The U.S. Food and Drug Administration (FDA) has issued a warning letter to DSE Healthcare Solutions LLC (DSE) regarding its labeling and website claims about its products Urinozinc Prostate Health Formula (for prostate health), Prelief (for heartburn), and Lydia Pinkham Herbal Tablet and Liquid Supplements (to relieve menstrual and menopausal pains).
According to the FDA’s investigation, Urinozinc Prostate Health Formula and Prelief are not generally recognized as safe and effective for their claimed uses and, because DSE lacked prior FDA approval, were not legally distributed or sold. The letter also states that the products lack adequate directions for safe use for their claimed and intended purposes.
The FDA’s investigation also found that DSE’s Lydia Pinkham Tablet and Liquid Supplements’ product labels failed to include: the number of servings per container, proper translations into foreign languages, adequate information regarding an added food preservative, accurate statements of weights and standardized names of their ingredients.
DSE’s other violations, according to the letter, include inadequate complaint-handling mechanisms, failure to establish various required product specifications, product adulterations in violation of federal regulations, and, with respect to Prelief in particular, improper use of scientific publications for marketing.
If you or someone you know has purchased Urinozinc Prostate Health Formula, Prelief, or Lydia Pinkham Herbal Tablet or Liquid Supplements, please contact FBFG to discuss your legal options.