Wednesday, August 12, 2015

Warning Letter of the Week: Can't Pass Up the Kardashians Edition, with extra stevia extract bonus

A pretty funny little story about Kim Kardashian West's celebrity endorsement (via Instagram) of a morning sickness pill that triggered an FDA warning letter. Here's David Kroll's take:
...But the FDA’s Office of Prescription Drug Promotion has ruled in a warning later dated last Friday, August 7, that those URLs were insufficient and inconsistent with the full material information required when such a drug is advertised in any medium. It turns out that this wasn’t just a happy celebrity sharing her health tips with her 40.8 million closest friends (the post alone received 464,000 likes). 
The OPDP became involved because the post was a paid endorsement to Kardashian West by the drug’s maker and, as required, had been submitted in advance to the Office for review. And as a piece of trivia, I believe this is the first time that an FDA warning letter has contained the acronym OMG...
Glad to see that FDA is on the case.

(One presumes that this was really the corporation and her social media underlings that screwed up.)

In other warning letter news, I was sort of puzzled to see that Ten Ren Tea of San Francisco received one for putting stevia into its teas? Apparently, the FDA has approved rebaudioside A for addition to drinks*, but not whole stevia leaf extract.

(For those of you who do not haunt Chinatowns on a regular basis, Ten Ren is a tea store chain. I've spent a few bucks in at the one in Chicago on Wentworth Avenue.)

*This feature of the regulatory state (give the okay to one specific molecule that only major multinational conglomerates can produce/purchase, disallow the extract) is a less than wonderful aspect, I think. That said, I can see the risk analysis (this molecule is okay, who knows about that whole leaf?) behind their thinking. 

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