Vital Hierbas Naturales Corporation FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

This is to advise you that the Food and Drug Administration (FDA) reviewed your product labels for Vital Clean Parasit, Vital Depresion Tea, VitalAshma Tea, VitalRelief Tea, VitalDiurec Tea, Vital Arthri Tea, Nopalinasa Vital Flax Seed Plus Vital, and VitalDiabe Tea following an inspection of your facility at 2100 W 24th St, Chicago, IL 60608 between August 22, 2017 and September 12, 2017. The claims on your product labels establish that the products are 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)] because they are intended for use in the cure, mitigation, treatment or prevention of disease.

Examples of some of the claims on your product labels that provide evidence that your products are intended for use as drugs include:

• “Basil: Helps to relieve stomachache… and to eliminate parasits”• “Aloe Vera: … [c]ontributes to overcome squares of ulcers and indigestion.”• “Garlic: … protects against infection, Helps to expel parasites.”• “Walnut Shell: Helps the scaring of ulcers.”• Pasaya Seed: Helps … indigestion and intestinal inflammation. Contributes to elimination of parasites”• “Pumpkin Seeds: … [h]elps eliminate intestinal worms and disorders.”• “Bentonite: Helps to remove parasites and toxins of the colon walls.”• “Epasete: Helps to cure stomachaches and indigestion. Antiparasite.”• “Parsley: … antiparasite.”• “Fiber: Reduces constipation, expels toxins in the colon and helps to prevent colon cancer.”

Potential Health Risks

Consumers should be aware of potential risks associated with products from Vital Hierbas Naturales Corporation.

Regulatory Context

Additionally, we have determined that your VitalWoman Tea, VitalRelax Tea, and VitalLaxan Tea products are misbranded under section 403 of the Act [21 U.S.C. 343] and its implementing regulations under 21 CFR part 101, and that, even if your Vital Clean Parasit and Nopalinasa Vital Flax Seed Plus Vital products were not drugs under section 201(g)(1)(B) of the Act, they would be misbranded under section 403 of the Act [21 U.S.C. 343] and its implementing regulations under 21 CFR part 101.

As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page atwww.fda.gov.

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.