FDA frustration sees tobacco companies choosing new path

Products without authorization coming to store shelves

By Diane Adam on Aug. 29, 2025 CSP

Despite not first receiving authorization from the Food and Drug Administration, (FDA) tobacco companies are beginning to balk and launch products anyway.

Helix Innovations LLC, a subsidiary of Altria, will be launching On Plus nicotine pouches this fall in North Carolina, Texas and Florida, the company posted on X. The launch of the nicotine pouch brand is without having first received authorization from the FDA.  “While the FDA’s review timelines have extended far beyond the 180-day statutory requirement, Helix has complied with all regulatory requirements to bring On Plus to market—disclosing ingredients, opening facilities for inspection, and submitting marketing materials for review,” the company said on X.  In June 2024, Helix submitted a Premarket Tobacco Product Application (PMTA) to the FDA.Comprising more than 25,000 pages of scientific and regulatory documentation prepared by a team of more than 50 experts, Altria said of the PMTA, “we’ve met the requirements under the Tobacco Control Act and proactively notified the FDA of our intent to launch.”

To date, the FDA has issued marketing granted orders to 20 Zyn flavored nicotine pouches. 

Other tobacco companies are beginning to push back on inconsistent standards. Starting in the fourth quarter of 2025, Reynolds American Inc., a subsidiary of British American Tobacco (BAT), will be piloting its Vuse One disposable vapor product in South Carolina, Florida and Georgia.  The FDA to date has authorized 39 e-cigarette products. These are the only e-cigarette products that currently may be legally marketed and sold in the United States. The FDA issued marketing granted orders for seven e-cigarette products from R.J. Reynolds Vapor Co. They are the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled and non-refillable. 

Excessive delay from the FDA is also waning for tobacco companies. Altria Group Inc.’s operating company Njoy LLC along with wholesalers and retailers of its products sued U.S. Department of Health and Human Services (HHS) and the FDA on Aug. 21. The lawsuit, filed in the U.S. District Court for Western Louisiana, alleges prolonged delays from the agency in ruling on Njoy’s appeal for flavored disposable vapes.  “FDA’s unlawful inaction over the nearly three years since Plaintiff Njoy LLC’s (NJOY) supervisory appeal of FDA’s marketing denial order for its flavored e-cigarettes has inflicted ongoing harm to Plaintiffs that only this Court can alleviate,” according to court documents.

The National Association of Convenience Stores (NACS) and four associations affiliated with the convenience store and travel center industries are calling on the White House to crack down on the sale of illegal vape products from China in the marketplace. The letter sent on July 18 was also signed by the Energy Marketers of America, National Association of Tobacco Outlets (NATO), National Association of Truck Stop Operators (NATSO) and the Society of Independent Gasoline Marketers of America (SIGMA).  In the letter, the organizations said the Trump administration needs to provide “clarity” and “enforcement” when it comes to the illicit vape market. The letter said that the c-store industry is “systematically” losing sales to businesses that sell illicit products. “The reasons why this is happening are clear and solvable,” it said. “The CTP has abandoned its fundamental responsibility as a regulator.”

In Goldman Sachs’ second-quarter 2025 Nicotine Nuggets survey, c-store retailers noted in the survey that customers have moved to illicit vapes. If illicit e-cigarettes were completely removed from the markets, 35% of retailers indicated they believe consumers would pivot to legal vapor products.

When reached for comment, the FDA told CSP Daily News it does not comment on litigation.