July 10 2014
“Like” Your Way to the FDA Watchlist
Patrice J. Lee
“Drugs” may be lurking in your medicine cabinet. If you share online how well products from one company worked, your Facebook post or tweet may just become evidence you used what the Food and Drug Administration views as illegal drugs.
The FDA is policing companies’ Facebook pages. In what appears to be a zany case of enforcement, they are going after Zarbee’s Naturals, which produces natural cough remedies for children, for liking comments posted on its Facebook page that suggest its products are being used as idrugs when it only claims to be a supplement company.
According to the Daily Caller, Zarbee’s products are designed for children too young to consume FDA-approved medication and their products have not yet received FDA approval or review. Therefore, the FDA views them as illegal drugs and is calling them unsafe. The FDA is also objecting to Zarbee’s tweets about their products because the FDA claims this constitutes drug promotion.
Meanwhile, satisfied customers continue to share how well they work for their little ones. To the FDA this is evidence that Zarbee’s is in fact selling drugs not supplements. If they don’t stop selling their products, the FDA threatens legal action, seizure and potentially shutting down their operations.
Here’s a warning letter from the FDA:
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs”… New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA…
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and/or injunction.
The FDA has regulatory authority and often uses it (perhaps even abuses it) in the name of our safety.
We may challenge here that its tampering with the operation of legitimate business by trying to shame it into action.
Should tweets and Facebook posts really be considered evidence? That seems like a lazy way of conducting an investigation. If they question the dietary value, why wouldn't they secure samples and test them?
Good to see our tax dollars at work isn't it?