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FDA issues warning letter to Electronic cigarette enterprises

Time: 2023-07-02

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From January 2021 to June 2023, the FDA Tobacco Center (CTP) issued over 570 warning letters and took multiple enforcement actions.

On June 29, Brian King, director of the Tobacco Product Center (CTP) of the Food and Drug Administration (FDA), issued an announcement. The following is a summary of the announcement:

In response to the report of the independent expert group organized by the Reagan Iğdır Foundation (RUF) on the evaluation of our center, including our plan to respond to the 15 suggestions put forward in the evaluation report, I announced the "center wide" approach of CTP in February this year. We immediately proceeded to implement the blueprint formulated in the statement and made significant progress.

The following summarizes our progress and next steps. A detailed and updated list of each recommendation can be found on the updated web page "Actions to Respond to the Recommendations of the Reagan Iğdır CTP Assessment".

Horizontal integration

A key recommendation in the report is to create a new strategic plan, and CTP is fully committed to developing this plan. I am pleased to report that CTP plans to release its proposed goals this summer and the final plan in December 2023.

In the past few months, the leadership at all levels of the center has held meetings and had fruitful discussions on the development direction and important plan of the center, including methods to promote health equity in various project areas. This effort was supported by colleagues from the Planning, Evaluation, and Risk Management Office of the FDA Operations Office. As part of the development process, CTP is seeking employee feedback. Public opinion is equally important, and we plan to hold a public meeting in the summer of 2023 to solicit feedback from stakeholders on the strategic plan.

Another horizontal suggestion in the report focuses on transparency, which is the guiding principle for all our efforts. Internally, CTP's Transaction processing Office is leading the development of an operational strategy to improve transparency and information sharing in all project areas, including through the establishment of transparency focal points. Externally, the center is planning an upcoming public meeting to gather opinions from stakeholders. CTP has also published a webpage listing all citizen petitions received by the center related to tobacco products, so that the public can easily access and use relevant information. In addition, the webpage regarding 'Request CTP Speaker' has been updated, listing information on my speeches in public and how to request slides of my speeches.

Scientific and application review

The center has reviewed over 26 million applications for tobacco products in the past three years and has made significant progress, completing the review of 99% of applications. As part of these reviews, CTP has approved 23 kinds of Electronic cigarette products and equipment with tobacco flavor. These are the only Electronic cigarette products that can be legally sold or distributed at present.

We recognize the opportunity to improve the application review process and are committed to engaging in meaningful interactions with stakeholders to seek their feedback on this matter. To this end, CTP is currently planning to hold a public meeting in the autumn of 2023 to discuss the application review process. More information about this public meeting will be released soon.



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WhatsApp:+86 13871529372


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