FDA Finally Bans Cancer-Linked Red No. 3 Food Dye

By Nicolas Hulscher, MPH

The Food and Drug Administration (FDA) announced on Wednesday that it is banning the use of Red No. 3, a synthetic dye responsible for the vibrant cherry red color in foods and beverages, citing its association with cancer in animal studies:

The dye is still used in thousands of foods, including candy, cereals, cherries in fruit cocktails and strawberry-flavored milkshakes, according to the Center for Science in the Public Interest, a food safety advocacy group that petitioned the agency in 2022 to end its use.

Food manufacturers will have until Jan. 15, 2027 to reformulate their products. Companies that make ingested drugs, such as dietary supplements, will get an additional year.

This ban was LONG overdue. Unfortunately, the other synthetic food dyes that have also been linked to serious deleterious health effects still remain on the market. A few months ago, I summarized the harm linked to synthetic food dyes — outdated FDA standards expose Americans to toxic food dyes linked to cancer, neurobehavioral issues, and other health risks, demanding urgent regulatory action:

Synthetic Food Dyes: A Half-Century of Harm

Nicolas Hulscher, MPH · November 25, 2024

by Nicolas Hulscher, MPH

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Batada et al found that nearly half (43.2%) of grocery store products contained artificial food colorings (AFCs), with Red 40 (29.8%), Blue 1 (24.2%), Yellow 5 (20.5%), and Yellow 6 (19.5%) being the most common. Candies (96.3%), fruit-flavored snacks (94%), and drink mixes/powders (89.7%) had the highest prevalence of AFCs, while produce contained none.

Oliveira et al summarized the deleterious health effects linked to synthetic food colorings in children: neurobehavioral disorders, allergic reactions, carcinogenic and mutagenic potential, gastrointestinal and respiratory issues, toxicity, developmental and growth delays, and behavioral changes.

Sultana et al illustrated the specific health hazards associated with particular synthetic food dyes:

Miller et al conducted a systematic review of the potential neurobehavioral impacts (activity and attention) of food dye consumption. They included 27 clinical trials of children exposed to synthetic food dyes and found that 16 of 25 challenge studies (64%) demonstrated evidence of a positive association, with 13 studies (52%) reporting statistically significant findings. The authors concluded, “Current evidence from studies in humans, largely from controlled exposure studies in children, supports a relationship between food dye exposure and adverse behavioral outcomes in children, both with and without pre-existing behavioral disorders.” They also noted that:

“Animal toxicology studies were used by FDA as the basis for regulatory risk assessments of food dyes [25]. All current dye registrations were made between 1969 and 1986 based on studies performed 35 to 50 years ago. These studies were not designed to assess neurobehavioral endpoints. Dye registration was accompanied by derivation of an “acceptable daily intake” (ADI) based on these studies. FDA ADIs have not been updated since original dye registration, although there have been several reviews of specific effects since then, the latest in 2011.”

Synthetic food dyes, widely prevalent in U.S. products and lacking nutritional value, rely on outdated FDA approvals despite evidence of widespread toxicity, carcinogenicity, and adverse neurobehavioral effects, strongly warranting urgent regulatory action to protect public health.

While the FDA has finally made a decision that will benefit public health, they are still allowing the dangerous COVID-19 genetic injections to be administered to all individuals aged 6 months and older despite far exceeding criteria for a Class I recall. The immediate removal of unsafe and ineffective gene therapy injections should be the first priority before anything other product bans.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

Please consider following the McCullough Foundation and Nicolas Hulscher on X (formerly Twitter) for further content.

 By Nicolas Hulscher, MPH

The Food and Drug Administration (FDA) announced on Wednesday that it is banning the use of Red No. 3, a synthetic dye responsible for the vibrant cherry red color in foods and beverages, citing its association with cancer in animal studies:

The dye is still used in thousands of foods, including candy, cereals, cherries in fruit cocktails and strawberry-flavored milkshakes, according to the Center for Science in the Public Interest, a food safety advocacy group that petitioned the agency in 2022 to end its use.

Food manufacturers will have until Jan. 15, 2027 to reformulate their products. Companies that make ingested drugs, such as dietary supplements, will get an additional year.

This ban was LONG overdue. Unfortunately, the other synthetic food dyes that have also been linked to serious deleterious health effects still remain on the market. A few months ago, I summarized the harm linked to synthetic food dyes — outdated FDA standards expose Americans to toxic food dyes linked to cancer, neurobehavioral issues, and other health risks, demanding urgent regulatory action:

Synthetic Food Dyes: A Half-Century of Harm

Nicolas Hulscher, MPH · November 25, 2024

by Nicolas Hulscher, MPH

Batada et al found that nearly half (43.2%) of grocery store products contained artificial food colorings (AFCs), with Red 40 (29.8%), Blue 1 (24.2%), Yellow 5 (20.5%), and Yellow 6 (19.5%) being the most common. Candies (96.3%), fruit-flavored snacks (94%), and drink mixes/powders (89.7%) had the highest prevalence of AFCs, while produce contained none.

Oliveira et al summarized the deleterious health effects linked to synthetic food colorings in children: neurobehavioral disorders, allergic reactions, carcinogenic and mutagenic potential, gastrointestinal and respiratory issues, toxicity, developmental and growth delays, and behavioral changes.

Sultana et al illustrated the specific health hazards associated with particular synthetic food dyes:

Miller et al conducted a systematic review of the potential neurobehavioral impacts (activity and attention) of food dye consumption. They included 27 clinical trials of children exposed to synthetic food dyes and found that 16 of 25 challenge studies (64%) demonstrated evidence of a positive association, with 13 studies (52%) reporting statistically significant findings. The authors concluded, “Current evidence from studies in humans, largely from controlled exposure studies in children, supports a relationship between food dye exposure and adverse behavioral outcomes in children, both with and without pre-existing behavioral disorders.” They also noted that:

“Animal toxicology studies were used by FDA as the basis for regulatory risk assessments of food dyes [25]. All current dye registrations were made between 1969 and 1986 based on studies performed 35 to 50 years ago. These studies were not designed to assess neurobehavioral endpoints. Dye registration was accompanied by derivation of an “acceptable daily intake” (ADI) based on these studies. FDA ADIs have not been updated since original dye registration, although there have been several reviews of specific effects since then, the latest in 2011.”

Synthetic food dyes, widely prevalent in U.S. products and lacking nutritional value, rely on outdated FDA approvals despite evidence of widespread toxicity, carcinogenicity, and adverse neurobehavioral effects, strongly warranting urgent regulatory action to protect public health.

While the FDA has finally made a decision that will benefit public health, they are still allowing the dangerous COVID-19 genetic injections to be administered to all individuals aged 6 months and older despite far exceeding criteria for a Class I recall. The immediate removal of unsafe and ineffective gene therapy injections should be the first priority before anything other product bans.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

Please consider following the McCullough Foundation and Nicolas Hulscher on X (formerly Twitter) for further content.