Colorado-based CBD company Infinite Product Company LLC dba Infinite CBD has been sued in federal court by a consumer who says its food and topical cream products are unapproved new drugs sold in violation of federal law.
The U.S. CBD (cannabidiol) product market, which includes a variety of food products such as chocolate bars and teas, as well as oil drops, capsules, syrups, topical lotions and creams, is anticipated to expand into a $16 billion-dollar industry by 2025, according to a report by Forbes.
The proposed class action lawsuit was filed last week in California Central District Court (Case #: 2:19-cv-10148) by plaintiff Adam DaSilva, a California resident, who alleges that Infinite CBD’s products are misleadingly labeled and are illegal to sell.
The lawsuit cites a recent warning letter from the U.S. Food and Drug Administration (FDA) to Infinite CBD detailing numerous violations regarding its products including food products such as its Asteroid Gummies, Sour Asteroid Gummies, Sweetened Dropper, Isolate Dropper and Nano Non Dairy Creamer products. The product labels describe the products as “delicious,” “tasty treat”, “sweetened flavor,” and something that can be “easily tossed into your lunch” or added to “your favorite recipes for delicious CBD infused meals” or added to beverages.
The lawsuit states: “CBD is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).”
The FDA had said last week it cannot conclude that CBD is generally recognized as safe (GRAS) for its use in human or animal food. The federal agency also said there is no food additive regulation which authorizes the use of CBD as an ingredient in human food or animal food, and the agency is not aware of any other exemption from the food additive definition that would apply to CBD.
“CBD is therefore an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient,” the FDA said.
Plaintiff DaSilva is seeking class action status for his lawsuit and asking the court to award the class “actual damages, treble damages, and/or any other form of monetary relief provided by law,” as well as order Infinite CBD to “disgorge…all or part of the ill-gotten profits it received from the sale of the products, or order [Infinite CBD] to make full restitution to [the class].”
In a revised Consumer Update, the FDA said last week that there exist “data gaps” regarding CBD toxicity as well as “only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”
“CBD can cause liver injury,” the FDA said. “CBD has the potential to harm you, and harm can happen even before you become aware of it.”
The agency said CBD can cause the following side effects:
- Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness)
- Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite
- Changes in mood, most commonly experienced as irritability and agitation
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” said Dr. Amy Abernathy, FDA principal deputy commissioner. “Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety, including reports of products containing contaminants, such as pesticides and heavy metals, and there are real risks that need to be considered.”