Delta-8 has been the topic of many conversations over the last year in various cannabis circles. Is it legal? How will hemp-derived Delta-8 THC impact the state-legal marijuana industry? How is Delta-8 THC extracted from hemp and in what quantities? Much of this was already covered in a recent webinar hosted by our firm a
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?
On August 20, 2020, the Drug Enforcement Administration (“DEA”) published an Interim Final Rule on industrial hemp and hemp derivatives (the “Interim Rule”), which immediately went into effect, to conform DEA regulations with the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”).
As we previously discussed, the 2018 Farm Bill effectively removed industrial hemp from the definition of “marijuana” in the Controlled Substances Act (CSA). Additionally, tetrahydrocannabinols contained in industrial hemp, such as Cannabidiol (commonly known as CBD), were also removed from the purview of the CSA.
In our previous post, we touched on the fact that state-legal medical and recreational marijuana businesses (including indirect marijuana businesses) could not receive federal financial assistance due to marijuana’s continued Schedule I status under the Controlled Substances Act (“CSA”). While state-legal medical and recreational marijuana businesses have been adversely affected due to government imposed…
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
Marshall Custer was quoted in the November 11, 2019 edition of Law Week Colorado on the U.S. Department of Agriculture first guidance on how
hemp can be lawfully produced under the 2018 Farm Bill.
Read the article here.
Last week, the US Center for Disease Control and Prevention (the “CDC”) announced what the agency considers to be an important breakthrough in their investigation on vaping illnesses. While the CDC has not ruled out other possible factors, the investigation has revealed a correlation between those suffering from symptoms and Vitamin E acetate. The…
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
The Federal Trade Commission (FTC) sent Warning Letters to three companies that sell products containing cannabidiol (CBD) and advertise that the products prevent, treat, or cure disease without substantiation of the purported health benefits. In a post on Husch Blackwell’s Food & Ag Insights blog, Emily Lyons explains the FTC’s actions and the effect they have on the advertising of CBD products.
Continue Reading FTC Issues Warning Letters to Three CBD Companies