BIG NEWS FOR U.S. DIETARY SUPPLEMENT MANUFACTURERS: FDA APPROVES CALCIUM CARBONATE AS A COLOR ADDITIVE FOR USE IN DIETARY SUPPLEMENTS!!

Listing of Color Additives Exempt From Certification; Calcium Carbonate

AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules. The FDA are taking this action in response to a color additive petition (CAP) submitted by Colorcon, Inc.

21 CFR § 73.70 Calcium carbonate.

BDRC Comments: Although there are no real safety concerns with TiO2, the overly precautionary food ban of TiO2 (E171) in Europe has caused food and dietary supplement manufacturers who sell into the EU to look for possible alternatives to TiO2 and, although there is nothing that can really work nearly as well as TiO2, Calcium Carbonate appears to be one of the best alternatives and can work in some applications. This was a real problem before, since Calcium Carbonate was not an approved color additive in the U.S. for dietary supplements. However, FDA's approval of Colorcon's color additive petition now resolves this regulatory hurdle for dietary supplement uses.

I am thrilled to see this development since I helped initiate this color additive petition back when I was still at Colorcon.

THANKS COLORCON!!! The industry will appreciate your efforts!!

You can access the Federal Register Listing at the following link: 2022-20819.pdf (govinfo.gov)