South Texas Botanicals FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

“Try this formula for mouth sores, gum disease, toothaches, cavities, sore throat. . .”

“[I]ncrease platelet count, preventing the need for a blood transfusion. . .”

“It appears to have been effective to increase platelet count, preventing the need for a blood transfusion . . .to use along when dealing withlyme (sic) disease. . . “

Potential Health Risks

Consumers should be aware of potential risks associated with products from South Texas Botanicals.

Regulatory Context

“[A]n aid to relieve irritation in the respirtory (sic) tract, lungs and bronchial, asbronchitis, allergies . . .”

You failed to establish specifications for each component that you use in the manufacture of a dietary supplement. Specifically, you failed to establish the following: an identity specification; specifications to ensure purity, strength and composition of dietary supplements manufactured using the components are met; and specifications that establish the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(1)-(3).

Youfailed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).