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Celiac.com 06/16/2022 - The odyssey began four years ago with a one-page bill authored by New York Representative Nita Lowey. It ended on August 2, 2004, when President Bush signed the Food Allergen Labeling and Consumer Protection Act (FALCPA) into law. There have been many questions about when the new law goes into effect, and what it will mean for individuals with celiac disease. Beginning on January 1, 2006, food labels will be required to list the top eight food allergens. This date was the earliest that the law could go into effect. In order to minimize the burden on business, the Food and Drug Administration (FDA) sets periodic effective dates timed in two year cycles. This date also coincides with the labeling changes required for trans-fats. The top eight allergens account for 90 percent of all food allergic reactions. For individuals with celiac disease, it is estimated that 90 percent of food products contain wheat, or a wheat derivative. Of the remaining problematic grains—rye is almost never used as an additive. Barley is sometimes found as a main ingredient, or is listed as “barley malt,” or simply as “malt.” In addition to food ingredient labels, labels on dietary supplements or vitamins will also need to conform to the new FALCPA law. Further, institutional-sized food packaging— such as ten pound cans of tomatoes used by restaurants—must also conform to the new regulations. The bottom-line according to a spokesperson for the FDA, food packaged in any form will have to list the top eight allergens. The new law mandates not just labeling, but various other factors as well. Specifically, it requires: Food labels must list—in everyday language—any of the eight main food allergens (milk, egg, peanuts, tree nuts, fish, shellfish, soy, and wheat) that are in the product. Allergens in flavoring, coloring, or incidental additives to be labeled in accordance with these requirements. The U.S. Centers for Disease Control and Prevention to track food allergy-related deaths. An examination of how to eliminate unintentional contamination and cross-contact of foods. The FDA to consider revisions of the Food Code to provide allergen-free preparation guidelines for restaurants and foodservice establishments. An investigation of consumer preference pertaining to advisory food labeling such as precautionary “may contain” statements. Guidelines to be established for use of the term “gluten-free” on product labels. Again, the changes to food labels go into effect on January 1, 2006. Many food manufacturers have already begun listing allergens in some form or another, but don’t expect to see wholesale changes until then. What Happens Next? While we anxiously wait for the label revisions, there will be a lot happening at the FDA on another key provision of the law—setting standards for the use of the term “gluten-free” on food packages. These standards would be for companies which choose to label their products as gluten-free. The standards will be set out in regulations. Developing regulations is very time intensive. On average, it takes about a year to make a rule; some can take up to four years! The more specific, or detailed a law is, the easier it is to develop the rules for implementing, or putting that law into action. At a regulatory agency like the FDA, there is an annual priority-setting process. Things they want to do are put on a list, along with new laws passed by Congress, which have specific deadlines. Although it is not clear when the FDA will begin work on the regulations for using the term gluten-free on labels, the process is well established. According to sources at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), they will begin by assembling a multi-disciplinary team with experience in labeling, economics, and enforcement. Based on the law, the team will rough out what the rule should look like, and the issues that should be addressed. This first draft will be reviewed by leaders at CFSAN, and then by the FDA management. Depending on the complexity of the issues involved, it may take several drafts before the document is ready to go to the next step, called “clearance.” Regulations and policy statements are “cleared” through an administrative hierarchy beginning with the center (CFSAN) level, then moving up to the agency (FDA) level. After approval by the FDA, the draft rule must pass review at the Department level—Health and Human Services (HHS)—and the Office of Management and Budget. At any one of these stages the rule could be forced to go back for revision and have to start the process over. The draft rule must be open for public comment. The time allotted for such comments vary, but will be no less than 60 days. Under FALCPA, the proposed rule must be published by August 2, 2006. After the internal clearances are complete, the proposed rule is published in the Federal Register. Comments on the proposal will be requested from the public, interest groups, other government agencies, and members of Congress. The notice in the Federal Register will provide information for when comments are due, and how they must be submitted. We will be closely monitoring this process and any information published by the FDA regarding this rule will be posted to the ACTF website: www.celiaccenter.org/taskforce.asp. Those signed up for the E-Action List will receive a news alert (go to www.capwiz.com/celiac for more information). Once the comment period closes, FDA will review all the comments and the rule may be modified based on the feedback received. In some cases, re-drafting to address the concerns presented can take years. Luckily, FALCPA requires the final rule to be issued no later than August 2, 2008, which will prevent any extreme delays. The final rule, just like the previous draft, must be published in the Federal Register. For rules that have a significant economic impact, Congress has at least 60 days to register its objection. After this waiting period, the rule can take effect. The only way to undo the final rule is to start the process all over again. Many individuals have suggested that the FDA could speed up the process by adopting the proposed Codex Alimentarius gluten-free standard—20 ppm for naturally gluten-free foods, and 200 ppm for foods with ingredients that normally contain gluten but have had the gluten removed, such as Codex quality wheat starch. Others would prefer that it adopt the more stringent Canadian gluten-free standard of 20 ppm for all foods. The FDA is clearly aware of these existing standards. While it might be easy to accept either and just move on, it doesn’t work that way. The agency will review how, and when, these other levels were established. But, in order to set a gluten-free standard for the United States, the FDA will conduct a thorough, independent analysis of the science. Among other things, it will assess research on safe thresholds of gluten contamination for persons on a gluten-free diet; current testing methods for products, the availability and accuracy of such tests; and the impact of different standards on food manufacturers. The FDA has been very supportive of the need for gluten-free labeling for persons with celiac disease. The foremost issue will be the safety of those who will be relying on such labels. It is not possible to set the threshold at zero, in part, because there is no way to determine that level. No test has that level of sensitivity. In all probability, the FDA will settle somewhere between zero and 200 ppm. There is a lot of room in the middle, and our job is to help the FDA find the best possible point within that spectrum. Just as politics drive the legislative process, they also loom over the rulemaking process. Some will argue that these are “our” rules, and therefore the celiac community’s perspective should carry more weight. There are other interests which will need to be balanced against those of persons with celiac disease. If we are to be taken seriously, our views must be supported by science. Individual stories supported solely by anecdotal evidence, will receive little consideration. Reasonableness will also be a major factor in the FDA’s decision making. Demanding a standard which imposes significant burdens on the nation’s multi-billion dollar food industry will not be perceived as reasonable. One FDA staffer noted this could be a real opportunity for the celiac community because, through the rulemaking process, companies will get to see the real potential in developing products for a ripe and relatively untapped market. Thanks to an incredible effort we were instrumental in the passage of FALCPA. The development of the gluten-free rules provides another prime opportunity to demonstrate our collective strength. The same unity, along with strong, scientific-based research, will be necessary to achieve a safe gluten-free standard.