New Illinois Law Regarding E-liquids

To our valued customers and friends,

We have received an influx of questions regarding e-liquid selection and brand options dwindling. Almost all of this is due to the FDA issuing MDO’s (Market Denial Orders) to all e-liquid companies who submitted a PMTA application. This has severely disrupted product availability and put the future of these companies and brands in limbo. Many have already ceased operations.

The FDA is currently being sued by multiple e-cig companies and federal judges have issued temporary stay orders siding with the e-cig companies who are fighting to stay in business. These stay orders only apply to companies that have been given these temporary stay judgments in their individual court cases against the FDA.

On top of the above mess, SB 0512, The Preventing Youth Vaping Act, took effect in Illinois on January 1st, 2022.

If you vape or support tobacco harm reduction, you need to pay attention to how this will affect your favorite products and the ability of any retailers to carry them moving forward.

Please see the following from The Continuum of Risk Blog

Under this new law, an electronic cigarette is broadly defined as

1. any device that employs a battery or other mechanism to heat a solution or substance to produce a vapor or aerosol intended for inhalation;
   
   
2. any cartridge or container of a solution or substance intended to be used with or in the device or to refill the device; or
   
   
3. any solution or substance, whether or not it contains nicotine, intended for use in the device
   
   

Critically, SB 0512 considers an electronic cigarette to be adulterated (and prohibited for sale) if, “it is required by 21 U.S.C. 387j(a) to have

premarket review and does not have an order in effect under 21 U.S.C. 387j(c)(1)(A)(i) or is in violation of an order under 21 U.S.C. 387j(c)

(1)(A).” In other words, if an e-cigarette is required by the federal Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387j(a)) to

have premarket authorization from the U.S. Food and Drug Administration and does not have a Premarket Tobacco Product Application (PMTA)

order in effect (or is in violation of such an order), it would be considered adulterated under the Illinois law.[i]

Although the law exempts e-cigarettes “first sold prior to August 8, 2016, and for which a premarket tobacco product application was

submitted to the U.S. Food and Drug Administration by September 9, 2020” from the adulteration definition, products that are subject to

timely submitted PMTAs that FDA has either refused to accept, refused-to-file, or have received marketing denial orders from FDA would

likely still be considered adulterated by the state (as well as FDA).

However, because this part of the state adulteration provision only applies to e-cigarettes that are required to have PMTA authorization, it

would appear not to apply to e-cigarettes that are not “tobacco products” under the federal Food, Drug, and Cosmetic Act – i.e., e-cigarettes

that do not contain tobacco-derived ingredients and that do not fall within the meaning of “components and parts” of tobacco products. In

other words, e-cigarettes that utilize synthetic (tobacco-free) nicotine or CBD-containing e-cigarettes, for example,

that arguably are not tobacco products under federal law, would not be considered adulterated in Illinois for not having authorized PMTAs.

Any distributor, secondary distributor, retailer, or person who violates the Illinois law shall be guilty of a Class 4 felony, which carries a 1-to-3-year prison sentence and fines of up to $25,000 if convicted.


[i] An e-cigarette is also considered adulterated if (A) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is

otherwise contaminated by any added poisonous or deleterious substance that may render the product injurious to health; or (B) it is held or

packaged in containers composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to

health. See section 15(a)(4) of SB 0512.

There is still a fight left in adults’ rights to tobacco harm reduction products. Please stay tuned with us for updates on these rapidly changing situations and from all of us here at Upper Limits, a sincere THANK YOU for your support during these trying times.