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FDA to ban all sunscreen ingredients except Zinc Oxide and Titanium Dioxide?
On February 21, 2019, FDA issued a proposed rule describing the conditions under which FDA proposes that OTC sun-screen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. As part of FDA’s ongoing efforts to ensure that sunscreens are safe and effective for regular, life-long use.GRASE* for use in sunscreens: Zinc oxide and titanium dioxideNot GRASE** for use in sunscreens: Aminobenzoic acid (PABA) and trolamine salicylate.***Insufficient data for use in sunscreens: Cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, avobenzone.Ok, so I doubt a widespread ban will happen, but what does this mean for formulators and brands?
Will big brand scurry to get the long-term safety data the FDA wants to see for the various organic sunscreens? Could they be effectively banned from use until conclusively proven to be safe (or unsafe)? -
5 Replies
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thanks for posting! This will be interesting to see. OTCS are not my field so I don’t know exactly how it works, but I would assume anything labelled as an active ingredient has to have GRASE rating to continue to be an approved drug. Seems like this will be hard to control though
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I don’t think the FDA is going to ban everything except Zinc Oxide and Titanium Dioxide. They are just requesting more data. There will be no change in sunscreens for the foreseeable future.
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Unless the FDA with more data deem any of the “insufficient data” ingredients to be not GRASE like they already did with PABA and trolamine salicylate - not so unrealistic? But no idea about the time-frame would be curious to know.
What I do know is, this is solid marketing juice for companies only making mineral sunscreens!
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My opinion is that even if the FDA were to ban non GRAS ingredients in sunscreens (unlikely)
companies will legally challenge that (taking it to the Supreme Court if needed) as you can sell anything as long as it ain’t PROVEN to be harmful.Insufficient data is no reason for banning ingredients.
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they could try permitting bisoctrizole and bemotrizinol (20 years after the rest of the world has), they’ve got tons of safety data behind them!Gunther said:Insufficient data is no reason for banning ingredients.on the other hand, many hair dyestuffs on Annex II of the cosmetics regs have insufficient safety data, and the volumes were so low their producers had no commercial incentive to generate it, so they were delisted for that reason
granted, given that hair dyestuffs potentially pose a much higher hazard than most cosmetic materials (and by that point, several dyestuffs previously thought to be benign had been found to be human carcinogens), this is hardly a typical situation, but still
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