In November of last year, we wrote about how Total Wine & More jumped into the cannabis drinks arena in Minnesota. Since then (and probably before that), there’s been an influx of “THC Beverages” hitting the marketplace, and I don’t mean the state-licensed cannabis marketplace either. At this point, you can buy these drinks online or in person at a number of retail outlets and locations that don’t have any kind of state cannabis licensing at all (here’s one in Alabama, for example). How, you may be asking, is this legally possible and why are these libations picking up great speed with consumers?Continue Reading What’s in Your “THC Beverages”?

Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When speculation about the Feds starts to explode in the industry, I usually ignore most of it as fairly useless hearsay backed by a lot of hope, negativity, and/or hypotheticals.

This time, the tea leaves surround the number one question in the industry, will there be a 2024 marijuana reschedule from the Drug Enforcement Administration (DEA) on the back of the Department of Health and Human Services (HHS) schedule III recommendation? Namely, is a marijuana reschedule imminent that could change the entire course of success for the industry? Continue Reading All the Outcomes of a Marijuana Reschedule

In October 2022, President Biden asked the Department of Health and Human Services (HHS) and the Attorney General to review how marijuana is scheduled under federal law. In August 2023, the HHS marijuana recommendation went to the Drug Enforcement Administration (DEA). In October 2023, HHS released a heavily redacted copy of its recommendation to DEA. And until last Friday, no one outside of Bloomberg News and choice government insiders had seen the totality of the HHS marijuana recommendation. However, thanks to a Freedom of Information Act legal battle by lawyer Matt Zorn, the public can now see all 252 pages of (and related to) HHS’s marijuana recommendation to DEA. Continue Reading HHS Marijuana Recommendation Now on Blast

As the cannabis industry continues to navigate choppy economic and legal waters into 2024, some cannabis companies are pivoting to the smokable herbs market. And I do not mean to those hemp-derived intoxicating cannabinoids (HDIC) either (which are part of a legally precarious loophole anyway depending on who you ask). The smokable herbs to which cannabis companies and entrepreneurs are turning to are things like wormwood, valerian, tarragon, and mugwort (among others). Of course, these smokable herbs face a different set of legal and compliance issues altogether than hemp and/or cannabis do.Continue Reading A Cannabis Pivot to Smokable Herbs

Many states with cannabis legalization have manufacturer and dispensary licensees that make and sell cannabis-infused beverages and even cannabis-infused drink mixes. What you don’t usually see is a major liquor retailer carrying any form of cannabis drink. Why? First, states with cannabis legalization on the whole ban alcohol and cannabis being mixed together in a single beverage, and, second, major liquor retailers won’t bother getting a state cannabis license due to a multitude of legal issues, including federal law and how it conflicts with cannabis negatively impacts alcohol licensing. However, Total Wine & More (“Total Wine”) is breaking the mold by offering cannabis drinks in Minnesota.Continue Reading Cannabis Drinks Hit Total Wine

Creating further confusion and uncertainty in the hemp derived cannabidiol (CBD) markets, the FDA has determined that the existing regulatory frameworks for food and supplements are not appropriate for CBD. The FDA cited various safety concerns as the impetuous in making this determination.

FDA has concluded that a new regulatory pathway for CBD is

The Federal Trade Commission (“FTC”) has joined the U.S. Food and Drug Administration (“the “FDA”) in enforcing laws related to marketing CBD products. The FDA has historically issued warning letters and pursued companies that illegally market CBD products with claims the products may treat medical conditions.  The FTC has joined the FDA is this pursuit and announced settlements with six different CBD companies involves fines ranging between $20,000-$85,000 in addition to notifications provided to consumers.  Pursuant to these settlement agreements the respondent companies are also prohibited from similar marketing efforts in the future, any health claims must have scientific evidence to support them.

Industry actors making any health or therapeutic claims are vulnerable to action by agencies such as the FDA and FTC, however, they may also be subject to civil suits based on enforcement by those agencies. In April of 2020 Charlotte’s Web Holdings, Inc. (“CWB”) was served with yet another (its second) class action lawsuit due to how their products are labeled. Benson v. Charlotte’s Web Holdings, Inc., No. 1:20-cv-00418 (N.D. Ill.)  The suit based a significant portion of the allegations on FDA guidance:

 “Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement”

Companies facing enforcement actions by the FTC may similarly be subject to civil allegations.

WHAT DOES THIS MEAN FOR YOUR BUSINESS
Continue Reading CBD Companies Now Facing Monetary Penalties For Deceptive Marketing, Will Civil Liability Follow?

With the legalization of industrial hemp, many are eager to jump into the booming market for cannabidiol (CBD) and hemp-infused products. However, for manufacturers and retailers of ingestible CBD products in particular, it is prudent to look before jumping headfirst onto the “green wave.”
Continue Reading Ride the “Green Wave” with Caution: Enforcement Against Companies Selling CBD Products Continues

The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD).  The Warning Letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims.  The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.

The fifteen (15) Warning Letters, each dated November 22, 2019, were issued to companies for marketing various CBD products. The products identified in the Warning Letters spanned conventional foods, dietary supplements and animal products.  FDA made specific mention in several Warning Letters about statements regarding the use of CBD products in infants and children.
Continue Reading FDA States CBD Is Not GRAS for Use in Food, Issues More Warning Letters

Beginning this summer, the Food and Drug Administration (FDA) through its Office of Criminal Investigations, launched a criminal probe to investigate the vaping-related lung illnesses that have affected over five hundred people across the United States. The Centers for Disease Control and Prevention (CDC) has a parallel investigation tracking the incidences of the illness. Both the FDA and CDC are working with state and local health officials to investigate the increasing number of cases nationwide.
Continue Reading FDA Announces Criminal Investigations of Vaping-Related Illnesses