FDA warning letters
UNITED STATES – As reported online by www.biospace.com, the United States Food and Drug Administration (FDA) sent warning letters to companies selling drugs containing Kratom, making false claims about Kratom’s health benefits.
The FDA recently sent warning letters to two companies, Cali Botanicals of Folsom, California and Kratom NC of Wilmington, North Carolina, alleging that the companies illegally sold drugs containing kratom that are not approved by the FDA. Kratom is a plant found in Southeast Asia. The companies allegedly made false claims to consumers stating that kratom could cure opioid addiction, treat withdrawal symptoms, and treat other health conditions, including cancer.
According to the FDA, there is no scientific data to back up the companies’ claims regarding the health benefits of kratom. As such, consumers are relying on inaccurate information when deciding whether to take drugs/medications that contain kratom. The FDA believes companies selling products containing kratom are taking advantage of opioid addicts looking for a safe way to recover from addiction.
Additionally, the FDA has found that some kratom products are contaminated with salmonella, have high levels of heavy metals, and microorganisms that have the potential to cause serious illnesses. The two companies are required to provide the FDA with a plan for addressing its alleged illegal activity and must do so within fifteen working days. If the two companies fail to respond to the FDA’s concerns, they may be facing law enforcement action, including seizure and injunction.
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