Vital Hierbas Naturales Corporation – FDA Warning Letter, Sep 12, 2017

The FDA issued a Warning Letter to Vital Hierbas Naturales Corporation following an inspection from August 22 to September 12, 2017, and a review of product labels. The letter identifies multiple violations related to product labeling and regulatory compliance.

Several products, including Vital Clean Parasit, Vital Depresion Tea, VitalAshma Tea, VitalRelief Tea, VitalDiurec Tea, Vital Arthri Tea, Nopalinasa Vital Flax Seed Plus Vital, and VitalDiabe Tea, are deemed unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] due to disease treatment claims on their labels. These products are not generally recognized as safe and effective, thus requiring prior FDA approval. Vital Clean Parasit, VitalDepresion, and Nopalinasa Vital Flax Seed Plus Vital are also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision.

Additionally, VitalWoman Tea, VitalRelax Tea, VitalLaxan Tea, Vital Clean Parasit, and Nopalinasa Vital Flax Seed Plus Vital are misbranded foods under