Category Archives: Cannabis

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FTC Issues Warning Letters to Companies Advertising Their CBD-Infused Products as Treatments for Serious Diseases

Tuesday, the FTC issued warning letters to three companies selling CBD products.  The companies, which FTC did not identify publicly, allegedly illegally advertised CBD products as being able to treat or cure serious diseases and health conditions without competent and reliable scientific evidence to support such claims. As we have written about previously, FTC and the … Continue Reading

NY and Ohio: Recent Legal Changes Diverge on Whether CBD Can Be Added to Food

We’ve written a lot about FDA’s current position on CBD in food and the ongoing process to evaluate a potential non-drug pathway for the ingredient that emerged seemingly out of nowhere to capture the attention of consumers, legislators, and regulators alike.  While we all wait for FDA to announce an update to its review, states … Continue Reading

Court Requires Drug Enforcement Administration To Explain Why Only One US University Can Currently Source Cannabis

As readers of this blog already may know, the Drug Enforcement Administration (DEA) currently allows cannabis – consisting of the marijuana plant, with greater than 0.3% THC content – to be grown for research purposes at only one location: The University of Mississippi. This past June, the Scottsdale Research Institute (SRI) challenged this federally-imposed limitation … Continue Reading

FDA Responds To Congressional Pressure To Speed Up CBD Review

Last week, FDA Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy released a series of tweets indicating that the agency is “expediting” its work towards addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Dr. Abernethy also stated that FDA plans to report on the agency’s progress around the end … Continue Reading

Senator Wyden Again Urges FDA to Clarify CBD Pathway; Agency Extends Comment Deadline and Issues New Communications

On June 25, 2019, Senator Ron Wyden (D-OR) issued a letter urging Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless to take action by addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Specifically, Senator Wyden requested that FDA issue guidance … Continue Reading

USDA Legal Opinion Seeks To Clarify Interstate Transport of Hemp

On May 28, 2019, the United States Department of Agriculture’s (“USDA”) Office of the General Counsel issued a Legal Opinion, which attempts to address open questions relating to interstate transport of hemp. While the 2018 Farm Bill legalized hemp production, the current state of the law as to whether it is legal to transport hemp … Continue Reading

House Appropriations Committee Cautions FDA To Focus on Public Health and Preserve Clinical Study Incentives As It Examines CBD Pathways

Earlier this week, the House Appropriations Committee approved the fiscal year 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill by a vote of 29 to 21. The committee report accompanying the bill included notable language on CBD.  Specifically, it expressed concern regarding potential safety issues such as drug interactions, somnolence, liver … Continue Reading

FDA CBD Public Meeting Features Overwhelming Calls For Robust Regulation and Enforcement; Relaxation of Obstacles to Research

FDA’s CBD Public Meeting featured a full house of manufacturers, researchers, health professionals, trade association representatives, and other stakeholders.  Each speaker was given a few minutes to offer their input in response to FDA’s call for submissions relating to health and safety risks; manufacturing and product quality; and  marketing, labeling, and sales.  Here are key … Continue Reading

California Bill to Allow Hemp-Derived CBD in Foods, Beverages, and Cosmetics

Assembly Bill 228 is a promising piece of legislation that could soon bring an end to California’s prohibition on adding hemp-derived CBD to foods, beverages, and cosmetics.  The bill, in its current form, would add two provisions to the California Health and Safety Code clarifying that food, beverages, and cosmetics are “not adulterated by the … Continue Reading

TTB Updates Guidance on Hemp Ingredients, Follows FDA’s Lead

The Alcohol and Tobacco Tax and Trade Bureau (“TTB”) recently updated its guidance on inclusion of hemp ingredients in beverages containing alcohol. Here’s a summary: • It remains TTB’s policy that it will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances under the federal Controlled Substances Act. • TTB … Continue Reading

FDA and FTC Issue Joint Warning Letters to Three Online CBD Marketers

The FDA and FTC jointly issued warning letters to three companies selling CBD products online. The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”). Although this is the first time the FDA and FTC have issued joint warning letters relating to CBD, the FDA … Continue Reading

Debunking Myths About the 2018 Farm Bill and CBD

The passage of the 2018 Farm Bill capped off a momentous year for cannabidiol, or CBD, a non-psychoactive derivative of cannabis.  As we wrote about here, the year kicked off with the rescission of the Cole Memo, the DOJ’s policy statement regarding enforcement in states where cannabis is legal.  The feared enforcement uptick never materialized, … Continue Reading

California Quietly Outlaws CBD in Foods

Earlier this month, the Food and Drug Branch of the California Department of Public Health (CDPH) updated an FAQ document relative to regulation of cannabidiol (CBD), a non-psychoactive derivative of cannabis, which has been in the news most recently relative to FDA’s approval of a CBD drug to treat rare forms of epilepsy.  CBD is … Continue Reading

Senator Schumer Introduces Legislation to Decriminalize Marijuana at the Federal Level

Making good on this April 20th announcement, Senator Chuck Schumer (D-NY) introduced legislation that would upend current federal regulation of marijuana. Specifically, the Marijuana Freedom and Opportunity Act removes marijuana from the list of scheduled substances under the Controlled Substances Act, effectively decriminalizing it at the federal level.  Under the bill, states would continue to … Continue Reading

Let The People Decide: President Trump Expresses Support for Bill To Protect State Regulation of Marijuana

Earlier this week, U.S. Senators Cory Gardner (R-Colo.) and Elizabeth Warren (D-Mass.) and U.S. Representatives David Joyce (R-Ohio) and Earl Blumenauer (D-Ore.) introduced the bicameral, bipartisan Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act). The purpose of the proposed Act is to protect the rights of individual states, the District of Columbia, U.S. … Continue Reading

Unanimous Recommendation for Cannabis-Based Epilepsy Drug; Trump Administration Lifts Threat of Cannabis Enforcement in States With Legalization; Schumer To Introduce Bill Decriminalizing Marijuana

On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention.  The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals.  The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found … Continue Reading

Advertising Marijuana Businesses: The Federal Criminal Law You Need to Know

As the gravitational pull toward marijuana legalization continues, new sources of revenue continue to emerge. Former Republican House Speaker John Boehner (and former opponent of legalization) recently announced that he joined the board of directors for a cannabis company, and sales of cannabis in California are expected to exceed $3.5 billion in 2018 and to … Continue Reading

AG Sessions Ends Obama-Era Policies Governing Federal Marijuana Enforcement; Sudden Wave of Enforcement Unlikely

Timed almost to the day that California legalized recreational marijuana, Attorney General Jeff Sessions announced on Thursday, January 4, that the Department of Justice has rescinded the Obama-era guidance (the Cole Memo) issued to federal prosecutors relative to marijuana enforcement. The announcement characterizes the move as an effort to restore prosecutorial discretion, noting that the … Continue Reading

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research.  This move is expected to expand and diversify the supply of marijuana for research use.  Under the current policy, the only authorized marijuana manufacturer is the University of Mississippi, which operates under a contract with the … Continue Reading

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat post-traumatic stress disorder, lupus, cancer, and other conditions rendered the products unapproved new drugs. This February, FDA again turned its attention to CBD products, issuing … Continue Reading

HHS Removes Extra Hurdle for Marijuana Research

The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana. Historically, in addition to the standard FDA and Drug Enforcement Administration approvals needed for research … Continue Reading
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