Phase out of Red dye, page-4

From Gemini:

You've raised an excellent and crucial point. The phrasing "food supply" used in the recent announcements (April 22, 2025) about phasing out all petroleum-based synthetic dyes can indeed be ambiguous regarding ingested drugs.

Here's a breakdown to address that:

1. Regulatory Framework: The FDA regulates color additives under the Federal Food, Drug, and Cosmetic (FD&C) Act. This act covers additives used in food, drugs, and cosmetics. Often, the regulations for substances used in both food and ingested drugs are closely linked, as they involve substances entering the body via ingestion.
   
   

   
   
2. Precedent with Red Dye No. 3: When the FDA announced the finalized ban on FD&C Red No. 3 in January 2025, the agency explicitly stated it was revoking authorization for its use in both food and ingested drugs. They even provided separate compliance deadlines (Jan 2027 for food, Jan 2028 for ingested drugs). This clearly demonstrates that when taking major action on such dyes, the FDA considers and includes ingested drugs alongside food.
   
   

   
   
3. Overlap in Additives: The same petroleum-based synthetic dyes (like Red No. 40, Yellow No. 5, etc.) targeted by the recent potential phase-out are commonly used in both processed foods and oral medications (tablets, capsules, liquid solutions like Trofinetide).
4. Likely Intent: While the public-facing announcement on April 22, 2025, may have emphasized the "food supply" (perhaps for broader public resonance, focusing on items like candies and cereals), it is highly probable that the underlying regulatory intent to remove these specific chemical additives based on health concerns would extend to ingested drugs as well. It would be inconsistent from a regulatory and public health standpoint to ban these dyes in food but allow them in medications taken orally.

Conclusion:

You are right to question the wording. However, based on regulatory precedent (like the Red No. 3 ban explicitly including both) and the fact that the same additives under the same Act are involved, it is very likely that the announced plan to phase out petroleum-based synthetic dyes from the "food supply" is intended to include ingested drugs.

Therefore, if this plan moves forward and is formally implemented, Trofinetide (Daybue), containing FD&C Red No. 40, would likely fall within its scope and require reformulation, even though the initial announcement emphasized "food supply." We would need to await formal FDA guidance or regulation updates for confirmation on the exact scope and timelines for drugs under this newer, broader plan.