Recalls & Warnings
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Posted December 12, 2022
FDA Warns Saffron USA for Promoting Teas to Treat Insomnia, Osteoporosis & Cancer
On September 23, 2022, the FDA issued a warning letter to Saffron USA LLC following inspection of the company’s website which found statements about its Allergy Blend, Chamomile Tea Petals, Diabetic Support Blend, Orange Blast Tea, and Saffron Loose Tea products to be drug claims.
For example, the company’s Saffron Loose Tea products were promoted with statements such as, “Fights Anxiety,” “Cancer prevention,” and “Help insomnia.” Chamomile Tea Petals were promoted with statements such as, “Slowing or preventing osteoporosis,” and “Treating diabetes.”
Additionally, the FDA stated in its letter it considers these products to be “new drugs” because they are not recognized as safe and effective for their promoted uses. Saffron USA’s products were also found to be misbranded because the labels did not provide adequate directions for their intended use.
Saffron USA LLC must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address any and all violations.
For more information about saffron, see the following:
Saffron Supplements Review
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What are the best supplements or lifestyle modifications for insomnia, and which can make insomnia worse?
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Warning: Saffron USA LLC
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