FDA: Lehigh Valley Manufacturer Mislabeled Cough Syrups

The Federal Drug Administration issued a warning to a Lehigh Valley-based manufacturer for mislabling cough syrups, which violates federal law.

The FDA sent a warning letter to Fragrance Manufacturing Inc. (FMI), on Jan. 21, stating the company had several cough syrup products mislabled, which violated the Federal Food, Drug, and Cosmetic Act. The products — Maty’s All Natural Cough Syrup and Maty’s All Natural Cough Syrup for Kids — were being promoted for conditions that caused them to be drugs, but were unapproved by the FDA, the warning letter said.

FMI’s use of the phrase “cough syrup” in the products’ names proved to be problematic, as it suggested they treat specific conditions.

“The therapeutic claims made on your products’ labels establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” the FDA said in the letter. “Introducing or delivering these products for introduction into interstate commerce for such uses violates the [Federal Food, Drug, and Cosmetic Act].”

The FDA made such observations during an inspection of an FMI manufacturing facility in Allentown in April 2014, the letter said.

FMI CEO Kevin Rhodes said the two products have been sold for several years and the FDA has not taken issue with the products or product labels before, according to The Express-Times.

Rhodes said FMI is cooperating with the FDA to resolve the issues the agency outlined in its letter, The Express-Times reported.

For more information about this story, read the entire FDA warning letter to FMI or visit The Express-Times.