Many were shocked to learn that before new Food and Drug Administration rules took effect Tuesday, there was absolutely no regulation behind using the term “gluten-free” on food packaging. The term pretty much meant whatever manufacturers decided it meant. 

As we reported recently, however, now the FDA is paying attention. As of August 5, any food labeled “gluten-free” must, in fact, contain less than 20 parts per million of gluten. Still, that left hypochondriacs people with many questions about the new regulations, which we hope to clarify here, using information from the FDA's Gluten-Free Food Labeling Final Rule. 

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See also: Gluten-Free Foods Must Now Really Be Gluten-Free

Q: What products does this rule apply to?
A: All FDA-regulated packaged foods, including dietary supplements. The rule excludes those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Generally, the USDA regulates the labeling of meats, poultry and certain egg products (FDA regulates the labeling of shell eggs). TTB regulates the labeling of most alcoholic beverages.

Q: If a food manufacturer uses the gluten-free claim on some of its foods, does that mean that every food made by that manufacturer is free of gluten?
A: No. That's a dumb question. Next?

Q: Why didn’t FDA adopt zero ppm gluten rather than less than 20 ppm gluten as the criteria for a food labeled gluten-free?
A: Because there' s no scientifically valid way to to measure amounts lower than 20 ppm. That means there's no gluten in there, OK?

Q: Does the final rule apply to gluten-free claims made for foods served in restaurants, including cafeterias and buffets?
A: The rule applies to packaged foods, which may be sold in some retail and food-service establishments. Restaurants aren't required to follow the rule for the food they serve.. But the FDA says that restaurants making a gluten-free claim on their menus “should be” consistent with the FDA’s definition.

Q: Does the rule apply to food products imported from other countries?
A: Yes.

Q: Can foods that are by nature free of gluten be labeled gluten-free?
A: Yes. Food manufacturers are still free to engage in this silly marketing ploy. Thus, you can be assured that your rice, oats, bottled spring water and Canadian bacon are “gluten-free.”

Q: Can a food be labeled gluten-free if it is made with small amounts of a gluten-containing grain or ingredients derived from such grains that were not processed to remove gluten, if the food contains less than 20 ppm gluten?
A: No. A food labeled gluten-free cannot be intentionally made with any amount of a gluten-containing grain (wheat, rye, barley or their crossbred hybrids like triticale) or an ingredient derived from such grain that was not processed to remove gluten. Seriously folks, no gluten means no gluten.

Q: Where should the “gluten-free” claim appear on the food label?
A: Anywhere the product manufacturer wants. Ideally as prominently as possible, according to the marketing department.

Q: Why didn’t FDA adopt a symbol for manufacturers to uniformly use to identify foods that meet the agency’s definition of gluten-free?
A: Why does everyone want a freakin symbol for everything? Just say “gluten-free.” Everyone gets that.

Q: Can manufacturers include the logo of a gluten-free certification program on their food labels? If so, which logo is more important for persons who are sensitive to gluten?
A: Yeah, they can go ahead, as long as it's “truthful and not misleading.” However, it's meaningless because the FDA “does not endorse, accredit, or recommend any particular third-party gluten-free certification program.”

Q: Are manufacturers required to test for gluten to make a gluten-free claim on their food labels?
A: No. The final rule does not specifically require manufacturers to test for the presence of gluten in their starting ingredients or finished foods labeled gluten-free. But most probably will anyway.

Q: Are there specific record-keeping requirements for manufacturers who label foods gluten-free?
A: No. 

Q: What about the “gluten-free” foods on store shelves now?
A: Products that were labeled prior to Aug. 5, 2014 may still appear on store shelves. However, any food product bearing a gluten-free claim that is labeled on or after the Aug. 5, 2014 date must meet the rule's requirements or be subject to FDA enforcement.

Q: So how do you plan to enforce this rule?
A: “Post-market monitoring activities” will include “sampling, periodic inspections of food manufacturing facilities; food label reviews; follow-up on consumer and industry complaints reported to the agency; and when needed, gluten analyses of food samples.”

Q: If a person sensitive to gluten eats a product labeled gluten-free and gets sick, can they report this to FDA?
A: Yes. Contact FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System called “CAERS” by phone, 240-402-2405, or email CAERS@cfsan.fda.gov, and they will bust the perp.

Q: Does gluten bother me?
A: With this new rule, only if you let it. 

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