Crown Laboratories, which maintains a corporate headquarters and manufacturing facility on Lafe Cox Drive, was sued by the U.S. Department of Justice on behalf of the FDA in U.S. District Court for the Eastern District of Tennessee for alleged violations of the Food, Drug and Cosmetic Act by introducing unapproved and misbranded drugs into interstate commerce.
Crown, which makes Blue Lizard branded sunscreens, was also the largest producer of prescription and over-the-counter urea creams and lotions marketed to treat dry skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratosis and calluses.
According to the consent decree — basically a settlement — entered into this week by the company and the federal agency, Crown will stop the manufacture and distribution of the drugs and destroy all of its remaining stock.
In February, the company stopped distributing its Rea Lo Cream and Lotion, Rea Lo 39 Cream, Dermasorb XM Complete Kit, Sodium Sulfacetamide and all other unapproved drugs similarly labeled with the same active ingredients, company CEO Jeff Bedard said.
Crown started manufacturing the urea creams and lotions in 2001.
No urea creams are approved by the FDA as a safe and effective treatment for any conditions, but have been sold and marketed for decades as unapproved treatments.
According to the complaint, during inspections and meetings in 2014 and 2015, the FDA told Crown the products were new drugs that needed approval, and at one point seized creams the company made for Ascend Laboratories, but in 2016, the company was still making and selling the products. The Justice Department filed the federal lawsuit on March 1.
Bedard said Thursday the company has been preparing to take the urea products off the market “for some time,” and he doesn’t expect the injunction to significantly affect Crown’s business.
“Crown’s growth has been substantial over the last half a decade, in fact, we were just notified last week for the fifth year in a row we’ve made the Inc. 5000 List of Fastest Growing Companies,” he said. “Blue Lizard is the fastest growing sunscreen brand in the U.S. … The future of Crown is very bright, the manufacturing facility is rock solid, we will continue to grow and our 200 employees will continue to provide safe products.”
Bedard added that Crown is in Phase II clinical trials seeking FDA approval for its urea cream. After satisfactorily passing the third phase, the company can be approved by the agency to again market the products. If it’s approved, Bedard said Crown will be the only FDA-approved urea cream on the market.
“We believe it will be approved,” he said. “We’re only in Phase 2 human clinical trials, but over the lifetime of this drug, half a billion people have used urea creams over the last 100 years. We don’t think anybody is going to say they’ve been harmed by them.”