Recalls & Warnings
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Latest Posted March 23, 2023
FDA Warns Herbal Vitality for Promoting Supplements to Treat Cold & Flu, Kidney Stones & More
On March 7, 2023, the FDA issued a warning letter to Herbal Vitality, Inc. after an inspection of the company’s facility and product catalogs found claims about Acute Kidney Stone Relief, Adult Cold & Flu, Antifungal Formula, Baby Cold & Flu, Children’s Antibiotic Formula, Children’s Asthma Formula, Hemorrhoid Remedial, Pregnancy Cold and Flu Formula, Prostrate Formula, Special Lyme Formula, Fibromyalgia Formula, Hepatitis C Formula Glycerite, Kidney Stone Remedial, Lung Tonic COPD, Children’s Antiviral Formula, Children’s Allergy Relief Formula, Antiparasite Formula, Anti-Amoeba Formula, Hyperthyroid Relief, PCOS Formula, and Children’s Tonsilitis/Otitis to be drug claims.
For example, Baby Cold & Flu products were promoted with statements such as, “…the herbs bring their actions to respiratory and digestive tracts and help clear a fever. Anti-viral, diaphoretic, expectorant, antispasmodic, carminative…” and Prostate Formula products were promoted with statements such as, “The herbs…have anti-tumor properties.”
In addition, several of the company’s products were found to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). These violations include failure to establish specifications for dietary supplements for identity, purity, strength, and composition, and failure to prepare written instructions for corrective action plans when specifications are not met. Some products were also found to be misbranded because serving sizes declared were incorrect and/or incomplete and because product labels failed to declare common or usual names of certain ingredients.
The company must respond within 15 days outlining steps taken to address any violations.
See ConsumerLab’s Review of Prostate Supplements for more information and tests of related products.
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Warning: Herbal Vitality, Inc.
See related recalls and warnings:
FDA Warns Companies Promoting Products to Treat Monkeypox, COVID-19, & Other Viruses
Seller of Elderberry, Tea Warned for Claims of Treating Cold, Flu, Cancer
FDA Warns Elderberry Fair & Co for Promoting Elderberry Supplements and Apple Cider to Treat Cold
FDA Warns Sellers of Prostate, Reishi, Immune Products, and More
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please visit the FDA MedWatch website.