Holistic Healer & Wellness Center, Inc.
FDA and FTC jointly issued a warning letter to Holistic Healer & Wellness Center, Inc. (Dearborn, MI) regarding its 'Diabalance Diabetes Supplement' product. The product's website claims established it as an unapproved new drug under the FD&C Act by asserting it could treat, mitigate, or aid diabetes and blood sugar conditions without FDA approval. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims. The company was required to respond within 15 working days and faces potential seizure, injunction, civil penalties up to $43,792 per violation, and consumer refunds.
Flagged claims (8)
The Bitter Melon, Dandelion, Bilberry and Ginkgo biloba in this vegetarian capsule helps balance blood sugar levels for people with diabetes.
We recommend people with type 2 diabetes or those who are experiencing insulin resistance to opt for this holistic diabetes treatment.
Blood sugar rises. . .It may lower elevated blood pressure. . .
Works great to lower high blood sugar. . .
The combination of these ingredients helps with blood sugar control. . .
The key ingredients are a helpful aid to people who have diabetes and hypoglycemia.
For those with type 2 diabetes. . .
Diabalance Diabetes Supplement
Required actions (6)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Notice is hereby given that you must cease and desist from making any claim that a product and prevent, treat, or cure diabetes without competent and reliable scientific evidence consisting of well‐controlled human clinical studies substantiating that the claims are true.
please notify Richard Cleland of the FTC via electronic mail at [email protected] within fifteen (15) working days of receipt of this letter of the specific actions you have taken to address FTC's concerns.
Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of a disease may be subject to a civil penalty of up to $43,792 per violation pursuant to Section 5(m)(1)(B) of the FTC Act
may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b).
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