Frequently asked questions
1,836 US drug labels list it, resolving to 1,451 marketed products, or about 1.06 percent of everything sold in the country. For scale, FD&C Red No. 40 appears on 19,444 labels, Blue No. 1 on 25,371 and titanium dioxide on 63,099. The dosage-form split matters more than the count: about 75 percent of affected products are capsules, where the colorant sits in the gelatin shell, and only 46 plain tablets and 14 film-coated tablets are affected. Eighty percent is prescription and roughly 75 percent is generic. Counts pulled from FDA structured product label data and the NDC directory on August 19, 2026.
FDA revoked the listing for FD&C Red No. 3 in food and ingested drugs in January 2025. Food must comply by January 15, 2027; ingested drugs by January 18, 2028. The lakes of Red No. 3 are a separate and older matter: 21 CFR 81.10(u) terminated their provisional listing for food, drug and cosmetic use effective January 29, 1990, so a Red No. 3 lake has not been lawful in a US drug for thirty-six years. A colorant that is not listed for the specific use it is put to renders the product adulterated, so the dates are firm. FD&C Blue No. 1 and Yellow No. 5 aluminum lakes remain permanently listed for drug use, so this is a targeted substitution rather than a purge.
Because a lake is a pigment, not a dye. It sits in a film-coating suspension, a softgel shell, a compressed tablet. Swap it and opacity changes, coating weight changes with it, and coating weight sits upstream of disintegration and dissolution. If the replacement is photolabile, light protection stops being optional and the pack becomes part of the specification: amber resin, an opaque bottle, a foil-backed blister. That changes the substrate the artwork lives on, and color qualified on clear PET does not transfer to opaque HDPE. The swap quietly triggers a full color requalification on a new material.
Easier to file. FDA’s May 2025 draft guidance proposed moving a colorant replacement in an approved drug product from prior approval to a thirty-day notice that can be implemented without waiting for a decision. The second-order effect is the one that matters for packaging: the prior approval step was functioning as a throttle that forced portfolios to batch color decisions into one staged event. Remove it and every colorant change, sourcing substitution and claim update arrives on its own schedule, each one touching artwork.
Six worth studying as architecture. Children’s Tylenol Dye Free fuses the absence into the variant name and keeps parent brand equity. Tide Free & Gentle and Henkel’s all free clear are deep tiers with white colorways and third-party seal walls carrying the trust. Seventh Generation presents Free & Clear as a scent option with its own image swatch, so absence gets a picture in the same visual grammar as presence. Vanicream is a whole brand built on an omission list. Listerine Cool Mint Extra Mild is the closest analogue to a health care colorant exit, because the liquid was carrying the cue, and it works by placing a clear liquid on a printed intensity ladder.
A badge on converted SKUs is fast and legible but implies the unbadged items are the alternative. A separate tier works only if the shopper genuinely segments that way and you intend to maintain both systems. A wholesale conversion costs the most to plan and the least to execute over three years, and it is the only one that does not leave the brand competing with its own back catalog. The default is none of those: a badge applied SKU by SKU as formulas clear. That is the architecture nobody chose, and the hardest to unwind.
They replace a serial process with a parallel one. Rather than qualifying one candidate per cycle, build the matrix of pigment candidates against finishes against the substrates a light-protection change might force, and choose from physical evidence in one sitting. Comp the whole affected block rather than a hero SKU, because coding only exists in relation to its neighbors. Comp the expected drift end point so packaging can proceed alongside stability work instead of behind it. Keep the comp set as a standing asset by palette and substrate so each later SKU is a delta rather than a new project.
Bob Jennings is CEO of 3D Color, which produces production-matched packaging comps, prototypes, and sales samples for more than 250 CPG brands. Reach Bob at bob.jennings@3dcolor.com to pressure-test a dye-free transition before it prints. Nothing here is regulatory advice; confirm your filing path with your regulatory group.