FDA Introduces New E-cigarette TPMP Regulations

On March 10, FDA issued a draft of Tobacco Product Manufacturing Practice ( TPMP ) on its official website, which will profoundly impact the global tobacco industry. 2Firsts connects with PMTA expert Zhi Zheng to interpret the primary content of TPMP and analyze the future development trend of the e-cigarette market. Zhi Zheng has been fully responsible for the PMTA certification project of the product FDA in Shenzhen Mcwell, and later founded Ziyuan Technology, focusing on the research of PMTA regulations, and has been working in the field of pharmaceutical and electronic cigarette testing plants for many years.

TPMP is the Last Step of PMTA.

On October 4, 2021, FDA announced two final rules on the pre-market review of new tobacco products on its official website. Products that have not passed PMTA certification cannot be listed in the United States. However, in the next two years, the efficiency of the Center for Tobacco Products (CTP), a subsidiary of the FDA, was extremely low. As of March 2023, only 23 e-cigarette products have finally passed PMTA.

The PMTA review includes two aspects: data review and on-site factory verification. In 2021, the FDA gave nearly 500 pages of guidelines as the basis for data review. This part is in charge of CTP's office of science, which is responsible for text review, proving that the product's quality and safety meet FDA requirements through application materials and test data.

In addition to the scientific and safety of the products, the production environment must also meet the requirements and standards. The requirement standard is shown in TPMP. However, no corresponding regulations in the factory site have a verification rule.

On March 10, CTP issued the Tobacco Product Manufacturing Practice ( TPMP ). Zhi Zheng, a professional who participated in the FDA inspection plant, told 2Firsts that TPMP has great significance; it completes the last link of PMTA.

Globalization is Inevitable.

According to Zhi Zheng's analysis, FDA's framework and terminology for producing tobacco products follow its model for drug management. The FDA has this set of standards for managing various industries under it, but the name is slightly different. It is called GMP (good manufacturing practice) in the pharmaceutical industry.

The pollution, cross-contamination, MMR, and CAPA used in this draft are standard terms in pharmaceutical systems, but common e-cigarette assembly plants such as ECN, ECR, and 8D are not mentioned. This also shows that the background and expertise of the document makers are more inclined to drugs or the pharmaceutical industry.

It also indicates that manufacturers such as e-cigarettes will face new challenges, which may be more acceptable for those who adopt drug production standards.

Zhi Zheng also said that the current version of TPMP is the predecessor of GMP, and each chapter's general content and requirements are almost the same as the drugs. Of course, there are also references to ISO9001 and ISO13485.

According to the global influence of GMP in the past, if this version of TPMP is determined, it will inevitably lead to the reference and imitation of national standards, therefore the globalization of e-cigarette production standards is inevitable.

The Inspection Process of TPMP

Zheng Zhi has participated in the FDA's factory inspection of Smoore. Based on his many years of FDA and EU factory inspection experience, FDA usually notifies the factory to be inspected two months before the formal inspection, and the formal inspection team is generally composed of 2 to 3 people. A leader and two auxiliary personnel cooperate, and the review of an e-cigarette factory can usually be completed in 2 to 3 days. Due to the clear division of labor, quality, production, or inspection are responsible for different groups. Respectively, to deal with the PMTA application factory, work efficiency will no longer be a problem.

"The last test for Smorre is three days, and Shenzhen First Union Technology is two days. So it is sufficient, and our factory is not complicated," Zhi Zheng said.

The inspection requires that the factory be a dynamic operation involving all aspects of the factory's overall production, including employees, equipment and facilities, materials, document records, quality management and quality control, production environment, and other links. Therefore, in the face of obvious problems on-site, the FDA factory inspection team will directly point out the problem and confirm with the person in charge.

Because 'He's afraid you won't admit it. '

For details, the inspection report will be issued to the factory within 1 to 2 months after the inspection is completed, and the factory will complete the rectification within the stipulated two months. After the factory meets the problem rectification, the FDA will check the rectification report.

If approved, the FDA's factory confirmation will generally be obtained within two to three months.

The FDA has previously limited the number of factory rectifications. Pharmaceutical factories usually have two times, meaning if they still need to complete the compliance requirements the first time, they must re-apply for factory inspection. However, Zhi Zheng believes the e-cigarette industry needs to have a new understanding of the FDA for tobacco. He believes that it should not only give two rounds of opportunities, and we are also concerned about this number limit. '

According to the FDA's previous dynamic regulatory model, the factory will be inspected again in 3 to 4 years after the inspection. This is because the follow-up regulations are progressing, the technology of e-cigarette products will change, and the internal personnel of the factory is also changing, so the inspection is cyclical. 'Zheng Zhi added.

This periodic inspection is called "routine" in the industry, but the follow-up inspection is relatively loose compared with the first time. Unless there is a significant safety accident in the factory, the FDA will re-evaluate the overall safety of the factory.

The advantage of TPMP is reflected in the fact that after the factory passes the inspection and fully meets the requirements of TPMP, if the factory declares any product again, there is a high probability that there is no need for on-site inspection unless significant adjustments such as new workshops are introduced. Therefore, the applicant only needs to focus on the scientific report of data review, which saves the cost of re-evaluation for e-cigarette brand factories or OEM factories.

Zheng Zhi stressed that 'if the two brands use the same factory production line, it can only be reviewed once. However, it still needs to be reviewed if it is different factories or production lines." The update and adjustment of the production line involved in this can be submitted to the review team in the periodic inspection, as long as the change conforms to the process can be passed.