LegitScript’s Associate General Counsel, Gerard Olson, dives deep into the regulatory landscape of vaping and tobacco in our Deep Dive Webinar Series. Read this recap of the webinar to understand who regulates tobacco and vaping products, and what it takes to get a tobacco product to market. Then, watch the full webinar at the button below.
Let’s Define What A Tobacco Product Is
Tobacco use can be traced to the Mayans as far back as the first century but what is it exactly? Tobacco is a plant with leaves containing an alkaloid called nicotine — a highly addictive chemical. Vapes and e-cigarettes are tobacco products that also contain the chemical nicotine.
The US Food and Drug Administration (FDA) regulates all tobacco products in the US and defines tobacco products 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 (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product); and
- “Is a drug defined under section 201(g)(1) of the FD&C Act, a device defined under section 201(h) of the FD&C Act, or a combination product described in section 503(g) of the FD&C Act, or a food under section 201(f) of the FD&C Act if it contains no nicotine, or no more than trace amounts of naturally occurring nicotine.”
Cigarettes, vapes, and other tobacco products can be sold legally, in the right jurisdictions, with the proper regulatory oversight. So what path does a company have to take to get a new tobacco product approved through the FDA?
Bringing Tobacco Products to Market: The Four Pathways to FDA Approval
New tobacco products must be approved by the FDA before they begin marketing in the appropriate jurisdictions in the United States.
The FDAs process includes four pathways to approval:
- Companies can submit a Premarket Tobacco Product Application (PMTA) under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
- A manufacturer can seek a Substantial Equivalence (SE) Report for new tobacco products.
- The original manufacturer can seek EX REQ, an exemption order, for a tobacco product under section 905 (j)(3) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
- A person can also submit a modified risk tobacco product (MRTP) application under section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Examples of Illegal and/or Illicit Problematic Tobacco Products
Though there are four official pathways to approving a new tobacco product — bad actors do not typically take the legal route. Sometimes, LegitScript detects illegal and/or illicit problematic tobacco products including but not limited to:
- Flavored vape juice
- Products appealing to youth
- And synthetic nicotine
Dive into the full webinar for examples of illegal and/or illicit problematic tobacco products.
Take a Deep Dive Into Our Webinar Series
Do you want to take an in-depth dive into the history and regulatory framework surrounding tobacco products? Click the button below to watch the second course in our Deep Dive Webinar Series on Vaping and Tobacco.
In this webinar you’ll discover:
- The current regulatory landscape of vaping and tobacco in 2023
- Recent enforcement changes in the vaping space
- Problematic merchants selling unapproved tobacco products (and their tactics)