It is difficult, if not impossible, to write about current U.S. “regulations” for sunscreens because as it stands, there is only a Deemed Final Order for them, as of Sept. 27, 2021. Before going over this Order, however, it would help to understand how it came to this.
In 1972, the U.S. Food and Drug Administration (FDA) established the non-prescription drugs system—now called over-the-counter (OTC)—to ensure that the drugs were safe and effective. Drugs were already being sold based on what they treated or prevented, and the system maintained such categorizations; there were 22-26 types of drugs at the start. As an aside, the person behind this program was often quoted as saying it would take as much as five years, from start to finish, to review all these drugs; he later denied this, saying he actually said six years—needless to say, it hasn’t worked.
The procedures were to establish a committee of experts to hold hearings about the current drugs and propose which were safe and effective and what labels and/or testing should be required. The experts came from universities and medical and pharmacy schools. The industries directly involved in the drugs under review were represented by trade associations. Frequently, these were employees of the trade associations, or they were from member companies. The FDA was not part of these hearings and was not writing the reports.
After the committee finished its work, its opinions were published in the Federal Register (FR) and called an Advance Notice of Proposed Rule Making (ANPR). The committee divided all approved pharmaceutical ingredients (APIs) into three categories: Category I—safe and effective. Category II—not safe and/or not effective and must be removed from the market. Category III—either not safe or not effective (or both) but could remain on the market until the additional requested data was submitted.
The first of two concurrent reviews then took over. One set of comments was from industries that expressed their views and suggestions for alternative proposed rules. They also submitted data to support the safety and/or efficacy of the active ingredients. The second party to this concurrent review was the FDA. After the concurrent review was completed, the FDA published a Proposed Rule, which was considered the Tentative Final Monograph (TFM). A second concurrent review took place and finally, the FDA published the Final Monograph (FM).
Of note was a court case that took place after the FM of the first drug. The court ruled that when the FM was issued, all APIs were either compliant with the FM or were not permitted—and there could be no Category III drugs. Of course, there is nothing actually final about an FM, as the FDA also issues changes or stays of enforcement of FMs.