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Did you know: FDA Considers Online Promotion as Labeling?

On June 27, 2014, the U.S. Food and Drug Administration (FDA) issued a warning letter to Zarbee’s Inc. regarding claims the company made on its website and social media.  According to FDA, the health claims made about some of the products that Zarbee’s sells online “cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act.” FDA warned that, because Zarbee’s had not completed the proper requirements for distributing drugs in the U.S., the products could not be legally introduced into U.S. commerce.

FDA also wrote that Zarbee’s website offered products as a treatment for conditions that are not self-diagnosable or self-treatable, making it impossible to include adequate directions for safe and effective use for those intended uses. Because of this, FDA deemed those products to be misbranded.

Many companies don’t consider their online presence when working to comply with FDA regulations. What many don’t know is that FDA considers websites and social media to be an extension of product labeling, meaning that claims and information that a company puts online regarding its FDA-regulated product are subject to FDA review and requirements. This is true for all domains because consumers in the U.S. can still access out-of-country domains. For example, a Canadian company cannot refrain from making an FDA-restricted claim on its “.com” domain while still making the claim on its “.ca” domain, even if that claim is allowed in Canada.

In some cases, FDA may even consider third-party promotion to be part of a company’s labeling if FDA believes the company had any influence over the promotion. For example, in the warning letter to Zarbee’s, FDA criticized the company for “liking” certain testimonials about its products’ health benefits on Facebook.  It appears that, though the testimonials were written by consumers, Zarbee’s “likes” were considered to be endorsements of the consumer statements.

Registrar Corp offers a label review service for drug, food and beverage, medical device, and cosmetic companies. Our Regulatory Specialists will assess all aspects of your labeling, including your website, and suggest modifications where necessary.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. If you have questions about FDA labeling regulations or any other FDA regulations, contact us at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.





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