White House Deletes FDA E-Cigarette Regulations

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Kryyptyk

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Looking through it, there are a few changes about e-cigs, but the real damage was to the cigar proposals. The original FDA proposals were very biased in favor of cigars, especially premium cigars, and the OMB just about destroyed any hope of a sweetheart deal.

So far the changes to the e-cigs proposals are: rewording face-to-face sales verbiage to include only vending machines, deletion of health concerns and opinions, and deletion of manufacturing safety concerns and opinions.

I'm going to keep reading.
 
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Weizenheimer

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Looking through it, there are a few changes about e-cigs, but the real damage was to the cigar proposals. The original FDA proposals were very biased in favor of cigars, especially premium cigars, and the OMB just about destroyed any hope of a sweetheart deal.

So far the changes to the e-cigs proposals are: rewording face-to-face sales verbiage to include only vending machines, deletion of health concerns and opinions, and deletion of manufacturing safety concerns and opinions.

I'm going to keep reading.

I thank you in advance for any further summarizing ;)
 

DrMA

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Here's one interesting tidbit added to page 88:

«If no valid predicate exists for electronic cigarette products, then changing the grandfather date would have additional implications for electronic cigarettes. In our analysis of the proposed rule, all electronic cigarette products would be new tobacco products and many would exit the market rather than bear the cost of submitting a premarket tobacco application, which would be required in the absence of a valid predicate product. By contrast, if we change the grandfather date, only electronic cigarette products introduced after the issuance of a final rule would be considered new, and a large number of candidate predicates would exist. We assume that new electronic cigarettes would then be marketed through the substantial equivalence (or exemptions) pathway. We would no longer assume that many electronic cigarette products would exit the market, but instead assume that all electronic cigarette labels would be changed to conform with the requirements of the proposed rule»

This section deals with the alternative of changing the grandfather date for "new products" from the infamous Feb 15, 2007 to «the date this rule is finalized». AFAIK, the specific inclusion of ecigs under this alternative is a completely new addition.
 

Jake6731

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Stay calm, don't declare victory.
What was changed by OMB is what we see released from the FDA.
EXACTLY -nothing new here. The changes were made prior to the release of the proposed Deeming regulations. I did find it extremely disappointing to see that , prior to the changes, the FDA was still harping about Diethylene Glycol!! Glad they got that out of there..
 
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