FDA Holds Public Hearing on E-cigarette Manufacturing Requirements

On April 12th, the US Food and Drug Administration's (FDA) Center for Tobacco Products held a public hearing to gather input and recommendations on the Proposed Requirements for Tobacco Product Manufacturing Practices (TPMP). Attendees included representatives from the electronic cigarette industry, public health advocates, researchers, and consumers.

A total of 18 participants spoke at the hearing, and 2FIRSTS summarized the important points related to e-cigarette manufacturing discussed during the proceedings. The following is a summary of their findings.

Shi Huiyu, medical manager at Chinese company Ziyuan Technology (previously employed by Stryker Corporation).

Proposal suggests revising Chapter 1120.34 of FDA’s tobacco product standards regarding the use of water in tobacco products. At present, the acceptable standard for Total Particulate Matter Per Puff (TPMP) is the United States Environmental Protection Agency’s (EPA) primary drinking water quality standard. This standard differs significantly from China's national drinking water quality standard and Shenzhen's drinking water quality standard. Compliance with the EPA standard for water monitoring and testing would be complex, expensive, and disadvantageous for Chinese enterprises. Therefore, it is recommended that FDA revise the standard so that the drinking water used in e-cigarette production meets the national standard of the relevant declaring country.

Patrick Murphy, Vice President and Chief Scientist of the Renault Foundation in the United States:

The article suggests that TPMP needs to provide clearer information on how product design, development and changes are carried out, as well as how validation and confirmation activities are conducted. These details are not clearly outlined in current regulations, and the current definition of TPMP does not apply to all types of tobacco products, requiring appropriate and specific explanations for different categories of products.

Retail store owner Delorse Orlando:

As a proprietor of five retail stores, the individual believes that no one is willing to use the few electronic cigarette products that have passed PMTA. They assert that the FDA disregarded scientific evidence and factual information in implementing PMTA and the TPMP proposal, solely focusing on political factors.

Maham Akbar, the director of public policy at the non-profit research organization Truth Initiative in the tobacco industry, stated that...

No tobacco product is safe, and the FDA is urged to address issues such as electronic cigarette labeling errors and battery dangers.

Researcher Michelle Page:

It is recommended that the FDA strengthen guidelines regarding the storage of products containing TPMP, with a particular focus on storage conditions and strict requirements for product expiration dates, especially for e-liquids.

Mark Anton, CEO of a small electronic cigarette manufacturer, stated...

The question was asked as to whether the FDA will provide opportunities for companies that do not comply with TPMP to rectify their non-compliance. It was also stated that TPMP appears to shift the responsibility of the FDA onto the companies, as it requires them to identify any potential risks that may arise throughout the entire production and transportation process, both foreseeable and unforeseeable. This places companies as the primary entity for risk identification, instead of the FDA, resulting in significant obstacles during production activities.

Samy Hamdouche, an employee of a tobacco company who has a cigarette in his mouth:

The existing TPMP regulations are extremely unfriendly to small businesses, as the heavy paperwork requirements prevent them from being able to compete with larger companies on an equal playing field. Additionally, these larger companies largely continue to manufacture traditional tobacco products that are harmful to health, whereas smaller businesses are increasingly focused on innovative reduced-harm products. Strict enforcement of TPMP regulations would stifle the innovation of these reduced-harm tobacco products among small businesses.

Meredith Berkman, co-founder of Parents Against Vaping e-cigarettes (PAVe):

It emphasizes the dangers of tobacco to the population, especially to young people, and demands strict FDA regulation of electronic cigarette products from China. It also strongly calls for the enforcement and acceleration of ENDS regulations.

Jason Hodge, a consumer of cigarettes and e-cigarettes:

As a user of both traditional cigarettes and electronic cigarettes, he shared his personal experience and claimed that nicotine e-cigarettes have no harmful effects. He stated that FDA's concerns regarding nicotine are unfounded.

Anti-tobacco volunteer Pamela Granger:

The desire to end all tobacco sales by 2035 was expressed and concerns regarding e-cigarettes were emphasized, along with specific methods of addressing them.

According to reports, the FDA will weigh the viewpoints of the public and stakeholders, and also convene a Tobacco Product Scientific Advisory Committee on May 18 to hear from independent experts.

Some of the content is sourced from Ziyuan Technology. (Translation to standardized journalistic English is already in the given sentence.)

Further Reading:

1. The FDA will host a public hearing on manufacturing regulations for tobacco and electronic cigarette products. 2. FIRSTS will provide ongoing coverage of the hearing.

Read in English:

During an FDA public hearing about e-cigarette manufacturing, a range of concerns were raised.