Maryland District Court Formally Moves FDA Marketing Order Deadline to 9/9/2020
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:
Language of interest within April 2020 update of PMTA Enforcement Guidance:
III. DEFINITIONS
For purposes of this guidance, FDA intends to use the following definitions:
Electronic nicotine delivery systems (ENDS) include devices, components, and/or parts that deliver aerosolized e-liquid when inhaled. For example, FDA considers vapes or vape pens, personal vaporizers, e-cigarettes, cigalikes, e-pens, e-hookahs, e-cigars, and e-pipes to be ENDS.
E-liquids are a type of ENDS product and generally refer to liquid nicotine and nicotine containing e-liquids (i.e. liquid nicotine combined with colorings, flavorings, and/or other ingredients). Liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control authorities.
Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system. An example of products that would not be captured by this definition include completely self-contained, disposable products.
[Source: Pages 9-10]
D. Enforcement Priorities for ENDS Products
In discussion that follows, we describe our current intent regarding prioritizing our enforcement resources with respect to certain illegally marketed ENDS products. …
[Source: Page 18]
… 4. Any ENDS product that is offered for sale in the United States after September 9, 2020.
[Source: Pages 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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Effect on Small Manufacturers
The FDA estimated the cost of PMTA for manufacturers to be between $117,000 and $400,000 per product. … different nicotine strength of vape juice is counted as a new product. Now imagine the amount you would need to apply for all products.
As an example, Freeman Vape Juice currently selling 24 flavors (without the nic salts); if you do the math, it adds up to ridiculous numbers. Between $2,808,00 and $9,600,000 just for us to be able to keep our products on the market!
There is no way for independent … liquid manufactures to survive these fees! … on the average, the PMTA application costs $2,000,000 in legal and other fees. And experts still believe these estimates are low and in fact, it will cost way more.
If we take a more in-depth look at small manufacturers and the size of their business, the cost is alarming, and the regulation would surely eliminate all small businesses selling vaping products. … the FDA is leaving small businesses to handle the bill of PMTA, even when they have tested and endorsed most of these products and ingredients to be safe.
So the regulation is only intended to save the big tobacco companies, which have the resources to survive the market even for a few years, waiting out for all the competition to be destroyed. Not to mention that they can afford multiple tests without breaking a bank. That’s a massive loss to small businesses that will be destroyed, without even having a fair chance to get their products tested.
Source (July 24, 2020):
