The FDA is revoking the authorization for the use of FD&C Red No. 3 based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Sorry, does that say that there is no evidence that it causes cancer but because it’s possible to trigger cancer in mice using higher doses than people get, triggering a mechanism that doesn’t apply in humans, they have no choice but to ban it because the law requires it?
No I think that’s right. The Delaney Clause just says to revoke authorization for food additives found to cause cancer in animals. The fact that the mechanism doesn’t apply in humans or that the dosage is not typical for humans is irrelevant to the law.
Huh. I mean, it doesn’t really matter in this case because there are alternatives and it’s only colouring but it’s interesting there’s such a black and white rule.
Sorry, does that say that there is no evidence that it causes cancer but because it’s possible to trigger cancer in mice using higher doses than people get, triggering a mechanism that doesn’t apply in humans, they have no choice but to ban it because the law requires it?
Or have I misunderstood?
No I think that’s right. The Delaney Clause just says to revoke authorization for food additives found to cause cancer in animals. The fact that the mechanism doesn’t apply in humans or that the dosage is not typical for humans is irrelevant to the law.
Huh. I mean, it doesn’t really matter in this case because there are alternatives and it’s only colouring but it’s interesting there’s such a black and white rule.