Food, Drug & Agriculture

Blogs RSS Link

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

…
Continue Reading USDA Issues Long-Awaited Hemp Production Rule, Some Questions Answered, Many Remain

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…
Continue Reading Pennsylvania Senators Introduce Recreational Marijuana Legalization Bill

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

…
Continue Reading House Passes First-Ever Standalone Cannabis Reform Bill, SAFE Act Would Provide Cannabis Businesses With Much Needed Banking Access

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

…
Continue Reading In Response to Vaping-Related Deaths and Injuries, Trump Administration To Ban Flavored E-Cigarettes; Impact on CBD an Open Question

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

…
Continue Reading FDA Publishes Court-Ordered Cigarette Graphic Warning Proposed Rule, Industry Challenge Expected

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),

…
Continue Reading NJ Establishes Permanent Hemp Program, Friendlier Environment for CBD Than NY and PA

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 …
Continue Reading Following FDA’s Lead, TTB Prohibits Hemp-Derived CBD in Alcohol Beverages

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

…
Continue Reading As Outgoing FDA Commissioner Addresses CBD Regulations and Upcoming Agency Hearing, FDA and FTC Issue Warnings to CBD Marketers

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)

…
Continue Reading Food Regulatory Update: FDA Issues Final Recall Guidance and Plans Strengthened Dietary Supplement Oversight, States and Cities Ramp Up CBD Enforcement

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…
Continue Reading Florida Cannabis Roundup—First Quarter 2019

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

…
Continue Reading Farm Bill Signed Into Law, Legalizing Hemp. What Can We Expect? FDA’s Response Sheds Some Light.

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…
Continue Reading DEA Schedules First FDA-Approved Cannabis-Derived Drug as Schedule V

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

…
Continue Reading Ninth Circuit Holds that Restaurant Workers in Dual Jobs are Entitled to Greater Wages

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 (i.e., fines) to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this

…
Continue Reading FDA Takes Sweeping Enforcement Action to Address “Epidemic” of Youth E-cigarette use, Could Move to Significantly Restrict Flavored Products

On June 5, 2018, the U.S. Food and Drug Administration (FDA or the Agency) and the U.S. Department of Agriculture (USDA) announced the alignment of USDA’s Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the Agency’s FDA Food Safety Modernization Act (FSMA) Produce Safety Rule (Rule).
Under the aligned program, USDA Secretary Sonny Perdue observed that “[s]pecialty crop farmers who take advantage of a USDA Harmonized GAP audit now will have a much greater likelihood of passing a FSMA inspection as well.”
Despite the differences between USDA H-GAP and FDA’s Produce Safety Rule, the agencies…
Continue Reading FDA and USDA Collaborate to Streamline Produce Safety Requirements for Farmers

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 would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content.  Under

…
Continue Reading Food Regulatory Update: Bioengineered Disclosure Coming to a Food Label Near You; Menu Labeling Rule Goes Live Today, May 7th – Are You in Compliance?

Food, Drug & Agriculture Blogs

The Regulatory Roundup