The United States Food and Drug Administration (FDA) has issued warning letters to several food firms under its jurisdiction over their adulterated cannabidiol (CBD) products, many of which are also deemed "appealing to children" by the agency. Per Food Safety News, the five firms in question include Infusionz, LLC; 11-11-11 Brands; Newhere Inc dba CBDFX; CBD American Shaman, LLC; and Naturally Infused LLC. Here's a closer look at the specific products and the violations:
Infusionz, LLC (Henderson, NV)
In a Nov. 16 warning letter, the FDA determined that all of the firm's CBD products — which includes gummies, fruit snacks, gum, candy, oil/tinctures and lollipops — are "adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), because they bear or contain an unsafe food additive."
There is currently no food additive regulation which authorizes the use of CBD.
Due to the violations, it is also "a prohibited act" to introduce the aforementioned products into interstate commerce.
The agency continued, writing, the "FDA is particularly concerned that some of your products are in forms that are appealing to children. For example, your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, and CBD lollipops products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, your products have not been evaluated by the Agency for safety, effectiveness, and quality."
The FDA also raised concerns about the company's CBD Dog Treats (Bacon & Cheddar Cheese Flavored) and Hemp CBD Tincture (also referred to as CBD Coconut Oil – CBD MCT Oil Broad/Full Spectrum), which are marketed to treat various health conditions in animals. In addition to CBD not being an approved food additive, the use of CBD in animal products does not satisfy the criteria for food safety.
11-11-11 Brands (Newtown, PA)
The FDA determined that the firm's Mood33 Hemp Infused Herbal Tea products are adulterated under section 402 of the FD&C Act because they contain an unsafe food additive. Due to the violations, it is also "a prohibited act" to introduce the tea products into interstate commerce.
"FDA is particularly concerned that your products are in a form (herbal tea or beverage) that consumers may confuse with traditional foods. The Agency has collected and analyzed a sample of your product and has confirmed the presence of CBD in the product," the agency wrote. "Therefore, with these products there is a risk of unintended consumption of the CBD ingredient by consumers, which is exacerbated due to the failure of the label to list CBD as an ingredient."
Newhere Inc dba CBDFX (Chatsworth, CA)
Following an extensive review of the firm's website and social media accounts, the FDA determined that the firm's CBD products — including its flavored Chill Shots (all strengths and varieties), CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg (in Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors) — are all adulterated under section 402 of the FD&C Act because they contain an unsafe food additive. Due to the violations, it is also "a prohibited act" to introduce the products into interstate commerce.
In the same vein as the Infusionz, LLC products, the FDA is concerned that some of the firm's products "are in forms that are appealing to children." These include gummies, vape pens, energy blends and balm sticks.
"For example, your CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children," the agency specified. "Furthermore, your products have not been evaluated by the Agency for safety, effectiveness, and quality."
CBD American Shaman, LLC (Kansas City, MO)
In a Nov. 16 warning letter, the FDA determined that the firm's CBD products — including its CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, CBD Honey, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Horsey Chews, Doggy Nugs, and Kitty Nugs — are adulterated because they contain an unsafe food additive. Due to the violations, it is also "a prohibited act" to introduce the products into interstate commerce.
The FDA is also concerned that some of the firm's products, specifically its suckers, gummies, candies and cookies, are "are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children."
"You also market other products that consumers may confuse with traditional foods for humans, including CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey; therefore, with these products there is a risk of unintended consumption of the CBD ingredient by consumers," the agency noted.
Naturally Infused LLC (New Port Richey, FL)
The FDA determined that the firm's CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, D8 THC Infused coffees, and Delta-8 THC Gummies products are adulterated because they contain an unsafe food additive. Due to the violations, it is also "a prohibited act" to introduce the products into interstate commerce.
Many of the firm's CBD products, specifically its CBD Lollipops, CBD Gummies, and Delta-8 THC Gummies, are also "in forms that are appealing to children."
The agency continued, "Furthermore, you market other products that consumers may confuse with traditional foods for humans, including CBD Infused Sugar and CBD and Delta-8 THC Infused coffees. Therefore, there is a risk that consumers of these products, including children, will unintentionally consume CBD or Delta-8 THC ingredients."
"Additionally, we note that the CBD coffee products appear to contain caffeine," the agency wrote. "Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine's effects."
