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On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium cigars” (as defined in the order) until the agency completes a review of the question of “whether a streamlined substantial equivalence process is appropriate for premium cigars.”  The opinion does not throw out the Deeming Rule in its entirety but only remands it to the agency for further consideration of this question.
Continue Reading FDA Premarket Review Process for Premium Cigars Halted

On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” While it contains little “new news,” the draft guidance describes FDA’s current thinking on several topics relevant to clinical research related to development of drugs containing cannabis or cannabis-derived compounds, including sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating delta-9 tetrahydrocannabinol (THC) levels. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.
Continue Reading FDA Issues Draft Guidance for Clinical Research Regarding Cannabis and Cannabis-Derivatives

Relying on the regulatory and legal uncertainty surrounding cannabidiol (CBD), Food and Drug Administration statements and state laws, several class actions have been filed since late 2019 against companies selling CBD products, a number of which have been filed in California federal courts. In at least two cases, courts have adopted defendants’ requests to delay the cases while the FDA continues to study CBD and how it should be federally regulated. These cases could represent a developing “wait and see” approach by federal courts dealing with CBD class action lawsuits.
Continue Reading Federal Courts May Be Trending Toward Delaying CBD Consumer Class Action Lawsuits

Following up the R.J. Reynolds-led challenge to FDA’s updated graphic warning label rule, which was filed in the federal court for the Eastern District of Texas, Philip Morris USA Inc. (“Philip Morris”) filed a second, similar challenge on May 6, 2020, in the U.S. District Court for the District of Columbia, Philip Morris USA Inc., et al., v. U.S. Food and Drug Administration, et al., (No. 1:20-cv-01181).

Philip Morris’ complaint makes many of the same challenges seen in the industry’s 2011 challenge to the previous iteration of the graphic warning rule and alleges that the graphic warning label rule violates the First Amendment for multiple reasons.
Continue Reading Philip Morris USA Leads Second Lawsuit Challenging FDA’s Updated Graphic Warning Label Rule

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