糖果、饮料和零食中发现的有争议的红色染料可能很快会被禁止

【中美创新时报2024 年 12 月 30 日编译讯】（记者温友平编译）美国食品和药物管理局即将决定是否禁止一种有争议的鲜樱桃红色染料，这种染料用于饮料和零食，但与动物癌症有关。

《华盛顿邮报》记者Rachel Roubein对此作了下述报道。

多年来，食品安全倡导者一直在向该机构施压，要求禁止在泡泡糖、糖果和水果鸡尾酒中使用这种染料，他们认为使用从甜菜和红甘蓝等植物中提取的天然色素会更安全。

FDA 坚持认为，这种 50 多年前获准永久使用的添加剂对人类来说是安全的，但监管机构的决定对食品行业来说仍然是一个关键时刻。当选总统唐纳德·特朗普挑选的美国卫生部部长罗伯特·F·肯尼迪二世、社交媒体影响者和两党议员正在越来越多地审查食品和饮料中的化学物质和成分。

关于红色染料 3 号的决定已经酝酿了三十多年。

1990 年，FDA 禁止在口红和腮红等化妆品中使用这种色素添加剂，因为研究表明高剂量使用可能导致大鼠患癌。该机构当时表示将“采取措施”消除食品和其他产品中的人工色素，而 FDA 的一位高级官员最近表示，没有证据表明摄入这种色素会导致人类患癌。

“联邦层面存在系统层面的失灵，导致不安全的化学物质在我们的食品供应中滞留了几十年，”非营利组织公共利益科学中心食品添加剂和补充剂首席科学家托马斯·加利根 (Thomas Galligan) 表示，该中心于 2022 年发起了一项请愿，要求该机构正式将这种染料从食品中获准的色素添加剂名单中删除。

代表色素添加剂行业的国际色素制造商协会支持这种染料。该组织坚持认为红色染料 3 号“对于其预期用途是安全的”，并认为从产品中撤下这种染料会导致消费者成本增加，该贸易组织的执行董事莎拉·科德里亚 (Sarah Codrea) 在一份声明中表示。

FDA 预计可能会在“未来几周”内发布公告，该机构负责人类食品的副局长吉姆·琼斯 (Jim Jones) 本月早些时候告诉参议员。

如果时机成熟，可能会在肯尼迪的任命表决之前做出决定。肯尼迪的任命预计在明年年初举行，特朗普已承诺让肯尼迪“在食品上大展拳脚”。肯尼迪一直强烈批评人工食用色素，科学家们长期以来一直在争论此类添加剂的安全性。

红色染料 3 号（也称为赤藓红或 FD&C 红色 3 号）的反对者认为，应该禁止使用这种染料，因为它只是为了增强食物的颜色，没有任何营养作用。

一些著名的消费者权益保护组织坚持认为，有足够的证据表明食用色素可能会对儿童造成一些伤害，他们认为一些研究将人工色素（包括红色染料 3 号）与负面行为问题联系起来。他们指出，加州环境健康危害评估办公室在 2021 年进行的一项审查得出结论，食用某些食用色素可能会导致一些儿童多动症和其他神经行为问题，尽管敏感性各不相同。

但 FDA 认为，两者之间并没有明确的联系。

“所有科学证据表明，这些食品中的色素添加剂——在批准的剂量下使用——对所有消费者都是安全的，”FDA 在给《华盛顿邮报》的一份声明中表示。

该机构批准使用色素添加剂，并于 1969 年将红色染料 3 号永久列入食品使用名单。但这种色素添加剂仅被暂时允许用于化妆品，这使得 1990 年更容易从化妆品和外用乳膏中撤出这种染料。

当时，联邦官员明确表示，这一决定不是基于科学证据，而是基于一项名为《德莱尼条款》的联邦法律，该法律禁止使用任何剂量的被发现会导致人类或动物患癌症的添加剂。《华盛顿邮报》报道称，时任卫生与公众服务部部长的路易斯·W·沙利文“几乎为禁止这种染料用于某些用途而道歉”。

该机构随后宣布打算禁止在食品中使用这种染料，但从未付诸实施。

当一种物质被证明会导致动物患癌症时，食品安全倡导者表示，这种物质被认为会导致人类患癌症。但红色染料 3 号给 FDA 带来了难题，琼斯说这个问题多年来一直“挑战”着该机构。

“你面临的情况是，尽管动物身上可能有致癌证据，但也有证据表明它对人类无害，”琼斯本月早些时候在参议院卫生委员会的听证会上表示。

但食品安全倡导者认为，FDA 别无选择。

“法律非常明确，”非营利性环境工作组副总裁梅拉妮·贝内什 (Melanie Benesh) 表示，该工作组签署了要求 FDA 撤销该染料批准用途的请愿书。如果有任何证据表明动物或人类致癌，“FDA 必须禁止它，”她说。“它根本就不允许出现在食品中。”

在没有联邦行动的情况下，至少有一个州已自行禁止该染料。去年，加利福尼亚州通过了一项法律，禁止在该州销售含有 3 号红色染料、溴化植物油和其他添加剂的食品。公司必须在 2027 年之前重新配制其食品和饮料，否则将停止销售这些产品。

甚至在加州法律生效之前，一些知名制造商就已经开始从热门产品中去除这种染料，例如雅培生产的 Peeps 糖果和 PediaSure 营养奶昔。

“他们已经看到了危险的迹象，”公共利益科学中心的监管顾问 Jensen Jose 说。

其他染料也面临公众的反对，例如红色染料 40 号，这是一种广泛使用的染料，存在于一些流行的早餐谷物中，其化学成分与红色染料 3 号不同。

共和党和民主党议员都向 FDA 施加压力，要求其打击红色染料 3 号。参议员 Tommy Tuberville（阿拉巴马州共和党人）在参议院卫生委员会听证会上就染料问题询问了机构官员。众议院能源和商业委员会的民主党高层众议员 Frank Pallone Jr.（新泽西州）表示，他担心这种染料会残留在商店货架上常见的食物中。

“这种化学物质在我们的食物中根本没有任何理由，除非通过改变食物的颜色来吸引和误导消费者，使其看起来更有吸引力，”帕隆本月在给 FDA 局长罗伯特·M·卡利夫的一封信中写道。“有可靠的科学证据支持 FDA 禁止这种化学物质。”

食品安全倡导者表示，FDA 重新评估食品中的化学物质需要太长时间。针对这些批评，该机构官员表示，他们最近完成了一项大规模重组，成立了一个新的人类食品计划，其中包括一个专门审查食品中化学物质的办公室。

在国会作证时，卡利夫恳求在特朗普第二届政府开始执政前一个月为他将监督的机构提供更多资金。

“我们一再要求为化学品安全提供更好的资金，”卡利夫本月告诉议员们。“请看一下我们的资金请求。”

题图：罐装水果鸡尾酒中的樱桃含有红色染料 3 号。

附原英文报道：

Controversial red dye found in candy, drinks, and snacks could soon be banned

By Rachel Roubein The Washington Post,Updated December 29, 2024

Cherries from a canned fruit cocktail that have red dye No. 3.

The Food and Drug Administration is on the cusp of deciding whether to ban a controversial bright cherry-red dye used in drinks and snacks but that has been linked to cancer in animals.

Food safety advocates for years have pressured the agency to ban the dye used in bubble gum, candy, and fruit cocktails, contending it would be safer to use natural coloring derived from plants such as beets and red cabbage.

The FDA maintains the additive approved for permanent use more than 50 years ago is safe for humans to consume, but the regulatory agency’s decision nonetheless arrives at a pivotal time for the food industry. Robert F. Kennedy Jr., President-elect Donald Trump’s pick to lead the nation’s health department, along with social media influencers and lawmakers from both parties are increasingly scrutinizing the chemicals and ingredients found in food and drinks.

The decision on red dye No. 3 is more than three decades in the making.

In 1990, the FDA forbade the use of the color additive in cosmetics, like lipstick and blush, because studies showed high doses could cause cancer in rats. The agency at the time said it would “take steps” to eliminate the artificial dye in food and other products, while a top FDA official recently said there is no evidence that ingesting the coloring causes cancer in humans.

“There is a systems-level failure at the federal level that allows unsafe chemicals to linger in our food supply for, in this case, decades,” said Thomas Galligan, the principal scientist for food additives and supplements at the nonprofit Center for Science in the Public Interest, which led a 2022 petition asking the agency to formally remove the dye from the list of approved color additives in foods.

The International Association of Color Manufacturers, which represents the color additives industry, stands behind the dye. The group maintains red dye No. 3 is “safe for its intended uses” and argues pulling the dye from products would lead to higher costs for consumers, Sarah Codrea, the trade group’s executive director, said in a statement.

The FDA expects to make an announcement probably in the “next few weeks,” Jim Jones, the agency’s deputy commissioner for human foods, told senators earlier this month.

If the timing holds, it could set up a decision before a vote on Kennedy’s confirmation, which is expected early next year, and whom Trump has pledged to let “go wild on the food.” Kennedy has been fiercely critical of artificial food dyes, and scientists have long debated the safety of such additives.

Opponents of red dye No. 3, also known as erythrosine or FD&C Red No. 3, argue it should be banned since it is only added to enhance the color of food and serves no nutritional purpose.

Some prominent consumer advocacy groups insist there is enough evidence to show food dyes may cause some harm to children, arguing that some studies have connected artificial dyes, including red dye No. 3, to negative behavioral problems. They point to a 2021 review performed by the California Office of Environmental Health Hazard Assessment, which concluded the consumption of some food dyes can result in hyperactivity and other neurobehavioral problems in some children, though sensitivity varies.

But the FDA contends a definitive link has not been established.

“The totality of scientific evidence shows that these color additives in food — when used at approved levels — are safe for all consumers,” the FDA said in a statement to The Washington Post.

The agency approves the use of color additives, and in 1969, it permanently listed red dye No. 3 for use in food. But the color additive had only been allowed temporarily in cosmetics, which made it easier to pull the dye from cosmetics and topical creams in 1990.

At the time, federal officials made clear the decision was based less on scientific evidence but instead on a federal law called the Delaney Clause, which prohibits additives found to cause cancer in humans or animals at any dose. Louis W. Sullivan, who was serving as Health and Human Services secretary, “all but apologized for banning the dye from certain uses,” the Post reported.

The agency then declared its intent to ban the dye in food, but it never followed through.

When a substance is shown to cause cancer in animals, food safety advocates say it is presumed to cause cancer in humans. But red dye No. 3 has posed a conundrum for the FDA, with Jones saying the issue has “challenged” the agency for many years.

“You have a scenario where although there may be cancer evidence in animals, there is also evidence that it is not harmful to humans,” Jones said at a hearing before the Senate health committee earlier this month.

But food safety advocates argue the FDA has no choice.

“The law is very clear,” said Melanie Benesh, a vice president of the nonprofit Environmental Working Group, which signed on to the petition asking the FDA to revoke the dye’s approved uses. If there’s any evidence of cancer in animals or humans, “the FDA is required to ban it,” she said. “It’s just simply not allowed in food.”

Absent federal action, at least one state has moved to ban the dye on its own. Last year, California passed a law prohibiting food from being sold in the state if it contains red dye No. 3, brominated vegetable oil, and other additives. Companies have until 2027 to reformulate their food and drinks or stop selling the products.

Even before the California law goes into effect, some prominent manufacturers have started removing the dye from popular items, such as Peeps candy and PediaSure nutritional shakes made by Abbott.

“They can see the writing on the wall,” said Jensen Jose, who serves as regulatory counsel at the Center for Science in the Public Interest.

Other dyes have faced public pushback, such as red dye No. 40, a widely used dye found in some popular breakfast cereals that has a different chemical composition from red dye No. 3.

The FDA is facing pressure to crack down on red dye No. 3 from both Republican and Democratic lawmakers. Sen. Tommy Tuberville (R-Alabama) quizzed agency officials on the dye during the Senate health committee hearing. Rep. Frank Pallone Jr. (New Jersey), the top Democrat on the House Energy and Commerce Committee, said he was frightened the dye remains in food commonly found on store shelves.

“There is simply no reason for this chemical to be in our food except to entice and mislead consumers by changing the color of their food so it looks more appealing,” Pallone wrote this month in a letter to FDA Commissioner Robert M. Califf. “Reliable scientific evidence exists for FDA to ban this chemical.”

Food safety advocates have said it takes far too long for the FDA to reassess chemicals in food. In response to the criticism, agency officials say they recently finalized a massive reorganization creating a new Human Foods Program, which includes an office dedicated to reviewing chemicals found in food.

Testifying before Congress, Califf pleaded for more money for the agency he’ll oversee for one more month before the second Trump administration begins.

“We have repeatedly asked for better funding for chemical safety,” Califf told lawmakers this month. “Please look at our request for funding.”