The U.S. Food and Drug Administration (FDA) issued two new rules and slightly revised the PMTA process. Although there are no substantive changes, it emphasizes that disposable products are better than open systems.
The published rules provide additional information on the content, format and review requirements of pre marketing tobacco product application (PMTA) and substantive equivalence (SE) reports, which are the two most common ways for manufacturers to obtain marketing authorization for new tobacco products.
The purpose of these rules is to ensure that all future submissions contain the basic information required to determine whether the new product effectively meets the relevant pre market requirements. "These final rules are an important part of the FDA's comprehensive approach to tobacco product regulation, including pre-market application review, the scientific use of product standard authority, and priority compliance and enforcement actions," said Dr. Janet Woodcock, FDA acting commissioner.
"The FDA is committed to protecting Americans from tobacco related diseases and deaths by ensuring that new tobacco products are subject to appropriate regulatory review to determine whether they meet the public health standards set by law. If new tobacco products do not meet the standards of these channels, they cannot be sold or sold in the United States," she added.
Mitch Zeller, director of the FDA tobacco products center, added that these new rules should make the applicant's process more efficient. "These final rules will provide greater clarity and efficiency in reviewing new tobacco products by describing the information that any company must provide when seeking to sell new tobacco products in the country," he said.
Disposable products are used more than open systems
In other news, a report recently released by ecigi intelligence analyzes more than 6 million submitted data received by FDA, emphasizing that the analysis shows that there are hundreds of applications for simpler disposable and cigarette like devices compared with open system hardware. These types of products often come from large companies such as tobacco manufacturers, while open systems are often produced by smaller professional enterprises.
Of the approximately 200 open systems brands available today, only about 30 have submitted PMTA applications to FDA. Even if all of these are approved, this difference means that about 85% of open system hardware brands will soon disappear from the market. "This may indicate that non tobacco companies are facing setbacks in applying for PMTA approval," said Tim Phillips, managing director of ecig intelligence.