How New Non-Smoke Tobacco Products like Nicotine Pouches and Flavorful Chewing Gums Can Legally Enter the U.S. Market

2025-01-17

Since the passage of the Family Smoking Prevention and Tobacco Control Act in 2009, the FDA has held the power to regulate all tobacco products. This sweeping authority covers everything from manufacturing to distribution and marketing. With growing interest in vape products and other non-smoke alternatives, new regulations have made it clear: nicotine pouches, nicotine-infused gums, and similar products fall under the same category as traditional tobacco, and companies must navigate a complicated approval process to market them in the U.S.

Let’s break down what’s really going on here, from the FDA’s regulatory powers to the complex maze of Premarket Tobacco Product Applications (PMTA) and why even non-tobacco nicotine (NTN) products now need official clearance.

The PMTA Process: A Necessary Step for Compliance

Back in 2021, the FDA implemented a final rule for the PMTA process, effective October 5. This regulation mandates that all tobacco products—whether made with traditional tobacco or synthetic nicotine—must go through a premarket approval process before hitting the shelves. The FDA’s new focus aims to ensure that these products are safe for public use and are not marketed in a way that targets minors or non-smokers.

But the plot thickens. In 2022, Congress passed new legislation expanding the FDA’s authority to cover all nicotine products, regardless of the source of nicotine. This included synthetic nicotine, which many manufacturers use in products like vape juices, nicotine pouches, and nicotine gums. Under this rule, anything with nicotine—no matter how it’s sourced—needs to submit a PMTA before it can be legally sold.

The key here? If manufacturers fail to submit the right application to the FDA, they risk facing enforcement actions, such as fines or having their products pulled off the market. The legislation made it crystal clear that NTN products—products containing non-tobacco nicotine—are subject to the same regulatory process as traditional tobacco products.

The Surge of Non-Smoke Alternatives

Over the past several years, nicotine pouches and flavored nicotine gums have exploded in popularity. These products are marketed as a cleaner, more convenient alternative to traditional smoking or even vaping. Many of these products rely on synthetic nicotine, which has raised eyebrows among regulators and health experts. Even though these products don’t involve combustion, they still carry nicotine—a substance that can be addictive.

While they may not be as harmful as smoking cigarettes, products like nicotine pouches are still addictive and need to be regulated. In fact, the FDA has stressed the importance of reviewing these products carefully. Manufacturers must submit a PMTA for each individual SKU (Stock Keeping Unit), and only once the Marketing Granted Order (MGO) is granted can they legally sell these items.

So far, there have been a few smokeless tobacco products—like nicotine gum and oral nicotine pouches—that have successfully obtained MGO from the FDA. But, and here’s the big caveat, nicotine pouches are still in limbo, with no major brands having received approval yet.

The Impact of Increasing Customs Scrutiny

As demand for nicotine products continues to surge in the U.S., particularly in the market for nicotine pouches, the FDA isn’t the only agency stepping up its game. The U.S. Customs and Border Protection (CBP) has also intensified its enforcement activities, especially when it comes to illegal imports. This past year, on September 4, 2024, the CBP released a new set of guidelines known as the ACAS (Air Cargo Advance Screening), which requires businesses to submit more data on low-value shipments, including product names, quantities, and values.

This means that any company trying to slip through the cracks with false declarations or unapproved imports could find their shipments delayed, seized, or even destroyed. As a result, the risk of getting caught with unapproved products is higher than ever. With enforcement tightening, the financial and logistical costs of non-compliance could become prohibitive for many small and mid-sized companies looking to enter the market.

The Path to Compliance

As these complex regulations evolve, manufacturers are facing the reality of navigating compliance in the U.S. market. One company that has been at the forefront of helping businesses get their PMTA applications in order is Tianjian Testing. Since 2019, Tianjian has been working with companies to ensure they submit complete, accurate, and timely PMTAs for products like nicotine pouches.

For businesses looking to break into the U.S. market, Tianjian Testing provides a one-stop-shop for PMTA submissions. Their service has already helped multiple clients successfully secure STN codes (Substantial Equivalence Number), which are necessary for legal marketing. Tianjian’s tailored solutions help businesses avoid the risks of non-compliance, which can be devastating in a marketplace that’s increasingly regulated.

What’s Next for the Smokeless Tobacco Industry?

With an eye on long-term success, businesses looking to sell nicotine pouches and other vape-related products in the U.S. need to plan ahead. In addition to PMTA approval, manufacturers must stay updated on shifting enforcement and regulatory trends. The FDA’s crackdown on non-compliant products is only expected to intensify, especially as teenagers and young adults continue to flock to alternatives like nicotine pouches and flavored vape juices.

Regulators are working hard to curb underage use of these products, which means companies will need to step up their game when it comes to marketing practices. This includes ensuring that their advertising doesn’t target young people or make exaggerated claims about the safety of their products. This has become an especially hot topic as flavored vaping products have come under fire for being particularly attractive to younger users.

Meanwhile, e-commerce platforms selling these products are also under pressure to ensure that they comply with age verification rules and submit the proper documentation for all products they sell. The rise in online shopping for smokeless tobacco means that retailers also need to play a critical role in ensuring compliance. In many cases, this will involve monitoring local and federal regulations and adapting to any new rules that emerge.

Wrapping It Up: A Complex Regulatory Future

The road to legal market entry for nicotine pouches and synthetic nicotine products in the U.S. isn’t a walk in the park. Manufacturers, retailers, and distributors must submit detailed PMTAs, obtain FDA approval, and navigate an increasingly complex regulatory environment. At the same time, new restrictions from U.S. Customs and Border Protection are raising the stakes for international businesses hoping to ship these products into the country.

So, while the nicotine pouch trend shows no sign of slowing down, companies need to be on top of their game. Compliance isn’t just about following the rules; it’s about staying ahead of them. Getting caught off guard by the latest enforcement action could have serious consequences, so businesses should make sure they’re fully prepared.

For businesses that want to ensure success, partnering with experienced firms like Tianjian Testing can make all the difference. With their expertise and hands-on approach to compliance, these firms are leading the charge for companies eager to break into the booming U.S. market for non-smoke tobacco products.

At the end of the day, compliance doesn’t have to be a headache. When handled right, it’s just another step toward making sure your products hit the market in a way that’s both legal and lucrative.

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