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Regulatory Update: Regulation Time
By: Jeff Falk
Posted: January 8, 2007, from the January 2007 issue of GCI Magazine.
page 5 of 6
“The real problem with consumer use of sunscreens is the fact that usually not enough is applied,” said Steinberg. “Adequate protection clearly requires application of enough product (usually dictated by the clinical SPF testing protocol) and clear directions for use,” said Carl Geffken, president of Carl Geffken Consultants. “Directions should identify both quantity and repeat application parameters, especially when swimming or sweating after exercising.”
When reading about the challenges and regulatory issues in sun care, it is clear that R&D and ingredient suppliers are on the front line in facing testing and labeling challenges. Steinberg notes that most formulations are developed two years before a product launch, so it makes sense that chemists are the de facto vanguard. However, it does not preclude other segments of the industry from playing an immediate and effective role in helping consumers use sunscreen correctly.
“Consumer education about product use could advisably go beyond the specific mandatory labeling of products in the required directions for OTC drug products,” said Geffken. “For example, marketers can provide a very responsible perspective by reminding consumers to seek advice from a skin care professional to understand the necessity of higher SPF value and greater protection required for certain skin types and for children. The idea of measured dose delivery systems can be a benefit for consumers to assure adequate application and protection with sun products. This concept is, of course, best for beach products rather than for face makeup. The question about adequacy of use and the appropriate instructions for use must not be confused by failure to consider the type of sun protection provided by different categories, such as incidental makeup with SPF versus true beach products.”
Because sun care products play such an important role in consumer safety, the continued proliferation of new sunscreen ingredients, technologies and products is inevitable, and regulatory scrutiny and debate over these products is sure to remain. For example, in May 2006, a citizen’s petition was filed with the FDA requesting that nanomaterial sunscreens be considered as new drugs and be removed from the market.
Better informed consumers will ease the growing pains of advancing technologies. Knowledgeable consumers may also facilitate additional advancements and improvements. According to Steinberg, getting consumers to use the required amount of sunscreens, for example, may force chemists to make better sunscreens and formulations that are less greasy and dry better.