FDA New Warning on OTC Pain Medications with CBD OIL

FDA New Warning on OTC Pain Medications with CBD OIL -- Welcome to Happy Healthy Healing -- The FDA Just Issued a New Warning About These OTC Pain Medications.

The FDA is warning that some CBD products are being illegally marketed as OTC pain medication.

On March 22, the FDA released a warning that said that several OTC products were being illegally marketed as pain medication containing cannabidiol (CBD), as they are unapproved by the administration. "The FDA has not approved any OTC drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application," the statement says.

The FDA sent warning letters to two U.S.-based manufacturing companies it says violated the Federal Food, Drug, and Cosmetic Act by selling CBD-containing OTC pain products: Honest Globe and Biolyte Laboratories.

According to the letters sent by the FDA, Honest Globe sold several products labeled as "Elixicure Pain Relief with CBD," and Biolyte sold CBD-containing products labeled "Therapeutic Pain Gel" and "Pain Relief Cream."

"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," the FDA letter to Honest Globe states.

The FDA says it has requested "written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law."

According to the agency, CBD can pose a risk to some people.
The FDA says that "as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA." And since these products have not been evaluated by the FDA, the administration cannot say whether these products are effective for the uses the manufacturers claim. The administration has previously sent warning letters to other companies that were illegally selling unapproved CBD products, which included claims that CBD could "prevent, diagnose, mitigate, treat, or cure various diseases."

The administration says that they cannot determine "what an appropriate dose might be" for the OTC products sold by Honest Globe and BioLyte Laboratories. Nor could they determine how these products "could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns," since they have not yet been evaluated.

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