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FDA

FDA Take on Unapproved CBD Products

The inception of the Food and Drug Administration has saved the lives of many Americans. Structured to tackle & create a level playing field for companies, this is one way to monitor & control the quality of the goods produced for consumption. The FDA is doing everything possible to enforce measures to protect the health and wellbeing of Americans. 

While this is the case, some firms still find it hard to abide by the rules and regulations governing their business operations. All of this is evident as the FDA has made its worries heard via letters issued Honest Globe Inc. and Biolyte Laboratories LLC. This letter comes as a warning to these firms for illegally marketing unapproved drugs labeled as containing cannabidiol (CBD).

The FDA And The Role It Plays 

Considering the FDA is yet to approve the use of any CBD rich OTC drugs, it’s shocking to think some firms continue to distribute CBD rich products. As complicated as this issue already is, these firms still manage to mislead the public. These firms claim that their CBD Products have been approved by the FDA which is not true.

To ensure serenity and put an end to such malpractice, the FDA tabled a letter to the firms in question to put an end to their business operations. The letter elaborates that though; the CBD comes with known pharmacological effects on humans sandwiched with demonstrated risks does not mean it should be marketed as an over-the-counter (OTC) drug. Notably, one which is yet to be reviewed and approved by the FDA.

Furthermore, the letter also cited substandard manufacturing practices, with the most appalling been the failure to conform with current good manufacturing practices. Especially those involved in the illegal trading of unapproved CBD products. Most of which they claim can prevent, diagnose, mitigate, treat or cure various diseases, though it is still in defilement of the FD&C Act (Federal Food, Drug, and Cosmetic Act).

The FDA’s Act 

According to the FD&C Act, any product envisioned to diagnose or detect a disease other than food is a drug. Under Federal law, all OTC drugs must meet all marketing requirements. All of which include drugs rich in CBD.

However, the FDA has approved just one CBD-containing prescription drug. This approved CBD-infused medication serves as a panacea for persons suffering from

  • Seizures related to tuberous sclerosis complex
  • Lennox-Gastaut syndrome
  • Dravet syndrome

Defaulters Should Be Aware 

The FDA has requested Honest Globe and Biolyte to provide written responses within 15 working days. This written response should detail the violations mentioned above while stating the reason for their actions and why they believe their products are not in violation of the law. Furthermore, the FDA says failure for firms to address these issues may lead to drastic measures such as legal action.

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