FDA Plans to Revisit PMTA Process in 2018 and 2019

FDA Plans to Revisit PMTA Process in 2018 and 2019

September 20th, 2018 // 2:24 pm @ jmpickett

Approximately one year after it announced a tobacco strategy that features nicotine levels in regular cigarettes and other similar measures to cut tobacco use, FDA stated that it intended to take another look at the process it uses to evaluate new products containing tobacco, as well as how the agency approves them for sale and marketing in the US.

The current regulatory process, which involves what many experts in the tobacco industry describe as a complex and expensive endeavor with the PMTA or premarket tobacco application, as well as a modified risk tobacco product application or MRTPA, will be under an FDA review. It will include a period for public comments, as well as a 2-day public meeting from Oct. 22-23 at HQ for FDA in Silver Spring MD.

Next steps for the agency in the tobacco regulatory space are:

• FDA will propose basic rules: FDA states on its website that regulatory authorities and industry must be on the same page about the rules of the road on premarket applications. FDA is working on new rules to assist the industry on things such as substantial equivalence, PMTAs, MRTPAs, and tobacco product manufacturing practices. These rules will be published in the next few months. FDA states it will provide a clear, modern and science-based framework for tobacco manufacturing practices, as well as developing of tobacco product applications.
• Public meeting: FDA will have its public meeting on tobacco premarket application and review processes at FDA HQ in October 2018. The purpose of the meeting is to allow comments on FDA processes and offer a venue for specific suggestions on how they can be improved. Possible discussion topics will be on how to get more efficiency in the review process and still protecting the health of the public. Also, FDA will discuss how to review products that are ‘new’ because of changes that were made to comply with the product standard.
• Develop e-cigarette product standards: FDA is also looking at developing a product standard for e-cigarettes to deal with existing industry and agency concerns. The agency will look at toxicant levels and impurities in nicotine, glycerin and glycol in e-liquids.
• How to accelerate FDA enforcement: FDA wants to be able to act more efficiently when it becomes aware of violations that affect how youth use e-cigs, including illegal marketing of the products to youth. FDA knows it needs to be faster and more efficient as it identifies new risks. FDA also is learning of some companies that could be marketing new products that they brought out after the FDA compliance period and were not subject to premarket review. These items are being marketed against the law and outside of agency compliance regulations.