Tobacco Asia

Tobacco Asia 19 such as depicting a cartoon-like fictional character; disguising its nature as a vaping product; or resem- bling a children's toy, phone, or gaming platform." FDA would also consider whether a tobacco product poses a significant public health or safety concern that exceeds the level generally associated with authorized e-cigarettes, nicotine pouches, or other tobacco products, including those with higher nicotine content, lacking child-resistant packaging, causing adverse health effects, or posing a fire hazard, according to Azim Chowdhury, a partner with the law firm of Keller & Heckman. "For foreign manufacturers, that means US compliance is no longer only a question of whether a distributor or retailer may be targeted," said Chowdhury. "FDA is increasingly looking upstream at the product, the application status, the importer, and the manufacturer." To promote transparency for consumers and retailers, FDA will maintain a publicly available list of products that identifies manufacturers and their prod- ucts that FDA does not intend to prioritize for enforcement. The agency said it expects the ap- proach to encourage companies to file PMTAs for lower-risk products and to bring those products to market more quickly. The notice also confirms that the guidance is immediately in effect, even though it remains open to public comment. FDA said it is implementing the guidance without prior public comment because prior participation was "not feasible or appropriate." Agustin E. Rodriguez, a partner with the law firm of Troutman Pepper Locke, told Tobacco Asia that the guidance greatly increases the incentives to submit (or improve) a PMTA. "Only products with applications that have cleared the acceptance and filing review qualify for en- forcement forbearance," he said. "This gives manufacturers a concrete reason to invest in application quality. "And for nontobacco-flavored ENDS, there is an additional condition: the application must include data sufficient for FDA to evaluate whether the product is appropriate for protection of the public health. This would appear to raise the bar for that product category and prompt manufacturers to invest in consumer perception, cessation, and population-level health studies." There is even more motivation for companies to submit an applica- tion. Sometimes it took years for a company to receive an acceptance letter after submitting a PMTA; however, those long waits may be over. In a May statement, Bret Koplow, acting director of the Center for Tobacco Products (CTP), said there is no longer a backlog of applications awaiting acceptance for review. "For the first time in years, a PMTA will, upon receipt, almost immediately enter the first phase of Application Review," he said. "The days when applicants might wait months or even years to learn if their application was complete enough to be accepted for further evaluation are behind us." CTP is also adopting new efficiencies for the second phase of review, in which FDA determines if an application contains sufficient information to enable substantive scientific review. The agency may now issue an MGO for a product's tobacco flavor, while a flavored or higher-nicotine-strength product of the same brand undergoes a more rigorous review. "Over the past year, we have realized efficiencies in filing reviews for nicotine pouch products and electronic nicotine delivery systems," Koplow said. "Upon review, if there are products included in a submission that can receive marketing granted orders

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