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FDA Warnings for CBD Companies!

FDA has been sending out cannabidiol related Warning Letters to companies that are making drug claims in their cannabidiol (CBD Products) marketing efforts for several years. This year three companies have received FDA Warning Letters for their marketing claims.


To view other CBD related Warning Letters, please see https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products

The FDA repeats in each letter that CBD products are excluded from the dietary supplement definition due to the fact that CBD products were not available prior to the public notification and authorization of investigation of the active ingredient as a drug. The FDA also states that “There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, the FDA has concluded that this is not the case for CBD.”

Several claims that FDA sited include treatment for Alzheimer’s Disease, Amyotrophic Lateral Sclerosis (ALS), Anxiety, Autoimmune Disorders, Cancer, Chronic Pain, Crohn’s Disease, Depression, Diabetes, IBS, Inflammation, Obsessive Compulsive Disorder (OCD), Panic Disorder, Parkinson’s Disease, Post-Traumatic Stress Disorder (PTSD), Psychosis, Rheumatoid Arthritis, Schizophrenia, and Substance Abuse Disorders.

Compliance Insight is one of the top experts in cannabidiol and we want to ensure that everyone is informed on this subject, as such we will provide updates as additional details come to light. If you have a Warning Letter or questions regarding cannabidiol, please contact us at 513-860-3512 or info@compliance-insight.com for a consultation.



Don’t be stuck in the weeds! Call Compliance Insight today for Quality Assurance and Regulatory Affairs services related to FDA compliance!

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