/>i- Yesterday, FDA and HHS announced a series of actions intended to phase out the use of petroleum-based synthetic food dyes. The news release can be found here and a video of the press conference here. Specifically, the agency announced that it would:
- Establish a national standard and timeline to transition from petroleum-based dyes to natural alternatives.
- Initiate the process to revoke authorizations for Citrus Red No. 2 (21 CFR 74.302) and Orange B (21 CFR 74.250).
- Work with the industry to eliminate the remaining six synthetic dyes – Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2 – from the food supply by the end of the year.
- Authorize four new natural color additives – calcium phosphate, Galdieria extract blue, gardenia blue, and buttery fly pea flower extract (expanded uses) –in the coming weeks and accelerate the review and approval of others.
- Partner with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
- Request that companies remove Red No. 3 sooner than the previously required 2027-2028 deadline.
- Speakers at the press conference included HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. Sweeping claims about the harms of the dyes, in particular to children, were made. Although the health effects of many of the dyes have been brought into question, there is little scientific consensus on the subject. See e.g., CA Department of Public Health Rejection of Synthetic Dye Warnings. FDA has not released any document providing an explanation for the agency’s change in position or providing a risk assessment to support its position. The speakers also discussed variations of state additive bans and the market harms of patchwork state regulation.
- Neither the press release nor the news conference referenced any formal process to revoke the authorizations for the synthetic food dyes that are not Citrus Red No. 2 and Orange B, and FDA will likely rely on voluntary phase out by industry and state additive bans to implement its plans.
FDA Announces Phase-Out of What it Referred to as “Petroleum-Based Synthetic Food Dyes”
Thursday, April 24, 2025
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