Although most nicotine products on the market use tobacco or tobacco-derived nicotine to create and facilitate addiction, within the last few years synthetic nicotine products have gained new attention and notoriety. Historically, synthetically created nicotine tended to produce nicotine that was not as bioavailable as tobacco-derived nicotine. (A drug’s bioavailability refers to its ability to be absorbed and used by the body and in the case of nicotine, addictiveness.) As early as the 1960s, the tobacco industry explored methods of creating and using synthetic nicotine (and other nicotine analogs), but internal documents reveal that the industry ultimately concluded that the cost of creating nicotine as bioavailable as tobacco-derived nicotine would be significantly more expensive than simply deriving nicotine from tobacco directly.  Recently, the cost of producing this more bioavailable synthetic nicotine seems to have plummeted. According to one recent trade article, the price to produce synthetic nicotine has dropped from 10 times to now only 3 to 4 times the cost to produce tobacco-derived nicotine.

 

Undoubtedly, recent regulatory actions have also incentivized manufacturers’ use of synthetic nicotine, especially in e-cigarettes. In 2019, the U.S. Food and Drug Administration (FDA) published a limited restriction on the sale of certain flavored cartridge-based e-cigarette pods. This led to an increase in the sale of self-contained, disposable e-cigarettes, which continued to come in several youth-alluring flavors. The most infamous brand was PuffBar. The FDA finally sent Puffbar a letter in 2020, warning the company that its products did not have proper premarket authorization. Puffbar appeared to remove its products from the marketplace, but a few months later its products reemerged (still available in an array of flavors), with the company claiming that the products now contained synthetic nicotine. What was clear from this is that, as the FDA exercised its premarket review authority but did not simultaneously regulate synthetic nicotine, this incentivized the use of synthetic nicotine.

 

As originally written under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA’s Center for Tobacco Products (CTP) had authority over nicotine-containing products that are “made or derived from tobacco.” Although many products that claim to contain synthetic nicotine are similar to other tobacco products, CTP could not regulate or remove these synthetic nicotine products from the market. This lack of regulatory authority undermined the effectiveness of the FDA’s regulation. For example, the e-cigarette manufacturer Breeze Smoke received a Marketing Denial Order (MDO) from the FDA – meaning it could no longer sell its denied products in the United States. After initially pursuing litigation, Breeze Smoke reemerged claiming it no longer used tobacco-derived nicotine.

 

In March 2022, Congress passed a law amending the Tobacco Control Act that granted the CTP authority over nicotine products made from any source of nicotine (not including products that contain nicotine that are drugs or food). Here is a general summary of amendments:

The Family Smoking Protection and Tobacco Control Act is amended to:

  • Define “tobacco product” as “any product made or derived from tobacco or containing nicotine from any source that is intended for human consumption, including any component, part, or accessory of a tobacco product ….”
  • Effective as of April 14, 2022.
  • Products that are on the market or come on the market by April 14, 2022, have 60 days (until May 14, 2022) to submit new product premarket review applications to CTP.
  • CTP has 90 days to determine (whether the product can stay on the market); if a manufacturer doesn’t have an affirmative marketing order by then, its products should be removed from the market.
  • A manufacturer that previously submitted an application for a tobacco product and received some sort of denial, is not eligible to remain on the market while the FDA decides on its premarket review application.

 

Although the FDA now has authority to regulate all nicotine products, the FDA has been notoriously slow to adopt comprehensive and effective policies. This leaves many gaps that Tribes, states, and localities can fill by restricting all nicotine-containing products.  Broad definitions of e-cigarettes and tobacco products in laws or statutes likely capture synthetic nicotine products. For example, in Minnesota’s minimum legal sales age law, e-cigarette is defined as “any product containing or delivering nicotine, lobelia, or any other substance, whether natural or synthetic, intended for human consumption through inhalation of aerosol or vapor from the product.” This strong inclusive definition most likely captures synthetic nicotine e-cigarettes. However, other emerging synthetic nicotine products also exist, such as synthetic nicotine pouches and gums. Those products may be captured in the definition of “tobacco” or “tobacco product.” For example, for purposes of assessing taxes, California defines tobacco product as “. . . a product containing, made, or derived from tobacco or nicotine that is intended for human consumption.”

 

Tribes, states, and localities are encouraged to fill the gaps left by the FDA’s lack of comprehensive regulation. Doing so requires an individual analysis of each jurisdiction’s definitions and regulations. The Public Health Law Center can help in this analysis and provide legal technical assistance to any jurisdiction that wishes to analyze or update its definitions to capture synthetic nicotine products.

 


By Natalie Hemmerich, Lead Senior Staff Attorney for California Technical Assistance
May 16, 2022