# FDA WARNING_LETTER - Holistic Healer & Wellness Center, Inc. - September 09, 2021

Source: https://www.keypedia.com/records/warning_letter/holistic-healer-wellness-center-inc/dfc9fafb-7ab3-46ea-8c80-19be49ddca48

> FDA WARNING_LETTER for Holistic Healer & Wellness Center, Inc. on September 09, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Holistic Healer & Wellness Center, Inc.
- Inspection Date: 2021-09-09
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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).

The

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