FDA Sends Warning Letters to CBD Food and Beverage Companies

Brad Avery

The U.S. Food and Drug Administration (FDA) appears to be cracking down on CBD food and beverage brands as the federal agency sent warning letters last week to five companies selling infused products.

In a statement published online yesterday, the agency said letters were sent to Mood33 manufacturer 11-11-11 Brands; candy and coffee maker Naturally Infused, LLC; CBDfx parent company Newhere Inc.; gummy and candy brand Infusionz; and beverage, snack and pet treats producer CBD American Shaman.

“These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD,” the FDA said in the release. “CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.”

The agency pointed to potential safety concerns around long term consumption of CBD, including harm to the male reproductive system and possible liver damage, as well as negative interactions with certain medications. The statement added that the FDA “has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant.”

The letters were dated November 16 and the companies have 15 business days to respond to the FDA, stating either how they will address the issues or defending why they believe their products are not in violation of the law.

The specifics of the violations vary from company to company. For example, Naturally Infused was cited for selling both CBD and Delta-8 THC infused food and drinks, while CBD American Shaman’s numerous product offerings were cited for being potentially appealing to children (candies and cookies), easily confused for non-infused foods (coffee, sparkling tea, sparkling water and honey sticks) or being made for animals (doggy chews and feline tinctures).

In the letter sent to 11-11-11 Brands, the FDA highlighted issues related to the mixing of CBD with caffeine in some flavors, suggesting CBD can impact caffeine metabolism. As well, the agency took issue with the use of CBD as an unregulated “food additive” and also noted the brand does not list CBD as an ingredient in its drinks, instead listing “full-spectrum hemp” which could create confusion for consumers.

Mood33 and 11-11-11 Brands are a subsidiary of New York agency BeyondBrands. Originally launched in 2018 as a THC-infused tonic, Mood33 later pivoted to solely selling a full-spectrum hemp-infused herbal tea line which was introduced in 2019. In 2020, the company began selling the teas direct-to-consumer nationwide through its website.

Reached by email, BeyondBrands CEO Eric Schnell said the warning letter arrives as Mood33 and 11-11-11 Brands are already winding down operations due to a number of economic factors. While the company was initially optimistic about the long term potential of the cannabis and CBD categories, he said the space has been “the hardest category to build and scale” that he’s seen in over two decades in the industry.

“While we appreciate the FDA’s enforcement responsibilities, we have already been in the process of shutting down the operations of 11-11-11 Brands,” Schnell wrote. “For a variety [of] reasons, including the pandemic and uncertainty in the industry, it was no longer a viable business and it had not been profitable for some time. We are not selling any new products and do not plan on restarting unless regulations change. Sad, as this category had so much promise after the Farm Bill was passed.”

A notice on Mood33’s website this morning stated the products are no longer sold online, but are still available in select retail stores. However, as of this afternoon the website itself was inaccessible.

The FDA warning letters represent a blow for the CBD category as brands have long struggled to operate in a legal gray zone while awaiting regulatory approval. Despite major alcohol distributors like Southern Glazer’s and Breakthru Beverage taking on CBD-infused brands over the past year, many mainstream retailers still refuse to carry CBD food and beverages before the government delivers definitive approval. According to research firm Brightfield, the CBD beverage category grew 50% in 2021 and is expected to increase around 62% this year.

Over the past two years, many beverage brands that launched with CBD lines – such as Recess, VYBES and Daytrip to name a few – have introduced non-infused lines in order to grow their businesses and expand their brand platforms beyond hemp products.

In response to the FDA letters, industry group U.S. Hemp Roundtable called for Congress to pass legislation clarifying food and beverages containing hemp-derived CBD as being generally recognized as safe (GRAS) per current FDA food additive requirements.

“This recent action by the FDA indicates the agency’s lack of urgency and reluctance to regulate CBD products, making it clear that Congress must act on behalf of our industry,” the group said in a statement on its website.