Two Naples companies that market products containing cannabidiol (CBD) have drawn the attention of the Food and Drug Administration for not complying with federal law, records show.
The FDA sent warning letters to the two businesses in the span of one month, which put the Southwest Florida retirement mecca at the top of the list for the most CBD-related warning letters so far this year, according to the FDA website.
Warning letters to companies regarding CBD products are infrequent: So far this year, the federal agency has sent seven. The FDA sent one letter last year and four in 2017.
The letters advise companies they need to take corrective against violations for selling unapproved new drugs, that do not contain the levels of CBD claimed, and the products are not approved for preventing or treating any disease, according to the FDA’s website.
One of the Naples companies, Rooted Apothecary with a residential address, was admonished for marketing CBD products for use with infants and children, for such things as teething, colic and earaches.
The letter to Rooted Apothecary was jointly issued with the Federal Trade Commission for its advertising claims.
What may be confusing to the public is that CBD products are readily available yet they are not lawful in the eyes of the FDA and many states are essentially taking a hands-off approach.
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“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” FDA principal deputy Commissioner Amy Abernathy said in a recent press release.
What gets the FDA’s attention are companies that have robust marketing of CBD products on websites and in social media, said Richard Blau, in the Tampa office of the law firm, GrayRobinson. Blau is chair of the firm’s alcohol and food department.
“In my opinion, the FDA is working hard to get appropriate standards and guidelines for labeling and dosaging (for CBD products) and those don’t exist yet,” Blau said.
When the FDA started sending warning letters, there was an expectation the agency would shut down companies and that hasn’t happened, Blau said.
From another standpoint, the CBD industry and the public assume the products are safe when they come across website advertising, he said.
“We call it the wild west,” he said.
The 2018 Farm Bill decriminalized hemp and reclassified it as an agricultural commodity, paving the way for states, including Florida, to develop a hemp licensing program for growers.
In June, Gov. Ron DeSantis signed a bill into law that allows the sale of hemp-derived CBD products where the hemp extract has been batch tested by a licensed laboratory and has .3% or less tetrahydrocannabinol, or THC, according to the law. The products must have a scannable barcode linked to the analysis performed by an independent testing laboratory.
But the Farm Bill’s removal of hemp as a controlled substance and the recently passed Florida law has no bearing on the FDA’s approval process for food and drug products. The federal agency has approved one CBD medication for a rare form of epilepsy and no other CBD products have been approved.
The FDA notifies companies, through warning letters, that they are selling CBD products that make medical claims to prevent or treat serious diseases like Alzheimer’s disease, psychiatric disorders, diabetes or cancer, according to the FDA website.
“We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement,” the FDA website says. “Under federal law, it is currently illegal to market CBD this way.”
Alternative Laboratories was the first company in Naples to receive the FDA warning letter Sept. 18; the second was sent Oct. 10 to Rooted Apothecary.
A third Florida company, PotNetwork Holdings Inc., in Fort Lauderdale, received a warning letter March 28 for gummies that have CBD and the company’s website claims they are drugs for disease prevention and treatment, according to the FDA notice.
The remaining four warning letters so far this year went to companies in Arizona, Massachusetts, New Jersey and Washington.
The correspondence to Alternative Laboratories, which manufactures and packages nutritional products, said its manufacturing plant in East Naples was inspected in May and June where product labels were reviewed.
The inspectors found CBD oil in a product for Green Roads, a CBD company based in Deerfield Beach, that was labeled as a dietary supplement, according to the letter. The FDA said the product does not comply with the definition of a dietary supplement.
In its Oct. 15 response to the FDA, an attorney for Alternative Laboratories said the FDA is wrong and that hemp-derived CBD qualifies as a dietary ingredient for a variety of reasons.
In addition, the company is not making any medical claims that the CBD oil can treat or prevent any diseases, Todd Harrison, a Washington, D.C., attorney for Alternative, said in the company’s response letter.
He questioned why the FDA sent the warning letter because it is inconsistent with the agency’s decision to exercise enforcement discretion when there is no medical claim attached to a CBD product.
“Indeed, since 2015, when the first batch of warning letters went out regarding CBD products, FDA has yet to take regulatory action against any of those companies, and the only steps those companies took were to remove impermissible disease claims,” the letter said.
Kevin Thomas, CEO of Alternative Laboratories, said they were the first company to receive a warning letter unrelated to medical or disease claims. Green Roads is a client and did not make medical claims with the product that Alternative Laboratories manufactures for Green Roads.
“Importantly, however, the letter did not request that we stop manufacturing the product,” Thomas said in a statement. “We believe we have fully addressed the agency’s preclusion arguments in our warning letter response as we believe, like the more than 1,700 different brands of CBD currently on the market, that CBD is not precluded from being marketed as a dietary or food ingredient.”
It’s unclear how the FDA will address the company’s response.
The warning letter to Rooted Apothecary, said the FDA was particularly concerned about online and social media marketing of products with CBD or hemp oils and capsules to infants and children for teething and earaches.
“The use of untested drugs can have unpredictable and unintended consequences, especially for vulnerable populations,” the FDA letter said to the company. “The agency is particularly concerned that you market unapproved new drugs for uses in infants and children.”
Rooted Apothecary is owned and operated by Dr. Cade Copeland, a chiropractor in Naples, according to its website. Copeland could not be reached for comment.
In a press release about the notice sent to Rooted Apothecary, the FDA said the agency is working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat or cure a number of diseases or conditions.
Rooted Apothecary made online claims that its products treat teething pain and earaches in infants, autism, attention deficit/hyperactivity disorder, and makes claims for Parkinson’s disease and Alzheimer’s disease, according to the FDA release.
The website for Rooted Apothecary includes a disclaimer that its products are not intended to diagnose, treat or cure any disease.
The federal agency said it is examining potential regulatory options for the lawful marketing of cannabis products but protecting and promoting the public health through “science-based decision-making” remains its top priority.