Sunday, September 12, 2010

FDA Sabre Rattling

First, here's the link to our lovely FDA's page:


http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm


Here's the face of the story - the FDA has sent warning letters to 5 distributors or manufacturers of either the hardware or the liquid, regarding their sales promotions of PV's...claiming (continuing to claim) that these are unregulated or adulterated drug-delivery devises which need a new drug application to be sold, as so stated by the FDCA, which is the Food, Drug and Cosmetic Act, and how the FDA was granted authority to regulate all food, drugs, and cosmetics sold in this country. 


The biggest problem I have with the letters the FDA sent out, is they are still trying to regulate the products as a drug-delivery device under the FDCA, when Judge Leon specifically said they have all the authority to regulate these under the FSCPA (Family Smoking Control Protection Act) that they need, when he tendered his opinion in January. Granted, I'm biased here, being a PV consumer, but I'm inclined to agree with Leon's opinion.

If they (the FDA) really wanted to, they could drop this absurd appeal, and be regulating the products RIGHT NOW, as tobacco alternatives or a reduced risk product. Think on this - they have the authority, granted them by Congress, to hold manufacturers to quality and purity standards...all they have to do is come up with WHAT standards are acceptable.

Instead, they continue to push the appeal, they continue to make noises that these are drug delivery devices, they have now stepped up to harass local distributors, and they continue to waste the taxpayer's money while doing so. This could be OVER, folks, if the FDA would accept the premise that has been laid down by Judge Leon, that PV's are recreational nicotine consumption products, JUST LIKE CIGARETTES, and regulate the marketplace accordingly.

Why will the FDA not yield to this? Face. To back down now, to state that 'we were wrong,' would cost the FDA face, reputation, and status.


Sick yet?  I am.




  

7 comments:

  1. FDCA, when Judge Leon specifically said they have all the authority to regulate these under the FSCPA (Family Smoking Control Protection Act) that they need, when he tendered his opinion in January. Mens sunglasses

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