Tom Branna, Editorial Director11.30.-1
Is a failure to communicate, so said the prison warden to Paul Newman in the 1967 classic, “Cool Hand Luke”—and these days, US sunscreen formulators are handcuffed by the US Food & Drug Administration, which has refused allow them to use eight active ingredients which are widely available and safely incorporated into sunscreen formulas around the world.
In order to communicate effectively, both parties must be willing to participate and listen to one another. That back and forth always seems to be lacking when it comes to discussions between the US FDA and industry on the subject of sunscreens. That impasse was evident at the recently concluded Sunscreen Symposium (p. 50). Once again, industry trotted out alarming statistics regarding soaring skin cancer rates in the US and the need for more effective active ingredients that are already available to formulators in other parts of the world. Those ingredients—amiloxate, enzacamene, octyl triazone, bemotrizinol, bisoctrizole, iscotrizinol, ecamsule and drometrizole trisiloxane—have been languishing on the Time and Extent Application list, awaiting FDA’s approval for years; most of them waiting for a decade or longer!
At this year’s Symposium, industry even came armed with The Sunscreen Innovation Act (SIA), a document signed by President Barack Obama that industry interprets as a path to getting effective sunscreens to market.
But FDA representative Dr. Michelle Walker told industry that the SIA does not:
Tom Branna
Editorial Director
tbranna@rodmanmedia.com
In order to communicate effectively, both parties must be willing to participate and listen to one another. That back and forth always seems to be lacking when it comes to discussions between the US FDA and industry on the subject of sunscreens. That impasse was evident at the recently concluded Sunscreen Symposium (p. 50). Once again, industry trotted out alarming statistics regarding soaring skin cancer rates in the US and the need for more effective active ingredients that are already available to formulators in other parts of the world. Those ingredients—amiloxate, enzacamene, octyl triazone, bemotrizinol, bisoctrizole, iscotrizinol, ecamsule and drometrizole trisiloxane—have been languishing on the Time and Extent Application list, awaiting FDA’s approval for years; most of them waiting for a decade or longer!
At this year’s Symposium, industry even came armed with The Sunscreen Innovation Act (SIA), a document signed by President Barack Obama that industry interprets as a path to getting effective sunscreens to market.
But FDA representative Dr. Michelle Walker told industry that the SIA does not:
- Guarantee new sunscreen ingredients would be on the market soon after enactment of SIA;
- Change Generally Recognized as Safe and Effective (GRASE) standards;
- Change FDA’s scientific review;
- Change rulemaking process for monographs or the overall monograph system; nor
- Provide additional FDA resources for monograph, TEA or SIA review.
Tom Branna
Editorial Director
tbranna@rodmanmedia.com