Curaleaf Issues Response to FDA Letter

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WAKEFIELD, Mass. Curaleaf has responded to a letter the company received from the Food and Drug Administration (FDA). The agency has accused the CBD maker of making unsubstantiated claims regarding the effectiveness of CBD to treat certain ailments. Curaleaf is considered to be a leading company among CBD makers and operates in multiple states. 

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency’s letter,” Curaleaf said in a release. “The Company will respond to the FDA letter within the required 15 working days. Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company’s cultivation and manufacturing processes. Curaleaf CBD products are all derived from hemp and meet the requirements of the Farm Bill.”

Curaleaf is not the first CBD producer to receive a warning from the FDA. The agency has issued warning letters to other companies that it claims have made unproven medical claims regarding CBD’s effectiveness. Although many consumers seem to find relief through cannabis and CBD use, research on the plant has been largely prohibited by federal agencies, making consumer testimonials the main source for information on the effectiveness of cannabinoids.

Many in the CBD industry have been confused as to exactly what is permissible by federal authorities. The Agricultural Improvement Act of 2018, known as the farm bill, removed industrial hemp from the Drug Enforcement Agency’s list of banned substances. This led to many believing that hemp-derived CBD was legal. At present, the FDA seems to be concentrating their enforcement efforts on those producing CBD infused foods and beverages as well as companies making claims that cannot be verified.

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