FDA Updates: VCRP Tally, Color Additives and Lead Acetate in Hair Dyes

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The U.S. Food and Drug Administration has issued several fall 2021 updates including activity in the voluntary cosmetic registration program (VCRP), that latest certifications on color additives and a closer look at the safety of lead acetate in hair dyes.

VCRP Activities

The number of online accounts activated for voluntary cosmetic registrations in October 2021 was 115, with a total 428 products filed. This brings the total activity since the launch of the online system—on Sept. 20, 2018—to 6,323 online accounts; 3,594 active cosmetic establishment registrations; 22,596 products filed; and 1,981 formulas discontinued.

The number of active products on file as of the VCRP's inception in 1972 is 38,725. And, the total number of product formulas discontinued since then is 122,186.

Color Additives Report

As previously described, color certification is a Congress­ionally mandated program for the FDA's enforcement of specific­ations (by batch certific­ation) of certifiable color additives for foods, drugs, cosmetics and medical devices. In relation, the agency issues a quarterly report on the certification of color additives. 

In the fourth quarter (July 1 to Sept. 30, 2021), certified additives totaled the following: 203,603.41 pounds of D&C; 6,158,459.75 pounds of FD&C; 6,406,445.8 total straight and lakes, including repacks; and 150 mixtures for an overall fourth quarter total of 6,406,595.8. See the full report for specific color additive totals.

Lead Acetate in Hair Dyes

Finally, in the Federal Register ruling on the "Termination of Listing of Color Additives Exempt From Certification; Lead Acetate," the FDA held to its delisting of lead acetate as a safe additive for coloring hair on the scalp. This decision responded to objections raised by hair dye manufacturer Combe.

According to the agency, on Oct. 31, 2018, the final rule was amended to no longer provide for the safe use of the ingredient because, "new data available since lead acetate was permanently listed [has] demonstrated that there is no longer a reasonable certainty that no harm will result from the use of this color additive." Concerns have particularly been raised over its dermal absorption

Combe referenced a 1980 study carried out with Moore, et al., which reportedly supported the safety of lead acetate as a hair colorant. However, the FDA cited flaws in the study and others, finding they under-represent the actual dermal absorption under the untended conditions of use.

"After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing," the FDA concluded. "Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp."