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FDA issues warning to 15 CBD companies

Janet Miller

Janet Miller

Last updated: November 26, 2019

FDA issues a press release that CBD may pose unidentified health risks and should not be marketed as a dietary supplement. It also issued warning letters to 15 companies that sell products with CBD.

  • FDA says that CBD might cause damage to the human body and could cause cause liver damage or other unknown health risks
  • It issued 15 companies warning letters that engage in the sale of CBD products
  • The companies have 15 days to respond with ways they will go about the CBD violations according to FDA regulations
  • The FDA also issued a broad consumer update that also raised issues in regards to CBD safety

Monday, the United States Food and Drug Administration (FDA) issued strict warning letters to 15 firms engaging in the illegal sale of products that contain cannabidiol (CBD). The FDA cited that CBD cannot be freely marketed and sold as therapeutic, food or dietary supplement since it may pose some unknown health risks.

The Real FDA’s Concerns on CBD Potential

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Shutterstock / Tinnakorn jorruang

CBD, also known as cannabidiol, is a chemical compound found in marijuana but doesn’t bring about an exhilarating high. While a majority of drug developers have buried themselves in labs and research fields in a bid to find out the health benefits associated with CBD, as we are speaking now, only a single product containing CBD has passed through the FDA approval. The product is a prescription drug that treats some forms of epilepsy in children.

The FDA did not stop there. It went ahead to publish a broad Consumer Update (revised version) containing safety concerns regarding CBD products. Due to a lack of scientific research that supports the safety of CBD in food, the Food and Drug Administration (FDA) also asserted that they could not conclude that CBD is safe for its use in animal or human food.

“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,” said FDA Principal Deputy Commissioner Amy Abernethy.

Monday’s actions came with the FDA continuing to look into possible pathways for other types of products that contain CBD to be legally marketed. This includes continuing to effortlessly work in a bid to obtain information and reports from research, and any other questions relating to the safety of CBD products.

“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” further reiterated Amy Abernethy.

According to the FDA, there are plenty of data gaps and unanswered questions regarding CBD toxicity, and quite a good number of available data raises some serious concerns regarding the potentially harmful effects of CBD.

FDA’s Consumer’s Update (revised copy) outlines a couple of specific health concerns that are related to CBD, such as drowsiness, diarrhea, liver injury, and mood changes.

Additionally, studies carried out in animals have established that CBD has got the potential of interfering with both the function and development of sperm and testes. Moreover, it could also negatively affect male sexual behavior and decrease the levels of testosterone. There are claims that CBD could have adverse effects on children, pregnant or breastfeeding women.

Who Suffer from This Act?

Those in the business of selling CBD market it in several types of products, such as capsules, oil drops, food products, creams and lotions, and syrups. As noted earlier in the warning letters issued by FDA yesterday, firms engaging in the sale of CBD products use product webpages, social media, and online stores to market these products in a manner that violates the FD&C Act. Still, these companies further violate the FD&C Act by stating that CBD products can treat some diseases and can be used for therapeutic reasons in both human beings and animals.

The 15 companies that were issued with stern warning letters are:

fda-not-approved-image
Shutterstock / Waldemarus
  • Noli Oil, a firm based in Southlake, Texas
  • Koi CBD LLC, a company based in Norwalk, California
  • Pink Collection Inc., based in Beverly Hills, California
  • Infinite Product Company LLLP, an organization, doing business in Lakewood, Colorado
  • Natural Natives LLC, located in Norman, Oklahoma
  • Whole Leaf Organics LLC, a company based in Sherman Oaks, California
  • Apex Hemp Oil LLC, based in Redmond, Oregon
  • Sunflora Inc., based in Tampa, Florida
  • Bella Rose Labs, an organization based in Brooklyn, New York
  • Organix Industries Inc., located in San Bernardino, California
  • Private I Salon LLC, of Charlotte, North Carolina
  • Healthy Hemp Strategies LLC, conducting business in Concord, California
  • Daddy Burt LLC, a company based in Lexington, Kentucky
  • Red Pill Medical Inc., based in Phoenix, Arizona
  • Sabai Ventures Ltd., based in Los Angeles, California

The FDA has directed the above companies to respond within 15 working days by stating how they will go about correcting the violations mentioned earlier. The FDA has further reiterated that failure for these companies to correct the violations within the shortest time possible may ultimately result in a series of legal action, such as product injunction and/or seizures.

The Food and Drug Agency (FDA) did go ahead and encouraged animal and human health care professionals and even the consumers to feel free and report any adverse reactions that they witness which are associated with products that contain CBD to the firm’s MedWatch program.

Being an agency within the United States Department of Health and Human Services, the FDA works to promote and protect the health of the broader public by, among other exercises, assuring the effectiveness, safety, and security of veterinary and human drugs, biological products, medical devices, and vaccines that are meant for human use.

Author

Janet Miller

Janet Miller

Janet is a medical specialist with 10 years of experience as a physician and writing passion. She aims to help people and expand humans mindset. Chat with Janet on Twitter @Janet_Miller_MD or via our contact page.

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