FDA gives e-cigarette makers a reprieve
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Correct me if I'm wrong, but isn't that the second extension of the registration deadline? Wasn't it originally December 31st?
Yes but that was only for the product listing deadline. And this has nothing directly to do with vaping (tho we do benefit). This delay is caused by the lawsuit from the Cigar industry, the trial being delayed by several months and therefore, the fda deadlines being pushed back the same amount of time.
My impression of budget negotiations is they are just that so a lot of stuff is thrown in the bill with the expectation that they will be negotiated away for the sake of other stuff and that's just what happened. As Conely saiid, there are millions of vapers and we have a vote.
- Apr 2, 2009
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Charlie Minato: FDA pushes back all Deeming Regulation deadlines by 90 days to accommodate cigar industry lawsuit timetable
FDA Pushing Back All Regulation Deadlines By 90 Days | halfwheel
The letter from FDA announcing the 90 day delay is below.
From: "Tobias, Lindsay" <Lindsay.Tobias@fda.hhs.gov<mailto:Lindsay.Tobias@fda.hhs.gov>>
Date: May 1, 2017 at 6:31:32 PM EDT
Subject: FDA Announces Information about Outstanding Compliance Deadlines related to Deeming Final Rule
The U.S. Food and Drug Administration is announcing information about the outstanding compliance deadlines related to the May 2016 final rule that extended the agency’s authority to additional tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.
In lawsuits regarding the final rule, the FDA has stated that it will defer enforcement of all future compliance deadlines under the rule for electronic nicotine delivery systems (ENDS) such as e-cigarettes, cigars, and pipe tobacco for three months. In light of this, the FDA also intends to defer enforcement of all future compliance deadlines for all categories of newly regulated products for three months and plans to issue guidance describing its position in the near future.
This concerns deadlines set for May 10, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.
This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.
This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.
Please contact me with any questions.
Lindsay R. Tobias
Policy Analyst, Stakeholder Relations Office
Center for Tobacco Products
Office of the Center Director
U.S. Food and Drug Administration
301-796-6743 (o)
240-507-8453 (m)
Lindsay.Tobias@fda.hhs.gov<mailto:Lindsay.Tobias@fda.hhs.gov>
FDA Pushing Back All Regulation Deadlines By 90 Days | halfwheel
The letter from FDA announcing the 90 day delay is below.
From: "Tobias, Lindsay" <Lindsay.Tobias@fda.hhs.gov<mailto:Lindsay.Tobias@fda.hhs.gov>>
Date: May 1, 2017 at 6:31:32 PM EDT
Subject: FDA Announces Information about Outstanding Compliance Deadlines related to Deeming Final Rule
The U.S. Food and Drug Administration is announcing information about the outstanding compliance deadlines related to the May 2016 final rule that extended the agency’s authority to additional tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.
In lawsuits regarding the final rule, the FDA has stated that it will defer enforcement of all future compliance deadlines under the rule for electronic nicotine delivery systems (ENDS) such as e-cigarettes, cigars, and pipe tobacco for three months. In light of this, the FDA also intends to defer enforcement of all future compliance deadlines for all categories of newly regulated products for three months and plans to issue guidance describing its position in the near future.
This concerns deadlines set for May 10, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.
This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.
This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.
Please contact me with any questions.
Lindsay R. Tobias
Policy Analyst, Stakeholder Relations Office
Center for Tobacco Products
Office of the Center Director
U.S. Food and Drug Administration
301-796-6743 (o)
240-507-8453 (m)
Lindsay.Tobias@fda.hhs.gov<mailto:Lindsay.Tobias@fda.hhs.gov>
"The delays are actually due to the trial brought on by the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipes Retailers Association (IPCPR)."
Seems the cigar suits have a bit more clout than those set in motion by the vaping industry.
Go figure.
Seems the cigar suits have a bit more clout than those set in motion by the vaping industry.
Go figure.
- Apr 2, 2009
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The FDA previously delayed the vapor product registration deadline from December 31, 2016 to June 30, 2017 (due in part to the Nicopure/Right2BeSmokeFree lawsuit).
Nearly the same thing has now happened due to the cigar lawsuit, which is scheduled for oral arguments this summer. A very similar argument was made to the court for this 90 day delay (as cigar manufacturers would have had to register their products before the lawsuit was scheduled to be heard).
Nearly the same thing has now happened due to the cigar lawsuit, which is scheduled for oral arguments this summer. A very similar argument was made to the court for this 90 day delay (as cigar manufacturers would have had to register their products before the lawsuit was scheduled to be heard).
- Apr 2, 2009
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Please note that the headline and first sentence of the Washington Post article at
FDA delays enforcement of stricter standards for e-cigarette, cigar industry
originally (and falsely) claimed FDA "suspends" enforcement of the Deeming Regulation.
That Post article was posted at
A little dance please - FDA delays enforcement of stricter standards for e-cigarette, cigar industry
The Post replaced "suspends" with "delays" after Charlie Minato exposed that false claim at
FDA Is Not "Suspending Enforcement" of Cigar, E-Cigarette Regulation | halfwheel
But Minato inaccurately insinuated that FDA's 90 day delay only applied to cigars and pipe tobacco (not e-cigs). So I posted the memo from FDA (that I posted above) as a coment to Charlie's article (which includes the court ordered 90 day delay (for cigars and pipe tobacco) issued by the judge adjudicating the cigar lawsuit.
FDA delays enforcement of stricter standards for e-cigarette, cigar industry
originally (and falsely) claimed FDA "suspends" enforcement of the Deeming Regulation.
That Post article was posted at
A little dance please - FDA delays enforcement of stricter standards for e-cigarette, cigar industry
The Post replaced "suspends" with "delays" after Charlie Minato exposed that false claim at
FDA Is Not "Suspending Enforcement" of Cigar, E-Cigarette Regulation | halfwheel
But Minato inaccurately insinuated that FDA's 90 day delay only applied to cigars and pipe tobacco (not e-cigs). So I posted the memo from FDA (that I posted above) as a coment to Charlie's article (which includes the court ordered 90 day delay (for cigars and pipe tobacco) issued by the judge adjudicating the cigar lawsuit.
Any delays are properly seen as an attempt to relieve the pressure on the anti-e-cigarette movement. Real science now that the propaganda machine is no longer funded is shining through. Mitch Ziller is a zealot and he isn't going to let the well planed demise of e-cigarettes to be trashed lightly.
My post doesn't apply to retailers. The regulations to protect us consumers are still very real and needed.
My post doesn't apply to retailers. The regulations to protect us consumers are still very real and needed.
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