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I'm not sure if the Food and Drug Administration (FDA) is especially good at empire-building or it's just that I pay more attention to this federal agency than others. But the FDA seems to spend a significant amount of its time trying to extend its reach.
Recently it has taken a manifest destiny mindset toward the digital landscape, attempting to broaden its regulatory jurisdiction to include Twitter, Facebook, message boards, blog comments, and more. Here are three absurd (and possibly unconstitutional) ways that the FDA is now policing food, drug, and other companies online.
Facebook Micromanagement
On June 27, the FDA sent a warning later to Zarbee's Naturals, a line of cough syrup, sleep aids, and seasonal-allergy remedies. Zarbee's products rely on active ingredients such as buckwheat honey, Butterbur leaf extract, and the sleep hormone melatonin. The FDA scolded Zarbee's for saying its products treat conditions such as coughs and congestion, as treating these conditions would "cause the products to be drugs." That's right—if your all-natural product does the same thing as a drug, that makes the product a "new drug" to the FDA.
"New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA," the agency warned Zarbee's. FDA drug approval is a lengthy and expensive process, of course (and no real guarantee of a drug's safety at all).
As examples of Zarbee's illegal promotion of its "new drugs", the FDA cited several Facebook posts from the company as well as personal testimonials that customers had posted to its Facebook page. Zarbee's "liking" these comments was considered "endorsing or promoting" them. From the FDA warning letter:
Zarbees “liked” the following comment made on February 4, 2014: “…I received your…Zarbee’s Naturals Children’s Sleep Product. I have a daughter…born with cerebral palsy and she suffers from Complex Regional Pain Syndrome…he took the samples you sent and slept through the night…best sleep she has had in years…”
On February 4, 2014: Zarbees commented “Mary, Thank you for writing this!!! We love to hear that we have helped people...” on this claim.
Zarbees “liked” the following comment made on January 7, 2014: “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…”
Zarbees “liked” the following comment made on October 30, 2013: “Love Zarbee’s this is the only medicine we use for our 2 year old. Colds and congestion clear up in 2 days.”
Zarbees “liked” the following comment made on October 15, 2013: “Received the sample for allergy relief and my husband had a terrible problem with allergies…he was very impressed on how well it worked for him…”
Good thing the FDA is going to step in and pull this dangerous product off the market until it gets a permission slip, or at least stop Zarbee's from making honest, accurate, non-FDA approved claims. These customers may think Zarbee's cold remedies are working for them and their children, but clearly that's only because they've been duped by the company's manipulative advertising (like this February tweet the FDA cites: "Try @Zarbees #naturalremedies for Cold and Cough Season").
The FDA must step in to break this false consciousness brought on by lived experience and not an external authority—for the ignorant masses' own good!, obviously. Coughs and colds, after all, "are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners," the FDA states. "Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes."
(h/t Tristyn Bloom/The Daily Caller)
Tweet Police
Zarbee's Naturals was also cited for several tweets. It's not the first company to come under FDA scrutiny on Twitter, and it certainly won't be the last: Draft guidelines released by the agency in June instructed drug companies that any pro-pharmaceutical tweet would also have to list product risks and side effects.
cont'd
http://reason.com/blog/2014/07/10/fda-goes-new-media-micromanagement-mad
Recently it has taken a manifest destiny mindset toward the digital landscape, attempting to broaden its regulatory jurisdiction to include Twitter, Facebook, message boards, blog comments, and more. Here are three absurd (and possibly unconstitutional) ways that the FDA is now policing food, drug, and other companies online.
Facebook Micromanagement
On June 27, the FDA sent a warning later to Zarbee's Naturals, a line of cough syrup, sleep aids, and seasonal-allergy remedies. Zarbee's products rely on active ingredients such as buckwheat honey, Butterbur leaf extract, and the sleep hormone melatonin. The FDA scolded Zarbee's for saying its products treat conditions such as coughs and congestion, as treating these conditions would "cause the products to be drugs." That's right—if your all-natural product does the same thing as a drug, that makes the product a "new drug" to the FDA.
"New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA," the agency warned Zarbee's. FDA drug approval is a lengthy and expensive process, of course (and no real guarantee of a drug's safety at all).
As examples of Zarbee's illegal promotion of its "new drugs", the FDA cited several Facebook posts from the company as well as personal testimonials that customers had posted to its Facebook page. Zarbee's "liking" these comments was considered "endorsing or promoting" them. From the FDA warning letter:
Zarbees “liked” the following comment made on February 4, 2014: “…I received your…Zarbee’s Naturals Children’s Sleep Product. I have a daughter…born with cerebral palsy and she suffers from Complex Regional Pain Syndrome…
On February 4, 2014: Zarbees commented “Mary, Thank you for writing this!!! We love to hear that we have helped people...” on this claim.
Zarbees “liked” the following comment made on January 7, 2014: “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…”
Zarbees “liked” the following comment made on October 30, 2013: “Love Zarbee’s this is the only medicine we use for our 2 year old. Colds and congestion clear up in 2 days.”
Zarbees “liked” the following comment made on October 15, 2013: “Received the sample for allergy relief and my husband had a terrible problem with allergies…he was very impressed on how well it worked for him…”
Good thing the FDA is going to step in and pull this dangerous product off the market until it gets a permission slip, or at least stop Zarbee's from making honest, accurate, non-FDA approved claims. These customers may think Zarbee's cold remedies are working for them and their children, but clearly that's only because they've been duped by the company's manipulative advertising (like this February tweet the FDA cites: "Try @Zarbees #naturalremedies for Cold and Cough Season").
The FDA must step in to break this false consciousness brought on by lived experience and not an external authority—for the ignorant masses' own good!, obviously. Coughs and colds, after all, "are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners," the FDA states. "Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes."
(h/t Tristyn Bloom/The Daily Caller)
Tweet Police
Zarbee's Naturals was also cited for several tweets. It's not the first company to come under FDA scrutiny on Twitter, and it certainly won't be the last: Draft guidelines released by the agency in June instructed drug companies that any pro-pharmaceutical tweet would also have to list product risks and side effects.
cont'd
http://reason.com/blog/2014/07/10/fda-goes-new-media-micromanagement-mad
