FDA to enforce against non-compliant U.S. manufacturers

Ben Green, a Broughton Program Manager working on large nicotine-related regulatory projects, writes on the latest move by FDA to enforce against non-compliant manufacturers in the U.S.

The recent news that the U.S. Food and Drug Administration (FDA) has announced the filing of multiple financial penalties against tobacco manufacturers means it is becoming clear that the Center for Tobacco Products is strengthening its resolve to enforce against non-authorized nicotine products illegally sold on the U.S. market.

The regulations are clear that it is illegal to manufacture, sell or distribute new tobacco or nicotine products that were not commercially marketed in the U.S. as of February 15^th 2007, without a Marketing Order from FDA. A Premarket Tobacco Application (PMTA) is required to be submitted for a Marketing Order to be granted. Non-compliance with this in the first instance results in a warning letter to the manufacturer, requiring the products to be removed from the market. Between January 2021 and February 17, 2023, FDA issued more than 550 warning letters to companies for continuing to sell e-cigarette products that lacked the required FDA marketing authorization.

FDA’s latest press release confirms that non-compliance will be met with a more robust response in the future. We have now seen four manufacturers receive civil money penalty complaints from the FDA, which is thought to be $20,000 per violation.

How should manufacturers react to this news?

The FDA press release provides some clarity about the PMTA enforcement process. Any manufacturer looking for ambiguity in the rules or anticipating the significant delays experienced with the PMTA review process will provide an opportunity to gain from selling new tobacco products without Marketing Orders should think again. With this latest enforcement policy, FDA has illustrated that they mean business.

“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA. We are prepared to use the full scope of our authorities to enforce the law — especially against those who have continued to violate the law after being warned by the agency.”

• Brian King, director of FDA’s Center for Tobacco Products. (Read the full statement here)

The only way to avoid enforcement against products currently on sale in the U.S. without a Marketing Order is to comply with the regulations and follow the PMTA process to obtain one.

So far, we have seen FDA issue marketing orders for several ENDS and oral tobacco products, with successful applications containing extensive scientific data and analysis to illustrate that the product is Appropriate for the Protection of the Public Health (APPH).

The PMTA pathway can seem complex to manufacturers starting their journey to obtain marketing authorization for the U.S. However, our scientific and regulatory experts have extensive experience compiling PMTAs for a range of global clients and deep knowledge of the nicotine industry. We understand the levels of data and analysis needed to meet FDA thresholds for proving APPH and offer a full-service PMTA package across strategy definition, testing, analysis, and dossier compilation to ensure our client’s success.

Benjamin D. Green, BSc (Hons)

Program Manager