Posted September 5, 2014

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

On July 30, 2014, the FDA issued a warning letter to Plexus Worldwide, Inc., following a review of the company's website and product labels, which found statements made about Fast Relief, BioCleanse and ProBio5 to be drug claims.

Fast Relief contains thiamin, riboflavin, niacin, vitamin B6, vitamin B12, biotin folic acid, magnesium, zinc, copper, acetyl-L-carnitine, alpha lipoic acid, horse chestnut extract, butchers broom powder and quercetin. It was promoted to treat nerve damage with statements such as "may reduce the associated symptoms from nerve damage of pain, numbness, tingling, 'pins and needles' sensations, and weakness ".

(See ConsumerLab.com's Reviews of B Vitamin Supplements, Magnesium Supplements, Zinc Supplements, Acetyl-L-Carnitine Supplements and Alpha Lipoic Acid Supplements for tests of related products.)

BioCleanse contains ascorbic acid, magnesium, sodium and a "bioflavonoid complex." It was promoted for various conditions with statements such as "Why do you need Plexus Bio-Cleanse? Many people are in a low oxygen/toxic state...[v]iruses, bacteria, fungi, and other pathogenic microbes thrive in this condition, and can lead to disease such as flu, Candida, chronic fatigue, etc. Plexus Bio-Cleanse can increase the oxygen levels around these microbes, causing them to die due to their high-oxygenated environment.".

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

ProBio5 contains proteases, chitosanase, cellulase and Peptizyme SP (enzymes), Bacillus coagulans, L. acidophilus, B. longum, L. longum, L. plantarum, S. boulardii (probiotics), vitamin C, vitamin B6 and grape seed extract. It was promoted to treat a number of conditions with statements such as " ProBio5 will typically provide the following results... jock itch, migraine headaches, recurring cystitis/vaginal infections...."

See ConsumerLab.com's Reviews of Probiotic Supplements and Resveratrol Supplements (Grape, Red Wine and Polygonum Sources) for tests of related products.

See Related Warnings:

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, use the link below.