Posted November 6, 2014

Seller of Prostate, Heart Supplements and More Warned for Drug Claims

On October 9, 2014, the FDA issued a warning letter to Health Research Laboratories, LLC/New World Health, following a review of the company's websites, which found statements made about AtheChel Advanced, Betarol, BioTherapex, Omega-3 Cardio Plus, RejuvaLifeRx, and Ultimate Health Formula to be drug claims.

Betarol contains beta sitosterol, saw palmetto berry extract, selenium, zinc and other ingredients. It was promoted to treat prostate inflammation, with statements such as "Betarol ...to combat the symptoms of prostatitis," and "Your prostate can reduce in size up to 60%, relieving symptoms."

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

BioTherapex was promoted to treat diabetes, arthritis, high blood pressure and high cholesterol with statements such as "Lower Risk of Diabetes," "[P]otassium to combat osteoporosis and hypertension," and "Enjoy lowered cholesterol, reduced risk of cardiovascular issues... relief from rheumatism, arthritis and osteoarthritis."

(See ConsumerLab.com's Review of Cholesterol-Lowering Supplements for tests of related products.)

Omega-3 Cardio Plus contains vitamin E, vitamin C, vitamin K, fish oil, EPA, DHA, L-carnitine, garlic oil, beta sitosterols, quercetin, green tea extract and policosanol. It was promoted to heart and brain disease with statements such as "Prevent Heart and Brain Disease," and "[Omega-3 Cardio Plus is a must have in your arsenal against heart disease and high cholesterol. It helps to eradicate decades worth of dangerous plaque buildup in your arteries, enables ideal blood pressure levels and even reduces the likelihood of terrifying chest pains or heart palpitations."

(See ConsumerLab.com's Reviews of Vitamin E Supplements, Vitamin C Supplements, Vitamin K Supplements, Fish Oil and Omega-3 Fatty Acid Supplements, Green Tea Supplements and Cholesterol-Lowering Supplements for tests of related products.)

Ultimate Heart Formula was promoted to treat heart disease with statements such as "Unclog Plaque Build Up from Arteries," and "Dramatically Decrease Risk of Heart Attack."

RejuvaLifeRx contains antioxidants, minerals, vitamin D, vitamin E, vitamin K and CoQ10. It was promoted to treat a variety of conditions with statements such as "RejuvaLifeRx can also help keep the heart healthy by regulating hypertension," "[It] can give relief from pancreatic conditions such as diabetes and hyperglycemia. There are also benefits.... that can help Parkinson's, Alzheimer's, and Huntington's disease patients," and "Both female and male sexual benefits ... this vitality supplement is a vasodilator."

(See ConsumerLab.com's Reviews of Vitamin D Supplements, Vitamin E Supplements, Vitamin K Supplements and CoQ10 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.