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Posted February 22, 2021

FDA Warns Seller of Melatonin & Other Sleep Supplements

On February 18, 2021, the FDA issued a warning letter to SANA Group LLC following a review of the company's website, which found statements made about the company's products Sleep Sana Sleep Drops and Sleep Shots to be drug claims.

Sleep Sana products were promoted with statements about some of their ingredients, such as "L-tryptophan is used for insomnia, sleep apnea, depression, anxiety, facial pain, a severe form of premenstrual syndrome called premenstrual dysphoric disorder (PMDD)... attention deficit-hyperactivity disorder (ADHD), Tourette's syndrome," "Valerian is most commonly used for sleep disorders, especially the inability to sleep (insomnia)," and "your body may produce melatonin either earlier or later in the day than usual. This change can lead to symptoms of seasonal affective disorder (SAD), or winter depression."

See ConsumerLab's Reviews of L-Tryptophan and 5-Hydroxytryptophan (5-HTP) Supplements, Valerian Supplements, and Melatonin Supplements for tests of related products.

Also see the CL Answer Which supplements can help me sleep and which cause insomnia? for more information.

In addition, the products were found to be misbranded because they do not contain adequate directions for safe use, as required by federal regulations.

For more information, use the link below.

Warning Letter: SANA Group LLC

See related warnings:

Seller of BioCBD+ Products Warned for COVID-19 and Drug Claims

Seller of Aloe Products Warned for Claiming to Treat Joint Stiffness

FDA Warns Seller of Reishi Mushroom Supplements

FDA Warns Seller of Ginger, Echinacea, and More

Seller of Omega-3 Warned for Making Claims to Treat Focus, Mood