Posted April 1, 2017

Maker of Prelief, Urinozinc Prostate Health Formula Warned for Manufacturing Violations

On March 16, 2017 the FDA issued a warning letter to DSE Healthcare Solutions, LLC, following a facility inspection which found the company's products, including Prelief and Urinozinc Prostate Health Formula 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 establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, and failure to satisfy the requirements for the review and investigation of product complaints, as required by federal regulations.

In addition, statements made about the products on labels and in marketing materials were found to be drug claims. For example, Prelief was promoted with statements such as "Taking Prelief . . . can often stop [foods] from causing painful bladder symptoms" and "If acid foods bother your bladder it could be interstitial cystitis. Prelief Dietary Supplement may help manage your bladder discomfort.". 

(See ConsumerLab.com's CL Answer What is Prelief? Does it really help for heartburn and/or bladder pain from acidic foods? for more about this product.)

Urinozinc Prostate Health Formula was promoted with statements such as "If you're a man and are experiencing the symptoms of an enlarged prostate . . . URINOZINC may be right for you". 

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

In addition, the company's Lydia Pinkham Herbal Tablet Supplement and Lydia Pinkham Herbal Liquid Supplement products were found to be misbranded because the labels did not include information required by federal regulations.

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

See Related Warnings:

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

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims

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