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FDA issued MDO to 31 companies applying for PMTA

2021/09/09|Knowledge

The U.S. Food and Drug Administration (FDA) said on Friday, September 3 that it had issued another round of marketing refusal orders (MDOs) to 31 companies, including about 300000 products. "After issuing a marketing refusal order (MDO) to the flavoring [electronic nicotine delivery system] ends products of three companies last week, @ fdatobacco issued MDOs of about 300000 flavoring ends products to 31 other companies from August 27 to September 2," the agency wrote on twitter.

FDA issued MDO to 31 companies applying for PMTA

Several of these MDOs were sent to companies that have not yet been proven to be selling their products. Regulators did not publish the names of these companies.

According to its website, FDA does plan to publish the names of companies that receive MDOs. Previously, the agency only provided the names of the three manufacturers of the first batch of e-cigarette products MDO. "FDA understands that the public may be interested in the specific names of currently marketed products affected by negative decisions," the FDA website said "However, before publishing this information, FDA needs to ensure that the agency does not publish the applicant's trade secret information. Due to the large number of products involved, sharing this information requires additional time and resources. Therefore, FDA is actively exploring options related to this."

In a press release, the FDA said that companies receiving these MDOs may have submitted pre marketing applications for other products, "(such as ends devices, tobacco flavored ends, or peppermint flavored ends)," these products, and if these products are still waiting, they are still under FDA review.

The press release said: "the FDA continues to make substantial progress in reviewing the unprecedented number of applications received by September 9, 2020, which is the deadline for the court to order the submission of pre marketing applications considered new tobacco products." "summary information on these actions will be provided on our regularly updated tobacco product application: indicators and reports page."

1000puffs Single Use Electronic Cigarette

1000puffs Single Use Electronic Cigarette

As of September 3, the FDA website listed 27 companies that had received MDOs:

▪  Great American Vapes

▪  JD Nova Group LLC

▪  Vapor Salon

▪  Big Time Vapes

▪  J-Vapor LLC dba North Shore Vapor

▪  SS Vape Brands Inc. Dba Monster Vape Labs

▪  Custom Vapors

▪  The Vaping Tiger

▪  Gothic Vapor

▪  TrendSetters E-liquid LLC

▪  SWT Global Supply

▪  Diamond Vapor

▪  American Vapor Group

▪  MV Enterprises

▪  Planet of the Vapes

▪  CITTG dba Orgnx E Liquids

▪  Vapors of Ohio Inc. dba Nostalgic Vapes

▪  Buckshot Vapors Inc.

▪  Royalty Premium E Juice

▪  Imperial Vapors

▪  Midwest Vape Supply

▪  Dominant Vapor

▪  Mountain Vaporz

▪  Sir Vapes -A-Lot

▪  Loveli Design LLC dba

▪  Alice in Vapeland

▪  Nicquid

The first MDOs were announced on August 26. JD Nova Group, great American vapes and vapor salon's products did not provide enough information to show that their products provided sufficient benefits to adult smokers to overcome the public health threat posed by the "well-documented and worrying level" of teenagers' use of such products.

FDA has received applications from more than 500 companies involving more than 6.5 million tobacco products. The agency has rejected more than 4.5 million applications from JD Nova Group. FDA must make a decision on the remaining 2 million PMTA applications submitted before September 9, 2020 as soon as possible.

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