Editor's note: This is the second article in a series interpreting the new regulations for electronic cigarettes from the FDA. The first article can be found by clicking on "Experts interpret the inspection standards and processes for the FDA's new electronic cigarette regulations".
On March 10th, 2023, the FDA released a draft of the Tobacco Product Manufacturing Practice (TPMP) requirements on their official website. This regulation is expected to have a significant impact on the tobacco industry globally. 2FIRSTS reached out to PMTA expert Zheng Zhi for his interpretation of the main points of the TPMP draft and his analysis on the future market trends of electronic cigarettes. Zheng Zhi was previously responsible for FDA's PMTA certification project at McWell in Shenzhen. He then founded Ziyuan Technology, specializing in PMTA regulation research, and has been deeply involved in the field of drug and electronic cigarette factory inspection for many years.
CTP's "three flames
The FDA's decision to launch TPMP in March may not be a coincidence. The Center for Tobacco Products (CTP), a branch of the FDA, has taken action against the tobacco industry, possibly in response to multiple criticisms in recent years. As we previously reported, in December 2022, the Reagan-Udall evaluation team found that CTP was "slow to respond, overworked" and struggling to regulate both traditional tobacco products and the rapidly expanding market for electronic cigarettes.
Speaking about the slow response from CTP institutions, Zheng Zhi recalled his visit with the inspection team to the factory in January 2020. At the time, the main inspector sent by CTP stated that they did not have a basis for factory inspection and that FDA was in the process of developing standards. However, they were uncertain about the specific timing of their implementation.
Zheng Zhi recalled that "at that time, they were still trying to collect and learn as much as possible. CTP really didn't understand e-cigarettes. After all, most e-cigarettes are produced in China. However, we knew that the FDA would issue this regulation, it was just a matter of time.
The FDA originally planned to implement a document that would cover all categories of the tobacco industry, which includes but is not limited to smokeless tobacco, cigarettes, cigars, hookah, e-cigarettes, and heated non-combustible products. However, the FDA is struggling to issue specific guidelines for these categories due to variations in product standards.
Zheng Zhi mentioned, "We have heard that the process of preparing chewed tobacco involves a step where it is mixed with feet and fermented. If this is indeed the case, how is the standard process described and what are the acceptable limits for it? Therefore, the FDA truly needs many people and to devote a lot of time and energy to researching these regulations.
The FDA's Center for Tobacco Products (CTP) was supposed to be a leader, but for the past two years, it has functioned as a regulator of the tobacco industry. In July 2022, the newly appointed director, Brian King, previously served in the Smoking and Health Office (OSH) at the Centers for Disease Control and Prevention (CDC) in the United States.
It is worth mentioning that Brian had previously worked with the anti-smoking organization Bloomberg Philanthropies, but in an interview with the Associated Press, he stated that the idea that e-cigarettes are as dangerous as smoking "is inconsistent with established science" and that the risks of e-cigarettes are "significantly lower.
Zheng Zhi speculated that Brian, after taking office, clearly wanted to change the public's negative perception of CTP by "lighting three fires in a row.
The first step was a reorganization of personnel and processes related to the PMTA, including the appointment of a new director for the Office of Scientific Review, Farrelly. The second step was the introduction of the TPMP standard, which completed the regulatory requirements for the PMTA. The third step should be the approval of multiple flavors of e-liquid.
There is a high likelihood that electronic cigarettes with multiple flavors will be approved.
Since 2019, various states and regions in the United States have implemented "flavor bans," which have had significant economic impacts on e-cigarette manufacturers and producers of disposable e-cigarettes. Many manufacturers are relying on the FDA's PMTA process for approval. In an interview with 2FIRSTS at TPE, it was revealed that many e-cigarette companies have invested tens of millions, and even hundreds of millions, of dollars into the PMTA process.
So far, only a few companies including Phillip Morris, Reynolds, NJOY, Logic and American Smokeless have been approved by the CTP. JUUL, a top electronic cigarette company in the US, saw its sales plummet after being removed by the FDA. With millions of applications, permission for multiple flavored e-liquids is crucial for the interests of major manufacturers.
Altria was willing to let go of JUUL and acquire NJOY for $2.75 billion, as NJOY is one of the few e-cigarette companies that ultimately received PMTA qualification.
The FDA has consistently taken a cautious approach to flavored e-liquids and has made it clear that, for closed-system electronic cigarettes, unauthorized flavors cannot be sold in the US market, except for tobacco flavor. The FDA is unlikely to change its position in the short term.
Offering a variety of flavors could be a selling point for open-system vaping products. According to Zheng Zhi, the United States may impose restrictions on the management of separately packaged e-liquids and open-system distribution channels.
He noted that "multiple flavors are only available in bottled e-liquids, which are sold exclusively in specialty vape shops." By isolating online purchasing channels, a pure offline regulatory model may be the future direction of development.
This approach combines mainstream criticism of multi-flavored electronic cigarettes in the United States with the cost considerations of American e-liquid manufacturers. If e-liquid manufacturers can prove through clinical and non-clinical trials that multi-flavored electronic cigarettes have no more impact on health than tobacco-flavored products, the FDA may lift flavor restrictions on open-system products.
Zheng Zhixiang believes in the FDA's commitment to scientific rigor. "The FDA is an institution that is 70% oriented toward technology and science, and 30% oriented toward politics. It is still more science-oriented in its approach to work. If guided purely by politics, they could simply ban e-cigarettes.
Challenges and Opportunities Coexist
Currently, China is the world's largest producer of electronic cigarettes. In January 2020, a FDA inspection team visited the factories of Smoore and Heyuan Technology for inspection, which allowed the FDA to learn about the processes and regulations of electronic cigarette production.
Zheng Zhi summarized that the draft rules also referred to the experience gained from the inspection of Simore and Heyuan Technology.
As some of the experiences from Chinese e-cigarette manufacturers have been accepted by the FDA, it is difficult to avoid referencing the experiences of Chinese e-cigarette manufacturers during the FDA's rule-making process. These large-scale industry leading enterprises have a subtle, yet influential impact on the regulations of the industry. The landscape of the e-cigarette industry will change after the implementation of the TPMP.
On April 12th, CTP will hold a public hearing followed by a 180-day comment period. After incorporating feedback from the public comment period, the revised TPMP will be implemented at a later date.
The FDA is undoubtedly the architect of this process, and with the implementation of TPMP, the qualification criteria for PTMA will become more transparent. This will not only speed up the approval process but also alleviate industry criticism of CTP. However, the FDA still holds the power to control the game and following the regulations does not guarantee approval. Influenced by American political sentiment, the FDA cannot ignore its own political value as a public institution.
According to Zheng Zhi, "politically speaking, there are standards here, but the implementation of these standards depends on one's own discretion." The United States' economic strategy is to break away from its dependence on a single market. Zheng Zhi discussed the US' actions towards Indian pharmaceutical companies, which were originally just regular suppliers for the US pharmaceutical market. However, in subsequent development, India's generic drugs have almost monopolized the US market. According to the "India 2021-2022 Economic Survey" released by the Indian Finance Department, the total value of drug exports during the period from 2020 to 2021 was US$ 24.4 billion, and the largest exporting country was the United States, which supplies 40% of the country's generic drug demand. The United States realized that relying too much on India, so it began to look for Chinese pharmaceutical companies as suppliers to balance India.
Zheng Zhi believes that the United States sees countries as suppliers, and the same applies to the electronic cigarette industry. To address these risks, Zheng suggests that manufacturers obtain PMTA as soon as possible, with scientific reports and through data review and TPMP inspections. Applying earlier can provide advantages in avoiding short-term political risks and obtaining US listing qualifications. This may be the direction for industry manufacturers to move towards.
This is not unfamiliar to domestic manufacturers.
In October 2022, the State Administration for Market Regulation released a mandatory national standard for electronic cigarettes, marking the beginning of a reshuffling of the domestic e-cigarette industry. Following the full implementation of the TPMP, the "Matthew effect" will be validated among the remaining e-cigarette manufacturers. However, for domestically grown e-cigarette businesses, the increase in factory standards will actually serve as protection for tech-savvy e-cigarette firms.
He explained, "It is well-known that the pharmaceutical industry is very profitable, but without a solid foundation, one cannot work in this industry. The same applies to e-cigarettes, and in the future, the entry requirements will gradually improve and become stricter. Small workshops will no longer be necessary.
Currently, e-cigarette manufacturers still have time to catch up. Their focus should not solely be on investing in hardware equipment. As the management standard system gradually establishes, companies should invest in management personnel, set up corresponding management positions, and train employees to operate correctly. This also includes the cost of making mistakes. To achieve this, they must study and follow the TPMP guidelines.
Implanting ideas into the minds of others is the most difficult task and cannot be achieved in the short term," said Zheng Zhi.
There are a few different ways to approach this request, as "standard journalistic English" can vary depending on the specific publication or writing style. However, one possible version of a translation could be: Zheng Zhi, also known as Zhi Zheng, is a Chinese professional footballer who currently plays as a midfielder for Guangzhou Evergrande Taobao in the Chinese Super League. He was born on August 20, 1980 in Shenyang, China, and began his career with the Shenyang Haishi team in 1998. Since then, he has played for a number of clubs both in China and abroad, including Charlton Athletic in England and Celtic in Scotland. With over 50 appearances for the Chinese national team, Zheng is considered one of the country's most successful footballers.
The individual obtained a Bachelor's degree in Pharmaceutical Chemistry from Shenyang Pharmaceutical University and a Master's degree in Pharmaceutical Science from the Tshwane University of Technology in South Africa.
WHO PQ Drug International Accreditation Program hires external consultants.
Translator for the UN Population Fund's Good Manufacturing Practice inspection.
Auditor for domestic raw material pharmaceutical factories in the EU EMEA region.
With 18 years of experience in international drug certification and 4 years of experience in electronic cigarette product certification in the United States through the PMTA process.
In August of 2019, this individual joined Shenzhen McWell and assumed full responsibility for the FDA PMTA certification project.
Shenzhen Ziyuan Technology was established in February 2021.
Specializes in international certification and registration of electronic cigarettes, the design of both non-clinical and clinical trials, environmental assessment, and TPMP systems.
Further reading:
The FDA has introduced new regulations for electronic cigarettes known as TPMP. Experts are interpreting the guidelines and procedures for factory inspections.
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