FDA sears maker of GolfersSkin Sunscreen in warning letter

Courtesy of Jaychem

According to the marketing for GolfersSkin Sunscreen, more top players in the world trust it than any other. According to an FDA warning letter to its New Zealand manufacturer, they probably shouldn't.

The warning, posted this week by the FDA, castigated lotion and liquid maker Jaychem Industries for failing in multiple ways to insure that its lotions are effective. It also said that labeling for GolfersSkin didn't cut it by FDA standards, leaving it in the "misbranded" category.

FDA investigators said that Jaychem was not testing APIs from suppliers to make sure they met standards and had no procedures in place to cull products that did not meet specs. "You stated that you released all (b)(4) lotions regardless of (b)(4) results," the FDA said. The manufacturer also had no data to demonstrate that the chemical and physical properties of one of its lotions remained acceptable throughout its shelf life.

The FDA letter then went on at length about the inadequate labeling of the company's GolfersSkin sunscreen and lip balm, taking issue with font size and the lack of inclusion of all applicable wording, among other concerns.

The FDA acknowledged that Jaychem said it would hire an outside firm to test all of its products, but the agency also wants to know what Jaychem intends to do about determining whether its products that are already in the U.S. meet required specifications and how Jaychem will make sure that its Quality Control unit rejects products that don't meet specifications, something it was not doing before the FDA checked on the manufacturer last year.

While OTC products don't have to meet all of the same standards as prescription drugs, their manufacturing has to be up to par and they still must hit certain specifications. Fort Worth, TX-based Sovereign Pharmaceuticals received a warning letter in 2013 laying out many of the same kinds of concerns that Jaychem must now address. And some Big Pharma players have faced tough FDA scrutiny as well for OTC products. Johnson & Johnson's ($JNJ) McNeil Consumer Healthcare unit went through years of issues because of problems at a plant in Pennsylvania, while Novartis' ($NVS) consumer health plant in Nebraska underwent massive recalls and years of limited availability of some of its top consumer brands.

- here's the warning letter