The Regulatory Roundup

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

Latest from The Regulatory Roundup

Website accessibility lawsuits have been on the rise over recent years, hitting businesses in various industries. The most recent one to be hit is the CBD industry. This blog discusses the typical allegations that support a claim under the Americans with Disabilities Act for website accessibility and the unsettled law underpinning these claims.  Additionally, this blog discusses why these cases are being filed in the Eastern and Southern Districts of New York. Click here to view the full article.…
New Year Brings Substantial Changes for Tobacco, Cannabis, and Food and Beverage Industries We saw plenty of significant federal and state policy, regulatory, and enforcement developments for the tobacco, cannabis, and food and beverage industries this holiday season.  Notably, (1) President Trump signed H.R. 1865 into law, which bans the sale of tobacco products to anyone under the age of 21; (2) the Trump Administration finalized its partial ban on flavored e-cigarette products, while the U.S. Food and Drug Administration issued its enforcement policy on unauthorized flavored e-cigarettes that appeal to children; (3) the U.S. Department of Agriculture approved the…
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 products. Although FDA raised these concerns and questions before (e.g., at its May 31, 2019 CBD hearing and in a previous version of the Consumer…
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 the rule, a State or Indian Tribe that wants to have primary regulatory authority over the production of hemp in that State or territory of…
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. The bill would also allow for cannabis delivery, consumption (i.e., “bring your own” or BYO) lounges, and home grow. Under the proposed legislation, the Pennsylvania…
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 businesses (e.g., a cannabis grower, processor, and/or dispensary that is duly licensed by a state with an established medical and/or adult-use cannabis program). The bill would…
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 yet clear that these are the products that have been causing vaping-related deaths and illnesses across the country.  Although federal and state regulators continue to…
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 of cigarette smoking,” including secondary harm to children, fatal lung disease in non-smokers, head and neck cancer, reduction of blood flow (which can lead to…
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 Act of 2018 (the 2018 Farm Bill, which we discussed previously), A5322 specifies that hemp, hemp-derived cannabinoids, and hemp products, including hemp-derived cannabidiol (CBD),…
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 Farm Bill removed hemp from the definition of “marihuana” (marijuana) in the Controlled Substances Act (CSA), thus taking it out of Schedule I.  The Agricultural
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 was quick to remind the public about what the legislation did not change: the Agency’s authority to regulate products containing cannabis or cannabis-derived compounds under…
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 announced plans to strengthen regulation of dietary supplements by modernizing and reforming the Agency’s oversight; FDA and the Federal Trade Commission (FTC or the Commission)…
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 rules adopted by the Florida Department of Health have been the subject of litigation from almost the instant they were enacted or adopted. Currently there…
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 Farm Bill) authorized states to establish agricultural pilot programs or other agricultural or academic research programs to study the growth, cultivation, or marketing of “industrial…
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 low potential for abuse and low risk of dependence) and consisting of preparations containing limited quantities of certain narcotics. Currently, the only FDA-approved drug that meets…
Ninth Circuit Holds that Restaurant Workers in Dual Jobs are Entitled to Greater Wages In an en banc ruling, the Ninth Circuit Court of Appeals reversed the district courts’ dismissals of various actions under the Fair Labor Standards Act (“FLSA”) by former servers and bartenders who alleged that they were not paid appropriate wages for non-tipped work by their respective employers. According to the U.S. Department of Labor (“DOL”) dual jobs regulation C.F.R. § 531.56(e) and its interpretation contained in its 1988 Field Operations Handbook, employees are entitled to the full minimum wage for any time spent in a non-tipped…