Did Elixinol Global Mislabel CBD Products as Dietary Supplements?

Despite the U.S. Food and Drug Administration (FDA) prohibiting products containing CBD to be marketed and sold as dietary supplements, some companies continue to try and do so.

Elixinol Global CBD-infused products, including Daily Balance, Stress Less, and Body Comfort, for example, are clearly labeled dietary supplements and reportedly offered for sale on the company’s website.

Who Is Elixinol Global?

Elixinol Global Limited is an international manufacturing company operating two businesses in the cannabis industry: Elixinol USA and Hemp Foods Australia.

Elixinol USA, founded in 2014 and based in Colorado, manufactures and distributes hemp-derived CBD products in 40 countries throughout North and South America, Europe, Asia, and the Pacific Region under its own label and as bulk CBD and wholesale CBD, according to its website. The company identifies its products as “dietary supplement and skincare products.”

CBD stands for cannabidiol, the second most prevalent active ingredient in cannabis. It can be derived from the hemp plant, which is a cousin of the marijuana plant. By itself, CBD does not cause a “high,” according to the Harvard Health blog.

On March 30, Elixinol Global announced a major rebranding campaign and a “product refresh of new innovative health and wellness products designed to build on its existing consumer trust and knowledge about hemp-derived CBD.” The efforts are part of the company’s strategy of focusing on high margin Elixinol branded products, it said in an official press release. Elixinol is launching eight new high-quality (products) which will be sold via its e-commerce platform at elixinol.com and at over 2,600 natural, specialty & conventional supermarkets and pharmacies across the U.S.,” according to a news release.

What Do Elixinol CBD Products Contain?

Per its own information, Elixinol CBD products are made with full or broad-spectrum hemp extract at the core. “Every Elixinol product is crafted with whole plant extract at the base, ensuring each … product delivers an effective amount of CBD and a wide range of complementary cannabinoids,” the company’s March press release states. Elixinol Global says its products are tested by independent laboratories to ensure the absence of microbiological contamination, heavy metals, and pesticides and to ensure the presence of Elixinol’s unique compound: terpene profile.

Why Shouldn’t Elixinol CBD Products Be Labeled as Dietary Supplements?

Hemp and its derivatives were legalized in the U.S. government’s 2018 Farm Bill, putting it under the regulation of the FDA. Since that time, the FDA has been working to devise rules about the marketing and labeling of CBD products.

While the process is ongoing (the agency has said it is exploring the possibility of allowing the marketing of cannabidiol as a dietary supplement), the FDA does not currently allow CBD-infused dietary supplements to be sold and hasn’t reached a final conclusion on regulating hemp-derived CBD products.

In November 2019, the FDA issued warning letters to more than a dozen companies. In March of this year, the agency issued a report to update Congress on its position on the matter.

We recognize the high level of interest in dietary supplements as a potential pathway for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements,” the FDA’s statement report said. “Given the significant public interest … as well as the extent to which many such products are available on the market, FDA has been … working to identify and review all available data to understand the risk profile of CBD and the potential for CBD to be safely included in dietary supplements, under certain conditions of use.”

But allowing CBD to be sold as a dietary supplement is risky, the agency’s report said, because supplement makers are not regulated as closely as pharmaceutical companies.

In June 2019, Chris Husong, Elixinol’s vice president of marketing and communications, told Weedmaps, a technology and software infrastructure provider to the cannabis industry, that the FDA was “asking for public guidance and guidelines around (the supplement labeling and marketing issue), which we’re happy to give them.” Husong also reportedly said consumers already treat CBD as a dietary supplement, adding CBD oil to food and drinks.

What Lawsuits Have Been Filed Against Elixinol CBD?

In December, a federal class action lawsuit was filed against Elixinol CBD in California, claiming that federal law makes the company’s products illegal to sell. The allegation was in direct reference to the FDA’s stated opposition to the labeling, marketing, and sale of CBD-infused products as dietary supplements.

Attorneys for Elixinol Global argued that the FDA’s position on CBD products is “in a state of flux” by the agency’s own admission, and therefore not illegal, according to a report in Hemp Industry Daily. 

Lead plaintiff Michele McCarthy claimed in her suit that Elixinol CBD capsules, tinctures, liposomes, Respira tinctures, and X-Pen products “are mislabeled as dietary supplements or contain the illegal dietary ingredient CBD.” She further argued the products fail to list “adequate” directions for use. 

McCarthy voluntarily dropped the case on May 7.

The Elixinol CBD Class Action Lawsuit was McCarthy, et al. v Elixinol LLC, et al., Case No. 5:19-cv-07948 in the U.S. District Court for the Northern District of California.

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This article is not legal advice. It is presented
for informational purposes only.