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11/10/2021

FDA Takes Second Look at Some PMTAs as Companies Challenge Agency's Marketing Denial Orders

Humble Juice Co., Bidi Vapor and Twist E-Liquids vapor products are among those having their submissions reviewed again.
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SILVER SPRING, Md. — As it works its way through its review of premarket tobacco applications (PMTAs) for newly deemed products, the Food and Drug Administration (FDA) is giving some submissions another look.

On Nov. 5, Humble Juice Co. announced that the agency rescinded the marketing denial order (MDO) issued on Sept. 15 for its flavored e-liquid products with pending PMTAs.

In October, Humble filed a petition with the U.S. Court of Appeals for the Ninth Circuit, challenging the FDA's decision and seeking to have the MDO vacated. Following the receipt of the rescission letter, Humble withdrew its petition. The brand's flavored e-liquids are now back into the PMTA review process.

According to Thousand Oaks, Calif.-based Humble, the FDA's rescission letter states that upon further review it identified information contained in the brand's PMTA that requires additional evaluation.

The agency also stated it will not initiate an enforcement action against any of Humble's flavored e-liquid products with pending PMTAs. Humble will continue to market its products while its application remains in the review process.

"FDA's decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process," said Humble CEO Daniel Clark. "We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble's adult consumers with flavor-filled and affordable e-juice long into the future."

Fumizer LLC

In mid-October, the FDA also notified Fumizer LLC, the manufacturer of Twist E-Liquids vapor products, that the agency rescinded its Sept. 9 MDO for certain flavored vapor products with pending PMTAs. The rescission noted that upon further review the FDA found relevant information that was not adequately assessed previously.

Similar to Humble's products, Sylmar, Calif.-based Twist E-liquids’ products have been placed back into the review process and will continue to be marketed while they remain under review.

Bidi Vapor LLC

The agency also issued a stay on its MDO for Bidi Vapor LLC's non-tobacco flavored BIDI Sticks, pending its review of the company's request that the MDO be rescinded based on product-specific scientific evidence in its PMTAs. The flavored BIDI Sticks can remain on the market without the threat of enforcement while the FDA considers Bidi's request.

Prior to the court-ordered Sept. 9, 2020, PMTA Bidi Vapor submitted PMTAs for all 11 flavor varieties of its BIDI Stick. The applications ran more than 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health. Bidi Vapor received an MDO for its flavored BIDI Sticks in early September 2021.

On Sept. 29, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the Eleventh Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act, as well as the U.S. Constitution.

Accordingly, Bidi Vapor has requested the appellate court to vacate the MDO, and provide additional relief as may be appropriate, including such relief as necessary to ensure that Bidi may continue to market the products subject to the MDO to its adult customers.

"We appreciate FDA's decision to stay, or put on hold, the MDO as it reconsiders its denial. As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored BIDI Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing," said CEO Niraj Patel.

"That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit," Patel added. 

The Melbourne, Fla.-based company has also filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals because of the continued irreparable harm the MDO has caused.

As of late October, the FDA denied PMTAs for 200,000 products and Mitch Zeller, director of the agency's Center for Tobacco Products, said many of the PMTA reviews were in final stages. He added the FDA is being sued for 46 of the refusals.

According to Vapor360, several other manufacturers are challenging MDOs from the agency. To see a list of companies, and updates on the challenges, click here.