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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 ConsumerLab’s answers to the following questions:

Do any supplements help prevent or treat osteoporosis?

What are the best supplements or lifestyle modifications for insomnia, and which can make insomnia worse? 

For more information, use the link below.

Warning: Saffron USA LLC
 

See related recalls and warnings:

Seller of Elderberry, Tea Warned for Claims of Treating Cold, Flu, Cancer

Seller of Moringa Tea and Other Herbal Products Warned for Drug Claims, Manufacturing Violations

FTC, FDA, and DOJ Take Joint Action Against Herbal Tea Companies for COVID Claims

Seller of Holistic Tea Warned by FDA

Poppy Seed Tea, Unwashed Poppy Seeds Pose Risk of Overdose, Death