Posted February 13, 2013

Manufacturer of Heart, Multivitamin, Cranberry, and Longevity Supplements Warned For Adulteration and Drug Claims

On January 29, 2013, the FDA issued a warning letter to M.D.R. Fitness Corp. following a facility inspection which found violations of good manufacturing practices which cause the company's products to be adulterated. 

A review of the company's website also found statements made about the dietary supplements Artery Factors, Cardio Tone, Cranberry Concentrate, Fitness Tabs for Men and Longevit-E to be drug claims. 

Artery Factors contains magnesium, hawthorn berries, grape seed extract, CoQ10, B6, B12, folate, natural cocoa powder, beet juice, cinnamon bark extract, alpha lipoic acid, bromelain and L-arginine. It was promoted to lower high blood pressure, lower high blood sugar, and treat erectile dysfunction.

Cardio Tone contains L-Carnitine, quercetin, hawthorn berries, CoQ10, lutein, lycopene, zeaxanthin, B6, B12, folate and alpha lipoic acid. It was promoted for cholesterol, homocysteine, energy and cardiovascular health.

(See ConsumerLab.com's Reviews of Cholesterol-Lowering Supplements, Sexual Enhancer Supplements, CoQ10 Supplements, B Vitamin Supplements, Alpha Lipoic Acid Supplements, L-Arginine Supplements, Lycopene Supplements and Vision Supplements With Lutein and Zeaxanthin for tests of related products.)

Cranberry Concentrate contains cranberries and was promoted to "help control bacterial growth in the urine" and treat urinary tract symptoms. 

See ConsumerLab's answers to the questions Can cranberry help with urinary tract infections? and Are cranberry supplements helpful for men? for more information.

Fitness Tabs for Men contain B1, B2, B3, B5, B6, B7, B9, B12, vitamin C, vitamin D3, vitamin E, alpha and beta-carotene, calcium, chromium, copper, fish liver oil, iron, lutein, zeaxanthin, lycopene, magnesium, manganese, garlic, selenium and zinc. It was promoted for overall health, energy, immunity, longevity, and brain function. Statements made about the alpha carotene in this product, including "it's being studied for its protective benefits against cancer," were cited by the FDA as violating federal regulations for dietary supplements.  

Longevit-E contains vitamin E, vitamin C, alpha lipoic acid and phosphatidyl choline. It was promoted for breast, prostate, skin and brain health.

(See ConsumerLab.com's Reviews of Multivitamins and Multiminerals, Memory Enhancing Supplements, Fish Oil Supplements, Magnesium Supplements, Chromium Supplements, Beta Carotene Supplements, Vitamin C Supplements, Vitamin E Supplements, Zinc Supplements, Garlic Supplements and Selenium Supplements for tests of related products.)

The FDA also noted that typing the key words "cancer" or "diabetes" into the M.D.R. Fitness website's product search produced results including Fitness Tabs for Men, Longevit — E and others products, and found that this implied the supplements were intended for use in the "diagnosis, cure, mitigation, treatment or prevention of such diseases." 

For more information about the FDA's warning letter, use the link below.