Michael Weber was diagnosed with celiac disease in 2004, and immediately adopted the gluten-free diet to protect his health. But after taking a prescribed generic drug for only a few days, the resident of Eastchester, New York, was distressed to find he was again developing symptoms, such as the dermatitis herpetiformis skin rash he’d had before the condition was discovered.
It turned out that the pills contained gluten as an inactive ingredient. Shocked to find this undeclared exposure, Weber contacted the FDA, but he was informed that the manufacturer wasn’t breaking any rules by not stating gluten’s presence overtly.
In 2008, Weber fled a citizen petition requesting that the FDA either ban gluten outright in medications, or require manufacturers to label for the protein. Then, for seven long years, he got politicians to write letters of support, and made follow-up inquiries. But he got no reply. Finally in early 2015, the consumer protection group Public Citizen filed a lawsuit to elicit a response from the FDA.
In May 2015, the agency issued a 21-page decision that denied the request for a ban and stated that manufacturers already need to identify gluten as an intentionally added inactive ingredient to any drug that is taken orally. The FDA said it did, however, plan to issue “draft guidance” for industry regarding gluten in drug products. But no timeline was given.
FDA spokesman Stephen King explained that decision in an interview with Allergic Living, saying that if people with celiac disease are doing well on a gluten-free diet, they should not be harmed by the very low amounts of gluten potentially present in oral drug products. Conversely, if they are not doing well, “we would expect [them] to consult with [their] physician about ways to further reduce overall exposure to gluten. Such efforts might first focus on the diet as the most significant potential source for oral gluten exposure.”
But Katie Einspanier, Weber’s lawyer through Public Citizen, criticized the ruling as nothing more than a super-technical reading of the petition since the FDA’s response focused on the possibility of gluten itself being an inactive ingredient. “The most likely scenario for gluten in drugs is that gluten is simply a natural component of another inactive ingredient and not separately added as an inactive ingredient,” she says.