Thursday, February 25, 2016

Continuing Coverage of the Budget Hearing - Food and Drug Administration - Thursday February 25, 2016

Budget Hearing - Food and Drug Administration Thursday, February 25, 2016 10:30 AM in 2362-A Rayburn Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

Meeting Adjourned - Final Thoughts It is apparent that any discussions regarding the deeming regulations has been skillfully dodged and avoided.  We saw both sides of the story represented and in both cases, the best answer we could get was that they are continuing to work on finalizing it - and there is not estimated date in the near future where we will have their ruling.  I continue to encourage everyone to reach out to our congressmen, representatives and senators and even the members of the FDA who spoke in today's hearing and continue to let your voices be heard.
Around the 1 hour 59 minute mark, Representative Harris shared an anecdotal story regarding a friend of his who successfully quit smoking a pack of cigarettes a day by using vaping.  And he mentioned that it seemed to be a safer alternative.
Around the 1 hour 52 minute mark, Mr Farr also asked when the deeming regulations will be finalized.  Mr. Ostroff again couldnt answer when, even when asked if it was going to be this year, but they are working as hard as possible to get it done.
Around the 1 hour 12 minute mark, Representative Nita Lowey, was VERY concerned that the FDA needs to have the ability to control tobacco products including e-cigs. She is extremely disappointed that "these kinds of shops" are opening up all over the place and there is no regulation. She states according to the CDC that nicotine is extremely harmful and youth use exceeds tobacco cigarette use. She even went to far as to make a condescending comment how she walked by one these shops in her neighborhood and saw tutti-frutti and other names that would be appealing to kids. She strongly supports STRICT FDA regulation and demanded to know when the deeming regulation would be finalized. Stephen Ostroff again responded with the politically correct answer that they are just as passionate as her to get these products under FDA regulation and they couldnt offer a date when it would be finalized but they are taking all comments and input into their decision.
Around the 1 hour 5 minute mark, Mr Yoder seems to be a strong supporter of pushing the predicate date forward, but also wants to establish standards without eliminating products currently on the market, or killing off many small businesses over something that (to date) has been shown to be less harmful that smoking. Stephen Ostroff's response to this question was to was with no surprise their biggest concern being that of youth use. He sited statistics that now shows more underage use vape than smoke. He also addressed the backlog of product applications, stating that 73% of the products have already been resolved, the remaining items already exist in the market.
Around the 49 minute mark, Mr Rooney asked if they have underestimated the number of pre-market tobacco SKUs based on the number of electronic cigarette items on the market and the number of new cigars added to the market recently. Mitch Seller was admitted to testify saying that they have taken in (over 135,000) comments but cannot disclose what their final ruling will be towards E-cigs.

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