Here is what Eddie owners
need to know about this broader initiative:
This is a voluntary
phase-out, not a ban. Unlike the Red #3 revocation—which is a formal,
legally binding FDA action—the phase-out of the remaining six dyes is a
voluntary request from the FDA and HHS to food manufacturers. No formal
rulemaking, no enforceable ban, and no legal deadline has been established for
these six colorants. They remain fully approved and legal for use today.
The FDA’s own website now lists
the voluntary target as “by the end of 2027,” having shifted from the original
“end of 2026” announced in April 2025. Whether this voluntary effort will
ultimately lead to formal bans remains to be seen, and opinion is sharply
divided.
On one side, consumer advocacy
groups such as the Center for Science in the Public Interest (CSPI) have
criticized the voluntary approach, arguing that relying on industry compliance
has historically proven unreliable and calling for stronger federal action.
On the other side, major food
companies and industry organizations are pushing back forcefully, demanding
scientific proof that these six additional dyes have ever caused harm in
humans. From a strictly scientific standpoint, this has never been demonstrated.
While some animal studies have shown correlations between certain synthetic
dyes and behavioral or health effects, none of the remaining six dyes have been
shown to cause cancer or other harm in humans. The FDA itself has maintained
that “the totality of scientific evidence shows that most children have no
adverse effects when consuming foods containing color additives.”
The International Association of
Color Manufacturers (IACM) has stated that color additives have been rigorously
reviewed by global health authorities with no identified safety concerns, and
that the FDA’s April 2025 announcement offered no new scientific evidence to
support the phase-out. IACM has gone further, filing a federal lawsuit against
the state of West Virginia’s synthetic dye ban, arguing the state “arbitrarily”
bans dyes without scientific evidence. Major manufacturers, including Mars
(maker of M&M’s and Skittles), were notable holdouts against the voluntary
phase-out, insisting that their approach be “consumer-focused and science-led.”
Companies across the food industry are vowing to fight further legislation,
insisting that science—not emotion—must prevail in regulatory decisions.
Primera has spoken directly
with senior regulatory scientists at the FDA. They have assured us that no
federal legislation exists—or is even being considered—for these other six
FD&C dyes, because they do not fall under the Delaney Clause. The
Delaney Clause is the specific legal provision that required the FDA to ban Red
#3, because Red #3 was shown to cause cancer in laboratory rats. Even then, Red
#3 has never been proven to cause harm in humans—only in rats. The remaining
six synthetic dyes have not triggered the Delaney Clause, and without that
legal basis, the FDA has no authority to ban them through the same mechanism.
Any future action on these dyes would require new legislation or a separate
regulatory pathway, and according to FDA scientists, nothing of that nature is
currently under consideration.
Several states, including
California and West Virginia, have also passed their own legislation
restricting or banning some or all of these synthetic dyes—particularly in
school meal programs. This growing patchwork of state regulations may push some
manufacturers toward reformulation regardless of federal action.
Primera’s position: The
voluntary phase-out assumes manufacturers have the ability to switch to natural
alternatives. In Primera’s case, that ability does not currently exist. Eddie’s
printhead technology produces 7-picoliter droplets—an extraordinarily small
size that demands ink with extremely fine particulates, precise solubility, and
consistent flow characteristics. The natural colorants currently approved by
the FDA simply cannot meet these requirements. Their particulates are too large
to pass through inkjet nozzles at this scale without clogging, and they lack
the color strength, stability, and shelf life needed for a reliable ink
cartridge product.
This is not a matter of
willingness—it is a matter of physics and chemistry. Primera would welcome
the opportunity to move to all-natural colorants the moment viable options
exist. Until the FDA approves new natural colorants that can physically
function in an inkjet printing environment, or until natural colorant
technology advances to overcome these particle-size limitations, switching to
all-natural ink is not possible. Our current plan to replace Red #3 with Red
#40 is fully compliant with all existing federal regulations. Should the
regulatory landscape change—whether through formal FDA rulemaking or state
legislation that affects our products—we will adapt accordingly and communicate
those changes to our Eddie community promptly.
Why Not Switch to All-Natural Ink?
This is the question we hear
most often, and we want to give you a candid, transparent answer.
Since our original article in
January 2025, Primera and our edible ink manufacturing partner, Sun
Chemical—the largest ink company in the world—have invested significant time
and resources into developing an all-natural edible ink formulation. Primera’s partnership
with Sun Chemical is itself an extra measure of safety and quality assurance;
their global expertise in ink chemistry and regulatory compliance is unmatched.
Sun Chemical has tested every FDA-approved natural colorant that could
potentially work in an inkjet ink application. The results have been
disappointing.
There are currently no
FDA-approved natural colorants available that produce viable red or yellow hues
for inkjet printing. The FDA approves only a very limited list of natural
ingredients for food coloring purposes, and the ones currently approved simply
do not perform in an inkjet printing environment. They fail for a variety of
reasons: incompatible particle sizes, poor solubility, inadequate color
strength, insufficient stability, or short shelf life.
Here is the truly frustrating
part: natural colorants that would work beautifully in Eddie do exist. Gardenia-derived
Red and Yellow colorants have been in widespread use across Asia for decades
with no ill effects. And unlike most other natural colorants, they jet
perfectly through our thermal inkjet printheads. However, Gardenia Red and
Yellow are not approved for use in the United States as food additives. Until
the FDA changes that, we cannot use them—no matter how well they perform.
The one natural colorant that
has received FDA approval and showed promise was Gardenia Blue. In a positive
development, the FDA approved Gardenia Blue for food use in July 2025—one of
four new natural color additives approved that year as part of the agency’s
push to provide alternatives to synthetic dyes. However, Gardenia Blue is
currently approved only for specific food and beverage categories (sports
drinks, flavored water, fruit drinks, teas, and candy). Whether it could be
extended to edible ink applications remains uncertain, and even if it were, it
would address only the blue component of our ink—not red or yellow.
The bottom line: at this
time, there is no viable pathway for Primera to go all-natural with its inks. Primera
is a specialty printer manufacturer—not a food processing conglomerate. We can
only follow the lead of larger food processing companies with far deeper
pockets who are driving the push for FDA approval of new natural colorants. The
limitation we face is not a lack of effort or investment on our part, nor a
lack of natural colorants that would technically work in our printheads. It is
a regulatory limitation: the FDA has not yet approved the natural colorants
that would allow us to make the switch.
If and when alternative
colorants such as Gardenia Red and Yellow are approved as food additives in the
United States, just as Gardenia Blue was in 2025, Primera and our ink partners
will move on it quickly.
Current Use of Red Dye #3
Until the ban takes effect on
January 15, 2027, Red Dye #3 continues to be used in a wide range of everyday
consumer products, including juice, yogurt, soft candy and gummies, baby food,
cookies, toaster pastries, frozen dairy desserts like ice cream and sherbet,
baking decorations such as frosting and edible ink, and certain medications
including some used to treat ADHD. Eddie ink containing Red #3 that is
manufactured before the ban takes effect may continue to be sold and used after
that date.
Primera’s Transition Timeline
Now through Q3 2026: Color
profile development and testing for new Red #40-based ink formulation.
Q4 2026: Final
validation, production ramp-up, and distribution of new ink SKUs.
December 31, 2026: Red #3
fully eliminated from Primera’s ink supply chain.
January 1, 2027: Eddie
owners fully supported with new, 100% FDA-compliant ink formulation.
January 15, 2027: Federal
ban on Red #3 in food products takes effect.
Looking Ahead
Primera is committed to strongly
supporting Eddie owners during this transition and beyond. The food dye
regulatory landscape in the United States is evolving rapidly—driven by federal
initiatives, state legislation, and growing consumer demand for cleaner
ingredients. We are watching all of these developments carefully.
Our immediate priority is clear:
deliver a seamless transition from Red #3 to Red #40 that maintains the print
quality and color accuracy Eddie owners expect. Our longer-term commitment is
equally clear: as natural colorant technology advances and the FDA approves new
options that work for inkjet printing, we will be among the first to adopt
them.
As these changes unfold, we will
keep you informed with updates. If you have any questions or concerns, please
don’t hesitate to reach out to our team. Together, we’ll navigate this
transition and continue empowering you to create exceptional designs on cookies
and other edible items with confidence.