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.
The United States’ retail cannabis industry continues exploding, and it doesn’t show any signs of slowing down. These numbers are guaranteed to change after this Tuesday’s election, but as of October 2022, 37 states have legalized some form of medical cannabis, and 19 have legalized the substance for recreational use. Now, only 3 states remain with no cannabis access laws on the books. Retail cannabis sales in the U.S. are projected to exceed $33 billion by the end of 2022. As the industry continues to boom, retail landlords have increased opportunities to diversify their retail spaces by leasing to cannabis tenants. However, with these new opportunities come unique challenges and important considerations landlords should address as they prepare to lease to tenants in this new sector of the market.
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
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.
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.
Husch Blackwell attorneys, Mike Annis and Emily Lyons provide an overview on the latest from the Association of Animal Feed Control Officials (AAFCO) and the U.S. Food and Drug Administration (FDA) regarding when and where hemp or hemp produced cannabidiol (CBD) can legally be used which could be of particular interest to animal feed and
Today, the U.S. Food and Drug Administration held a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including cannabidiol (CBD). Read more about what topics FDA expressed interest in receiving comments.
On May 28, 2019, the United States Department of Agriculture (the “USDA”) and the Office of the General Counsel (the “GC”) issued a legal opinion on the status of hemp following the passage of the 2018 Farm Bill. The opinion confirms: first, hemp must be produced under the 2014 Farm Bill until the USDA creates
The Alcohol and Tobacco Tax and Trade Bureau (TTB) recently issued an industry circular which makes clear that cannabidiol (CBD), a product derived from hemp, is not permitted in alcohol beverages.
Read the full post here.