The US FDA Has Issued Guidelines On Key Enforcement Points Regarding Unauthorized E-cigarettes And Nicotine Pouches.

Recently, the FDA's official website published an article stating that the agency is committed to cracking down on illegal tobacco products within the United States. The illegal market has undermined the regulatory framework and exposed consumers to risks associated with products that have not undergone any scientific scrutiny.
The FDA will continue to implement an active strategy to prevent the entry of illegal tobacco products by focusing on the most deceptive and dangerous products, the worst offenders, and serious violations related to illegal e-cigarettes and nicotine pouch products (such as failure to submit pre-market tobacco applications, abbreviated as PMTA, including counterfeit products and false declarations). The FDA will prioritize these efforts and continue to closely cooperate with other federal agencies such as the Department of Justice, Customs and Border Protection, etc., to seize and destroy illegal products at the border to prevent them from eventually entering the US shelves or being used by minors.
To support this priority, on May 8th, the FDA released a guideline titled "Enforcement Focus for Certain New Tobacco Products Sold Without Pre-market Authorization". This document outlines the enforcement policies for certain unauthorized e-cigarettes and nicotine pouch products.
More specifically, for e-cigarettes and nicotine pouch products sold without FDA authorization, the policy describes under what circumstances the FDA does not intend to prioritize enforcement.
If the product has been submitted and is under review for an application, or the manufacturer has submitted and is under review for a supplementary pre-market tobacco product application (PMTA), and the FDA has determined that the application contains the necessary data to assess whether the product is suitable for protecting public health (for non-tobacco flavored e-cigarettes), then the FDA does not intend to prioritize enforcement of these products. Unless the product has certain presumed elements that attract minors, such as: depicting cartoon images, e-cigarettes disguised as other products or similar to children's toys, mobile phones or game platforms, otherwise the FDA does not intend to prioritize enforcement of the above categories of products.
The FDA will also consider whether a certain tobacco product poses a more serious public health or safety hazard compared to e-cigarettes, nicotine pouches, or other tobacco products:
High nicotine content and serious adverse reactions or more unexpected related adverse reactions compared to approved e-cigarettes or nicotine pouch products. Non-compliance with the child safety packaging (CRP) regulations of the 2015 "Prevention of Nicotine Poisoning in Children Act". Potential fire hazards.
To enhance transparency for consumers and retailers, the FDA will create and maintain an open product list, listing the manufacturers and their products that the FDA does not intend to prioritize enforcement under this policy.
This policy suggests that those manufacturers whose products are sold in accordance with this policy and who wish to be listed on this public webpage should contact the regulatory health project manager (RHPM) of their pending application or can contact the following email:
CTP_enforcementpriorities@fda.hhs.gov. Manufacturers using this email will receive an automatic reply and can expect to receive more detailed information about the webpage soon.
However, the FDA emphasizes that whether an e-cigarette or nicotine pouch product falls under any enforcement policy of this policy has nothing to do with whether the product may obtain pre-market authorization.