The U.S. Food and Drug Administration (FDA) sent New Jersey-based DSE Healthcare Solutions LLC a warning letter about DSE’s labeling and website claims pertaining to certain over-the-counter (OTC) products, including Urinozinc for prostate health and Prelief for heartburn. DSE Healthcare Solutions sells the products in drug stores throughout the United States.
The FDA conducted an inspection of DSE’s Edison, New Jersey facility. Upon reviewing DSE’s product labels and websites, the FDA concluded that certain products violated the food labeling requirements of the Federal Food, Drug, and Cosmetic Act (the Act). The warning letter stated that the therapeutic claims on product labels and websites established that the Urinozinc Prostate Health Formula and Prelief products are drugs under the Act because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
The FDA objected to claims appearing Urinozinc’s labels and website indicating its use may improve symptoms of enlarged prostate. DSE claimed use of Prelief would lessen bladder discomfort. DSE’s Prelief website indicates that interstitial cystitis is a possible cause of bladder discomfort. The FDA also objected to DSE’s use of customer testimonials recommending or describing the use of Prelief for the cure, mitigation, treatment, or prevention of disease.
The warning letter noted that DSE’s website contained citations to scientific publications, which, when used commercially by the seller of a product to promote the product to consumers, may be evidence of the product’s intended use for disease treatment or prevention.
The warning letter goes on to state that Urinozinc Prostate Health Formula and Prelief products are not generally recognized as safe and effective for the claimed uses and, therefore, these products are “new drugs” as defined in the Act. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA. The FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The warning letter also notes that Urinozinc Prostate Health Formula and Prelief are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use the products safely for their intended purposes. Accordingly, the letter indicates that Urinozinc Prostate Health Formula and Prelief products are misbranded and their introduction or delivery for introduction into interstate commerce violates the Act.
Other cited violations related to manufacturing, including a failure to create product specifications and a faulty complaint-handling process. Inspectors noted violations of Current Good Manufacturing Practice (CGMP) standards, causing DSE’s dietary supplement products to be adulterated within the meaning of the Act.