The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD.
“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 FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “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.”
Honest Globe
In the letter FDA said, that they reviewed the website at www.elixicure.com and has determined that the company take orders there for the products “ELIXICURE ORIGINAL PAIN RELIEF with CBD” (roll-on and pump versions) and “ELIXICURE LAVENDER PAIN RELIEF with CBD” (roll-on and pump versions) (hereinafter referred to as “ELIXICURE PAIN RELIEF with CBD” products). “ELIXICURE PAIN RELIEF with CBD” products are labeled to contain cannabidiol (CBD)1 and are made available for purchase by consumers without a prescription.
“Your “ELIXICURE PAIN RELIEF with CBD” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your “ELIXICURE PAIN RELIEF” products are misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 502(a), 502(ee), and 301(a) of the FD&C Act, 21 U.S.C. 352(a), 352(ee), and 331(a),” – The FDA said.
Currently, a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient.
BioLyte Laboratories Selling CBD Products
The firm manufactures the products “(b)(4) Silver Gel,” “(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,” which are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
In addition, your “(b)(4) Silver Gel,” “(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” are also misbranded under section 502 of the FD&C Act, 21 U.S.C. 352. Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301(a) and 502 of the FD&C Act, 21 U.S.C. 331(a) and 352.
“The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns,” – FDA commented.
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