Recalls & Warnings
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Posted July 12, 2023
FDA Warns Company for Promoting Kratom Products for Pain, Mood, and More
On July 3, 2023, the FDA issued a warning letter to Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom following a review of the company’s website that found statements about the company’s red, green, and white kratom products, including Green Maeng Da Kratom Powder, Green Malay Kratom Powder, Red Bali Kratom Powder, Yellow Vietnam Kratom Powder, and White Borneo Kratom Powder, to be drug claims.
For example, kratom products were promoted with statements such as, “What Are The Benefits of Using Kratom? . . . Kratom contains alkaloids such as mitragynine and 7-hydroxymitragynine that acts [sic] on the opioid receptors to produce opioid-like effects. It can help relieve pain, improve mood, increase concentration or focus, relaxation, and more. Some users with opioid withdrawal have also reported that kratom helps eases [sic] their symptoms” and “Kratom Benefits . . . Energy Boost . . . Mental Clarity and Focus . . . Mood Elevation . . . Relaxation . . . Pain Relief . . . Opiate Withdrawal.”
The FDA has previously advised consumers against using kratom, which is often promoted for pain relief and for relieving symptoms of opioid withdrawal. However, the active compounds in kratom are opioids which can have effects similar to morphine and heroin. Consumption of kratom has been associated with agitation, irritability, tachycardia, nausea, drowsiness, and hypertension. Risks of using kratom include hepatotoxicity, psychosis, seizure, weight loss, insomnia, tachycardia, vomiting, poor concentration and hallucinations. The CDC states there are at least 91 deaths associated with its use.
As stated in the FDA's warnings, "The Department of Health and Human Services has determined that a public health emergency exists nationwide involving the opioid crisis…The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction." The agency also states that these products were unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and are not generally recognized as safe and effective for uses mentioned.
The company is required to notify the FDA in writing of the specific steps taken to correct the violations within fifteen working days of receipt of the warning letter.
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Warning: Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom
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