FDA Rescinds Several Tobacco Product Marketing Denial Orders

Products may continue to be marketed until agency completes further review of PMTA
FDA building
Photograph: Shutterstock

LAKEVILLE, Minn. —A federal court set a deadline of Sept. 9, 2020, for manufacturers to file premarket tobacco product applications (PMTAs), and the agency received PMTAs for millions of electronic cigarette and other tobacco products. This same court ordered required the FDA to complete a substantive review of all filed PMTAs within one year, or Sept. 9, 2021.

Given the volume of applications, and the detailed scientific and other information filed to support each PMTA, the FDA was unable to complete the review process for all the applications by the court-imposed deadline, but has indicated that it has finalized about 98% of the filed PMTAs and continues to review the remainder.

While making determinations on the PMTAs, the FDA has issued a Marketing Denial Order (MDO) to many different companies for a variety of brands and types of products. The impact of the issuance of an MDO is that any product for which an MDO is issued must not be marketed; that is, it must be removed from the market and retail store shelves immediately.

In some instances, the manufacturers which filed PMTAs and received a MDO have sought, through various avenues, further review by the FDA, and at this time, several applicants have been successful in obtaining further review. On some PMTAs, the FDA had noted in a MDO letter that the PMTA did not include the information that the applicant was required to file for the agency to properly review the product to determine whether the product is “appropriate to the protection of the public health.” 

This standard, which FDA refers to as APPH, means the manufacturer must demonstrate that the product had met certain criteria which provides an adequate basis to conclude that, for public health purposes, it was better to allow marketing of the product than not allow it to be sold. A marketing authorization order does not mean that the FDA “approves” of the product, and the few applications that have thus far been issued marketing authorization orders by the FDA clearly state that the manufacturer may not state or suggest that the product has “FDA approval” or any similar message.

In several instances involving MDOs issued by the agency, the FDA has agreed with the manufacturers and subsequently rescinded the MDOs for these products or granted an agency stay regarding enforcement of the MDO, meaning that the products may continue to be marketed until such time as the FDA completes further review of the PMTA. According to a non-comprehensive listing on the FDA’s website, as of Nov. 1, MDOs issued to the following applicants were either rescinded by the agency or the subject of an agency or court stay putting enforcement on hold:

  • Avail Vapor LLC
  • Bidi Vapor
  • Fumizer
  • Gripum LLC
  • My Order
  • Turning Point Brands
  • Vapetasia LLC
  • Wages & White Lone Investments dba Triton Distribution

Again, the fact that the MDO may be rescinded or put on hold does not imply that their marketing will be granted in the future, as the FDA must continue its thorough review of all PMTAs, including the applications for which MDOs have been rescinded. Retailers should be cautious when considering this information. Due to the sensitive and proprietary nature of the PMTA process, the FDA is not at liberty to provide some details on these matters and may be unable to publish information on the status for some products at all. Also, it should be noted that the MDOs at issue may not relate to all the products for which the applicant submitted PMTAs.

If a retailer is unsure of whether a tobacco product or electronic nicotine product can legally be sold, the retailer should contact the manufacturer and request verification whether the company’s PMTA has been denied, remains under review, or has been authorized.

Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.

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