The Regulatory Roundup

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

Latest from The Regulatory Roundup

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…
Food Regulatory Update: FDA Issues Final Recall Guidance and Plans Strengthened Dietary Supplement Oversight, States and Cities Ramp Up CBD Enforcement Despite the cold temperatures across much of the country, federal and state policy, regulatory, and enforcement developments have been heating up in the food and beverage space.  In the last few weeks alone: The U.S. Food and Drug Administration (FDA or the Agency) issued final guidance regarding public warning and notification of recalls; FDA…
Litigation and Legislation For those who may not know, even though Florida’s legislature adopted a low-THC medical marijuana statute in 2014, 71.8 percent of Florida voters adopted a constitutional amendment to legalize all medical marijuana (MMJ) in 2016. See, Florida Constitution, Article X, Section 29. Based on the resistance to implementation of the MMJ amendment by Florida’s executive and legislative branches of government, the statutes adopted by the Florida legislature, and the policies and…
Farm Bill Signed Into Law, Legalizing Hemp. What Can We Expect? FDA’s Response Sheds Some Light. On December 20, 2018, President Trump signed into law the Agriculture Improvement Act of 2018 (the 2018 Farm Bill).  Among other things, the 2018 Farm Bill removes hemp from the definition of “marihuana” (marijuana) in the Controlled Substances Act (CSA), thus taking it out of Schedule I.  By way of background, the Agricultural Act of 2014 (P.L. 113-79) (2014
The U.S. Drug Enforcement Administration (DEA) is expected to publish in the September 28, 2018 edition of the Federal Register an order scheduling U.S. Food and Drug Administration (FDA or the Agency)-approved drugs that contain cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols (THC) in Schedule V. By way of background, Schedule V products are those with a lower potential for abuse than Schedule IV (i.e., a drug product that has a…