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Court Delays FDA Doomsday by 120 Days (to Sep 9, 2020)

Maryland District Court Formally Moves FDA Marketing Order Deadline to 9/9/2020

Late yesterday, April 22, 2020, the U.S. District Court for the District of Maryland issued its long-awaited Order formally extending the May 12, 2020 deadline for submitting marketing applications for those deemed “new tobacco products” that were on the U.S. market on August 8, 2016. That deadline is now September 9, 2020.

The Court Order for 120-day delay (filed on April 22, 2020):

This 120-day delay was granted by the presiding judge to the FDA (being represented by the US DOJ):

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Related Background (January 14, 2020):

while FDA’s focus is on flavored cartridge and pod-systems, ENDS companies should be aware that FDA’s guidance is broad enough to capture a wide variety of open and closed-system products that may be viewed by FDA as accessible to youth, marketed to, or easily used and/or concealed by, youth.

All deemed tobacco products, including ENDS, intended to be introduced to the U.S. market for the first time after August 8, 2016 still require FDA premarket authorization “up front” and do not qualify for the compliance policy.

The above category includes nearly all vaping products - thus the “doomsday” moniker for U.S. sales.

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The FDA (in April, 2020) published a revised version of their Jan, 2020:

Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS)
and Other Deemed Products on the Market Without Premarket Authorization (Revised)

Of interest:

4. Any ENDS product that is offered for sale in the United States after September 9, 2020. (Page 27-28)

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Technically, all vape products are on the market illegally, even the ones the FDA has not singled out in its new policy. That’s because to be legal, a product would’ve had to receive premarket authorization, and no e-cigarette product has yet received such authorization.

Companies and stores have nevertheless been allowed to sell e-cigarettes to legal-age customers because the FDA decided not to enforce the premarket authorization requirement - at least, not yet.

In part because of the regulatory limbo, the new flavored e-cig policy is actually what the FDA refers to as a “guidance” document, which notifies the industry that the agency will be prioritizing its enforcement actions against certain vaping products. In this way, the agency is informing the industry that it will no longer tacitly permit specific vapes, as it has been doing for several years.

Source: https://www.factcheck.org/2020/01/qa-on-the-fdas-flavored-e-cig-policy/

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I guess that is a plus… remains to be seen.
Wonder if by then we will have our own “ruling authority” …

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Hi Smoky. I do not know what you are talking about there. Tobacco jurisdiction removed from FDA ?

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Yesh… they need to remove us… :slight_smile:

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My impression is that this (once) floated “trial balloon” was one of many of the (historically, over many administrations, “DOA”) budget requests that has very low to zero chance for effectuating the actual (congressional) action that would be required in order to accomplish such major administrative changes.

I (myself) would not count such “mystery chickens”, or assume that such a (mere momentarily) “fire” would necessarily be a better situation than the present (rhetorical) “frying pan” that we are stewing in. Note that it is clearly “Ginormous Tobacco” and Fed/State Operating Revenue interests that have so far been (and still would surely be) dominantly served - not smokers, vapers, or (by comparison, relatively quite) minor industries comprised of small businesses operated by “nice people”. (Nobody) in that mix (of power-playing operatives) appears to have been (or would in any likelihood be) motivated by any particular “libertarian” concerns surrounding and regarding various affected members of the public.

(STAT, February 10, 2020):
Under the budget proposal, a new agency would be created within the Department of Health and Human Services dedicated solely to regulating tobacco, including e-cigarettes.

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