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Candy crisis of 1950 -

In 1950, Halloween candy caused sickness among dozens of children in cities across the United States. While no fatalities occurred, the culprit was a toxic FDA-approved dye used to color candy, known as Orange No. 1.

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Widespread -

This Halloween incident marked a wake-up call for food safety regulation. Orange 1 was a color additive that could be found in all types of food at the time, including candy and hot dogs.

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A toxic legacy -

Orange 1, a common food dye, was popular for its bright festive hue, but caused severe health issues in consumers, including rashes and diarrhea.

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Regulatory shift -

The Halloween incident triggered a regulatory overhaul as the FDA banned Orange 1 and other unsafe additives, including Red No. 3 and Orange No. 2.

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The emergence of Red 3 -

Another synthetic dye, known as Red No. 3, has replaced earlier additives, but brought new concerns. Red 3 can be found in candy and almost 3,000 other food products in the United States.

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Varied uses -

Red No. 3, also known as erythrosine, has also been used as a printing ink, dental plaque disclosing agent, and even as a sensitizer for orthochromatic photographic films.

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A link to cancer -

Red 3 has been been linked to thyroid cancer in rats and also behavioral issues in children. Despite these issues, the additive can still be found in thousands of products today. Why is that?

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A century of reliance -

Synthetic dyes have been part of food manufacturing since 1907, before the FDA even existed. Red No. 3 is one of nine synthetic dyes that have been approved for use in the United States.

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The start of regulation - The regulation of synthetic dyes began in earnest with the FDA, but the list of approved dyes has seen little significant revision since the late 1960s. Red No. 3, for instance, was last revised and approved in 1969.

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Limited approval -

Of the nine approved synthetic dyes, Orange B and Citrus Red No. 2 have been approved only for limited use, but the other seven are approved for a multitude of products, including drugs, cosmetics, and food. However, Red 3 is the exception.

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Uneven regulation - While Red 3 is widely used in foods, it is banned from use in cosmetics and topical drugs in the United States. What makes Red 3 so unique in its restrictions?

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Legislation -

After the 1950 Halloween fiasco, new legislation came into effect across the US, which included the 1958 Food Additives Amendment and the 1960 Color Additives Amendment. These laws required the FDA to evaluate all food dyes for safety.

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New revision -

As a result of the new legislation, all color additives used prior to that required revision and formal approval once again. Several additives were permanently approved in the following years, but loopholes still existed.

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Approval -

In 1969, Red No. 3 was approved for use in food based on the limited research available at the time. Two decades later, the cosmetics industry in the US petitioned the FDA to approve Red 3 so that it could be used in cosmetics and topical drugs.

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Cancer concerns -

Studies in the 1980s found that Red 3 increased the risk of thyroid cancer in rats. These findings prompted the FDA to ban its use in cosmetics and drugs, but, strangely, it remained approved for food products.

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The Delaney clause -

The 1958 Food Additives Amendment includes a provision known as the Delaney clause, which legally obligates the FDA to ban food additives that are shown to cause cancer in humans or animals. Red 3 meets this criterion, yet it continues to be used en masse.

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Inaction -

Despite clear evidence of cancer risks, the FDA has failed to act on Red 3 for more than three decades. This prolonged inaction has raised questions about the agency’s priorities and its ability to enforce its own rules.

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Justification for delay -

The FDA’s website argues that research linking Red 3 to cancer in rats has “limited relevance to humans.” This position has drawn criticism for downplaying potential risks and failing to uphold the health of citizens.

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Consumer advocacy -

In 2021, the Center for Science in the Public Interest (CSPI), an advocacy group focused on improving the consumer system in the US, petitioned the FDA to ban Red 3. But today the petition remains under review.

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In California -

In 2023, California passed legislation to ban Red 3 from food in the state by 2027. The bill includes considerations for the manufacture, delivery, and distribution of food products containing the additive.

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The behavioral toll on children -

A compilation of 25 studies found that synthetic dyes like Red 3 are linked to behavioral problems in children. Many studies used to approve synthetic dyes in the late 1900s are outdated, as they were not designed to detect neurobehavioral effects in children.

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State laws -

California’s ban on Red 3 is a reflection of the state’s frustration with the FDA’s failure to act, and it isn’t the only one to feel this way. Other states (including Washington and Missouri) are following suit, introducing legislation to address gaps in the federal food regulatory system and protect their residents.

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Bans around the globe -

Red 3 and other synthetic dyes are already banned or require warning labels in Europe and other regions. The European Food Safety Authority (EFSA) only allows Red 3 in pet foods and processed cherries.

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Economic influence -

California’s Red 3 ban is making waves across the US, since the state boasts the world’s fifth-largest economy. Companies are unlikely to produce separate products for California, which could lead to a nationwide shift away from this harmful dye.

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Industry alternatives -

Food manufacturers already produce dye-free products for stricter markets like Europe. California’s ban pressures them to extend safer practices to the United States. Red 3’s removal is not only feasible, it is also long overdue.

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Lessons from trans fats -

California previously led the way in 2010 when it banned artificial trans fats, which prompted a ripple effect across the US. Similarly, the state’s action on Red 3 could accelerate nationwide changes in food manufacturing standards.

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A history of disease -

In the 1990s, artificial trans fats were linked to heart disease and strokes. The FDA took time to gather evidence, but California intervened earlier. It was only in 2018 that the FDA issued a nationwide ban.

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A superficial purpose -

Food dyes like Red 3 serve no practical purpose beyond enhancing visual appeal. They do not affect flavor, nutrition, or preservation, but they present a larger risk to human health that is especially unjustifiable.

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A never-ending fight -

California recognizes the importance of protecting children from unnecessary exposure to potentially harmful chemicals during critical developmental stages. Only time will tell whether the rest of the United States takes up the mantle as well.

Sources: (Vox) (Center for Science in the Public Interest) (CBS News) (Britannica)

See also: Who produces some of the world's most famous candy?

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