The Regulatory Roundup

Food & beverage, cannabis, tobacco, life sciences, and agriculture regulatory updates

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By: Saul Ewing Arnstein & Lehr

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Latest from The Regulatory Roundup

FDA Issues Round of CBD Warning Letters and Revised Consumer Update, Restates Potential Risks and Unknowns On November 25, 2019, the U.S. Food and Drug Administration (FDA or the Agency) announced that it had issued Warning Letters to 15 companies for illegally selling products containing cannabidiol (CBD). Simultaneous with its latest round of CBD-related enforcement, the Agency also published a revised Consumer Update, in which it detailed specific safety concerns and questions about CBD…
USDA Issues Long-Awaited Hemp Production Rule, Some Questions Answered, Many Remain On October 29, 2019, the U.S. Department of Agriculture (USDA) issued a pre-publication version of its long awaited hemp production interim final rule. Public comments are due 60 days after USDA publishes the rule in the Federal Register. While we are still digesting the 161-page rule, below are our initial observations regarding the rule. USDA State and Tribal Plan Review, Producer Compliance Per…
Overview This week, Pennsylvania Senators Daylin Leach (D-Montgomery/Delaware) and Sharif Street (D-Philadelphia) introduced a bill, the “Adult-Use Cannabis Act” (Senate Bill 350), that would legalize adult-use (i.e., recreational) cannabis in the Commonwealth. If passed, the bill would legalize adult-use cannabis for individuals 21 years of age and older, and establish a permitting process for growers, processors, and dispensaries; the current measure would not place a limit on the number of permits that could be issued.…
House Passes First-Ever Standalone Cannabis Reform Bill, SAFE Act Would Provide Cannabis Businesses With Much Needed Banking Access On September 25, 2019, the U.S. House of Representatives overwhelmingly passed the Secure And Fair Enforcement (SAFE) Banking Act (SAFE Act) by vote of 321 to 103. If it passes the U.S. Senate and is signed into law, it would prohibit federal banking regulators from penalizing a depository institution simply because the bank provides services to legitimate marijuana-related…
In Response to Vaping-Related Deaths and Injuries, Trump Administration To Ban Flavored E-Cigarettes; Impact on CBD an Open Question On Wednesday, September 11, 2019, in response to a number of highly-publicized vaping-related deaths and illnesses, the Trump Administration (the Administration) announced its intention to ban most flavored e-cigarette products.  While the Administration’s proposal would target nicotine-containing e-cigarettes, regulated by the U.S. Food and Drug Administration (FDA or the Agency) as tobacco products, it is not…
FDA Publishes Court-Ordered Cigarette Graphic Warning Proposed Rule, Industry Challenge Expected On August 15, 2019, the U.S. Food and Drug Administration (FDA or the Agency) published a court-ordered proposed rule that, if finalized, would mandate graphic health warnings for cigarette packaging and advertisements to “promote greater public understanding of the negative health consequences of smoking.”   FDA’s proposed warnings are undeniably graphic and feature “photo-realistic” images of “some of the lesser-known, but serious health risks…
NJ Establishes Permanent Hemp Program, Friendlier Environment for CBD Than NY and PA On August 9, 2019, New Jersey Governor Phil Murphy signed A5322 into law, making the Garden State the latest to establish a permanent program for the cultivation, handling, processing, transport, and sale of hemp and hemp-derived products. A5322 is immediately effective and it repeals New Jersey’s prior Industrial Hemp Pilot Program, which went into effect in 2018. Consistent with the Agriculture Improvement…
NJ Establishes Permanent Hemp Program, Friendlier Environment for CBD Than NY and PA On August 9, 2019, New Jersey Governor Phil Murphy signed A5322 into law, making the Garden State the latest to establish a permanent program for the cultivation, handling, processing, transport, and sale of hemp and hemp-derived products. A5322 is immediately effective and it repeals New Jersey’s prior Industrial Hemp Pilot Program, which went into effect in 2018. Consistent with the Agriculture Improvement…
Although hemp is now federally legal, as a result of the enactment of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) late last year, the Alcohol and Tobacco Tax and Trade Bureau (TTB) recently declared that adding hemp-derived cannabidiol (CBD) to alcohol beverages is impermissible. By way of background, and as we discussed previously, on December 20, 2018, President Trump signed into law the 2018 Farm Bill.  Among other things, the 2018…
As Outgoing FDA Commissioner Addresses CBD Regulations and Upcoming Agency Hearing, FDA and FTC Issue Warnings to CBD Marketers On April 2, 2019, outgoing U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., further addressed FDA’s approach to cannabis-containing and cannabis-derived products (e.g., cannabidiol (CBD)-containing products). Background As discussed previously, in response to the Agriculture Improvement Act of 2018 (2018 Farm Bill) being signed into law, which legalized hemp, Gottlieb…