At a time when the entire world is focused on beating a deadly pandemic, Senate Majority Leader Mitch McConnell added an oddly placed sunscreen provision to the “Families First” Coronavirus Response Act.
Buried on page 404 in the 880-page legislation, is a series of new rules making it possible for the FDA to expedite sales of a sunscreen ingredient without requiring their manufacturer to prove that they are safe (for humans or the environment).
The “innovative” sunscreens just happen to be made in Florence, Ky. – McConnell’s home state – by international manufacturer L’Oreal.
I don’t find this surprising at all, considering five years ago, the FDA approved one of L’Oreal’s sunscreen actives called Ecamsule (AKA: Terephthalylidene Dicamphor Sulfonic Acid or Mexoryl SX), which the FDA recently found absorbs into the human bloodstream at three times the level of concern for human systemic toxicity.
Since that time, the FDA has removed Ecamsule from the Category I (GRASE – safe for human use) list into Category III (need more data to determine human safety) and the FDA is requesting toxicokentics, carcinogenicity (topical and oral), developmental & reproductive toxicity studies (topical and oral) among other tests to determine if this active drug is safe and effective for human use.
L’Oreal would also like to have the FDA approve Drometrizole Trisiloxane (AKA: Mexoryl XL), however, the FDA has already concluded that “… the scientific record is not sufficient to establish that Drometrizole Trisiloxane is generally recognized as safe and effective (GRASE) for over-the-counter (OTC) sunscreen use.”
This concept and practice of pressuring government leaders into fast-tracking special interest legislation is a very dangerous one. This addition to the Cares act could require the FDA to approve potentially dangerous drugs.
Mitch McConnell: At a time when you should’ve been thinking of the American people, you chose to push L’Oreal’s harmful chemical sunscreen rhetoric. You should be ashamed of yourself.
Formulator & CEO
From Stream2Sea – Protect what you love