Industry Debate: US FDA vs. Sunscreens

By: Cosmetics & Toiletries LinkedIn Members

Posted: June 7, 2011

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Answer 3: I can't comment too much as I'm not a US formulator, but this has been dragging on in one form or another for most of the time that I have been involved in the industry. I suspect that as mentioned above, products being classified as OTC drugs is partly the issue. From what I understand, the FDA has been criticized in relation to approvals of pharmaceuticals such as anti-depressants, some of which have been found to have unfortunate side effects. I suspect in this sort of climate, the administration feels that it needs to be seen taking its time, to ensure it is thorough. I come from the European mentality; to me, it would make much more sense to pull sunscreens out of OTC classification. I don't think, however, that will happen any time soon. US market formulators and manufacturers have my sympathies, as I know it is incredibly frustrating.

Answer 4: Well, could it be the lack of or fewer rules in United States regarding cosmetics that may be the reason for the OTC classification? If so, why not take the chance and put them in the Safe Cosmetics Act? (Admittedly, I am not well-versed in this text.) The problem is more than a minor issue; if you see the latest announcement from the Environmental Working Group (EWG) regarding sunscreens, in some cases, the group says that products are so bad that cannot be sold in European Union (EU).

Answer 5: Firstly, I take the FDA’s delay with a grain of salt. The first time I heard about the proposed review of the Monograph, it was in my third year in school, back in 1985! Since then, it has been proposed, revised, etc. What I am most worried about in the Monograph is some of the proposed labeling changes that would bring the United States closer in line with the European standard. While I feel that nanometer wavelengths and other labeling information is more useful, I also believe that there will be a scramble to catch up in the knowledge, as well as to redesign all the packaging. Otherwise, I think a more coherent direction in this matter, and in cosmetics in general, from the FDA is a good thing.

Answer 6: I have never understood the rationale behind the OTC classification for sunscreens. In my opinion, I believe it would be more sensible that, rather than being incorporated into "THE" Safe Cosmetics Act, sunscreens be incorporated into "A" Safe Cosmetics Act. Incorporation into the current proposed Safe Cosmetics Act would be disastrous for the US industry. Whilst the current system could use some improvement, it should be possible to do so without destroying the majority of the industry. (Sorry, off on a tangent, there.)

Answer 7: I agree with "A" Safe Cosmetic Act; if the US industry would move in this direction I am sure it could find a good solution. Maybe the OTC classification is partly due to the lack of a regulation, and so sunscreens have been placed in the nearest classification available; however, the FDA does not seem to have too many excuse for the delay.