(Update: adding comments from owner, FDA)
REDMOND, Ore. (KTVZ/CNN) -- The owner of a Redmond superfoods company that sells CBD hemp oils said Wednesday he was surprised, but understanding, when he received a warning letter from the US Food and Drug Administration. Owner J.T. Taylor said his company has already taken steps to address concerns raised in the letter.
The FDA sent a warning to 15 companies -- including Redmond-based Apex Superfoods regarding its Apex Hemp Oil -- that they said have illegally sold cannabidiol products, better known as CBD, by adding it to food or marketing it as a dietary supplement.
The FDA claims they sold CBD products that violate the Food, Drug and Cosmetic Act by adding it to food or marketing it as a dietary supplement.
“There’s a lot of confusion in this industry,” said J.T. Taylor, owner of Apex, a 2-year-old firm that has six employees. “Basically, everybody in this industry is just rolling with the punches. It’s evolving and changing, and we have to evolve and change with it, if we want to stay relevant.”
Taylor noted the Apex Superfoods business he owns does “all kinds of oils, not just CBD. CBD is nothing more than a slang term now. It’s one cannabinoid out of 112. (The FDA) singling out a molecule that makes up a quarter of the plant in general and making hemp legal … is like saying you can have peanut butter and jelly, but you can’t put them together. Every kid in the lunchroom is putting it together.”
The FDA also said, "these particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals."
Taylor said Apex will not change how it makes these products, but the company's already taken the steps to fix the issue.
"Go through our labels and our website and scrub everything that they wanted us to get rid of," Taylor said. "Basically that's the use of the word CBD, and the word therapy, together."
Apex Hemp Oil, he said, is the only such product that is USDA-certified organic, and that’s not the only difference he touts.
“The way I process is completely different from the rest of the crowd,” he said. “They use solvent, heat and toxins. I mechanically cold press it. I don’t adulterate the molecule, so it’d be no different than if you cut down the plant and squeeze the oil out of it.”
Of the 15 companies who received warning letters, Apex Superfoods is the only one cited for creating a CBD product intended for food-producing animals.
"I'm really pushing for the FDA to allow farmers to be able to feed hemp to livestock, much like corn is made in a silage," Taylor said.
The FDA also released a consumer update about CBD, the non-psychoactive ingredient in marijuana increasingly used to treat pain and anxiety. Until it learns more about the effectiveness and safety of CBD, the FDA said it cannot generally recognize the ingredient as safe or approve products that contain it.
"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,'" FDA Principal Deputy Commissioner Amy Abernethy said.
The FDA sent letters to the following 15 companies for selling CBD products that violate the Food, Drug and Cosmetic Act, for marketing the products to treat illnesses or for therapeutic use, claiming it's a dietary supplement or adding it to food for humans and animals.
-Red Pill Medical Inc. of Phoenix, Arizona
-Pink Collections Inc. of Beverly Hills, California
-Healthy Hemp Strategies LLC (does business as Curapure) of Concord, California
-Koi CBD LLC of Norwalk, California
-Sabai Ventures Ltd. of Los Angeles, California
-Organix Industries Inc. (does business as Plant Organix) of San Bernardino, California
-Whole Leaf Organics LLC of Sherman Oaks, California
-Infinite Product Company LLLP (does business as Infinite CBD) of Lakewood, Colorado
-Sunflora Inc. of Tampa Florida/Your CBD Store of Bradenton, Florida
-Daddy Burt LLC (does business as Daddy Burt Hemp Co.) of Lexington, Kentucky
-Bella Rose Labs of Brooklyn, New York
-Private I Salon LLC of Charlotte, North Carolina
-Natural Native LLC of Norman, Oklahoma
-Apex Hemp Oil LLC of Redmond, Oregon
-Noli Oil of Southlake, Texas
It's not illegal to sell products that aren't approved by the FDA, but it is illegal to add certain drug ingredients to products unless they're approved food additives (CBD is not). CBD is also not characterized as a dietary supplement under the Food, Drug and Cosmetic Act, the agency said.
Some of the companies marketed products to infants and children, the FDA said, who may be at a heightened risk for negative side effects of CBD due to differences in the way they metabolize, absorb and excrete the ingredient.
Reports of pesticides and heavy metals in CBD have also raised questions about its safety and toxicity, Abernethy said.
The FDA has never evaluated the effectiveness of CBD products, the amount in a "proper" dosage, potential side effects of consuming the products and the manufacturing process.
The agency has only approved one prescription drug that contains CBD, Epidiolex, used to treat two forms of childhood epilepsy. Most other marketed CBD products contain different amounts of the ingredient, which the FDA hasn't evaluated, the agency said.