The Long Wait for a Safer Way to Quit Smoking

After a five-year wait, the U.S. Food and Drug Administration (FDA) has finally greenlit marketing for a tobacco-free alternative that’s 95% safer than conventional smoking: Zyn nicotine pouches. Unfortunately, thousands more products to help smokers quit are stuck in regulatory limbo—meaning the FDA is still limiting access to safer alternatives for the estimated 1 in 5 U.S. adults who currently use tobacco.

Zyn pouches are small, rectangular bags of nicotine powder that are placed between an individual’s lip and gum. The user absorbs the nicotine directly into the blood stream and is able to avoid many of the chemicals conventional cigarettes contain.

The FDA’s action last month represents the first ever authorization of a nicotine pouch, and the first ever approval of multiple flavors other than menthol or tobacco.

So why did the FDA wait five long years to authorize these pouches for marketing to American adults?

Alternatives meant to help Americans quit smoking, like Zyn pouches, must go through the FDA’s Premarket Tobacco Product Applications (PMTAs) pathway for newer generation products—a lengthy process filled with numerous and often arbitrary regulatory obstacles.

As a result, thousands of products that could save lives—including different brands of pure nicotine pouches—are in a backlog while they wait for the regulatory thumbs up. In some cases, the FDA has even denied products that have been proven to be safer and more effective cessation tools than many FDA-approved Nicotine Replacement Therapies like lozenges and gum.

Lives are at stake, but the federal government is blocking products that could help.

That’s why Goldwater Institute filed a brief in October urging the Supreme Court to hold the FDA accountable for imposing arbitrary roadblocks within the PMTA pathway, and open the door to innovative products that can help smokers quit.

But this is not just an issue at the federal level. In Oregon, for instance, the government banned businesses that sell e-cigarettes from accurately describing those products in their packaging—a blatant infringement on the right to free speech. Only after the Goldwater Institute filed suit on behalf of a local small business owner did the Oregon Court of Appeals strike down the state’s absurd restrictions on a product that is proven to be a safer and healthier alternative to combustible cigarettes.

Americans who face addiction need options—whether it’s a variety of flavors, or products such as vapes, or nicotine pouches. Instead of blocking the marketing of products that could save lives, government should embrace technological advancement and let Americans decide for themselves if, when, and how they want to quit.

Amanda Hagerman is a Senior Policy and Research Analyst at the Goldwater Institute.