I remember when I was at the FDA and presenting at a meeting discussing a guidance that industry had been waiting for the FDA to publish for a year or so.  I noted that it would be released soon!  Immediately someone from the audience asked, “what’s the FDA’s definition of soon?”  I thought for a second and replied, “Soon is from now until it happens!”  I became famous for that quote.  Anyway, the FDA has announced that it will be revoking the use of FD&C Red No. 3 in foods and drugs (see Federal Register notice here).  But in this case, it is not very soon as the FDA has given drug manufacturers who use FD&C Red No. 3 in ingested drugs until January 18, 2028 to reformulate their products.  In addition, the FDA has noted that products already on the market on or after the reformulation date won’t be recalled (but no additional products containing FD&C Red No. 3 may be manufactured).

“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).  The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.”

The data for the Red Dye #3 studies indicates, while showing that exposure can cause cancer in rats, there is no evidence that it causes cancer in humans.  Despite that, “the Delaney Clause [does not] permit FDA to find an ingested color additive safe for human consumption if the color additive has been found to induce cancer in animals.”

The “FDA intends to issue guidance to provide drug manufacturers with recommendations regarding replacing color additives used in approved and marketed drugs, including recommendations for reformulation when a color additive regulation is revoked.”

We will see how this all plays out over the next three years but, right now, the schedule seems to be clear.  Expect further guidance from the Agency on the specifics that will impact manufacturers.  Also, remember that this ban will include dietary supplements.  Begin planning to say goodbye to Red Dye #3 now!