Jack Surrette weighs in on the Final Sunscreen Rule and Proposed Sunscreen Rule announced this week by the US Food and Drug Administration.
The Final Rule establishes standards for UVA protection, clarifies claims on the label, and mandates new testing methods.
But what does all this mean to the public?
The consumer will get a clearer understanding of how a sunscreen performs.
There will be uniform standards and testing for “Broad Spectrum” UVA/UVB protection.
Although these new regulations are intended to help consumers—they are far from perfect.
Are there issues relating to sun protection that the FDA Final Rule missed?
Generally, the regulations are a respectable start, but there are good, bad and ugly parts when you dig into the details:
The Good –The FDA finally took action (after over 30 years), instituted better labeling and claims standards, and established a minimum protective level for “Broad Spectrum” protection. Unfortunately, however, it did not go far enough.
The Bad – The new testing standard actually lowered the UVA protection level proposed by the FDA in a 2007 recommendation. In fact, the new level is less than most sunscreens provide–on the market today. This means consumers will receive less, not more UVA protection. The UVA bar was set too low.
The Ugly – The new rules did not address application amount…the testing standards require the use of much more sunscreen than a consumer would ever apply. The FDA simply states “when used as directed…” Here’s the ugliest part. Most sunbathers apply less than a half of what’s needed, so they will actually receive far less protection than is stated on the label.
What about capping the SPF at 50+?
The 50 SPF cap is a Proposed Rule, so it may never be implemented into a Final Rule. The FDA is concerned whether there are actual clinical benefits to sunscreens above 50 SPF. In fact, there is solid evidence that higher SPFs DO provide more protection. Consequently, I think that some high protection formulas will remain on the market. They are particularly important, because, as mentioned earlier, consumers simply do not apply enough sunscreen.
The FDA also seemed concerned about sunscreen sprays…
Yes, they are requesting that the industry supply information based on the amount of sunscreen that actually reaches the skin, in an open air environment. Inhalation of the product is also a concern. These are valid health issues that should be explored.
Overall, are the rules that go into effect next year beneficial to consumers?
The FDA’s final ruling improves sunscreens by standardizing the labeling. Consumers will now be able to make a more informed decision about choosing healthier formulas. Unfortunately, the formulas are simply not required to be healthy enough. The broad spectrum standard is too low and proper product application was not addressed. The proposed rules and pending investigations are as important as this final rule. Getting these additional aspects resolved may take a very long time. Keep in mind it took the FDA over 30 years to establish this “final” regulation.
Jack Surrette served as Chief Marketing Officer and Executive Vice President of Hawaiian Tropic® for 17 years and was considered the driving force in building a small, Florida marketing/manufacturing company into the number two supplier of suncare products in the Western Hemisphere. His direct responsibilities grew during his 30-year career to managing global marketing and all R&D/QC functions. Jack nurtured and shaped the Hawaiian Tropic brand until April 2007 when Playtex Products acquired the company. Playtex was subsequently purchased five months later by Energizer Holdings. Jack now serves as President of Surrette Associates, a marketing consulting firm and Executive Director of SkinHealth Technology, both located in Ormond Beach, Florida.