Pharmaceutical

Medicinal lotion maker agrees to stop selling unapproved treatments

lotion application Pixabay 315x210 Medicinal lotion maker agrees to stop selling unapproved treatmentsCEO Jeffrey Bedard was informed that his company Crown Laboratories Inc. was selling creams and lotions for various skin conditions including eczema, psoriasis and acne that violated federal law, yet the company continued to market and sell the products. But once the Food and Drug Administration (FDA) filed a complaint in Tennessee federal court last week seeking an injunction to stop the company, Bedard and Crown finally vowed to stop.

The FDA argued that the products Crown was peddling were misbranded under the Federal Food, Drug and Cosmetic Act and claimed to cure, treat or mitigate disease, deeming them drugs. Yet, the company has never sought FDA approval to market the products.

Crown sold a variety of Rea Lo creams and lotions, Dermasorb XM Complete Kit and Sodium Sulfacetamide 10 percent and Sulfur 5 percent. The company claimed the Rea Lo products and Dermasorb kit could treat hyperkeratotic conditions, which include conditions that cause the thickening of the outer layer of skin, such as psoriasis, eczema, dermatitis, as well as calluses, rough skin and fissures. Crown also claimed its Sodium Sulfacetamide could treat acne, acne rosacea, and a skin condition called seborrheic dermatitis.

According to the complaint, the FDA informed Crown during inspections and meetings in 2014 and 2015 that its products were new drugs under the Federal Food, Drug and Cosmetic Act and required premarket approval before they could be sold to the public. The agency also seized the unapproved products made for Ascend Laboratories. In March 2014, Bedard stated in a letter that Crown didn’t intend to file a new drug application.

Crown and Bedard agreed to the FDA’s request for a permanent injunction, and agreed to destroy any products identified by the FDA as unapproved new drugs in its possession.

Source: Law360