Use this button to switch between dark and light mode.

CBD Class Actions Placed on Hold for FDA Rulemaking

June 19, 2020

Many cannabis users say the drug distorts their perception of time, making it feel as if time has slowed to crawl. Now, plaintiffs with lawsuits over CBD-containing products may begin to feel the same sensation.

Two proposed product liability-related class actions involving CBD products have been placed on hold until the U.S. Food and Drug Administration clarifies its regulatory stance towards them. The most recent ruling just came from the Central District of California in Colette et al. v. CV Sciences, Inc. (2020 U.S. Dist. LEXIS 93553).

The term “CBD” comes from cannabidiol, a chemical found in hemp that is non-psychoactive (i.e., it won’t get you high) but is thought to possess “soothing, anti-inflammatory properties.” In the last few years, a world of CBD-containing products has hit the shelves: skin creams, lip balms, sleeping masks, chewing gum, gumdrops, hemp-oil-infused coffee, vape pens, vaporizers and the list goes on.

The timing isn’t coincidental. The 2018 Farm Bill legalized hemp, from which CBD is extracted. Taking that as a green light (pun intended), makers of CBD-containing products got to work.

First, they enticed consumers. But by 2019, they had also enticed a number of class action lawsuits. The litigation only intensified late last year, after the FDA warned 15 retailers about their marketing of CBD products and issued a consumer alert warning that “too little is known about the chemical to say it is safe for consumption.” That designation, if given, would allow companies to use CBD as a food additive without getting FDA approval first.

But the FDA has not put the “safe for consumption” label on CBD, nor has it issued its long-anticipated comprehensive regulations of CBD, despite holding rulemaking hearings as far back as May of 2019. A recent report to Congress did offer some hope that the agency would soon take “clarifying regulatory action.”

In the meantime, defendants are using the regulatory limbo to hold class action lawsuits at bay.

Back in January, the defendant in Synder v. Green Rds. of Fla. LLC (2020 U.S. Dist. LEXIS 1145) won the first stay of a CBD case on this theory. In Snyder, Green Roads of Florida, which makes CBD teas, coffees, syrups and other products, faced a proposed class action claiming that it had misrepresented the amount of CBD in its products. The defendant asked the judge to stay the case based on the primary jurisdiction doctrine, which applies “where a plaintiff’s claims implicate a federal agency’s expertise with a regulated product.” After applying a four-factor test, the Southern District of Florida court determined that the doctrine applied and that the case should await FDA action.

More than five months later, the Central District of California reached the same conclusion in Colette et al. v. CV Sciences, Inc. (2020 U.S. Dist. LEXIS 93553). The defendant in Colette, another proposed class action, makes CBD sprays, softgels and other products. In a nutshell, the plaintiff claimed that they violate the Food, Drug, and Cosmetics Act, based largely on the FDA’s current position that it’s illegal to “add CBD to a food or label CBD as a dietary supplement.

The Colette court agreed with the defendants that the primary jurisdiction doctrine should apply. Although the FDA had issued warning letters to retailers and taking the position that CBD cannot be used as a food additive, the court said, that isn’t the same as a rulemaking. “The fact remains that the FDA has not formally established its position,” Judge Virginia Phillips wrote. The court should wait for that formal establishment here, she said further, given that the case is one of first impression and because the large number of CBD class actions “makes clear the danger of inconsistent adjudications.”

Bottom line: it looks like class action plaintiffs around the country are going to have to wait for FDA action, which has already had a long gestation. As their wait drags on, and time slows down for them, CBD plaintiffs may come to understand the more potent form of cannabis use better than ever.