The U.S. Food and Drug Administration (FDA) has sent warning letters to two companies for illegally selling over-the-counter products labeled as containing cannabidiol (CBD).
The FDA accused the two companies -- Honest Globe Inc. and Biolyte Laboratories LLC -- of labeling certain products as containing CBD without receiving its approval to do so. The agency said this is a violation of the Food, Drug and Cosmetic Act.
To date, the FDA has only approved one prescription drug containing CBD. The drug is intended to help treat seizures associated with several syndromes. Since CBD has “demonstrated risks” to consumers’ health, the agency said it “cannot be legally marketed as an inactive ingredient in OTC drug products” without its approval.
"The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country," said Dr. Amy Abernethy, the FDA’s principal deputy commissioner, in a statement.
"It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”
Clock is ticking for company responses
In the letter sent to Honest Globe Inc., the FDA said the company’s "ELIXICURE ORIGINAL PAIN RELIEF with CBD" and "ELIXCURE LAVENDER PAIN RELIEF with CBD" are "misbranded drugs" that haven’t received approval to be marketed as a way to treat, cure, or prevent disease or “affect the structure or any function of the body.”
Biolyte Laboratories LLC was warned about its "(b)(4) Silver Gel," "(b)(4) Silver Gel with Aloe," "(b)(4) Silver Liquid Supplement," "(b)(4) Therapeutic Pain Gel," "(b)(4) Pain Relief Cream," and "(b)(4) Magnesium Oil Spray” for the same reason.
The companies have 15 days to let the FDA know how they plan to address the violations or provide supporting information on why they believe the products aren’t in violation of the law.