FDA's Quarterly Color Additives Report: Red Alert

Dreamstime Xxl 177106534

Color certification is program mandated by the U.S. Congress­ for the Food and Drug Administration's (FDA's) enforcement of specific­ations (by batch certific­ation) of certifiable color additives for foods, drugs, cosmetics and medical devices.

...The two most widely used [red] pigments in the lip category ... have been markedly down [as a] result of masking and decreased social activity."

Total Certified, Q1

The latest FDA report covers Oct. 1 through Dec. 31, 2021 (first quarter of the 2022 fiscal year) and totaled the following:

  • 98,729.46 pounds of D&C Straights
  • 87,677.46 pounds of D&C Lakes
  • 2,877.8 pounds of D&C Repacks
  • 3,881,251.31 pounds of FD&C Straights
  • 1,806,195.22 pounds of FD&C Lakes
  • 20,661.88 pounds of FD&C Repacks
  • 62,094.74 pounds of External Straights
  • 1,486.5 pounds of External Repacks

The sum of all certified additives amounted to 5,960,974.37 pounds. 

Red Alert

Upon closer examination of the FDA's certification data, Kelly Dobos, a Cincinnati-based cosmetic chemist and industry expert, observed the following.

"Red 6 Lake and Red 7 Lakes are the two most widely used pigments in the lip category and the amount of these materials being certified by the FDA has been markedly down during the pandemic; the result of masking and decreased social activity.

"Most notable in this certification report is the total absence of Red 6 Lake, which unless is an error, represents that first quarter without Red 6 Lake since 2012 when the FDA began posting the data online."

See archived: Two Decades of Transfer-resistant Lipstick

More in Regulatory