- Toxicological Study
- Clinical Study
- Other Parts
Pre-market Tobacco Applications
Any modified tobacco product that was commercially marketed after February 15, 2007 must approved by the U.S. Food and Drug Administration, which is determined with respect to the risks and benefits to the population as a whole, including users and non-users of tobacco products.
Any tobacco product that was commercially marketed in the United States on February 15, 2007 does not require an application. If you were marketing a deemed tobacco product that is new and that was on the market as of August 8, 2016, you were required to submit a marketing application. The submission due date is September 9, 2020.
Firstunion Group always puts product safety in the first place and is committed to being responsible to the industry, users and society. After more than a year of work, we have completed more than 100,000 pages of application material evidence to support our claims, and multi-faceted testing data and reports prove that our products are suitable for protecting public health.
We believe that under the new regulatorys, a fair and honest PMTAs process will be adopted to establish a higher standards for the industry to meet the needs of development for industry. By assisting customers to apply with PMTAs services, protect the health and safety of global consumer users, and promote the orderly and sound development of the industry.
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