Zarbee’s Naturals, the manufacturer of numerous over-the-counter remedies aimed at relieving coughs, colds, allergies and sleeplessness was issued a warning letter by the Food and Drug Administration for making therapeutic claims which would cause their products to be classified as drugs under the federal Food, Drug, and Cosmetic Act. Zarbee’s products, described by the company as “natural relief,” have not been approved by the FDA
The FDA identified the following products in its warning letter:
- 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
- Zarbee’s Naturals Children’s Sleep
The FDA noted that claims made by the company indicate the products are intended for use as drugs, such as the statement that Zarbee’s Naturals Seasonal Relief 10 Count is “clinically supported to work fast and offer congestion relief so you can breathe better in every season.” The FDA also took issue with Twitter testimonials, both in the form of original tweets from Zarbees and “retweets” or sharing tweets of others endorsing the products.
The FDA warning letter also stated that Zarbee’s had numerous posts indicating their products were intended for use as drugs, and that the company “liked” and responded to Facebook testimonials by consumers recommending products for use as drugs. The agency also warned that three of Zarbee’s products are considered misbranded.
“Furthermore, your products “Zarbee’s Naturals Children’s Cough Syrup+Mucus Relief,” “Zarbee’s Naturals Children’s Cough Syrup Nighttime,” and “Zarbee’s Naturals Children’s Sleep” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
Noting that the warning letter was not meant as an all-inclusive list of deficiencies, the company was given 15 days to respond to the FDA. The warning letter was dated June 27, 2014. Zarbee’s spokesperson did not respond to Wolters Kluwer’s request for comment.