Pharmaceutical

FDA slaps dietary supplement maker with warning letter

dietary supplements pills probiotics FDA slaps dietary supplement maker with warning letter New Jersey-based DSE Healthcare Solutions LLC, which sells over-the-counter specialty products and dietary supplements in drugstores nationwide, was slapped with a warning letter from the Food and Drug Administration (FDA) for claims it has made regarding its Urinozinc for prostate health and Prelief for heartburn.

The agency fussed at the company for its language used on the products’ labels and on its website, like Urinozinc’s benefit in treating painful and frequent urination. The website states that the product’s main ingredient, beta sitosterol, can treat symptoms of enlarged prostate. The FDA also took issue with claims that Prelief can stop “painful bladder symptoms” and is “the most desirable and least compromising way of dealing with food-triggered bladder discomfort.”

DSE also used consumer testimonials. One customer was quoted as saying that Prelief “not only protects my bladder, but now my acid reflux is so good I don’t take any more antacids, either.”

The FDA warning letter also called out other products made by the company, including Lydia Pinkham Herbal Tablet Supplement and Lydia Pinkham Herbal Liquid Supplements for confusing labeling and for listing ingredients such as “pleurisy,” which the agency said, “is not a standardized common name as noted in Herbs of Commerce.”

The company was given 15 working days to provide specific steps that it is taking to correct violations and ensure the violations will not be made again.

Sources:
Law360
FDA Warning Letter