6 Sanitizer Offenses, Color Additives and Cosmetic Registrations: FDA Update


Color certification reports, voluntary cosmetic registrations and six hand sanitizer additions to the 'do not use' list are among recent updates issued by the U.S. Food and Drug Administration (FDA).

See related: FDA Releases Color Additives Q4 Report

Certified Colors

As most readers know, 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. Following are the two latest updates:

For fiscal year 2021, in the first quarter (Oct. 1-Dec. 31, 2020), D&C totals amounted to 148,923.03 pounds; FD&C totals amounted to 5,404,458.45 pounds; and "external" additives totaling 36,479.22 pounds were reported, for a collective certification total of 5,589,865.7 pounds of straight and lakes, including repacks.

For fiscal year 2021, in the second quarter (Jan. 1-March 31, 2021), D&C totals amounted to 149,037.3 pounds; FD&C totals amounted to 4,855,451.5 pounds; and "external" additives totaling 48,786.38 pounds were reported, for a collective certification total of 5,053,275.18 pounds of straight and lakes, including prepacks.

See related: FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls

Voluntary Cosmetic Registrations

Since cosmetic firms are not required to register or file their product formulations with the FDA, the Voluntary Cosmetic Registration Program was initiated for proactive participants. This provides some information on the current product landscape, though it is not fully comprehensive.

Activity reported for the month of March 2021 included 112 online account activations. In addition, 809 products were filed during in the same month. This brings the total number of accounts since the program's online activation (in 2018) to 5,189, with the number of filed products amounting to 18,797.

Hand Sanitizer Violations

Finally, the FDA added six products to its "do not use" list of hand sanitizers. The majority were from China and flagged for subpotency. One from Florida, USA, however, was voluntarily recalled for microbial contamination, while another used packaging resembling bottled drinking water.

Specific entries include: 

  • Heal the World LLC, for its namesake sanitizer in packaging resembling bottled drinking water, which presents an increased risk of accidental ingestion;
  • Sanit Technologies LLC, dba Durisan (Florida, USA), for its Durisan Antimicrobial Solutions Hand Sanitizer, Alcohol-free, which was company-tested and found to contain microbial contamination (note: the product was voluntarily recalled on 3/24/2021);
  • Guangzhou Minghui Cosmetics Co. Ltd. (China), for its Qi Yu Hand Sanitizer, which was FDA-tested and found to contain subpotent ethanol alcohols; and two additional products purported to be made at the same facility producing said subpotent products; and
  • Waxman Industries (China), for its Waxman Kleen Freak Hand Sanitizer, which was purported to be made at the same facility as another subpotent product.

Follow us as we continually monitor for FDA updates. For the full list of "do not use" hand sanitizers, see the FDA website.

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