In a May 21, 2020 Vapor Voice article, the Troutman Sanders Tobacco Team discuss the FDA’s enforcement actions against manufacturers and retailers whose electronic nicotine delivery system (ENDS) products and “other components” allegedly target youth. Having targeted flavored e-liquid products, ENDS items that resemble food and ENDS products that resemble devices such as gaming
In recent weeks the U.S. Food and Drug Administration and the Federal Trade Commission have teamed up to prevent companies from advertising and selling products that claim to treat COVID-19. The agencies have specifically targeted companies selling cannabidiol (CBD) products such as Nova Botanix LTD, CBD Online Store, Indigo Naturals, and Native Roots Hemp.
Continue Reading FDA and FTC Target CBD Companies Over COVID-19 Claims
Late yesterday, April 22, 2020, the U.S. District Court for the District of Maryland issued its long-awaited Order formally extending the May 12, 2020 deadline for submitting marketing applications for those deemed “new tobacco products” that were on the U.S. market on August 8, 2016. That deadline is now September 9, 2020.
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In early April, Virginia Governor Ralph Northam signed Senate Bill 918, approving industrial hemp extract, such as cannabidiol (“CBD”), as a food, subjecting it to applicable laws and regulations. The bill defines “food” as “any article that is intended for human consumption. . . [and] does not mean drugs as defined in [Va. Code] § 54.1-3401.” The bill establishes requirements for the production and manufacture of hemp extracts and authorizes the Virginia Board of Agriculture and Services to adopt regulations regarding contaminant tolerances, labeling, and batch testing.
Continue Reading Virginia becomes the most recent state to regulate hemp extracts as food
On April 3, 2020, several tobacco companies, including R.J. Reynolds, Imperial and Liggett, filed suit in a Texas federal court challenging the U.S. Food and Drug Administration’s (“FDA”) March 2020 rule requiring the placement of graphic warnings on cigarette packaging and advertising (“the Rule”).
Continue Reading Tobacco Companies Challenge FDA’s Rule Requiring Cigarette Graphic Warnings
Will the May 12 deadline for premarket tobacco applications and substantial equivalence reports remain in place? The FDA has decisively moved in that direction, but the final answer will depend upon further proceedings
There was a significant development on April 3, 2020, when Judge Paul W. Grimm of the U.S. District Court for the District of Maryland issued an indicative ruling in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), on appeal, Nos. 19-2130, -2132, -2198, -2242 (4th Cir.). Judge Grimm indicated that, “if the case were remanded for that purpose,” he would grant the FDA’s motion to extend the deadline to September 9 “in light of the global outbreak of respiratory illness caused by a new coronavirus.” The case is pending with the U.S. Court of Appeals for the Fourth Circuit, which would have to order a limited remand prior to Judge Grimm’s issuing any actual ruling on the extension.
Continue Reading FDA and Federal Court Move Toward Extension of May 12 Deadline for Premarket Review Applications
The U.S. Court of Appeals for the D.C. Circuit will hear another challenge to the FDA’s rule Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”). The challenges are based on the Constitution’s Appointments Clause and First Amendment. The cases are Moose Jooce, et al. v. FDA, et al., Nos. 20‑5048, -5049, & -5050 (D.C. Cir.).
Continue Reading D.C. Circuit to Hear Appointments Clause Challenge to Deeming Rule; Challengers Request Expedited Consideration
Following its appeal to the U.S. Court of Appeals for the Sixth Circuit, Vapor Stockroom LLC (the “Appellant”) has filed a motion for injunction pending the decision on the merits or, alternatively, for the expedition of briefing, oral argument, and decision of its appeal.
In the Appellant’s words, “The impetus for the present motion . . . is that if this Court fails to grant injunctive relief . . . by May 12, 2020, FDA has threatened industry-wide enforcement action after that date that would require [Appellant] to shutter its business.”
Continue Reading Injunction and Expedition Sought in Sixth Circuit Appeal over May 12 PMTA Deadline
On February 15, 2020, Plaintiff Vapor Stockroom LLC filed a notice of appeal in Vapor Technology Association v. FDA, No. 5:19-cv-00330-KKC (E.D. Ky.). Vapor Stockroom is appealing the district court’s order granting the FDA’s motion to dismiss and denying their motion for preliminary injunction. The Plaintiffs alleged that, in requiring the submission of premarket tobacco applications by May 12, 2020, the FDA violated the Administrative Procedure Act, 5 U.S.C. § 500, et seq., and the Due Process Clause of the Fifth Amendment to the Constitution.
Continue Reading Vapor Company Appeals Dismissal of Challenge to PMTA Deadline
On January 2, 2020, the FDA issued guidance concerning its enforcement priorities for electronic nicotine delivery systems (“ENDS”) and other deemed products on the market lacking premarket authorization (the “Guidance”). Just over a month later, the Comptroller of the State of Maryland has announced that the State will increase its enforcement against certain flavored ENDS products. The State purports to shore up a “loophole” in the FDA’s Guidance.
Continue Reading After FDA Guidance, Maryland Increases Enforcement Against Flavored Cartridge-Based and Disposable ENDS