FDA Seeks Input On CBD Regulations, Sends Out Warnings
- The FDA will be holding a meeting on June 14th to discuss regulatory issues related to the use of CBD in foods, dietary supplements, and cosmetics.
- Recent clinical trials show that FDA concerns over liver damage and male reproduction issues caused by daily CBD use are unfounded.
- The FDA recently sent warning letters to four companies for marketing CBD products intended for medicinal use in animals.
- The FDA has sent out dozens of similar letters in the past.
After years of delay in the FDA’s approval of CBD for use in food and supplements, it looks like some progress is finally being made. On June 14th, the Science Board, a subsidiary committee of the FDA, will be hosting a day-long conference to gather expert testimony and industry input on “evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.”
FDA Commissioner Dr. Robert Califf, a South Carolina cardiologist who also served as FDA commissioner in the Obama administration, told a Congressional hearing on May 16:
“I am very committed to taking a path on this. And just to put a marker down, I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward. We’re going to have to come up with something new.”
Califf also cited the “amazing plethora of the cannabis plant,” noting that the potential medicinal and supplemental uses for cannabinoids are “quite profound and astounding.”
Califf succeeded recently departed FDA chiefs Dr. Steven Hahn and Dr. Scott Gottlieb, both of who failed to prioritize a path for full FDA consideration of CBD efficacy.
The full-day conference will be held at Food and Drug Administration headquarters at 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD.
Anyone who has input on the topic can email comments to the FDA at Rakesh.Raghuwanshi@fda.hhs.gov.
CBD clinical trials
Recently, a CBD clinical trial found that 30 days of CBD use produced no liver toxicity, no male reproduction issues, and no “daytime fatigue.” These are all issues that the FDA has cited as concerns in the past.
A spokesperson for Charlotte’s Web, a leader in the CBD market, called the study results “proof of the hemp CBD industry working cooperatively to support rigorous scientific research to inform regulators, the FDA, and the U.S. Congress.”
“With 1,060 participants in two cohort studies, industry stepped up and delivered the requested science for hemp CBD, again, by providing evidence outcomes in liver safety, drowsiness, testosterone impact and diabetes prevalence.” ~ Tim Orr, president of its CW Labs Division
Based upon these results, the U.S. Hemp Roundtable this week asked the FDA to “take immediate action to issue an enforcement discretion policy for CBD and other lawful hemp-derived products, similar to your actions on NAC, to help pave a regulatory pathway for these products.”
The 8-month VALIDCARE clinical trial was funded by 12 leading CBD makers. It involved 839 subjects. Details of the study can be found here: https://app.hubspot.com/documents/4153268/view/303614964?accessId=54034b
Recent FDA warnings on CBD
On a related note, the FDA recently warned four companies about illegally marketing CBD for medical use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest.
Marketing CBD for this purpose violates the Federal Food, Drug, and Cosmetic (FD&C) Act. In their letter, the FDA wrote:
“Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children.”
Because CBD-based Epidiolex, was approved for prescription use in 2018, the FDA considers all CBD products intended for medical use to be unapproved drugs and thus illegal to sell.
Marketing CBD And The FDA
According to the FDA, the companies were claiming that CBD products help “farm animals with stress, anxiety, pain, inflammation [and] injuries,” and provide “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, [and] maintain a normal inflammatory response.”
In other words, the companies are marketing CBD as a drug.
Recent FDA Press Release
In a recent press release, the FDA wrote:
“Unapproved drugs like these CBD products have not been evaluated by the FDA to determine whether they are effective for their intended use, what the proper dosage might be, how the products could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.”
The agency is concerned about potential safety risks for the animals consuming the products and the safety of food products such as meat, milk, and eggs derived from these animals.
“After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system. Part of the animal drug approval process includes setting a withdrawal period to establish the minimum amount of time between the last dose of a drug and the slaughter or harvesting of food products from the treated animals. Since CBD is an unapproved drug, the FDA has not had the opportunity to evaluate CBD residues in food or to establish an appropriate withdrawal period.”
All four companies also sell CBD products for human consumption. In its announcements, the FDA called some of these products including oils, creams, extracts, salves, and gummies, “adulterated human foods.”
The business had 15 working days to respond to the accusations and explain how they plan to address FDA concerns or otherwise face legal action.
This isn’t the first time the FDA has issued a warning. Dozens of warning letters have been sent out in recent years.