Tuesday, August 13, 2019

On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco products on the market as of the August 8, 2016 deeming rule that extended FDA’s regulatory jurisdiction to include all tobacco products. Accordingly, manufacturers of e-cigarettes now have until May 2020 to submit applications for market approval in order to continue selling their products.

E-cigarette manufacturers have thus far been able to sell products without FDA approval. In 2016, FDA announced its deeming rule that extended its regulatory jurisdiction over these products. Initially, FDA established a 2022 deadline for existing companies to submit applications for FDA approval. FDA requested in the application information about why the applicant companies should be permitted to keep selling these products. FDA decreased the deadline by one year, to 2021, after numerous studies found a sharp increase in the number of teenagers vaping. Unsatisfied with the one year difference, anti-tobacco groups filed a lawsuit[1] against FDA claiming the agency’s lack of urgency threatened public health. During the course of this lawsuit, FDA proposed the ten-month deadline for application submissions and a one-year deadline for approval. The judge noted that the four-month submission deadline for which the plaintiffs advocated was less reasonable and provided less time for applicants to present sufficient information to FDA. The judge’s ruling removed any agency discretion in regards to these deadlines.

In a response to the court order, Acting Commissioner of FDA Norman E. “Ned” Sharpless stated that “FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products. . . .” and “remain[s] committed to tackling the epidemic of youth vaping using all available regulatory tools at our disposal.” Despite the impending deadline, the judge acknowledged that these companies “have large purses and the resources to complete promptly the applications that they have had before them for years.” However, in a brief filed last month FDA noted that by the end of April 2019 it had received over 400 premarket applications, ninety-nine percent of which did not meet the basic requirements. Clearly, it will require more than simply “large purses” to get these products approved.

Companies can look to FDA’s final guidance published in June 2019 for premarket tobacco product applications (“PMTAs”) for ENDS, which include, e-cigarettes, vape pens, and e-liquids. According to Commissioner Sharpless, the guidance provides companies seeking to market e-cigarette and ENDS products with “recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product.” The guidance contains, among other things, the following components: (1) Background regarding FDA’s regulation of ENDS; (2) Products to which the Guidance applies; (3) General procedures for ENDS PMTA review; and (4) Content required in an ENDS PMTA and recommendations for demonstrating appropriateness for the protection of the public health (“APPH”).

ENDS are regulated under the federal Food, Drug, and Cosmetic Act (“FD&C Act” or the “Act”). Under section 910 of this Act, companies and/or persons wanting to market a new[2] tobacco product are required to follow the 905(j) pathway and submit either (1) a report to obtain a substantial equivalence determination or (2) a report notifying FDA of the product’s exemption under the FD&C Act. If the new product is not found to be substantially equivalent to an appropriately identified predicate product, companies must then submit a PMTA and seek a marketing order before marketing the product.

Applicable Products and When a PMTA Is Required

The Guidance applies to three subcategories of ENDS products: e-cigarettes, e-liquids, and “ENDS products that package e-liquids and e-cigarettes together” when they are sold or distributed for consumer use. For example, an e-liquid in a sealed and final package to be sold or distributed for consumer use would fall under FDA’s enforcement scope and be subject to the PMTA requirements.

ENDS PMTA Review

After the company submits its ENDS PMTA, FDA will conduct a preliminary review to determine whether the application appears to be complete on its face.[3] If initially accepted, FDA will then process a filing review, where it determines whether the ENDS PMTA is sufficiently complete to be filed and warrant a substantive review. Under the FD&C Act, once the FDA receives a complete ENDS PMTA and is filed, FDA has a 180-day period to conduct its substantive review and approve or deny the ENDS PMTA. During this substantive review, FDA may request clarification of deficiencies or additional information to supplement the ENDS PMTA.[4] FDA may also inspect manufacturing, clinical research, and/or nonclinical research sites to assess the accuracy and validity of information provided in the ENDS PMTA and confirm that the product and manufacturing process meets applicable standards. In the Guidance, FDA stated that it intends to issue regulations that will contain requirements for tobacco product manufacturing practices.

Contents of an ENDS PMTA

A complete ENDS PMTA must contain the required information under section 910(b)(1) of the Act. In the Guidance, FDA provides a recommended organization of this information, which should have, at a minimum: (1) general information with a cover letter that details any prior FDA submissions for the new product; (2) a table of contents; (3) “Descriptive Information” that describes major aspects of the new product, including an overview of its formulation and design, the nicotine strength, instructions for its use, any restrictions on sale and distribution that would support a showing that its marketing would be APPH, and specific e-cigarette and e-liquid recommendations like battery capacity/wattage and package quantity/type; (4) product samples; (5) proposed labeling that would minimize risk associated with product use (e.g., an e-cigarette’s battery failure warning based on storage conditions); (6) an environmental assessment[5]; and (7) detailed scientific studies and analyses of research findings.

FDA recommended that companies make sure to provide information on how to minimize risks associated with ENDS batteries and to address the likelihood of use and misuse leading to overheating, fire, and explosion. FDA also appeared especially concerned with these ENDS products’ appeal to youth and young adults (e.g., certain e-liquid flavors being more desirable to young adults). In fact, in FDA’s press release for the Guidance, FDA assured it would “explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive with an intense focus on youth.” Recently, FDA appears to be adhering to this pledge with its first launch of youth e-cigarette advertisements.

Commissioner Sharpless encouraged companies to “use this valuable document now as a guide to submit applications,” especially since there are no authorized e-cigarettes on the market.

[1] American Academy of Pediatrics v. Food & Drug Admin., No. 8:18-cv-00883 (D.C. Md. 2019).

[2] FDA defines a “new” tobacco product as one that “was not commercially marketed in the United States as of (i.e., on) February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007.”

[3] FDA’s criteria for acceptance of a premarket submission for tobacco can be found in 21 C.F.R. 1105.10.

[4] As a note, FDA stated that “ENDS product[s] with a differing flavoring variant and/or nicotine strength” are considered different products and therefore must clearly indicate which information pertains to which product when submitting the PMTA for the group of products.

[5] More information on environmental assessments for PMTAs can be found in 21 C.F.R. Part 25.