New USA Gluten-Free Label Rules for 2013 / 2014 —Clear Definition of "Gluten-Free" at 20PPM MAX
When do these new Gluten-Free Labeling Standards Take Effect?I placed this paragraph before all others because it is very important to make sure you realize that these regulations and standards are NOT immediate — we have just a short one-year wait (unless something changes yet).
We have all been waiting anxiously (many years for many of us) for such standards to come about. And, finally, we have the ruling that becomes effective on September 4, 2013 (although, NOTE: the all-important [gluten-free products labeling] compliance date of this final rule is August 5, 2014).
Finally, Standards for Gluten-Free Products / Ingredients Labels!This topic of United States gluten-free labeling laws has gotten quite a bit of attention lately now that the US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published their final ruling on the matter in the very detailed 26-page PDF document: 47154 Federal Register/ Vol. 78, No. 150 / Monday, August 5, 2013 / Rules and Regulations — section 21 CFR Part 101 [Docket No. FDA–2005–N–0404] RIN 0910–AG84 Food Labeling; Gluten-Free Labeling of Foods.
I have included the quoted summary-text of the ruling (see below). But, feel free to read that ruling in its entirety if you have time... it is interesting, and seems to really make a good attempt at preventing GF product manufacturers from "gaming the system" by playing with label wording and so forth; such attempts will lead to a product being deemed "misbranded", and presumably enforcement action will ensue quickly to minimize our risk of exposure to gluten.
What Counts as Truly "Gluten-Free" under new Standards?Thankfully, the HHS / FDA ruling has made this about as simple as possible for everyone with Celiac Disease. In short, a product labeled as "gluten-free" MUST test at less than 20 parts-per-million (20ppm / 20 ppm)! That is really about it. And, this of course means that, in practice, there can be essentially zero traces of grains like wheat, rye, barley and hybridized / derivative / related grains like spelt, kamut, triticale, and so forth in your foods, or that 20ppm would be exceeded for sure.
20 ppm means that you cannot have over 20milligrams of gluten per kilogram of food. Keep in mind that a milligram is 1/1000th (a thousandth!) of a gram, and a gram is approximately what a small paper-clip weighs — so this is saying that a full kilogram of food (2.2 pounds of food) cannot contain more than 1/50th-of-a-small-paperclip's weight in gluten within in! That is a rather small amount (chop a small paperclip into 50 pieces to see) across a rather large pile of food (eating a kilogram of food at once is quite a bit, unless it is nearly all liquid).
What About "Gluten-Free" Oats?The HHS / FDA made gluten-free oats an acceptable gluten-free product label using the same standards: i.e., oats labeled as "gluten-free" MUST test at less than 20 ppm gluten in order to be considered gluten-free. Again, simple. You don't have to eat the GF oats if you still feel unsafe doing so, but at least you will know how much gluten is in such "gluten-free" oats if you choose to consume them — the same percentage of gluten as any other "gluten-free" labeled diet products.
The Ruling: HHS / FDA Summary TextQuoted from that PDF:
SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ‘‘gluten- free’’ for voluntary use in the labeling of foods. The final rule defines the term ‘‘gluten-free’’ to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten- containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ‘‘no gluten,’’ ‘‘free of gluten,’’ or ‘‘without gluten’’ in its labeling and fails to meet the requirements for a ‘‘gluten-free’’ claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ‘‘wheat’’ in the ingredient list or in a separate ‘‘Contains wheat’’ statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ‘‘gluten-free’’ will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ‘‘gluten-free’’ claim. Establishing a definition of the term ‘‘gluten-free’’ and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
DATES: Effective date: The final rule becomes effective on September 4, 2013. Compliance date: The compliance date of this final rule is August 5, 2014. See section II.B.4 (comment 35 and response 35) for an additional explanation of the compliance date and implementation of this final rule.
Continue to read this Gluten-Free Blog for all sorts of gluten-free recipes, product-reviews, and related information. In addition, visit my Gluten-Free Recipes Site where many of the recipes I have featured on this blog are available.