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

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…
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)…
FDA Takes Sweeping Enforcement Action to Address “Epidemic” of Youth E-cigarette use, Could Move to Significantly Restrict Flavored Products ​On Sept. 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) announced a series of significant enforcement actions related to the sale and marketing of e-cigarettes to minors.  According to FDA, this was the largest coordinated enforcement effort in the Agency’s history, comprised of over 1,300 warning letters and civil money penalty complaints…
Food Regulatory Update: Bioengineered Disclosure Coming to a Food Label Near You; Menu Labeling Rule Goes Live Today, May 7th – Are You in Compliance? On May 4, 2018, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published in the Federal Register a proposed rule that, if finalized, will provide a mandatory uniform national standard for disclosure of information to consumers about the bioengineered (BE) status of foods.  More specifically, the proposed rule…
FDA to Evaluate Minimally or Non-Addictive Cigarette Product Standard, Also Plans to Look at Flavors and Premium Cigars Earlier today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels (Nicotine ANPRM).  Gottlieb’s announcement comes nearly eight months after the Agency unveiled its planned tobacco regulatory…