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.
CBD Companies Now Facing Monetary Penalties For Deceptive Marketing, Will Civil Liability Follow?
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…
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Ride the “Green Wave” with Caution: Enforcement Against Companies Selling CBD Products Continues
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.”
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FDA States CBD Is Not GRAS for Use in Food, Issues More Warning Letters
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. …
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FDA Announces Criminal Investigations of Vaping-Related Illnesses
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.
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FTC Issues Warning Letters to Three CBD Companies
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.
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FDA Requests Data on CBD and Other Cannabis-Derived Compounds
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.
TTB Prohibits use of CBD in Alcoholic Beverages
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.
Clarity at Last? FDA Announces Plans for Meeting on Cannabis-Derived Compounds
On Wednesday, April 3, 2019, the U.S. Food and Drug Administration (FDA) announced plans to hold a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including cannabidiol (CBD). The public hearing, which is scheduled to be held on May 31, 2019, is intended to obtain scientific data and information…
Unique Issues with Cannabis-related Patents and Their Enforcement
Chapter 1 – The Double-Edged Nature of the FDA Approval Process
2018 proved to be a very busy (and frankly dizzying) year for the cannabis industry as three more states, including Missouri, passed laws legalizing some form of cannabis use, bringing the total number of such states and U.S. territories to well over thirty, despite the fact that cannabis, and its use, remains unlawful, under federal law that is. Today, there are thirty-three states that allow for medical use of cannabis, while ten states have legalized the recreational use of cannabis. What is more, several state governments and governors are expected to prioritize new cannabis-related policies in 2019. As more states decide to permit various uses of cannabis, one issue that remains generally unanswered lies at the intersection of these emerging state laws and U.S. patent law, which falls within the exclusive purview of the federal government, both statutorily and in enforcement of patent rights.…
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