For individuals with celiac disease, trust in a gluten-free label can mean the difference between health and harm. But recent claims circulating in the community suggest that unless a product is certified gluten-free by a third party, it may not be safe, leaving many confused and concerned. So, what does the gluten-free label actually mean in the United States, and what standards are truly in place to protect people with celiac disease?
In the United States, the only enforceable standard for labeling a product as gluten-free is governed by the U.S. Food and Drug Administration (FDA). On August 2, 2013, the FDA issued a final rule that defines gluten-free for food labeling. According to this rule, a food may be labeled gluten-free if it contains less than 20 parts per million (ppm) of gluten and meets all other FDA requirements. This threshold was established based on the best available science to protect individuals with celiac disease.
The gluten-free label is a voluntary claim, meaning food manufacturers may choose to use it, but only if they comply with the FDA’s strict standards.
On August 12, 2020, the FDA issued a final rule extending these requirements to fermented or hydrolyzed foods. This includes products such as yogurt, sauerkraut, pickles, cheese, green olives, hydrolyzed plant proteins, and certain FDA-regulated alcoholic beverages like beers and wines with less than 7% alcohol. While the rule does not change the definition of gluten-free, it establishes how manufacturers must demonstrate compliance in these more complex foods, including guidance for how the FDA will assess labeling claims in distilled products such as vinegar.
Importantly, third-party certification is not required to meet the FDA’s gluten-free standard. Some brands voluntarily pursue certification as a marketing tool, but certification programs are not regulated by the federal government, and a certification seal does not mean the product is held to a higher safety standard than FDA-regulated products.
Suggesting that products must be certified gluten-free to be considered safe is misleading. While third-party certifications may offer peace of mind for some consumers, it is not accurate to claim that certified products are inherently safer than those simply labeled gluten-free under FDA rules. In fact, many safe and widely trusted products on the market meet FDA standards without bearing a certification seal.
We encourage all consumers with celiac disease to:
- Look for the gluten-free label on packaged foods.
- Read ingredient lists carefully.
- Contact manufacturers directly when in doubt.
Educational efforts should be grounded in the regulatory reality and science-based safety standards that protect individuals with celiac disease. Misinformation risks creating unnecessary fear, confusion, and mistrust in the gluten-free food supply.