If you vape and you haven’t heard of the FDA’s deeming regulations, it’s time you did – here’s everything you need to know…
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The U.S. Food and Drug Administration (FDA) implemented deeming regulations to regulate all tobacco products, including e-cigarettes, cigars, and hookah.
The deeming regulations, which went into effect on August 8, 2016, subject these products to the same rules as traditional tobacco products.
This was big news at the time, and we’re still feeling the fallout from it now. The deeming regs have reshaped the entire market, killed thousands of businesses, large and small, and deterred smokers from switching to vaping products.
Basically, they have been something of a headache for all concerned parties, including the FDA itself.
In this blog post, we’ll provide a comprehensive overview of the FDA’s deeming regulations and their impact on the vaping industry. We’ll also discuss the controversies surrounding the regulations and potential changes.
What are the FDA’s Deeming Regulations?
Deeming regulations refer to a regulatory process used by the FDA to extend its authority to new and emerging tobacco products.
The FDA’s deeming regulations for tobacco products were issued in 2016 and expanded the agency’s regulatory authority to include e-cigarettes, cigars, and other tobacco products that were previously unregulated.
The deeming regulations apply to all manufacturers, importers, and retailers of tobacco products.
They require these entities to submit premarket tobacco product applications (PMTAs) for any new tobacco products that they wish to introduce into the market.
The regulations also require manufacturers to register with the FDA and provide a list of ingredients used in their products.
Key Components of The Deeming Regulations
The FDA’s deeming regulations for tobacco products contain several key components that manufacturers, importers, and retailers must comply with:
- Health warning requirements: All tobacco product packages and advertisements must carry a warning statement about the health risks associated with tobacco use. The warning statement must occupy at least 30% of the front and back of the package or advertisement.
- Ingredient listing requirements: Manufacturers must provide a list of all ingredients used in their tobacco products, including any harmful or potentially harmful ingredients.
- Pre-market review requirements: Manufacturers must submit PMTAs to the FDA for any new tobacco products they wish to introduce to the market. The PMTA must include information on the product’s design, composition, ingredients, health risks, and intended use.
- Prohibition on marketing to minors: The deeming regulations prohibit the sale of tobacco products to individuals under the age of 18.
- Restrictions on vending machine sales: The regulations restrict the sale of tobacco products through vending machines, except in facilities where the sale is restricted to adults and the machines are located in areas that are not accessible to minors.
- Sampling restrictions: The deeming regulations prohibit the distribution of free samples of tobacco products, except in certain adult-only facilities.
- Compliance deadlines: Manufacturers and importers of tobacco products must comply with the deeming regulations by the deadlines set forth by the FDA.
Impact of The Deeming Regulations on The Vaping Industry
The deeming regulations have had a significant impact on the vaping industry.
Many small businesses have struggled to comply with the new regulations, which require expensive and time-consuming PMTAs for new products.
The PMTA process can take years to complete and cost millions of dollars, making it difficult for small businesses to compete with larger companies.
The deeming regulations have also had an impact on public health. By subjecting e-cigarettes and other tobacco products to the same regulations as traditional tobacco products, the FDA has been able to monitor and regulate these products more effectively.
This has led to increased awareness of the health risks associated with e-cigarettes and other tobacco products, and has helped to reduce the use of these products among minors.
Controversies Surrounding The Deeming Regulations
The deeming regulations have been subject to several controversies since they were implemented in 2016.
Critics of the regulations argue that they have placed an undue burden on small businesses and have made it more difficult for smokers to switch to e-cigarettes which, according to both The Royal College of Physicians and Public Health England, are around 97% safer than smoking cigarettes.
- U.S. Food and Drug Administration. (n.d.). Deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act: Final rule. https://www.fda.gov/media/89462/download
- Campaign for Tobacco-Free Kids. (2020, August 31). FDA deeming rule: What you need to know. https://www.tobaccofreekids.org/assets/factsheets/0383.pdf
- American Lung Association. (2021, February 22). FDA’s deeming regulations for e-cigarettes, cigars, and all other tobacco products. https://www.lung.org/policy-advocacy/tobacco/deeming-regulations
- Public Health Law Center. (n.d.). FDA tobacco deeming rule: The basics. https://www.publichealthlawcenter.org/sites/default/files/Deeming%20Rule%20Basics.pdf
Drake EquationCo-founder and Editor of VapeBeat. I make the words.
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