FDA Sued for Failing to Regulate Gluten

Those with celiac and gluten intolerance know the deal. Gluten is hiding everywhere: in our food, in our makeup, and yes, in our medication.

One man has had enough, and is taking his complaint as high as the FDA, who he is now suing.

Michael Weber has celiac. 7 years ago he took a generic drug that induced symptoms similar to those associated with gluten ingestion. As gluten is sometimes used to coat prescription drug and over-the-counter medicine capsules, he grew concerned and decided to look into the issue.

As the medication Weber took had no labeling regarding gluten, he decided to call the pharmacy where the drug came from. They were unable to determine if the drug was gluten-free. After jumping through numerous hoops, including scouring the website for contact information, contacting the manufacturer and various other individuals at the company, Weber was told that it could not be guaranteed that there was no gluten in the product, and that he should refrain from taking it.

Michael Weber then decided to petition the FDA to either eliminate gluten in their medicines or to instill a new labeling policy which would mark medicines with gluten clearly on their labels.

In 2011 (a whopping 3 years later), the FDA sought public comments on the issue, but otherwise have taken absolutely no action. In response to the inaction of the FDA, Weber has now filed a lawsuit demanding that they do something.

Weber’s lawsuit claims that the FDA’s failure to label their products as containing gluten is hurting millions of Americans. It details that gluten is sometimes used as a capsule coating or as a filler starch, but because generics can use different ingredients than branded drugs, it is impossible to tell which drugs contain gluten. “The absence of rules to address wheat gluten in prescription medications has serious and ongoing public health implications,” says his attorney, Katie Einspanier.

There are no official numbers regarding which FDA-regulated medications contain gluten. Steve Plogsted, a nutrition support pharmacist in Columbus, Ohio, maintains a list of over 150 medicines containing gluten. He has compiled this list by contacting drug makers and government sources, and does this work voluntarily without funding. This list is by no means inclusive or complete.

Both the FDA and spokespeople for the Pharmaceutical Research & Manufacturers of America have declined to comment on the lawsuit. The latter has argued in the past that “banning the use of specific grains would disrupt the supply chain, resulting in a major reformulation of products.” This reformulation, they added, “would have significant consequences to manufacturing costs and resources.” On the other hand, groups such as the American Academy of Pediatrics are arguing that gluten in medications should be banned.

It is clear that comprehensive testing, research and analysis is needed in order to answer questions about the prevalence and potential effects of gluten in medications. If Weber’s lawsuit is successful, it would force the FDA to ban or label wheat gluten as an ingredient in both prescription and OTC medication.

We fully support Weber’s lawsuit and wish him all the best! We hope to update in the future with positive news that the FDA will take action so that we can be well informed regarding gluten in our medications!