Violations of FDA Policy Lead to 15 Warnings to Companies Over Sale of CBD Products
As the 2019 year wraps up, where the world saw CBD rise to the top of the charts in terms of popularity and supplement sales, the FDA issues stark warnings to 15 more brands for illegally selling products with cannabidiol in them.
- The FDA states that each of the 15 cannabidiol-centric companies is in direct violation of the FD&C Act (Food, Drug, and Cosmetic Act).
- The majority of the warnings were issued in California, which was the first state to legalize medical marijuana.
The CBD industry, at least legally, is still fairly new, and many improvements still need to be made before it runs smoothly as a whole, especially at the state and federal levels combined.
However, there still seems to be many companies that attempt to circumvent the laws to suit their agenda, selling products that are knowingly breaking the law. Recently, the Food and Drug Administration decided to take action by sending warnings out to 15 separate companies, making the total number of CBD brands they contacted to be well over twenty in 2019.
The FDA published a press release on November 25th, 2019 that they had sent out the letters for “illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.” They also revised their CBD Consumer Update, publishing new guidelines for all buyer's and user's of cannabidiol-infused products.
Here is the list of companies who received the letter dreaded FDA letter in the mail:
- Koi CBD LLC (Norwalk, California)
- Pink Collections Inc. (Beverly Hills, California)
- Noli Oil (Southlake, Texas)
- Natural Native LLC (Norman, Oklahoma)
- Whole Leaf Organics LLC (Sherman Oaks, California)
- Infinite Product Company LLLP (Lakewood, Colorado)
- Apex Hemp Oil LLC (Redmond, Oregon)
- Bella Rose Labs (Brooklyn, New York)
- Sunflora Inc., of Tampa, Florida/Your CBD Store (Bradenton, Florida)
- Healthy Hemp Strategies LLC (Concord, California)
- Private I Salon LLC (Charlotte, North Carolina)
- Organix Industries Inc. (San Bernardino, California)
- Red Pill Medical Inc. (Phoenix, Arizona)
- Sabai Ventures Ltd.(Los Angeles, California)
- Daddy Burt LLC (Lexington, Kentucky)
The FDA is trying to send a very direct, clear and concise message to these CBD brands. When combining on the same day, the FDA releasing a modified version of the Consumer Update, which describes the concerns that the authority has with the safety of CBD use still, they bring their tally to nearly 25 companies this calendar year who were operating in the grey area of the hottest trending supplement ingredient in 2019.
Furthermore, since there has yet to be enough research on the substance, the press release also states that CBD is not going to be categorized as “generally recognized as safe” for use in animal or plant food. Other companies have previously been sent warning letters for violating these laws, which stated that CBD can prevent, diagnose, treat, or cure major diseases.
Amy Abernethy, M.D., Ph.D, who is the FDA Principal Deputy Commissioner, had many pointed opinions and thoughts on the matter, sharing more clarity and direction the government agency will be taking in the weeks and months to come in 2020. She said:
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate” […] “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.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
As clearly stated, there are a multitude of other concerns that the FDA has, including the marketing of the products for infants and children, the combination of CBD and edible foods, and the fact that some of the products are advertised as dietary supplements. One of the most unique warning letters was issued to Apex Hemp Oil LLC, as their CBD is meant to be used “for food-producing animals.”
However, that doesn’t mean the battle is lost but just beginning. The FDA is still seeking to find ways to lawfully market different CBD products, which will be posted in an update soon. As we saw Amy Abernethy, the Principal Deputy Commissioner of the FDA, state that the authority is trying to push along the regulations that they need to implement, though they will continue to “take action as needed against companies that violate the law in ways that raise a variety of public health concerns.” And when you magnify what she stated regarding the FDA is “concerned” that so many consumers are convinced that CBD products have already been determined to be safe by the FDA, which isn’t the case, you can bet your bottom dollar the FDA is not done regulating or overseeing the growing cannabis oil-infused product industry.
Presently, there is only one prescription drug that has been approved by the FDA – Epidiolex – and it is meant to treat two pediatric epilepsy disorders. However, there has been no approval issued otherwise yet, and any company that claims differently is advertising falsely.
Many questions still exist in the CBD industry, especially when it comes to CBD toxicity, and there is still no clear information on the potential harm consumers can succumb to with it. The current, and recently revised, Customer Update states that the use of CBD can lead to liver injury, drowsiness, diarrhea, and mood changes. Furthermore, CBD use can negatively impact sperm function, reduce testosterone and impair sexual behavior, and there are still questions over what this product can do to women who are pregnant or breastfeeding.
As we just covered yesterday, when The Washington Post tested CBD products from Amazon, over 80% of the “hemp oil extract” products actually contained cannabidiol in them, one even having THC, further highlighting the need for legal oversight and accountability moving into 2020. Again, to read the full statement from the FDA, it can be viewed here.