MARCH 2015 • Vol. 21 No. 3
New York Society of Cosmetic Chemists
www.nyscc.org
The Road to the Sunscreen Innovation Act … by Nadim A. Shaath
P
resident Obama finally signed the Sunscreen Innovation Act (SIA) into law in late November 2014. This process has taken years to achieve. As most of us know, the Final Monograph in sunscreens in the U.S. has not been finalized. An uneven bureaucracy and delays have prolonged a tenuous situation, leaving a population at risk. The process of regulating sunscreens started in the early seventies, forty years ago, culminating in the publication of the Advanced Notice for Public Record (ANPR) in 1978. The ANPR seemed to function as law for numerous years with suppliers, manufacturers, and consumers adhering to its tenets. It provided guidelines and testing protocols for sun protection factors (SPF), specifying SPF 15 as the highest SPF possible. It also provided a list of twenty-one ingredients that were labeled Category I that had a specific use percentage in cosmetic formulations. It allowed manufacturers to make a claim that, “The use of sunscreens reduces the risk of skin cancer and early skin aging when used as directed.” Soon it was discovered that SPF 15 was inadequate in protecting consumers from the ravaging rays of the sun and that the twenty-one filters were insufficient. For one thing, only titanium dioxide and red petrolatum were considered “physical” blockers of ultraviolet radiation, and zinc oxide was not yet approved. It took years for the FDA to include zinc oxide in its Category I listing. New research uncovered that UVA protection is paramount and that the benzophenones and menthyl anthranilate (meradimate) are the only four ingredients apart from the inorganic filters that protect the consumer from UVA rays. These ingredients were obviously inadequate to properly protect the consumers from UVA, especially from UVA-1. Companies were prompted to introduce better UVA filters in the U.S., but met with an inflexible bureaucracy. The first such ingredient, avobenzone, was introduced into the U.S. by Givaudan (later on it was marketed by Roche). They soon discovered that the only mechanism to introduce a UV filter in the U.S. was through a New Drug Application (NDA). Givaudan pursued that process and obtained an NDA for avobenzone with Herbert Laboratories in California. The problem with this process is that when you deal with drugs, the issue of dosage and combinations with other active and inactive ingredients generally requires an amended NDA every time an ingredient change is requested! In cosmetics, we live and die by changing the percentages of ingredients, including new excipients, and modifying the chemical and physical characteristics to produce lotions, creams, aerosols, gels, mousses etc. Flexibility is key, permitting responsiveness to the market. Thus, the original formula that contained padimate O (2-ethylhexyl 4-dimethylaminobenzoate) with avobenzone had to be changed in the 1990s when that ingredient fell out of favor. Another costly NDA! (Continued on page 6)
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To p i c : F r a g r a n c e C h e m i s t r y • T h e B e t h w o o d , To t o w a , N J