FDA extends comments on controversial Red No. 3 through May


Dive Brief:

  • There will be another month to weigh in on a petition from several consumer and health groups, including the Center for Science in the Public Interest, calling on FDA to ban the use of dye FD&C Red No. 3 in food, supplements and drugs.
  • CSPI and other groups behind the petition say studies have shown there is convincing evidence that Red No. 3 is carcinogenic. Based on studies done on animals in the 1970s and 1980s, FDA banned uses of the dye in cosmetics and externally applied drugs in 1990. In Europe, it can only be used for certain cherries.
  • Consumer groups have been petitioning FDA and food manufacturers for years to discontinue the use of some common synthetic food dyes. Through the years, not much has changed.

Dive Insight:

Consumer groups’ fight against artificial dyes in food and beverages has been long and unwavering, though some periods have seen more action than others.

The petition against Red No. 3 — as well as campaigns and meetings about the dangers consumer groups say the dye poses — has created a more active front in the battle in recent months. According to Regulations.gov, 14,916 comments have been submitted on the petition as of Wednesday.

The extension was requested in two letters. One letter was from the American Bakers Association, Consumer Brands Association, National Confectioners Association and SNAC International. Another letter came from the International Association of Color Manufacturers. None of these groups has commented on the docket yet.

At the time that FDA rejected the use of Red No. 3 in cosmetics, it had been permanently approved for use in food and drugs in the U.S.

Leaders at the Environmental Working Group, Consumer Reports, CSPI and a former director at the National Institute of Environmental Sciences hosted a media call last week to talk about the issue of Red No. 3.

“FDA has known since the early 1980s, they’ve had the data in their hands since I think 1983, [that] Red 3 causes cancer, thyroid cancer to be specific, when it’s eaten by animals,” Thomas Galligan, principal scientist for food additives and supplements at CSPI said on the call. “And on the basis of that evidence, they banned its use in cosmetics. …But if ingestion is the route of exposure that we’re concerned about, if eating it is the route of exposure that caused cancer in animals, then why is it still in our food 33 years later?”

Past consumer-based movements against artificial colors, Red No. 3 included, have not gotten far. CSPI has been advocating for artificial colors to be banned since 2008, when the group formally petitioned FDA. Its reasoning was that synthetic food dyes had been linked to problems in children’s behavior since the 1970s, and evidence of the association was mounting. That petition led to a 2011 meeting of FDA’s Food Advisory Committee about synthetic food dyes, which resulted in no action.

In 2015 and 2016, Mars, Incorporated, General Mills and Kellogg all committed to removing artificial flavors and colors from their products — which comprise brightly colored offerings including Skittles, M&Ms, Lucky Charms, Trix and Froot Loops. The companies all stepped away from their pledges, citing reasons including that U.S. consumers weren’t as concerned with artificial colors, and were less willing to buy products made with more dull natural colors.

Regulation of artificial dyes have also been floated in state legislatures. Starting in 2017, California lawmakers have proposed state laws to require warning labels on products using these kinds of colors. In 2018, legislators appropriated almost $500,000 to study the issue.

A stronger California state bill that would prohibit the manufacture, sale or distribution of products with Red No. 3 and other controversial colorants including titanium dioxide is currently pending in the state’s legislature.



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