Posted November 6, 2014

Seller of Cholesterol, Arthritis Supplements and More Warned for Drug Claims

On October 17, 2014, the FDA issued a warning letter to Vitamins Direct (USA) and Golden Pride, Inc., which distribute Flexezy and Physician's Signature brands of dietary supplements, following a facility inspection which found statements made about certain supplements to be drug claims.

Pulsate Plus contains vitamin E, vitamin B6, B12, folic acid, magnesium, potassium, noni juice extract, sea buckhorn extract, green tea extract, resveratrol and CoQ10 and other ingredients. It was promoted as a source of vitamins and antioxidants for the treatment of a variety of conditions, with statements such as "It has also been reported by past customers to have virtually eliminated their rosacea and lowered their blood sugar levels enabling them to cut their usual insulin doses in half!," and " Pulsate Plus has been known to help reduce the risk of heart disease and lower Total and LDL Cholesterol."

(See ConsumerLab.com's Reviews of Vitamin E Supplements, B Vitamin Supplements, Magnesium Supplements, Potassium Supplements, Green Tea Supplements, Resveratrol Supplements and CoQ10 Supplements for tests of related products.)

Lipid Results contains niacin, guggul gum extract, and garlic, red yeast rice and fenugreek seed, and other ingredients. It was promoted to treat diabetes, arthritis, high blood pressure and high cholesterol with statements such as " Lipid Results is a doctor-formulated, cutting-edge supplement designed to help manage your ...blood pressure," " Other key ingredients found in Lipid Results are ...fenugreek seed which may help in controlling diabetes and arthritis..., and " The ingredients found in Lipid Results ...contribute to lowering your cholesterol."

(See ConsumerLab.com's Reviews of Cholesterol-Lowering Supplements, Red Yeast Rice Supplements, Garlic Supplements and B Vitamin Supplements for tests of related products.)

OC-Max contains plant sterol esters, enzymes, sodium alginate, disodium ethylene diamine tetracetic acid, sodium hexametaphostate, royal jelly, bee pollen, sodium alginate, lipoic acid, and rose hips. It was promoted to treat blood clots, inflammation and high cholesterol with statements such as "Provides anti-inflammatory effects," and "[S]errazymes may be used to help dissolve blood clots, arterial plaque...."

(See ConsumerLab.com's Review of Alpha-Lipoic Acid Supplements for tests of related products.)

Cardio Results Omega III contains omega-3 fatty acids EPA and DHA from fish oil. It was promoted to treat rosacea and high blood sugar with statements such as "It has been reported by past customers to have virtually eliminated their rosacea and lowered their blood sugar levels enabling them to cut their usual insulin doses in half!"

(See ConsumerLab.com's Review of Fish Oil and Omega-3 Fatty Acid Supplements for tests of related products.)

Flexezy-GC contains glucosamine and chondroitin. It was promoted to treat arthritis with statements such as "Flexezy-GC... is great for those suffering from conditions such as ...arthritis, bursitis, osteoarthritis, and rheumatoid arthritis."

(See ConsumerLab.com's Review of Joint Health Supplements for tests of related products.)

Honey Bee Propolis III was promoted to treats a variety of conditions with statements such as "Honeybee Propolis can help build the body's natural resistance to infections and diseases while offering strong antibiotic, antiseptic, antiviral, anti-fungal, and anti-inflammatory properties," and "Helps regulate histamine and seratonin [sic], two substances needed by the body to help cope with allergies, hay fever."

Glyco Results III contains vitamin C, niacin, vitamin B6, biotin, magnesium, zinc, chromium and other ingredients. It was promoted for high blood sugar and metabolism with statements such as "Physician's Signature Glyco Results is a doctor-formulated, cutting-edge blood sugar management supplement," and " Chromium: Helps stabilize blood sugar levels, improve insulin function, and manage diabetes."

(See ConsumerLab.com's Reviews of Vitamin C Supplements, B Vitamin Supplements, Magnesium Supplements, Zinc Supplements and Chromium Supplements for tests of related products.)

See Related Warnings:

Seller of Multivitamin Warned for Drug Claims

Seller of Joint Pain Supplement Warned for Drug Claims

Seller of "Nerve", "Cleanse" and Probiotic Supplements Warned for Drug Claims

Seller of Immune Supplement Warned for Drug Claims

Seller of Joint Supplement Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below.