Why was Red #4 banned (E125)

[Melbourne]

Red #4 is not permitted in foods. It was banned a long time ago. Just curious, what did it do?

[engineer_comp_geek]

Here is a news article from when it was banned:

F.D.I. Bans Use of Red No. 4 Dye And Carbon Black in Food Items (Published 1976)

This is the reason given for the ban:

The Food and Drug Administration said the safety of the two dyes was questionable. The one called Red. No. 4 may cause urinary bladder polyps and atrophy of the adrenal glands, it said. And for the color carbon black, there is no reliable testing method to assure that it does not contain a cancer‐causing byproduct, the F.D.A. said.

[2Bits]

Just want to mention that a red dye still commonly used in U.S. is banned in a few European countries.
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[Earl_Snake-Hips_Tucker]

"May cause. . . " It would have been nice if that article had included a little background on what led them to that concern. Presumably lab rats or something, but who knows.

[Peter_Morris]

If it was banned without an announcement, then it was probably a previously banned dye that returned with a new name.

[wevets]

Yes, lab rats - but also dogs (this was in the 1960s, not sure use of dogs would be approved today.) Here’s an older toxicology monograph on Red No. 4 (also known as “Ponceau SX”)

Additional experiments, using groups of 200, 100 and 100 Osborne-
Mendel rats of both sexes and 200, 100 and 100 Sprague-Dawley rats of
both sexes fed a diet containing 0, 10 000 or 20 000 mg ponceau SX per
kg of diet, resulted in tumour incidences of 67/171 (39%), 23/89 (26%)
and 32/89 (36%) in Osborne-Mendel rats and 38/147 (26%), 16/83 (19%)
and 14/74 (19%) in Sprague-Dawley rats in the respective groups (the
numbers of animals given are those examined for pathology). Survival
rates at 80 weeks were 79, 75 and 78%, respectively, in Osborne-Mendel
rats and 61, 66 and 54%, respectively, in Sprague-Dawley rats (Davis
et al., 1966).

Commercial ponceau SX was fed at a level of 0, 10 000 and
20 000 ppm in the diet to five female beagle dogs (age six months) for
up to seven years; three dogs died at six, nine-and-one-half and 64
months of treatment. A second group of five females received ponceau
SX at a level of 10 000 mg/kg of diet for seven years, while nine
females served as controls. Two (20 000 ppm), five (10 000 ppm) and
nine (control) dogs, respectively, survived the seven years of
treatment. There was no apparent effect on weight gain during the
first six months or any change on haematological parameters examined
at any time during the duration of the experiment. Haemorrhagic
streaks and/or projections in the urinary bladder of all test animals
surviving more than six months were found.

From: Summary of Toxicological Data of Certain Food Additives: Ponceau SX

The dosages are high (unlikely that people would ingest 20g/kg of dye) but the point is made in the differences of tumor incidence between the controls and experimental groups.

I’m not sure why they even did the dog study, a sample size of five in the experimental group and nine in the control seems just about useless to me.

[wevets]

@wevets

(this was in the 1960s, not sure use of dogs would be approved today.)

Oops - missed the edit window - the 1970s

[szabrocki]

I thought it was red dye #3 in the 60’s.

[KarlGauss]

Am I the only one who wondered why I hadn’t noticed Red #4 post much around here before he was banned?

[Darren_Garrison]

@KarlGauss

Am I the only one who wondered why I hadn’t noticed Red #4 post much around here before he was banned?

Nope.

[kenobi_65]

@szabrocki

I thought it was red dye #3 in the 60’s.

FD&C Red No. 3 (erythrosine) was partially banned in the U.S. in 1990, but it’s apparently still allowed for use in some applicaitons.

You may also be thinking of the more infamous FD&C Red No. 2 (amaranth), which was completely banned in the U.S. in 1976, the same year that Red No. 4 was banned for use in foods.

[szabrocki]

I stand corrected.

[Northern_Piper]

I remember when Red #4 was banned. Weekend Update on SNL did a short story on it. Played it completely straight as a news item, explaining that it was banned as a cancérogène.

Then the next news item: “Ronald Reagan has been admitted to hospital suffering from cancer of the hair .”