The Food and Drug Administration (FDA) has made it difficult for people who are actively involved in the Cannabidiol, popularly called CBD, business.
A revised consumer update was released on Monday that revealed that the FDA considers it illegal for marketers to sell CBD by labeling it as a food product or dietary supplement. The agency mentioned that it is not able to conclude whether CBD is “GRAS” or “generally recognized as safe”, as per the opinion of qualified experts in the animal and human food industry. In addition, the FDA also mentioned that the CBD products that are sold for therapeutic uses, including topicals, aren’t approved, and their safety and claims remain uncertain.
FDA’s principal deputy commissioner, Amy Abernethy, mentioned that many people consider CBD products that are available on the market have been evaluated by the FDA and are thought to be safe, but in actuality, several of them are illegal. Apart from a single prescription drug that is used for treating pediatric epilepsy disorders, all others haven’t been approved by the FDA. Abernethy wants to make it clear to the public who are concerned about the safety aspect related to CBD, especially when there are reports of CBD products coming into the limelight for containing contaminants, like heavy metals and pesticides.
She also added that it is essential to address the real risks associated with the use of CBD products. The growing public interest in CBD cannot be ignored, and all stakeholders in the industry must work together in order to fill the knowledge gaps that exist in the quality, safety, and science of these products.
The FDA also issued warning letters to about 15 companies who are known for selling CBD products illegally in ways that are violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The companies that received the warning letters include Daddy Burt LLC (dba Daddy Burt Hemp Co.), Sabai ventures Ltd., Red Pill Medical Inc., Organic Industries Inc. (dba Plant Organix), Private I Salon LLC, Healthy Hemp Strategies LLC (dba Curapure), Sunflora Inc. (dba Your CBD Store), Bella Rose Labs, Apex Hemp Oil LLC, Infinite Product Co. LLLP (dba Infinite CBD), Whole Leaf Organics LLC, Natural Native LLC, Noli Oil, Pink Collections Inc., and Koi CBD LLC.
CBD is available in many kinds of products, such as syrups, capsules, oil drops, food products like teas and chocolate bars, and topical creams and lotions. The warning letters outlined that these companies use product web pages, social media, and online stores for marketing the CBD products in various states using methods that violate the FD&C Act, which also includes advertising CBD products for treating diseases or offering therapeutic uses to animals and humans. Other violations included marketing the products in the form of dietary supplements or food for animals and humans.
The Risks
As per the FD&C Act, the FDA mentions that a drug would be any product that intends to have a therapeutic use or treat a disease, just like any other product that has the potential to affect the function or structure of the body of animals or humans. The FDA mentioned that CBD products hadn’t been evaluated like other drugs that are approved by the agency to be effective for the intended purpose. It means that the proper dosage, as well as drug interactions with other FDA-approved drugs, safety concerns, or dangerous side effects, aren’t determined. In addition, when it comes to unapproved CBD products, the manufacturing process has also not been reviewed by the FDA.
Scientific research on consumer products made from CBD is in its early stages. Some of the data gained from these studies raise questions about serious health concerns, as per the FDA. They include interference with sexual function and development, mood changes, diarrhea, drowsiness, interactions with other drugs, potential liver injury, and so on.
After acknowledging the increasing demand for CBD products, the FDA is trying to explore pathways for the offerings to be marketed legally.
Once the FDA is about the gain some clarity on the regulatory approach for products that contain cannabis or compounds like CBD, it will be able to keep a tab on the marketplace and take necessary action against the firms that violate laws that may ultimately endanger the lives of the public.
Retailers’ Situation
There are many stores, such as Heavenlyhempflower, that sell CBD products to customers following the proper regulatory framework regarding the safety, labeling etc. However, some stores remain shady in this line of business.
The Foods Marketing Institute commented to the FDA mentioning the commercialization of beverage, food, and other products that contain cannabis-derived or cannabis compounds, such as CBD. The comment was made to address a comprehensive and clear regulatory framework that is needed for the sale and marketing of these products.
However, many grocery retailers small and large are having products containing CBD in their stores, though they might be mostly topicals.
Because hemp was removed from the Agriculture Improvement Act of 2018, it means that the federal law didn’t consider hemp to be a controlled substance any longer, even if marijuana is still a Schedule I drug.
Brightfield Group’s CBD research manager, Virginia Lee, mentioned that CBD is expected to see steady growth. After the FDA issues a framework and allows CBD’s use in beverages, foods, and dietary supplements, more retailers are expected to get on board.
