Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted February 22, 2021
Sellers of Supplements for Depression, Mood, Warned by FDA
On February 18, 2021, the FDA issued warning letters to four companies following reviews of the companies' websites, which found statements made about the companies' mood enhancer products to be drug claims. These products include Enlifta Mood Elevator and Enlifta Anxiety from Enlifta, LLC, Mood Support from Mountain Peak Nutritionals, MindSoothe Drops and MindSoothe Capsules from Native Remedies dba Silver Star Brands, and Mood Boosting Probiotic from Lifted Naturals.
More information about each warning is below (use the links to read the full warning letter):
- Enlifta, LLC (Enlifta Mood Elevator and Enlifta Anxiety) were promoted with statements such as "The Only Doctor Designed Depression Pill, Enlifta Depression Supplement - Best Natural Antidepressant" and "A new natural supplement is providing relief to people across America suffering with severe anxiety and stress!"
- Mountain Peak Nutritionals (Mood Support) was promoted with statements such as "5-hydroxytryptophan (5-HTP) [an ingredient in Mood Support] increases serotonin levels, which plays a significant role in treating depression, anxiety" and "We also include the B-complex vitamins that are often shown to be deficient in depressed patients," "In over 25 double-blind studies examining the effectiveness of St. John's wort [an ingredient in Mood Support] extract, the results showed that it was just as effective as pharmaceutical antidepressants in alleviating symptoms of mild to moderate depression, and with very few side effects."
- Native Remedies dba Silver Star Brands (MindSoothe Drops and MindSoothe Capsules) were promoted with statements such as "Regulates disturbed sleep patterns (insomnia or hypersomnia)" and "Relieves feelings of depression."
- Lifted Naturals (Mood Boosting Probiotic) was promoted with statements such as "Our blend is especially potent with our PREBIOTIC, GOS-- the ONLY prebiotic that's been proven to help with anxiety."
See ConsumerLab's Reviews of L-Tryptophan and 5-Hydroxytryptophan (5-HTP) Supplements, B Vitamin Supplements, St. John's Wort Supplements and Probiotic Supplements for tests of related products.
Also see the CL Answer What are the best supplements for depression and anxiety? 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.
See related warnings: