Elixinol Hit with Class Action Over Alleged Mislabeling of CBD Products
Last Updated on December 13, 2019
McCarthy v. Elixinol, LLC
Filed: December 4, 2019 ◆§ 5:19-cv-07948
A class action alleges CBD retailer Elixinol's products are are “illegal to sell” in that they’re mislabeled under federal law.
The wave of proposed class actions against CBD companies rolls on with a complaint in California’s Northern District alleging Elixinol, LLC’s cannabidiol products are “illegal to sell” in that they’re systematically mislabeled under the federal Food, Drug, and Cosmetic Act (FDCA).
The complaint provides that Colorado-based Elixinol was one of 15 CBD companies to receive an FDA warning letter concerning the apparent mislabeling of their products. The lawsuit alleges Elixinol’s CBD capsules, tinctures, drops and dog treats have been misrepresented under federal law as dietary supplements, misbranded drugs and adulterated animal foods.
Alleging that the defendant has “intentionally marketed and sold” illegal CBD products, the complaint says that, with regard to certain Elixinol goods, the company overstepped FDA regulations by including supplement facts on the back of each product’s container. Citing FDA rules, the lawsuit relays that at this time it is “currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” Overall, the case claims, Elixinol’s CBD products cannot be dietary supplements given they fail to meet the FDA’s definition of such under the FDCA.
Further, Elixinol’s capsules, tinctures, liposomes and “X-Pen” are misbranded under the FDCA, according to the suit, in that their labeling includes inadequate directions for use. The lawsuit claims that the products “are not amenable to self-diagnosis and treatment” by those who are not doctors and, therefore, require adequate directions for use “so that a layperson can use these drugs safely for the intended purposes.”
Lastly, the suit focuses on Elixinol’s CBD dog treats in alleging the product cannot be sold legally given the FDCA requires food additives, including those for animal food, to undergo substantial clinical investigation. No animal food additive regulation allows for the inclusion of CBD in animal food, the complaint reads.
Per the suit, consumers would not have bought Elixinol’s CBD items, or would have paid less for the products, had they known they were mislabeled within the scope of federal law.
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