Regulation Happens… To Synthetic Nicotine

Newer Five Pawns synthetic nicotine flavors

I have never tried synthetic nic. I never wanted to, but for those who do, there is trouble ahead. Even Five Pawns switched to synthetic nic. Here is breakdown from the National Law Review by Azim Chowdhury.

“FDA Receives Authorization to Regulate Synthetic Nicotine
Wednesday, March 16, 2022
On March 15, President Joe Biden signed a $1.5 trillion omnibus spending bill to fund the federal government through September. The bill, as passed, includes a provision amending the definition of “tobacco product” in Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.” 21 U.S.C. 321(rr). Now that it is law, this provision closes the synthetic nicotine “loophole” and puts synthetic nicotine products under the U.S. Food and Drug Administration’s (FDA) tobacco regulatory authority.

The law will become effective 30 days after the bill’s enactment, i.e., on April 14, 2022 (“Effective Date”). Any synthetic nicotine product currently on the U.S. market as of April 14, 2022, can remain on the market for an additional 30 days until May 14, 2022 (the “Synthetic Nicotine PMTA Submission Deadline”). Manufacturers of synthetic nicotine products wishing to take advantage of FDA’s compliance policy and enforcement discretion after that date must submit a premarket tobacco product application (PMTA) to FDA by the enforcement date. If a PMTA is submitted in a timely manner, the product(s) may remain on the market for an additional 90 days after the effective date, i.e., until July 13, 2022. After July 13, 2022, any synthetic nicotine product not authorized by FDA must come off the market.

EVENT DATE NOTES
Bill Enactment March 15, 2022
Effective Date April 14, 2022
Deadline for any new* synthetic nicotine products to enter the market

Deadline for modified synthetic nicotine products to remain on the market

Synthetic Nicotine PMTA Submission Deadline May 14, 2022 (Saturday)
Deadline for submitting PMTAs for all synthetic nicotine products on the U.S. market as of the Effective Date
Final date July 13, 2022 (Wednesday) Deadline for unauthorized synthetic nicotine products to remain on the U.S. market
Notably, under the provision, a synthetic version of an existing nicotine product that went through the PMTA process and is now subject to a Refuse-to-Accept (RTA), Refuse-to-File (RTF), Marketing Denial Order (MDO), or withdrawal of a marketing order may not be marketed beyond the effective date, i.e., April 14, 2022. In other words, products originally formulated with tobacco-derived nicotine that were refused or denied authorization by FDA, then modified to use synthetic nicotine instead (and that is the only modification), will effectively be banned on April 13, 2022. Manufacturers of these products will not be given an opportunity to submit a new PMTA. This appears to be Congress’s way of doubling down on products that, in Congress’ view, switched to synthetic nicotine to get around the PMTA process.

Beyond the PMTA submission requirement, manufacturers of synthetic nicotine products will be subject to all requirements of regulations for tobacco products. This likely includes all other Tobacco Control Act requirements, including tobacco product establishment registration and product listing; ingredient listing; label compliance; and health document submissions, among others. We anticipate that FDA will provide guidance on deadlines for these requirements in the near future.”

https://www.natlawreview.com/article/fda-receives-authorization-to-regulate-synthetic-nicotine

Stop The Excessive Tax!

A crippling new federal tax on safer nicotine products and low-risk alternatives to smoking is being proposed as part of the funding bill for President Biden’s “Build Back Better” plan. This tax would severely limit Americans’ access to safer alternatives and would only punish people who are trying to quit smoking by making all nicotine and smoke-free tobacco products unaffordable. 

Below is a table showing the devastating effects of this proposed tax on nicotine (TFN, synthetic, and tobacco-derrived), and how it would affect bottled e-liquids. These figures are just the extra taxes you’ll be paying and don’t include the cost of the e-liquid.

Take Action Now : https://casaa.org/call-to-action/stop-an-excessive-federal-tax-on-safer-nicotine-products/

From the CEO…

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“As expected, reports of people being hospitalized due to a “mystery lung disease” continue to grow. The non-communicable lung disease that is increasingly being linked to products such as K2/Spice and/or adulterated THC cartridges–sold by underground sellers–is now under investigation in 22 states including CA, CT, FL, IL, IN, IA, MN, MI, NC, NJ, NM, NY, PA, TX, UT, WI, and as of Thursday, Colorado has its first confirmed case.

As of Friday morning, one death in Illinois is being attributed to an unknown substance that people are consuming by way of vaping. CASAA extends our condolences to the family and share in everyone’s disappointment in knowing that this tragic death could have been prevented if more compassionate policies were in place.

In last week’s Heads Up Round Up we briefly highlighted the concern that state and federal drug policy is complicating diagnosis, patient care, and accurate reporting about these clusters of lung disease. But in the wake of these reported illnesses, almost all of the usual anti-tobacco campaigners are using this event to elevate their cries for an all-out ban on nicotine vaping products–especially e-liquids sold in flavors other than tobacco.

Anti-tobacco campaigners are advocating for policies that will do absolutely nothing to prevent events like this in the future. Rather, it is more likely that heavy regulation–even if it isn’t total prohibition–will lead to more instances of people being harmed by fake pot, adulterated THC, or poorly manufactured nicotine products sold on an unregulated, illicit market. According to an article on TechCrunch, the FDA is still uncertain if the products being used even fall under the agency’s regulatory authority.

CASAA is reaffirming our advice to consumers that vapor products (THC and nicotine) should be purchased from reputable sources and not “on the street.” We also note that the terminology used to discuss this issue can benefit from including a clear distinction between nicotine vaping, THC/cannabis vaping, and synthetic cannabinoid vaping (k2/spice). Simply reporting that a mysterious lung disease is generally attributable to “vaping” will have harmful unintended consequences such as sending people back to combustible tobacco or discouraging them from making the switch at all.”

Stay safer,

Alex Clark, CEO
CASAA