Holistic Healer & Wellness Center, Inc. – FDA Warning Letter, Sep 9, 2021

The FDA issued a Warning Letter to Ms. Stacy Sanchez regarding the "Diabalance Diabetes Supplement" sold on holistichealeronline.com, following a website review in August 2021. The FDA determined the product is an unapproved new drug and misbranded.

The product is deemed a drug under 21 U.S.C. 321(g)(1)(B) due to claims indicating its intent for disease diagnosis, cure, mitigation, treatment, or prevention. Examples of such claims include "Diabalance Diabetes Supplement," "helpful aid to people who have diabetes and hypoglycemia," "Blood sugar rises. . .It may lower elevated blood pressure," and "helps balance blood sugar levels for people with diabetes."

As a "new drug" (21 U.S.C. 321(p)), it lacks FDA approval for safety and effectiveness, violating 21 U.S.C. 331(d) and 355(a). Furthermore, the product is misbranded under 21 U.S.C. 352(f)(1) because it lacks adequate directions for use (21 CFR 201.5). Since diabetes is not amenable to self-diagnosis or treatment, adequate directions for layperson use are impossible, making its interstate commerce introduction a violation of 21 U.S.C. 331(a).

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