In 2011, the FDA opened a docket for discussing gluten-free food labeling to help those wth celiac disease and high gluten intolerance. This year’s subject open for discussion is gluten in drugs. The products in question include prescription, nonprescription, biologic, and homeopathic drugs. Learn about the FDA’s assessment results on the percentage of gluten tolerated by those with celiac disease and what they are seeking in regards to comments on gluten in medication and from whom.
FDA’s Open Docket for Gluten in Drugs
As part of determining how much gluten an individual with celiac disease may tolerate safely, the FDA’s Office of Food Safety in the Center for Food Safety and Applied Nutrition surveyed celiac patients to determine what their gluten exposure experiences were. From this assessment it was determined that a conservative amount of gluten tolerated by individuals with celiac disease, per day, is 0.4 mg for adverse physiological effects and 0.015 mg gluten per day for adverse clinical (observable) effects.
Sometimes it is nearly impossible to determine whether or not a drug contains gluten. More importantly, the FDA realizes that in emergency cases, drugs need to be administered to celiac patients without having to take the time to investigate whether a drug is or is not gluten-free.
Though the FDA believes that wheat is not used to any significant extent in ingredients used for manufacturing drugs that are marketed in the United States, and that barley and rye is rarely used, if at all, they are aware that certain ingredients in drugs may be derived from wheat. The FDA also believes that gluten in drugs that are taken orally cause more harm than other ways drugs may be administered.
Currently the National Formulary (NF) and the U.S. Pharmacopeia (USP) manuals allow starches, possibly gluten in drugs.
If the FDA does not hear from manufacturers on why gluten is needed in the making of drugs it may lean towards not allowing gluten in drugs at all. They wish to know how important these ingredients are, how removing gluten from drugs would impact manufacturers, and what problems would arise from doing so.
The FDA particularly is interested in hearing from interested parties on the following topics:
- Known inactive ingredients which contain wheat, barley or rye (gluten) used in drugs;
- How many drugs exist; and the prevalence of such drugs
- To what extent are there active ingredients derived from wheat, barley or rye in drugs?
- Does the manufacturer’s process remove the gluten that is used in making their drug?
- If the manufacturing process removes the gluten, to what extent; what testing method are used, if any, and the testing method’s sensitivity?
- What negative consequences would arise from removing gluten from the drug?
- Is there a specific reason gluten must be used and why?
- Documentation showing that drugs derived from minute amounts of gluten are not harmful to those with celiac disease
- Documentation on how non-orally administrated drugs which contain gluten effect celiac patients
- Are any of the processing or production aids (media used in filtration or fermentation) derived from gluten?
How to Submit Comments
- To submit comments regarding this issue go to http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0842-0001 by March 20 2012, at 11:59 PM Eastern Daylight Time.
- Click on “Submit a Comment” at the top right corner of the page.
- Fill out the short form, and if applicable, attach any documentation you wish to submit.
- Click “Submit”.