Industry News
FDA to Replace 2021 PMTA Rule: A Faster Path for Hookah and Cigarillos?
The Food and Drug Administration announced on September 28 that it intends to replace the 2021 rule that governs how new tobacco and nicotine products are reviewed before they can be sold. The announcement followed a Wall Street Journal report, confirmed by Reuters on September 23, that the administration planned to speed up authorizations for newer nicotine products. It also came less than four weeks after Altria subsidiaries and a group of retailers sued the agency over the same rule.
For retailers and consumers of "deemed" products—such as hookah tobacco, flavored cigarillos, filtered cigars, and pipe tobacco—the fight over this rule is the fight over which new products reach the market and how quickly they arrive on shelves.
What the FDA Actually Said
The agency's statement was short. The FDA said it is reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent court developments, including a federal lawsuit in the Northern District of Texas that challenges the current framework. Citing that experience, the growth of an illicit and unregulated market, and the pace of new product introductions, the FDA said it intends to evaluate changes to the framework, including new rulemaking to replace it.
The FDA also stated it will keep processing applications and issuing decisions under existing law in the meantime, and that any changes will go through public comment. No timeline was given, and no specific product categories were singled out. A Department of Health and Human Services spokesperson told Reuters the administration wants to keep nicotine away from kids, get counterfeit vapes off the streets, and provide safer alternatives for adults trying to quit cigarettes.
Why the 2021 Rule is Under Attack
Congress originally gave the FDA 180 days to decide on a premarket application. However, the 2021 rule created acceptance and filing stages that run before that clock starts, and it lets the agency request product samples along the way. Manufacturers argue the result is a process that almost never finishes on time, whether the product is a hookah blend, a cigarillo, or a pouch.
"Manufacturers argue the result is a process that almost never finishes on time, whether the product is a hookah blend, a cigarillo or a pouch."
The September 2 lawsuit, filed by Altria's Helix Innovations and NJOY along with several retailers, asks the court to throw the rule out. The complaint says Helix's original applications from 2020 sat for more than 2,270 days. Even a resubmission under a 2025 pilot program took 361 days, about twice the statutory limit. Reynolds American's vapor, oral nicotine, and snuff subsidiaries joined the case in mid-September, according to Tobacco Insider.
FDA Had Already Started Moving
The agency's tobacco center did not wait for the lawsuit to change course. In a May 7 statement, the center said it cut its application backlog by roughly 70 percent in 2025 and used a pilot program to authorize six products within about three months of scientific review. On May 8, the FDA published enforcement guidance that deprioritizes action against newer products with accepted and filed applications, while keeping youth-appealing products at the top of its list.
Public-health groups are not applauding. Inside Health Policy reported on September 29 that anti-smoking organizations criticized the plan to revisit the rule. Critics argue that lowering evidentiary standards risks reversing progress against youth nicotine use, the same concern that led the first Trump administration to pull flavored e-cigarettes from shelves.
What it Means for Shoppers
Nothing on the shelf changes today. The FDA said it will keep applying the current standard while it writes a new one, a process that takes many months. However, the pipeline for new products could shift:
- Hookah Tobacco: Brands like Al Fakher Harvest Moon Hookah Shisha Tobacco and Fumari Hookah Tobacco - Plum Flavor (100g Pouch) sell dozens of flavors. A rule with a clear clock could make flavor launches less of a regulatory gamble.
- Cigarillos and Filtered Cigars: Machine-made cigars from Swisher Sweets Cigarillos & Cigars, Backwoods Cigars & Natural Leaf Cigarillos, and Good Times are deemed products too. A faster path could mean more frequent and predictable limited-edition releases.
- Pipe Tobacco and Wraps: Blends such as Golden Harvest Pipe Tobacco and natural-leaf wraps fall under the same rules, though they rarely make headlines in the fight.
The Bottom Line
The FDA has now said in writing what industry lawsuits had been signaling: the 2021 review rule is going to be rewritten. That is a win for manufacturers that have waited years for decisions, and a worry for groups that see faster flavor approvals as a youth risk. For shoppers, the practical effect is slow and indirect, but the direction is clear. The hookah tobacco, cigarillos, and pipe blends sold at retail will eventually be judged under a new set of rules that are only just starting to be written.