{"id":4782,"date":"2016-01-20T10:06:40","date_gmt":"2016-01-20T15:06:40","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=4782"},"modified":"2016-01-21T09:40:02","modified_gmt":"2016-01-21T14:40:02","slug":"seeing_red_on_food_dyes","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2016\/01\/20\/seeing_red_on_food_dyes\/","title":{"rendered":"Seeing Red on Food Dyes"},"content":{"rendered":"<p><em><a href=\"https:\/\/www.edf.org\/people\/tom-neltner\">Tom Neltner, J.D.<\/a>,\u00a0<\/em>is Chemicals Policy Director<em>.<\/em><\/p>\n<p><strong><em>The Center for Science in the Public Interest\u2019s (CSPI) <\/em><\/strong><a href=\"http:\/\/cspinet.org\/reports\/seeing-red-report.pdf\"><strong><em>\u201cSeeing Red: Time for Action on Food Dyes\u201d report<\/em><\/strong><\/a><strong><em>, released yesterday, makes clear that certified colors added in food are not safe at the current levels that children consume them. The Food and Drug Administration (FDA), the food industry, and consumers should ta<\/em><\/strong><strong><em>ke action to protect children from the behavior problems associated with these chemicals.<\/em><\/strong><\/p>\n<p>[pullquote]<\/p>\n<p><strong>What are color additives?<\/strong><\/p>\n<ul>\n<li>The FD&amp;C number on a color means it is a \u201ccertified\u201d color pursuant to <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=74&amp;showFR=1\">21 CFR Part 74<\/a>. These colors are synthetically made from oil or coal. Decades ago, FDA determined they were safe and only certifies that each batch meets quality standards and does do not contain particularly dangerous contaminants.<\/li>\n<li>A color additive is not <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=70.3\">safe<\/a> unless there is \u201cconvincing evidence that establishes with reasonable certainty that no harm will result from the intended use.\u201d<\/li>\n<li>FDA <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=101.22\">labeling rules<\/a> maintain that all added colors to food are artificial. Technically, there are no natural colors \u2013 not even beet juice \u2013 since they mask the natural color of the food.<\/li>\n<li>FDA does not limit the amount of a certified color that can be added to food except in one case. The food manufacturer decides how much is needed.<\/li>\n<\/ul>\n<p>[\/pullquote]Last Friday, FDA released a stream of <a href=\"https:\/\/twitter.com\/EDFHealth\/timelines\/689534157668507648\">five consecutive tweets<\/a> telling people why certified artificial color additives, commonly known by their FD&amp;C number, are used and how to avoid them if people are sensitive to them. The tweets, while true, said nothing about who may be sensitive to the chemicals. They should have said that any child may be sensitive and that the 6.4 million children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) appear to be particularly sensitive.<\/p>\n<p>So what prompted FDA\u2019s tweets? Most likely the agency anticipated CSPI\u2019s report <a href=\"http:\/\/cspinet.org\/reports\/seeing-red-report.pdf\">\u201cSeeing Red: Time for Action on Food Dyes\u201d<\/a> issued January 19. It follows on the organization\u2019s 2010 <a href=\"http:\/\/cspinet.org\/new\/pdf\/food-dyes-rainbow-of-risks.pdf\">\u201cFood Dyes: Rainbow of Risks\u201d<\/a> report and its <a href=\"https:\/\/www.cspinet.org\/new\/200806022.html\">2008 citizens petition<\/a> calling on the agency to: 1) revoke its approvals of eight synthetic food dyes; 2) require warning labels on the package in the interim; and 3) correct statements about the dyes on its website and other materials.<\/p>\n<p>While FDA has yet to take action on the citizens petition, the marketplace has already passed judgment. In 2015, <a href=\"http:\/\/business.edf.org\/projects\/featured\/sustainable-supply-chains\/behindthelabel\/a-blueprint-for-safer-food-additives\/who-is-promising-what-on-food-additives\/\">leading food manufacturer and restaurants<\/a> committed to reformulating their iconic brands to remove certified artificial colors. They follow the lead of major retailers who reformulated their private brands to remove the chemicals.<\/p>\n<p><!--more-->According to <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=70.3\">FDA\u2019s regulations<\/a>, a color additive is not safe unless there is \u201cconvincing evidence that establishes with reasonable certainty that no harm will result from the intended use.\u201d In addition, the law requires the agency to consider \u201cthe cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet\u201d in determining safety.<\/p>\n<p>The standard is the most protective of any chemical use. It is similar to the one for <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=170.3\">food additives<\/a> except that the evidence of safety must also be \u201cconvincing.\u201d<\/p>\n<p>CSPI\u2019s report makes a compelling case that FDA effectively stacked the deck when it sought advice from the agency\u2019s <a href=\"http:\/\/www.fda.gov\/AdvisoryCommittees\/CommitteesMeetingMaterials\/FoodAdvisoryCommittee\/ucm149740.htm\">Food Advisory Committee in 2011<\/a> in response to CSPI\u2019s citizens petition. The agency asked whether or not a causal relationship between consumption of certified color additives in food and hyperactivity in children in the general population had been established. Causality a much higher scientific burden of proof than the actual safety standard required by the law.<\/p>\n<p>Not surprisingly, the advisory committee did not find causal evidence and as such did not recommend FDA act to restrict use. If the committee had instead been given the actual safety standard for color additives and asked whether there was convincing evidence the chemicals were safe, CSPI maintains the committee would have recommended that FDA remove the colors from foods, or at a minimum, require a <a href=\"http:\/\/www.foodsafetynews.com\/2010\/07\/eu-places-warning-labels-on-foods-containing-dyes\/\">warning label similar to the one used in Europe<\/a>.<\/p>\n<p>CSPI\u2019s report also cites post-2011 scientific evidence that strengthens the association between ADHD and certified color additives and demonstrates that food marketed to children contains higher levels of colors than previously assumed.<\/p>\n<p>Will FDA follow the lead of the marketplace and act to protect children from the risk associated with the use of these chemicals? A proper interpretation of the law demands it.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tom Neltner, J.D.,\u00a0is Chemicals Policy Director. The Center for Science in the Public Interest\u2019s (CSPI) \u201cSeeing Red: Time for Action on Food Dyes\u201d report, released yesterday, makes clear that certified colors added in food are not safe at the current levels that children consume them. The Food and Drug Administration (FDA), the food industry, and &#8230;<\/p>\n","protected":false},"author":69548,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[69,114082],"tags":[39443,91625,91632,91629,91628,91626,91624,91622,91617,91633,91630,91627,91619,5206,91621],"coauthors":[114044],"class_list":["post-4782","post","type-post","status-publish","format-standard","hentry","category-fda","category-food","tag-adhd","tag-artificial-colors","tag-behavior","tag-center-for-science-in-the-public-interest","tag-cspi","tag-certified-colors","tag-citizens-petition","tag-color-additive","tag-fdc","tag-fda","tag-food-advisory-comittee","tag-food-dyes","tag-red","tag-safety","tag-yellow"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4782","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/users\/69548"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=4782"}],"version-history":[{"count":0,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4782\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=4782"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=4782"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=4782"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=4782"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}