Making Sense of the FDA's New Gluten-Free Labeling Law

The highlights and limitations of the FDA's new ruling.


The U.S. Food and Drug Administration, at long last, has issued a formal rule regulating use of the term "gluten-free" on foods and beverages. When the news was announced last Friday, collective sighs of "finally!" came from all corners of the gluten-free universe. The FDA regulation limits the use of the "gluten-free" claim to foods and beverages that contain fewer than 20 parts per million (or, 20 ppm) of gluten – which translates into less than two-hundreths of a gram of gluten per kilogram (2.2 pounds) of the food.

Industry experts and consumer advocacy groups have generally lauded the final rule. Some have objected that even 20 ppm of gluten may pose a risk for a minority of extra-sensitive individuals with celiac disease – though available research data don't necessarily support this position.

Indeed, the FDA's decision was in part a pragmatic one based on the limitations of available analytical testing methods – currently available tests cannot reliably detect gluten at lower levels – as well as concern that too strict a standard would reduce the ability of food companies to legally label their products gluten-free and therefore reduce consumer choice. Of note, the 20 ppm level is aligned with existing gluten-free labeling standards in Europe and Canada.

[Read: What is Gluten, Anyway?]

Beyond the well-publicized definition of the gluten-free labeling standard, there are some important nuances to the rule that have received little coverage thus far. If you've got celiac disease – or shop for someone who does – read on for more details on the highlights, and limitations, of the FDA's new rule.

The Good News

• The FDA standard also applies to dietary supplements. Wheat-derived fillers and coatings – including modified food starch and maltodextrin – are commonly used in pills. So in theory, the FDA regulation should help consumers navigate the vitamin aisles more safely.

And yet, the supplement industry has a checkered history when it comes to abiding by FDA labeling claim regulations. Furthermore, many raw ingredients used in these pills – and often the entire pill itself – are sourced from China, where quality control standards are lax. Smaller supplement marketers may not have the resources to test their imports before selling them, and therefore may rely on suppliers for guarantees that the product is gluten-free when making the claim. For these reasons, I advise patients to choose larger, more established supplement brands, specifically ones that can afford to – and do – test their products in-house.

[Read: Making Sense of the Gluten-Free Food Frenzy.]

Even if a food contains less than 20ppm of gluten, it cannot be labeled gluten-free if it was made from a gluten-containing grain that wasn't specially processed to remove the gluten. While this seems a somewhat convoluted principle, it's actually quite relevant. Wheat starch, wheat-derived dextrins (starches) and wheat-derived glucose syrup are ingredients that circulate in the supplement, packaged food and confectionery realms.

These ingredients are especially common in Europe, so you're even more likely to encounter them in imported packaged foods. Essentially, they are highly processed carbohydrates derived from wheat – meaning that the protein (gluten) portion should have been fully separated from it. The operative phrase is: "should have been." It usually is, and as a result, it's not uncommon to see products that contain these ingredients bearing a "gluten-free" claim. But serendipitous removal of most gluten isn't good enough by the FDA's rule; these wheat-based products must be deliberately processed to ensure the raw ingredient is thoroughly decontaminated from gluten.

[Read: Great New Foods for Restricted Diets.]

The Caveats

• Manufacturers using the gluten-free claim aren't actually required to test their products to ensure they meet the standard. Any manufacturer can make the gluten-free claim, whether or not they've tested a final product or its raw ingredients.

The FDA, in theory, has the authority to monitor compliance of suspected cheaters. In practice, surprise spot checks of gluten-free cookie factories are not likely to take priority in an agency whose limited resources must also be allocated to ensure food safety of all domestic and imported foods. If you have celiac disease and have an adverse reaction to eating a food labeled gluten-free that you believe to be gluten-related, the FDA encourages you to report it to your state's local FDA Consumer Complaint Coordinator as well as the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) at 240-402-2405.

[See: Fresh Fish Shouldn't Stink and Other Rules of Thumb.]

• Naturally grain-free products are also allowed to use the "gluten-free" claim. From bottled water to hummus to bananas, grain-free foods that are naturally gluten-free can shout it out on their labels. On one hand, such claims pose no risk to gluten-free consumers and may even help novices to the diet navigate the supermarket more easily. On the other hand, since many consumers (falsely) equate products labeled "gluten-free" as somehow healthier than their peers, the FDA's rule ups the competitive ante for every product on supermarket shelves. I fear we are about to encounter an onslaught of "gluten-free" labeling claims that confer an undeserved health halo on products ranging from cola to Crisco.

• Manufacturers can skirt around the "gluten-free" standards with related claims. A product can claim it was made with "no gluten ingredients" without being subject to the FDA's regulation of the term "gluten-free." This is of particular concern for products that contain conventionally-processed oats and oat flour – like cereals, energy bars and granola – that are very likely to be cross- contaminated with significant amounts of gluten. For my patients with celiac disease, I'm concerned that such claims might give the impression that a food is safe and gluten-free when, in fact, it very likely is not.

[Read: 5 Sources of Hidden Gluten in Your Diet.]

• The FDA standard does not apply to most alcoholic beverages, since they are not covered under its regulatory authority. Alcohol is a tricky area for celiacs to navigate, as many beverages – from beer to spirits – originate from wheat, malted barley or rye. It's well accepted that conventional beer and malt liquor are not gluten-free. But debate rages on about whether distilled spirits are safe for celiacs.

I advise my patients that plain distilled spirits – like vodka, gin, rye, whiskey and scotch – are safe. The distillation process fully separates all traces of protein (gluten) from the ethanol (alcohol). As for distilled spirits in which flavorings or colorants are added to the product after distillation, there's no way to be sure of safety unless all ingredients are clearly labeled. As a result, some gluten-free labeling could really come in handy here. Here's hoping the Alcohol Tobacco Tax and Trade Bureau (TTB) follows the FDA's lead and issues some guidance soon, too!

[See: Top-Recommended Health Products: Stomach and GI.]

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Tamara Duker Freuman, MS, RD, CDN, is a NYC-based registered dietitian whose clinical practice specializes in digestive disorders, Celiac Disease, and food intolerances. Her personal blog,, focuses on healthy eating and gluten-free living.