CiCi · Learn · 5 min read

Gluten in medications

Allergen labeling law does not apply to drugs at all. Here is what that means for risk versus effort.

The law does not cover this

The FDA issued draft guidance on gluten in drug products in December 2017 recommending a voluntary statement. As of 2026 it remains draft, never finalized, more than eight years on.

Keep the risk in proportion

The most useful number the FDA has published: wheat starch and other wheat-derived excipients would contribute no more than 0.5 mg of gluten to a unit dose. That is less than a 30 g serving of food labeled gluten-free.

The problem is the verification burden rather than the danger itself. Your pharmacy can substitute a different generic manufacturer at any refill without telling you, and the same drug can be gluten free from one maker and not from another. A scoping review of 1,239 medications found only 5 of 100 manufacturers had a gluten-free production policy, and 41% of pharmacists rated their own celiac knowledge as poor or limited.

The practical approach: ask your pharmacy to flag manufacturer changes on refills, and call the manufacturer directly for anything you take daily. It is tedious, and it is currently the only reliable method.

Check it yourself

CiCi is not the authority on this. These are. Every link below goes to the regulator, charity or paper the answer above rests on.

Allergen-free, gluten-free and cross-contamination statementsCanadian Food Inspection AgencyThe enforcement-side guidance for Canada, including why "wheat-free" is not interchangeable with "gluten-free" and when a "may contain" statement is and is not permitted.
Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (CXS 118-1979)FAO/WHO Codex Alimentarius CommissionThe international standard most national rules are built on: "gluten-free" at no more than 20 mg/kg, and a separate "reduced gluten" band of 20–100 mg/kg that may not be called gluten-free.
21 CFR 101.91 -- Gluten-free labeling of food.U.S. National Archives — Electronic Code of Federal RegulationsThe binding US regulation itself: it defines "gluten-containing grain", sets the "gluten-free" claim at less than 20 ppm, and states how manufacturers must demonstrate compliance.
Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in foodEuropean Union — EUR-LexThe EU/EEA law governing "gluten-free" and "very low gluten" statements on food, in its official consolidated text.
Food Labeling; Gluten-Free Labeling of FoodsU.S. Federal Register (Food and Drug Administration)The 2013 final rule as published, with the full preamble explaining why FDA chose the 20 ppm figure and how it weighed evidence from people with coeliac disease.

The scanner

Reading a page is fine. Standing in the aisle is the hard part.

This site answers the question you knew to ask. The app answers the one you didn't: the barley malt in a rice cereal, the wheat starch in a gummy. Scan the barcode, or photograph the panel when the barcode isn't in any database, and CiCi shows which words on the label produced the answer.

360,000+ packaged foods already read. Ingredient statement, allergen declaration and nutrition panel, each one assessed by the same rules you can see working on this page, so most scans are an instant answer rather than a lookup.
Unlimited scanning, about two seconds an answer. Fig and Spoonful both cut you off at five scans a month.
Carbs and the full nutrition panel on every scan. Total and net carbohydrate with the arithmetic shown. For the roughly 6% of people with type 1 diabetes who have coeliac disease too, that is two apps collapsed into one.
Your glutening log. Record a reaction and CiCi shows what those days had in common. It counts overlaps and never tells you what caused it.
Saved products. The regular shop in one place, so next week is not a re-scan of the same forty items.
Scanning happens on your device. No scan is ever attached to you, sold, or sent to an analytics service.

Try it free for 14 days →See pricing

14 days free, then $29.99 a year. Cheaper than Fig, and it does what three separate apps do. This website stays free forever either way: every answer on it, permanently, with no account.

Sources
FDA — medications and gluten

Food guides

Keep reading

How to read a label for glutenWhat a US label guarantees, what it quietly does not, and the asymmetry that explains most accidental exposures.Cross-contact: what actually mattersWhich precautions are supported by measurement, which are folklore, and where the real risk concentrates.Are oats gluten free?The most contested ingredient in the diet, and the one where the correct answer changes by country.Gluten-free rules by countryWhat "gluten-free" legally means in each place you might travel, and where the surprises are.