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Regulatory Update: Regulation Time

By: Jeff Falk
Posted: January 8, 2007, from the January 2007 issue of GCI Magazine.

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“These efforts form another important part of our public-private partnership working to ensure consumer safety and provide FDA with the information needed to effectively do its job,” stated CTFA. “We have been meeting with FDA’s Office of Cosmetics and Colors to discuss the Code and how FDA can expect to use it, commencing in January 2007 when companies sign on. The industry already ensures product safety, while the code will provide FDA with a voluntary mechanism to verify and confirm specific safety concerns under specified circumstances.”

But is it enough to register ingredients or cite the CTFA or Colipa system or EU’s Dangerous Substances Directive? Action can’t end there, because that, on its own, does not reach the consumer. The VCRP, for example, cannot be used to market a product or be cited as an FDA endorsement of a product. However, there may be long-term benefits in simply marketing the existence of these online databases.

Suncreens: A Regulatory Hot Spot

In June 2006, Colipa announced that European, U.S., Japanese and South African cosmetic industry associations signed the International Sun Protection Factor Test Method. SPF, according to Colipa’s press statement, has become key in consumers’ choice of personal sun care products. Colipa sees the recently adopted method “as the basis for a harmonized way for companies to substantiate claims on sun protection products worldwide.” The new method is being implemented to assure consumers that the same testing standard has been applied regardless of which country the products were purchased and that SPF claims can be substantiated. In the U.S., manufacturers still must comply with the FDA-mandated method.

According to David Steinberg, former president of the Society of Cosmetic Chemists, however, SPF is not an accurate test. An SPF level of 15 can measure anywhere from 12–18 and an SPF of 30+, the maximum claim allowed by the FDA, could mean a level of protection from 31–100. In the November 2006 issue of Cosmetics & Toiletries magazine, Steinberg demonstrates that only a marginal increase in protection is provided as SPF numbers increase. An SPF level of 15, for example, filters out 93.3% of UV exposure while an SPF of 18 filters out 94.4%; SPF 30, 96.7%; and SPF 45, 97.8%; etc.

Even if consumers get and understand the message that SPF testing has become standardized globally, it is likely that many consumers don’t understand SPF ratings, the marginal increases in protection as the SPF number increases and, more importantly, how to apply sunscreen to effectively protect themselves. As sun protection attributes are being touted in an increasing number of products, the prospect of truly protecting one’s self may actually be more confusing and less effective than ever.