Marketing of “Tobacco-Free” and “Synthetic Nicotine” Products - White Paper - Published March 8, 2022

Oct 13, 2026

Aims to characterize the scope and scale of “tobacco-free” and “synthetic nicotine” products in the market and explain regulatory implications. The study surveys nicotine products sold online that claim synthetic nicotine or tobacco-free status and evaluates how these products may circumvent government regulation, tobacco taxation, and sales bans by major marketplaces. Findings highlight increasing “not derived from tobacco” claims as FDA deadlines approached and mixed use of synthetic nicotine versus purified tobacco-derived nicotine. Regulatory conclusions argue for closing loopholes and ensuring proper FDA classification.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages35

Reading Time12 min

AccessFree to download

ABSTRACT

Aims

Design

Findings

Conclusions

Glossary of Terms

Synthetic Nicotine (SYN)

Tobacco-Free Nicotine (TFN)

Tobacco Leaf-Free Nicotine

Nicotine Analogs

Executive Summary

Marketing of “Tobacco-Free” and “Synthetic Nicotine” Products Divya Ramamurthi, MS Cindy Chau, BS Zhuojing Lu Ilina Rughoobur Keon Sanaie, BS Partha Krishna Robert K. Jackler, MD White Paper Stanford Research into the Impact of Tobacco Advertising Published March 8, 2022 Correspondence to: Robert K. Jackler, MD Stanford University School of Medicine 801 Welch Road Stanford, CA 94305 650 725 6500 [jackler@stanford.edu](jackler@stanford.edu) Key words: Tobacco-free, non-tobacco, synthetic, nicotine, regulation, advertising Disclosures: Dr. Jackler serves as expert witness in JUUL Labs litigation. The other authors have no relevant financial relationships Funding Source: Stanford Research into the Impact of Tobacco Advertising Authorship Statement: RKJ conceptualized the study and was primary author of the paper. DR, CC, ZL, IR, KS, PK, RJ all contributed to data collection, analysis, and editing of the paper. Marketing of “Tobacco-Free” and “Synthetic Nicotine” Products 2 ABSTRACT Aims: To characterize the scope and scale of“tobacco-free” and “synthetic nicotine” products on the market and their regulatory implications. Design: Survey of nicotine products offered for sale online which claim either to be made from“synthetic nicotine” or that they are “tobacco-free.” Analyze the extent to which these novel products circumvent governmental regulations, tobacco taxation, and tobacco sales bans of major online marketplaces. Findings: As the deadline for FDA authorization of novel tobacco products approached, a rapidly increasing number of brands assert that their products are not derived from tobacco and thus are exempt from the Agency’s regulations. Six manufacturers offer synthetic nicotine while others that claim to be “tobacco-free” use a purified form of tobacco derived nicotine.“Tobacco-free” labeling conveys advantages to the seller beyond exemption from tobacco regulation and taxation. Major online marketplaces, which prohibit both sales and paid advertising of tobacco products, allow them for brands claiming to be “tobacco-free.” Conclusions: There is no rationale for products using non-tobacco sourced nicotine to be exempt from regulation. As nicotine is highly addictive, this regulatory loophole needs to be closed by designation as either a drug or tobacco product. These brands assert that they are not tobacco products, and many make reduced harm and even therapeutic claims. Logically, they are unauthorized drugs and should be removed from the market pending new product application. Those products claiming to be “tobacco-free,” which use highly purified tobacco-derived nicotine, are subject to existing FDA tobacco regulations. Glossary of Terms Synthetic Nicotine (SYN): Nicotine produced via synthesis using chemical precursors derived from non-tobacco sources. Tobacco-Free Nicotine (TFN): A term loosely used by a number of emerging nicotine products, sometimes with ambiguous meaning. Technically, it should be a broad term encompassing synthetic nicotine and nicotine derived from other nightshade family plant sources such as tomato and eggplant. Some companies may be using this label inaccurately, describing their brands as “tobacco-free” but actually using a highly purified form of tobacco-derived nicotine or merely inaccurately labelling standard tobacco-derived nicotine. While “TFN”is the registered trademark of synthetic nicotine manufacturer Next Generation Labs, it is also used generically by many brands. Tobacco Leaf-Free Nicotine: Term used by a handful of brands referring to a more highly purified form of tobacco-derived nicotine depleted of residual tobacco chemicals. Nicotine Analogs: Any of a family of compounds which mimic the structure of nicotine. Some of these possess psychoactive and addictive properties. Marketing of “Tobacco-Free” and “Synthetic Nicotine” Products 3 Executive Summary: • A 2009 US law assigned tobacco regulation to the FDA

FAQs

What is the purpose of the white paper?

The white paper aims to characterize the scope and scale of “tobacco-free” and “synthetic nicotine” products and assess their regulatory implications.

How were products evaluated in the study?

The authors surveyed nicotine products offered for sale online that claim either “synthetic nicotine” or “tobacco-free,” and analyzed how these products may circumvent regulation, tobacco taxation, and sales bans of major marketplaces.

What do the findings suggest about labeling and market access?

As FDA authorization deadlines approached, many brands claimed they were not derived from tobacco. The report also finds that marketplaces that prohibit tobacco sales and paid advertising may still allow brands that claim to be “tobacco-free.”

What regulatory action does the paper recommend?

It argues there is no rationale to exempt non-tobacco sourced nicotine from regulation and recommends closing the loophole by designating such products as either a drug or tobacco product, while products using purified tobacco-derived nicotine should remain under existing FDA tobacco regulations.

Oct 13, 2026

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