Issue link: https://www.ascpskindeepdigital.com/i/325995
Create your free business website! www.ascpskincare.com 29 The Medication Connection The reason why new ingredients seldom appear is that under US federal law, sunscreen is considered a medication. This is not the case in most other industrialized nations. As an over-the- counter medication, sunscreen must meet federal standards for safety and efficacy—and the approval process for a new ingredient can take a very long time. The US Food and Drug Administration (FDA) has not expanded its list of approved active sunscreen ingredients since 1999. Part of the reason for the holdup was a technical detail: until 2002, the law required a lengthy rule-writing process for any new ingredient the FDA wanted to approve. In 2002, in a move aimed at speeding up the process, the law was revised to state that if an ingredient has already been on the market in another country for five years or more, it may go through a different approval process known as "time and extent." This means an advisory committee of experts may weigh in on the safety and effectiveness of the product, and then the FDA makes the final determination as to whether it is approved. However, even after this change, many applications for review of active sunscreen ingredients are still languishing in bureaucracy, some dating back to 2003. None have yet completed the approval process and reached consumers. Ingredients still awaiting FDA approval include eight new chemical UV filters, such as Tinosorb S and Tinosorb M. In some cases, the FDA found a lack of safety data for a potential new ingredient. In other cases, the significantly differing standards used in different countries meant that an ingredient considered safe in Canada or Japan, for example, might not get approval in the United States. Ingredients still awaiting FDA approval include eight new chemical UV filters. Label Confusion The most recent legislative change came in 2011, when the FDA announced its long-awaited new rules for sunscreen labeling. Meant to reduce misleading information and give consumers a clearer understanding of the products they are using, the new rules barred the use of the terms sun block, sweatproof, and waterproof. The agency said such claims overstated the effectiveness of sunscreen. Sunscreen manufacturers can still describe a product as water resistant, but must state how long it will remain effective in water, up to an acceptable maximum of 80 minutes. In addition, only products that meet the FDA standard for protecting against both UV-A and UV-B rays can be labeled as providing broad-spectrum protection. At the same time, the FDA proposed to limit the maximum sun protection factor (SPF) that could be mentioned on labels to 50, saying there wasn't sufficient data to prove higher SPF values provide significantly greater protection. However, this part of the 2011 ruling remains only a proposal, so higher SPF numbers still appear on many product labels. Where Are We Now? Currently, there is a public push for the FDA to review at least some of its backlogged applications for new sunscreen ingredients. This is known as the Sunscreen Innovation Bill (S. 2141 and H.R. 4250). It was introduced in March 2014, by US Senator Jack Reed (D-RI) and US Representative Ed Whitfield (R-KY). If passed, it would make two primary changes to the approval process: • It would institute an eight-month deadline for the FDA to approve or deny an application (the current review process has no mandatory time limit). • It would no longer require the FDA to issue a new regulation for the use of a newly approved sunscreen ingredient (this would cut out a lengthy part of the current review process). These changes would certainly go a long way toward encouraging innovation in this important area of skin care and protection. In the meantime, when it comes to new sunscreen ingredients, the wait continues. Harry Fallick, DO, is a triple board-certified esthetic surgeon and current Industry Member of the American Academy of Dermatology. He is co-founder of Fallene Cosmeceuticals, which specializes in sun-protective skin care. Learn more at www.tizofusion.com.