The applications did not provide sufficient evidence to show comparative health risk data.Read More
The agency said the product applications covered a variety of flavored e-cigarettes, including menthol.Read More
Among other things, the company believes the FDA’s marketing denial order was ‘arbitrary and capricious.’Read More
Based on the latest status report, the FDA plans to have 55 percent covered by Sept. 30. Read More
The CTP created a fact sheet to help with amending applications and a video to help navigate the CTP portal.Read More
Judges agree that the FDA changed the decision-making criteria after the PMTA submissions were made.Read More
R.J. Reynolds Vapor Co. was granted a stay by the Fifth Circuit Court of Appeals on Monday.Read More
The FDA said the products did not demonstrate its menthol products provide an added benefit.Read More
The FDA also announced it issued a refuse-to-accept letter to a company that submitted 17 million PMTAs.Read More
News This Week
PMTA
Regulation
U.S. FDA
U.S. FDA Files First Civil Money Penalties for Illicit Sales
Manufacturers of e-liquids could pay nearly $20,000 per violation for selling vaping products without approval.Read More
