FDA WARNING_LETTER - Herbal Vitality, Inc. - July 15, 2022

On March 7, 2023, the FDA issued a Warning Letter to Dr. Rochon following a July 11-15, 2022, inspection of their Sedona, Arizona manufacturing facility. The inspection and product labeling review revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that 21 of Dr. Rochon's products, including "Acute Kidney Stone Relief" and "Adult Cold & Flu," are unapproved new drugs because their labeling and catalog claims indicate intent for disease cure, mitigation, treatment, or prevention. These products are not generally recognized as safe and effective and lack FDA approval, violating sections 201(p), 301(d), and 505(a) of the Act. Additionally, several products, such as "Special Lyme Formula," are misbranded under section 502(f)(1) for lacking adequate directions for layperson use, as they are intended for conditions requiring professional supervision.

The inspection also found significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering them adulterated under section 402(g)(1). Deficiencies include: 1. Failure to establish component specifications for contaminants (e.g., microbes, pesticides, heavy metals) as required by 21 CFR 111.70(b)(3). 2. Failure to establish finished product specifications for identity