I have been in the cosmetics industry for nearly 45 years, and for 18 of them, I have written about regulations for Cosmetics & Toiletries magazine. Sadly, this will be my penultimate column, and a reflection of my time in the industry. My final column will be about the future of cosmetic regulations.
As I began to think about my years, I realized that the industry has suffered a thousand little cuts. None of these are fatal, but their accumulation continues to make the industry bleed, and without a solution, the industry will continue to suffer. Below are examples of the cuts the cosmetics industry has endured over the past 45 years.
Carbon Black and Pigments
In 1976, the U.S. Food and Drug Administration (FDA) banned the dye amaranth, better known as FD&C Red No. 2 (CI 16185). This was based on findings from an animal feeding study conducted in the Soviet Union that the pigment could potentially cause cancer.1 Since the study took place during the Cold War, many scientists questioned it. Nevertheless, it had to be banned due to the Delaney Clause, which prohibited the use of any chemical found to induce cancer in man or animals. Other studies found no hazard with amaranth, and even the FDA’s studies were inconclusive. Red 2 is still allowed just about everywhere except the United States. When it was banned, it was the most popular red dye in the cosmetics industry.
Also in 1976, the important color carbon black (Black 2, CI 77266) was banned in the United States because the industry could not prove the absence of polyaromatic nuclear hydrocarbons (PAHs). The FDA finally allowed carbon black again on July 16, 2004, with specifications for PAHs, benzo(a)pyrene and dibenz(a,h)anthracene, and required each batch to be certified by the FDA. Israel is left as the only market where carbon black is still prohibited.