Save to favorites
This feature is restricted to active members.
Join now to save favorites and get all member benefits, including over 1,400 reviews.
Join NowAlready a member? Sign in here.
Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
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
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
Thank you for submitting your report.
Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
Thank you for submitting your report.
