Relief, Zarbee's Naturals Children's Cough Syrup, Zarbee's Naturals Children's Cough Syrup Nighttime, Zarbee's Naturals Seasonal Relief, Zarbee's Naturals Sleep, and Zarbee's Naturals Children's Sleep, to be drug claims.

Zarbee's Naturals Children's Cough Syrup contains honey, vitamin C and zinc. It was promoted on the company's website with statements such as "Calms cough."

Zarbee's Naturals Children's Cough Syrup+Mucus Relief contains honey, vitamin C, zinc and ivy leaf extract. It was promoted on the company's Facebook page with statements such as "Natural Ivy Leaf extract ...helps thin and loosen wet mucus coughs."

(See ConsumerLab.com's Reviews of Vitamin C Supplements and Zinc Supplements for tests of related products.)

Zarbee's Naturals Seasonal Relief contains butterbur extract. It was promoted on the company's website with statements such as "Clinically supported to work fast and offer congestion relief so you can breathe better in every season," and "Proven congestion relief."

Zarbee's Naturals Sleep contains melatonin and L-theanine. It was promoted on the company's website with testimonials such as "I feel much safer taking these tablets, compared with prescription or OTC sleeping pills, because melatonin & L-theanine are natural substances."

(See ConsumerLab.com's Review of Melatonin Supplements for tests of related products.)

The FDA also noted that Zarbee's promoted its products as drugs on Twitter with posts such as "Try @Zarbees #naturalremedies for Cold and Cough Season..." and by "liking" testimonials posted on its Facebook page, such as "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."

See Related Warnings:

Seller of Brain, Diabetes, Echinacea Supplements and More Warned for Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below.