FDA CTP Director Brian King: Submitting PMTA is No Equivalent to Legal Sale

Ellesmere Zhu from Seoul - On the afternoon of September 21st, at the 2023 Global Tobacco and Nicotine Forum (GTNF), Brian King, Director of the Tobacco Center at the U.S. Food and Drug Administration (FDA), was interviewed by 2FIRSTS. During the interview, he shared his views on compliance issues regarding e-cigarettes, tracking and tracing systems, and innovative products. Brian emphasized that submitting a premarket tobacco product application (PMTA) does not automatically mean legal sales, and he did not rule out the possibility of establishing a tracking and tracing system.

Submitting PMTA does not Equate to Legal Sale

The current abundance of illegal e-cigarette products is impeding the healthy development of the e-cigarette market in the United States. The improvement of legality and regulatory measures is becoming a crucial issue that the FDA must consider.

In response, Brian told 2FIRSTS that manufacturers from all over the world are illegally exporting products to the United States. While many people abide by US laws, there are also many who do not. Therefore, he emphasized the legal framework in the United States, particularly the procedures for authorizing tobacco products, to ensure that only products that have undergone scientific review and obtained US authorization can legally enter the market.

"I certainly welcome the manufacturers' innovation in developing new products, but it is also important that we adhere to necessary procedures, conduct scientific research, and submit legal applications. Only after the products have been authorized can they legally enter the market, ensuring their legitimacy."

Currently, many brands or products are taking advantage of the PMTA review gap to submit applications. The FDA has neither acknowledged nor rejected these applications, indicating that these products do not fall under the category of truly illegal products. Many companies are using this window to sell their products, with the ultimate goal not being to obtain PMTA approval for legal sales. Is this a regulatory loophole for the FDA?

In response, Brian made it clear to 2FIRSTS that submitting an application for approval does not equate to legal sales, as only authorized products can be legally sold. Currently, the FDA has authorized 23 e-cigarette products, and any other products not authorized fall within the realm of illegal sales.

"We have 23 authorized products and any other sales without authorization are illegal."

Brian believes that some companies assume they can obtain a "golden pass" by simply submitting an application. "This is incorrect; unless you are authorized, you will face enforcement risks, and the FDA can take action based on the situation.

Possibility of Establishing Tracking and Tracing System

The 2FIRSTS organization has discussed the newly implemented Tobacco Product Manufacturing Practices (TPMP) regulations with the FDA. Through recent enforcement actions, the FDA has collaborated with customs and other departments to crack down on illegal e-cigarette products. This raises the question of whether the FDA will enhance product tracing and monitoring.

Brian stated that although TPMP currently does not include tracking and tracing, it is laying the groundwork for potential tracking and tracing systems. This will aid in monitoring products entering the market to support law enforcement, but a tracking and tracing system has not been actively implemented at this time.

"The implementation of such rules and guidelines must go through a transparent rule-making process, hence TPMP will lay the foundation for some components of potential tracking and tracing systems. However, we are not actively implementing tracking and tracing at the moment. Nonetheless, considering the perspective of monitoring products entering the market, this is meaningful."

However, Brian does not rule out the possibility of the FDA establishing a tracking and tracing system. "The Center for Tobacco Products (CTP) has been established for 13 years, implementing regulations including the TPMP rule, upon which we can further develop. This may include a future tracking and tracing system," he said.

Demonstrate Scientific Feasibility of Product

Finally, Brian emphasized to 2FIRSTS his welcoming attitude towards e-cigarette innovation and stated that as long as a product demonstrates scientific feasibility, it has a possibility of receiving authorization for sale in the United States. He encouraged manufacturers to follow proper legal procedures, including submitting pre-market tobacco product applications, and emphasized the FDA's commitment to expedite the review process for these applications.

"People must follow the necessary procedures and conduct thorough scientific research to support their applications. The FDA is committed to reviewing these applications as quickly as possible and granting them qualification based on scientific performance."

For the details of the interview, please click: FDA CTP Director Brian King: Submitting PMTA Application is No Equivalent to Legal Sale