The US Food and Drug Administration has warned 15 companies for illegally selling CBD infused products in ways that violate the Federal, Food, Drug, and Cosmetic Act on Monday.
The agency also released an updated version of the Consumer Update detailing the new safety guidelines about CBD products, especially for edible CBD products. The FDA said it could not conclude that CBD is safe for human or animal consumption.
Cannabidiol, or CBD, is a non-psychoactive compound derived from hemp plant, a Cannabis Sativa plant. It is used to treat pain, anxiety, acute ache, chronic pain, inflammation, insomnia, and others. It is also used to alleviate the symptoms of Parkinson’s disease, Crohn’s disease and many other severe conditions like Alzheimer’s, cancer and epilepsy.
After the annual Farm, Bill legalized hemp in December last year, the CBD market exploded. Hemp is a Cannabis Sativa plant that contains CBD and is free from any THC concentration, the psychoactive substance found in marijuana plants. THC is the substance that is responsible for causing “high” when people smoke weed or have a joint. It alters the chemicals in your brain and produces hallucinations that can trigger seizures.
According to the Farm Bill, the maximum legal limit for THC per unit is 0.3%, above which the product will be considered illegal.
The recent warning letters issued by the FDA and the new consumer update could drastically impact the CBD market. CBD products such as gummies, creams, topical, oils, syrups, capsules, oil drops, tincture, isolate, and pet products are widely available on the shelves in stores.
But what concerns the FDA is the unregulated marketing of these products. Many companies claim their cannabis products have medical benefits and could replace legal medication. However, there’s a long way to go in research when it comes to CBD. Although it is effective in treating patients with a variety of ailments, there’s no evidence that it can replace medication completely and has no side effects in the long run.
The FDA is working quickly to further clarify the regulatory guidelines surrounding CBD products. The agency said it would continue to track the CBD marketplace and take necessary action against companies that violate the federal law in ways that could impact public health.
Amy Abernethy, the Principal Deputy Commissioner of the FDA said that the agency is approaching CBD as it would approach any other substance that they regulate. They remain concerned as many people believe in the medical claims made by companies in the advertisements of their CBD products. In addition to this, many consumers think that these products are evaluated by the FDA and are safe for consumption, which causes a lot of confusion.
So far, the Food and Drug Administration has approved only one cannabis-based medicine, known as Epidiolex. It is an oral solution containing CBD that is used to reduce seizures in two rare and severe forms of epilepsy in children – Gravet syndrome and Lennox Gastaut syndrome. Epidiolex is made by GW Pharmaceuticals (GWPH).
There are plenty of companies that have hopped on the CBD bandwagon, but there are not many that have regulated products or any sort of certifications or standards. The FDA has been monitoring brands and testing CBD products to identify the unregulated ones.
Nic Easley, the CEO of Multiverse Capital, a Denver-based firm that runs three cannabis venture funds said the warning letters issued by the FDA say that the agency has tested their products and it does not contain what it says on the label. The warning letters seem to be an attempt to warn the consumers about fake products in the market and to generate awareness.
Easley said that about 90% to 95% of CBD companies have unregulated products as they have no authorizations, no certifications, and no testing.
Issues raised in the warning letters:
- Some of the CBD products are marketed for children and infants which could be dangerous if the products are not properly tested, authorized and licensed as their ability to absorb, metabolize and excrete a substance like CBD may be limited.
- Edible products containing CBD are questionable as there are no regulatory guidelines that outline the method to infuse human and pet edibles with CBD. It is an unapproved food additive that many companies are using in their products.
- Some of the CBD products are marketed as dietary supplements but they do not meet the definition of a dietary supplement under the FD&C act.
- A product by Apex Hemp Oil LLC is made for food-producing animals and the FDA remains concerned about the safety of human food products that are derived from these animals such as milk, egg, meat, etc. There is a lack of data to determine the safe residue levels of CBD currently.
You can check out the list of companies that received the warning letters here.