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CRITICALNutrition / Supplements

Pharmaganics LLC

FDA and FTC jointly issued a warning letter to Pharmaganics LLC (CEO Tom Redmond III) regarding its 'Diabetes Doctor Pre-Diabetes' and 'Diabetes Doctor Blood Sugar 24 Hour' dietary supplement products sold via its website, Amazon, Walmart, Facebook, and Instagram. The products were found to bear disease-treatment claims — including preventing, treating, and mitigating Type 2 diabetes and insulin resistance — that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated efficacy claims, warning of civil penalties up to $43,792 per violation and potential consumer redress. Both agencies required written response within 15 working days.

Lower protein in the urine (marker of kidney damage) in patients with diabetic kidney disease

[C]omprehensive product that is designed to help you meet your daily diabetes needs from blood sugar control to diabetes specific organ health …. help that insulin function better and cut through insulin resistance …

Milk Thistle [ingredient in product] … has been clinically proven to fight resistance for significant benefits on blood sugar health

Lower HbA1C by 1.5%

Curcumin/Turmeric [ingredient in product]…In a research study of people with pre- diabetes, taking curcumin for 9-months significantly reduced the number of prediabetic individuals who eventually developed Type 2 diabetes. Curcumin treatment appeared to support healthy function of β-cells, the insulin producing cells of the pancreas.

Diabetes Doctor Early Defense – Pre-Diabetes and Diabetes Support … Stabilize Blood Sugar Levels

Research shows that cinnamon [ingredient in product] does NOT work to lower blood sugars….. unless used at doses of 500-1000 mg/day! Blood Sugar 24 Hour Support includes Cinnamon at the right dose (750 mg/day)

Lower fasting blood sugars by 11%

Diabetes Doctor Daily Support – 7 in 1 Blend for Daily Diabetes Needs and High Blood Sugar Regulation - Target Insulin Resistance and Sensitivity, Organ Health …

Banaba [ingredient in product] acts as a natural insulin sensitizer to support healthy blood sugar and A1C . …[B]anaba can reduce blood sugars by 30%, and A1C by 0.65%

Lower insulin needs by 14%

COMBAT INSULATION RESISTANCE: Diabetes Doctor's powerful blend of Cinnamon, Banaba, Magnesium, and Chromium helps promote healthy insulin function …

Vitamin D3 [ingredient in product] Clinical research has demonstrated that in people without diabetes, increasing blood levels of vitamin D is associated with a lower risk of developing type 2 diabetes. Our formula uses the activated form of Vitamin D (D3).

Bilberry [ingredient in product] …shown improved retinal (eye) circulatory health in adults with diabetic retinopathy after 6 months

Magnesium [ingredient in product]...Research shows that a 100 mg/day increase in magnesium intake is associated with a 15% risk reduction for developing type 2 diabetes…

ESSENTIAL NUTRIENTS: Early Defense contains a blend of key ingredients like Magnesium and Vitamin D3 [ingredients in the product] that are critical in diabetes health.

Take control of your diabetes naturally with the help of Blood Sugar 24 hour Supplement by Diabetes Doctor. Help maintain healthy blood sugar levels …which helps your body's natural insulin work better.

Studies have shown cassia cinnamon [ingredient in product] at high doses can reduce fasting blood sugars by 25mg/dL

Lower abnormal liver enzymes in patients with non-alcoholic fatty liver disease

Maintain healthy function of vital diabetes organs

Fights Insulin Resistance

This product is not only a multivitamin but has been specifically designed to target the root cause of high blood sugar and Type 2 diabetes

REVOLUTIONARY BLEND AND HIGH DOSES: … natural ingredients needed for daily Diabetes support and blood sugar regulation

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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

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.

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, 15 U.S.C. § 45(m)(1)(B)

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)

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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.

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