FDA Releases Deeming Vaping / E-Cigarette Regulations
On May 5, 2016, the FDA announced its long-awaited final deeming rule, the regulation that brought e-cigarettes, vape juice and vaping hardware under federal tobacco law for the first time. The announcement set off a day of fast-moving news and anxious reaction across the vaping world, and the rule went on to shape the market for years.
Here is what the rule did, why it worried the industry so much, and how things have developed since.
Short version: The 2016 deeming rule classified vaping products as tobacco products under federal law. It set a national minimum age, led to the nicotine warning on vape packaging and, most important, required FDA authorization for products to stay on the market. Several of those rules have since been tightened, and FDA review of vaping products is still ongoing.
What the deeming rule did
The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority over cigarettes and smokeless tobacco, and it let the agency bring other tobacco products under the same law by deeming them covered. The FDA proposed doing that in 2014 and finalized the rule in May 2016, and the rule took effect on August 8, 2016.
The rule reached well beyond vaping, covering cigars, pipe tobacco and hookah too. For vapers, its scope was broad. The 499-page document released that day listed e-liquids, atomizers, batteries, cartomizers, clearomizers, tank systems, flavors, vials that hold e-liquid, digital displays and the software used to adjust settings.
Among the changes that applied nationwide:
- A federal minimum age. Selling to anyone under 18 became illegal nationwide, and retailers had to check photo ID for customers under 27.
- No free samples, and vending machine sales only in adult-only facilities.
- A nicotine warning. Packaging and ads had to carry a warning that the product contains nicotine and that nicotine is an addictive chemical. That requirement took effect in 2018, and it is the same warning you will see at the end of this post.
- No reduced-risk marketing without FDA permission. Companies could not claim their products were less harmful without an FDA order.
- Reporting. Manufacturers had to register with the FDA and report their products and ingredients.
The premarket review problem
The part that alarmed the industry most was premarket review. Any tobacco product that was not on the market on February 15, 2007, needed FDA authorization to stay on sale, and almost no vaping products existed on that date. Nearly everything on the shelf in 2016 was affected.
Manufacturers had two main routes. A substantial equivalence (SE) application compares a product with one sold on that 2007 date, which was rarely possible for vaping products. The other route was a premarket tobacco product application (PMTA), a far more detailed and expensive filing. The rule also treated any change in ingredients or ingredient levels, including a different PG/VG ratio, as a new tobacco product, so each flavor, strength and ratio could need its own application.
The rule gave manufacturers staggered compliance periods of 12, 18 and 24 months to file their paperwork, depending on the route, and products could stay on sale while they did.
How the vaping world reacted
The reaction was swift. Manufacturers and shop owners warned that the cost of the PMTA process would push small businesses out and wipe out most products on the market. The Smoke-Free Alternatives Trade Association (SFATA), a vapor industry group, called on Congress to change the 2007 predicate date. It backed H.R. 2058, a bill from Rep. Tom Cole, and a related appropriations amendment from Reps. Cole and Sanford Bishop. Vapers circulated petitions against the rule, and many stocked up on their favorite products.
At ZampleBox, members asked whether prices would rise as demand spiked. At the time, we said we planned to keep prices the same unless our own costs went up, and we asked the community to stay calm and wait for the full legal picture. The predicate date change never became law.
What happened next
- 2017: The FDA pushed the application deadline for vaping products back by several years.
- 2019: A federal court ruled against that delay and set an earlier deadline. In December, federal law raised the minimum age for all tobacco and vaping products from 18 to 21.
- 2020: Applications for vaping products already on the market were due in September.
- 2021: PACT Act rules for vaping products took effect. The US Postal Service no longer delivers them to consumers, and carriers require an adult signature.
- 2022: Congress extended FDA authority to nicotine made in a lab, closing a gap some brands had used to sidestep the rules.
Where things stand now
Every vaping product sold in the US needs FDA premarket authorization. The FDA has authorized a limited number of products and denied many others, and many applications are still under review, so the market keeps shifting. Flavor rules also vary by state and city and change often.
To follow the rules as they stand today, go to the source. The FDA’s tobacco products site has current federal requirements, and your state health department covers local rules. Our overview of vaping regulations by state explains how federal, state and local laws fit together.
Common questions
What is the FDA deeming rule?
It is the 2016 regulation that extended the FDA’s tobacco authority to e-cigarettes, vape juice, cigars, pipe tobacco and hookah. It took effect on August 8, 2016.
What is a PMTA?
A premarket tobacco product application. A manufacturer files one to show the FDA that allowing a new tobacco product, including a vaping product, onto the market is appropriate for the protection of public health. The FDA then authorizes or denies it.
Is the federal minimum age for vaping still 18?
No. Federal law raised the minimum age for all tobacco and vaping products to 21 in December 2019.
Did the deeming rule ban vape flavors?
No. The 2016 rule did not ban flavors. Flavor restrictions came later through FDA decisions and state and local laws, which vary by place and change often.
WARNING: This product contains nicotine. Nicotine is an addictive chemical. For adults 21+ only.