Exclusive interview: FDA Center for Tobacco Products director says filing a PMTA does not equal lega

Two Supremes interviewed Brian King, the director of the FDA Center for Tobacco Products, who shared his views on vaping compliance issues, tracking and tracing systems, and innovative products.

[Two Supremes from Seoul, South Korea] On the afternoon of September 21, at the 2023 Global Tobacco and Nicotine Forum (GTNF), Brian King, the director of the FDA Center for Tobacco Products, was interviewed by Two Supremes, sharing his views on vaping compliance issues, tracking and tracing systems, and innovative products. Brian stated that filing a PMTA application does not equate to legal sales and does not rule out the possibility of establishing a tracking and tracing system. 

Filing a PMTA application does not equate to legal sales 

The large number of illegal vaping products is affecting the healthy development of the U.S. vaping market, and how to improve legality and regulatory measures has become an important issue for the FDA to consider. 

In this regard, Brian told Two Supremes that manufacturers around the world are illegally exporting products to the U.S., with many complying with U.S. laws, but many not. Therefore, he emphasized the legal context in the U.S., particularly the process for authorizing tobacco products, ensuring that only products that have undergone scientific review and received U.S. authorization can legally enter the market.

"I certainly welcome manufacturers' innovation in developing new products, but it is also important that we follow the necessary procedures, conduct research, and submit legal applications, so that products can only legally enter the market after authorization to ensure their legality." 

FDA Center for Tobacco Products Director Brian King talks with Two Supremes International Editor Zhu Hongxu | Source: Two Supremes 

Currently, many brands or products are taking advantage of the review gap of PMTA applications, and the FDA neither acknowledges nor rejects these applications, which means these products do not fall into the category of truly illegal products. Many companies are using this window period to sell products, with the ultimate goal not to obtain PMTA for legal sales. Is this a regulatory loophole for the FDA?

In this regard, Brian clearly stated to Two Supremes that filing an application does not equate to legal sales; only authorized products can be legally sold. Currently, the FDA has authorized 23 vaping products, and all other unauthorized products fall under illegal sales.

"We have 23 authorized vaping products; everything else is illegal unless authorized." 

Brian believes that some companies simply submit applications and think they can obtain a "golden ticket," which is incorrect. "Unless you have authorization, you will face enforcement risks, and the FDA can take action as appropriate." 

Possibility of establishing a product tracking and tracing system not ruled out 

Two Supremes also discussed the FDA's newly launched TPMP (Tobacco Product Manufacturing Practices) rules with Brian. In recent enforcement actions, the FDA has collaborated with customs and other departments to crack down on illegal vaping products. Does this mean the FDA will strengthen product tracking and tracing?

Brian stated that while TPMP currently does not include tracking and tracing, it lays the foundation for a potential tracking and tracing system. This will help monitor products entering the market to support enforcement, but a tracking and tracing system has not yet been actively implemented.

"The implementation of such rules and guidance must go through a public rulemaking process, so TPMP will lay the groundwork for some components of a potential tracking and tracing system, but we are not actively implementing tracking and tracing at this time. However, from the perspective of monitoring products entering the market, it makes sense." 

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 rules including TPMP, and we can further develop on this basis, which may include future tracking and tracing systems," he said. 

Demonstrating the feasibility of product science#p#分页标题#e#

Finally, Brian emphasized to Two Supremes his welcome of innovation in vaping and stated that as long as products demonstrate scientific feasibility, they have the potential to obtain authorization for sale in the U.S. He encouraged manufacturers to follow appropriate legal procedures, including submitting pre-market tobacco product applications, and emphasized the FDA's commitment to reviewing these applications as quickly as possible.

"People must follow the necessary processes, conduct sufficient research to support their applications, and the FDA is committed to reviewing these applications as quickly as possible and authorizing them based on scientific performance."