Jaychem Industries in New Zealand manufactures a product called GolfersSkin Sunscreen, aimed specifically at those who like to walk the course. The product has come under the spotlight following an inspection by the U.S. Food and Drug Administration (FDA).
Via a warning letter, the FDA has criticized Jaychem Industries for not ensuring that its lotions are effective. Furthermore, the drug and cosmetics regulator noted that the labeling for GolfersSkin did not meet current standards and the Agency stated that the product was “misbranded.” This comment was aimed at GolfersSkin™ SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin™ SPF 30 Plus Sunscreen Lip Balm. These products are designed to prevent sunburn; however, there was no test data to support the claims
The main concern from FDA was that Jaychem does not test key ingredients from suppliers (what are termed “active pharmaceutical ingredients”). Such testing is necessary to ensure ingredients meet industry standards. Furthermore, there was no system in place to ensure that any purchased materials that did not meet specification were not used in the process.
In the letter, FDA writes: “You stated that you released all (b)(4) lotions regardless of (b)(4) results.”
To add to this, Fierce Pharma notes that the “company also had no data to demonstrate that the chemical and physical properties of one of its lotions remained acceptable throughout its shelf life.”
Control of sunscreen is important and the products are borderline medicinal (in that they claim to prevent the burning of skin and have moisturising properties.) This means that standards and controls must apply. Back in 2013, W.S. Badger Co. recalled all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion (lot # 3164A) due to microbial contamination. This was due to a breakdown of the preservative system.
