With apologies to Novelist Sarah Dessen, “Everything, in the end, or in this case, the beginning, comes down to timing.” Just as the US Food and Drug Administration (FDA) is finalizing the Final Monograph for Sunscreens, there’s a new player in the testing category that is run by an industry executive who is well-versed in the science behind efficacy claims.

According to Brian Ecclefield, founder and managing director of Validated Claim Support (VCS), Teaneck, NJ, VCS was developed as an alternative to the status quo of the traditional contract research organization (CRO).

“It’s not often that a new privately-held skin care testing company opens, and based on the current regulatory changes on the horizon for both FDA and International Standards Organization (ISO) the timing just seemed right,” explained Ecclefield. “VCS is proud to have obtained our FDA registration before we opened our doors and, with everything that is going on in the industry, it is particularly important to ensure that product claims are supported by a registered and validated claim support laboratory. It might take a little time, but we expect to make a huge name for ourselves in the industry and to become a big player at the international scene.”

It all starts with sun care. At press time, the US FDA had not issued the Final Monograph on Sunscreen, which is mandatory under the 2014 Sunscreen Innovation Act. But whatever regulators decree, Ecclefield said his company is well-positioned to meet clients’ needs. For example, the VCS facility includes several customized, water-immersion tubs to measure water-resistance as well as multiple Solar Light Multiport Simulators. Couple these with what Ecclefield describes as a “virtually limitless” panelist pool through its strategic partnership with Assistance in Marketing, and VCS provides efficient and accurate SPF and UVA testing every time, he insisted.

“Our goal is to help further educate consumers on what claims like SPF and ‘broad spectrum’ actually mean, and to ensure that all tests are conducted to meet and exceed relevant international standards,” he told Happi.

Specifically, VCS is compliant with all major international standards including FDA static, 40- and 80-minute water resistant; ISO 24442, 24443 and 24444; Colipa water resistant and very water resistant, Australia/New Zealand modifications and the Japan Cosmetic Industry Association UVA.

Ecclefield said his company also has the facilities to test conditions for custom protocols involving chlorinated water, salt water, sand resistance, towel/abrasion resistance and wet application. Furthermore, the company is well-equipped to conduct phototoxicity studies, photostability studies and photo-allergy maximization, which is similar to a combination of repeat insult patch testing (RIPT) and phototoxicity to provide data demonstrating that successful products have documented superior safety data over 98% of existing products.

More than UV

Although UV protection claims are making headlines, VCS offers many other testing services for skin and hair care formulators. For example, RIPT/patch testing demonstrates that products or ingredients have no direct immediate irritating or long-term sensitizing reactions with the skin through continued use. According to Ecclefield, generally, multiple products are tested in an array on either 50 or 100 subjects to minimize costs, but exclusive panels are available on request. Repeat open application testing is conducted on daily use products to ensure that localized reactions are not experienced on a panel of 20 or more test subjects. VCS also conducts ophthalmological testing for sensitive eye area, as well as anti-inflammation and counter irritation tests.

Skin care claims and efficacy testing include self-assessed questionnaires that enable users to take products, apply them and report back their sensory findings after extended use. VCS also offers instrumental claim evaluations that are more robust and objective in documenting efficacy claims such as smoothness, evaporation and wrinkle depth. Finally, technical grading, involving instrumental assessments, clinical photography or qualitative questionnaires, are effective in verifying a range of claims such as firmness, pore size reduction and irritation/inflammation reduction.

Hair care claims begin with sensory reviews and take home questionnaires where users provide feedback after extended use. These self-assessments can be supported with results generated by VCS’ three salon-style wash stations. The company can contract cosmetologists or host client-provided onsite application specialists. Claim support can include a range of attributes including volume, color persistence, dandruff reduction and frizz control.

Finally, VCS can support all claims with custom extreme resolution photography that can be assembled in a compelling visual format.

“Sponsors should be educated about a testing company’s capabilities,” explained Ecclefield. “We want to educate sponsors about proper testing methods.”

By all accounts, it seems that he and his team at Validated Claim Support are ready and eager to be put to the test.