Posted November 21, 2014

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

On October 7, 2014, the FDA issued a warning letter to dietary supplement distributor Windmill Health Products, LLC, following a facility inspection which found the company's products, including Nutri-Betic caplets, Vita-betic caplets, ProstrinRx tablets, Polyflavanol capsules, and Glucoflex Joint Lube liquid products to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to ensure the quality of dietary supplements the company distributes, failure to ensure that the dietary supplements are packaged and labeled as specified in the master manufacturing record, and failure to establish and follow written procedures for holding and distributing operations.

In addition, statements made about Nutri-Betic caplets, Vita-betic caplets, ProstrinRx tablets, Polyflavanol capsules, and Glucoflex Joint Lube liquid products were found to be drug claims.

Nutri-Betic caplets contain vitamin C and bilberry, along with other ingredients. They were promoted to treat diabetes with statements such as "Targeted nutritional support for diabetics," and "Supplementing with vitamin C (an ingredient in your product) may benefit people with type 1 diabetes ... including by reducing sorbitol levels, urinary protein loss, glycosylation, and eye damage."

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

Vita-betic caplets contain vitamin D, vitamin E, biotin, magnesium, chromium, zinc, and other ingredients. They were promoted to treat diabetes with statements such as "Vitamin D is needed to maintain adequate insulin levels, and supplementing with it may reduce the risk of developing type 1 diabetes."

(See ConsumerLab.com's Review of Multivitamin and Multimineral Supplements, as well as Reviews of Vitamin D Supplements, Vitamin E Supplements, B Vitamin Supplements, Magnesium Supplements, Chromium Supplements and Zinc Supplements for tests of related products.)

ProstrinRx tablets contain zinc, saw palmetto, beta-sisterol and nettle. They were promoted to treat prostate problems with statements such as "ProstrinRx might be the natural solution to BPH (Benign Prostatic Hyperthophy), "Saw Palmetto (an ingredient in your product), the leading natural treatment for BPH, has been shown to help keep symptoms in check when used regularly," and "[C]an help fight BPH and reduce prostate inflammation restoring normal prostate function."

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

Polyflavanol capsules contain ginkgo and other ingredients. They were promoted to treat tinnitus with statements such as "Proven results for ringing in the ears," "[G]inkgo may be useful in treating tinnitus," and "You do not have to live with tinnitus any longer!"

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

Glucoflex Joint Lube liquid products contain glucosamine hydrochloride. They were promoted to treat arthritis pain with statements such as "Glucosamine Hydrochloride ... effective at reducing pain and improving symptoms in people with osteoarthritis."

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

See Related Warnings:

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements 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.