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zoom RSS 人工着色料が子どもの多動を悪化させるか? 警告表示再検討を表明/FDA

<<   作成日時 : 2011/04/15 20:02   >>

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 Jell-O, Lucky Charms cereal and Minute Maid Lemonadeといった人工着色料が子どもの多動といった行動上の問題を悪化させるという警告を出すべきかどうかについて連邦政府は初めて再評価することを公表した。
 FDAは以前に着色料と行動や健康上の関連はないと断定しており、すぐにその考えを否定することはないだろうが、専門家委員会にたいして再検討と助言を求めた。着色料と行動異常との関連についての報告が目立つようになったことに注目するようになったと思われる。通常では影響を受けないが、行動障害がある場合には影響を受けやすい可能性がある。
 しかしそうした関係は存在しないと考える医師もいる。
 1950年に、Orange No. 1 dye を含んだハロウィーンキャンディを食べた子どもが病気になり、FDAは禁止した。1976年にRed No. 2 が発ガン性を疑われて禁止となった。
 現在使用されている着色料の多くはBlue No. 1, Yellow No. 5 and Red No. 3 を含め、1931年に認可されたものである。
 1970年代にベンジャミン・ファインゴールド博士により、着色料を除いた食事で子どもの多動症状が改善したと報告された。
 2007年のランセットに発表された研究では、人工着色料が普通の子どもの行動に及ぼす可能性があるという。
 消費者グループは、色素を禁止するか、少なくともメーカーが警告表示をするよう政府に要求しているが、FDAは却下している。

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食品着色料の禁止要求 多動と関連/欧州
http://kurie.at.webry.info/200804/article_18.html
食品添加物が行動異常を誘発/ADHD
http://kurie.at.webry.info/200709/article_12.html

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F.D.A. Panel to Consider Warnings for Artificial Food Colorings
By GARDINER HARRIS
Published: March 29, 2011
http://www.nytimes.com/2011/03/30/health/policy/30fda.html

画像WASHINGTON ― After staunchly defending the safety of artificial food colorings, the federal government is for the first time publicly reassessing whether foods like Jell-O, Lucky Charms cereal and Minute Maid Lemonade should carry warnings that the bright artificial colorings in them worsen behavior problems like hyperactivity in some children.

The Food and Drug Administration concluded long ago that there was no definitive link between the colorings and behavior or health problems, and the agency is unlikely to change its mind any time soon. But on Wednesday and Thursday, the F.D.A. will ask a panel of experts to review the evidence and advise on possible policy changes, which could include warning labels on food.

The hearings signal that the growing list of studies suggesting a link between artificial colorings and behavioral changes in children has at least gotten regulators’ attention ― and, for consumer advocates, that in itself is a victory.

In a concluding report, staff scientists from the F.D.A. wrote that while typical children might be unaffected by the dyes, those with behavioral disorders might have their conditions “exacerbated by exposure to a number of substances in food, including, but not limited to, synthetic color additives.”

Renee Shutters, a mother of two from Jamestown, N.Y., said in a telephone interview on Tuesday that two years ago, her son Trenton, then 5, was having serious behavioral problems at school until she eliminated artificial food colorings from his diet. “I know for sure I found the root cause of this one because you can turn it on and off like a switch,” Ms. Shutters said.

But Dr. Lawrence Diller, a behavioral pediatrician in Walnut Creek, Calif., said evidence that diet plays a significant role in most childhood behavioral disorders was minimal to nonexistent. “These are urban legends that won’t die,” Dr. Diller said.

There is no debate about the safety of natural food colorings, and manufacturers have long defended the safety of artificial ones as well. In a statement, the Grocery Manufacturers Association said, “All of the major safety bodies globally have reviewed the available science and have determined that there is no demonstrable link between artificial food colors and hyperactivity among children.”

In a 2008 petition filed with federal food regulators, the Center for Science in the Public Interest, a consumer advocacy group, argued that some parents of susceptible children do not know that their children are at risk and so “the appropriate public health approach is to remove those dangerous and unnecessary substances from the food supply.”

The federal government has been cracking down on artificial food dyes for more than a century in part because some early ones were not only toxic but were also sometimes used to mask filth or rot. In 1950, many children became ill after eating Halloween candy containing Orange No. 1 dye, and the F.D.A. banned it after more rigorous testing suggested that it was toxic. In 1976, the agency banned Red No. 2 because it was suspected to be carcinogenic. It was then replaced by Red No. 40.

Many of the artificial colorings used today were approved by the F.D.A. in 1931, including Blue No. 1, Yellow No. 5 and Red No. 3. Artificial dyes were developed ― just as aspirin was ― from coal tar, but are now made from petroleum products.

In the 1970s, Dr. Benjamin Feingold, a pediatric allergist from California, had success treating the symptoms of hyperactivity in some children by prescribing a diet that, among other things, eliminated artificial colorings. And some studies, including one published in The Lancet medical journal in 2007, have found that artificial colorings might lead to behavioral changes even in typical children.

The consumer science group asked the government to ban the dyes, or at least require manufacturers to include prominent warnings that “artificial colorings in this food cause hyperactivity and behavioral problems in some children.”

Citizen petitions are routinely dismissed by the F.D.A. without much comment. Not this time. Still, the agency is not asking the experts to consider a ban during their two-day meeting, and agency scientists in lengthy analyses expressed skepticism about the scientific merits of the Lancet study and others suggesting any definitive link between dyes and behavioral issues. Importantly, the research offers almost no clue about the relative risks of individual dyes, making specific regulatory actions against, say, Green No. 3 or Yellow No. 6 almost impossible.

The F.D.A. scientists suggested that problems associated with artificial coloring might be akin to a peanut allergy, or “a unique intolerance to these substances and not to any inherent neurotoxic properties” of the dyes themselves. As it does for peanuts and other foods that can cause reactions, the F.D.A. already requires manufacturers to disclose on food labels the presence of artificial colorings.

A spokeswoman for General Mills refused to comment. Valerie Moens, a spokeswoman for Kraft Foods Inc., wrote in an e-mail that all of the food colors the company used were approved and clearly labeled, but that the company was expanding its “portfolio to include products without added colors,” like Kool-Aid Invisible, Capri Sun juices and Kraft Macaroni and Cheese Organic White Cheddar.

The panel will almost certainly ask that more research on the subject be conducted, but such calls are routinely ignored. Research on pediatric behaviors can be difficult and expensive to conduct since it often involves regular and subjective assessments of children by parents and teachers who should be kept in the dark about the specifics of the test. And since the patents on the dyes expired long ago, manufacturers have little incentive to finance such research themselves.

Popular foods that have artificial dyes include Cheetos snacks, Froot Loops cereal, Pop-Tarts and Hostess Twinkies, according to an extensive listing in the consumer advocacy group’s petition. Some grocery chains, including Whole Foods Market and Trader Joe’s, refuse to sell foods with artificial coloring.

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Certified Color Additives in Food and Possible Association with Attention Deficit Hyperactivity Disorder in Children
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/UCM248549.pdf


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The Lancet, Volume 370, Issue 9598, Pages 1560 - 1567, 3 November 2007
doi:10.1016/S0140-6736(07)61306-3Cite or Link Using DOI
Published Online: 06 September 2007

Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial

Donna McCann PhD a, Angelina Barrett BSc a, Alison Cooper MSc a, Debbie Crumpler BSc a, Lindy Dalen PhD a, Kate Grimshaw MSc b, Elizabeth Kitchin BSc a, Kris Lok MSc a, Lucy Porteous BSc a, Emily Prince MSc a, Prof Edmund Sonuga-Barke PhD a, Prof John O Warner MD c, Prof Jim Stevenson PhD a Corresponding AuthorEmail Address

Summary
Background
We undertook a randomised, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food colour and additives (AFCA) affected childhood behaviour.
Methods
153 3-year-old and 144 8/9-year-old children were included in the study. The challenge drink contained sodium benzoate and one of two AFCA mixes (A or B) or a placebo mix. The main outcome measure was a global hyperactivity aggregate (GHA), based on aggregated z-scores of observed behaviours and ratings by teachers and parents, plus, for 8/9-year-old children, a computerised test of attention. This clinical trial is registered with Current Controlled Trials (registration number ISRCTN74481308). Analysis was per protocol.
Findings
16 3-year-old children and 14 8/9-year-old children did not complete the study, for reasons unrelated to childhood behaviour. Mix A had a significantly adverse effect compared with placebo in GHA for all 3-year-old children (effect size 0?20 [95% CI 0?01―0?39], p=0?044) but not mix B versus placebo. This result persisted when analysis was restricted to 3-year-old children who consumed more than 85% of juice and had no missing data (0?32 [0?05―0?60], p=0?02). 8/9-year-old children showed a significantly adverse effect when given mix A (0?12 [0?02―0?23], p=0?023) or mix B (0?17 [0?07―0?28], p=0?001) when analysis was restricted to those children consuming at least 85% of drinks with no missing data.
Interpretation
Artificial colours or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children in the general population.

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人工着色料が子どもの多動を悪化させるか? 警告表示再検討を表明/FDA 医師の一分/BIGLOBEウェブリブログ
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