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.

Also see:

Which supplements and foods reduce or increase the risk of kidney stones?

Do any supplements help prevent or treat a cold?

Do any supplements help for flu?

For more information, use the link below.

Warning: Herbal Vitality, Inc.

See related recalls and warnings:

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FDA Warns Sellers of Prostate, Reishi, Immune Products, and More