TPB did in fact submit studies that the agency decided during the PMTA process were needed.Read More
The U.S FDA today issued warning letters to 20 companies for MDO rules, 28 total for PMTA violations.Read More
The rules reflect clarifying changes made from the previous versions, but no significant substantive changes.Read More
The TPB petition forced the FDA to provide an administrative record for its decisions on PMTAs. Read More
Flavors
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PMTA
U.S. FDA
Vaping
FDA Urged to Deny Applications for All Flavored E-Cigarettes
The organizations cite concerns about youth appeal and public health impact of flavored vaping products.Read More
As of Sept. 23, the agency has issued 323 MDOs accounting for more than 1,167,000 ENDS.Read More
The U.S. FDA has issued 295 marketing denial orders (MDOs) to date for flavored e-liquid products.Read More
The U.S. FDA has now issued marketing denial orders to some of the largest e-liquid manufacturers.Read More
The company has not received a marketing denial orders (MDOs) or refuse-to-file letters.Read More
Iowa Attorney General Tom Miller says he become concerned about the impact of the regulatory agency's actions. Read More
