FDA Warning Letter to the seller of Prelief and Urinozinc

Company Behind Prelief, Urinozinc, Warned By FDA For Bogus Claims

The company behind Prelief was recently sent an FDA warning letter.
Screengrab of Prolief.com with unallowed medical claims clearly visible.

The company behind products like Prelief® and URINOZINC® has been formally warned by the US Food and Drug Administration, or FDA, for what the agency calls “significant” problems related to how the dietary supplements are marketed.

In a warning letter to Moaiz Daya and his company, DSE Healthcare Solutions, the FDA reveals that it spent several August Days at the company’s New Jersey facility, reviewing the company’s packaging and its recordkeeping practices. In addition to some shoddy quality control allegations, the agency also takes issue with the company’s marketing of two of its supplements.

Unallowed Medical Claims For Urinozinc Prostate Health Formula:

The problems with Urinozinc’s marketing were found both on the product’s packaging and its website, urinozinc.com. Some of the non-allowed claims reportedly included:

  • Relief from pain
  • Less frequent urination
  • Relief from enlarged prostate

Unallowed Medical Claims For Prelief:

The problems with the Prelief product’s marketing were also found on both its packaging and its website, prelief.com. Some of those included:

  • Pain relief
  • Reduction in urinary urgency
  • Acid reduction

In the case of the Prelief product, the company was also dinged for linking from its website to medical studies on a Prelief ingredient.

The FDA says that such claims go well beyond what hawkers of dietary supplements are allowed to make. The products have never been officially recognized as safe or effective for those conditions. The supplements are further “misbranded” because they’re promoted for conditions the average person is simply not able to self-diagnose or successfully treat with over-the-counter supplements.

As is always the case with these types of warning letters, Moaiz Daya and DSE Healthcare Solutions was given 15 working days to address the FDA’s concerns. The letter is dated March 16, 2017.

As of my visit to their websites this afternoon, I found the claims I looked up still prominently visible:

The company behind Urinozince was recently sent an FDA warning letter.