In my work as an author, researcher, and gluten-free advocate, I work hard to help the gluten-sensitive and celiac communities live a healthy, balanced lifestyle, free from the threat of gluten ingestion. Over the past several years, I am grateful to have witnessed a marked increase in gluten-free awareness and celiac disease research, with many benefits for gluten-free consumers, such as gluten labeling laws, more companies devoted to manufacturing gluten-free alternatives, and helpful online resources. Nevertheless, there is one arena that needs to be addressed—gluten labeling requirements of medications. As it stands, the FDA hasn’t implemented any such requirements, putting celiac patients at risk.
It’s estimated that three million Americans have celiac disease, an autoimmune reaction to gluten, a protein found in wheat, barley, and rye. Genetic in origin, the disease works by attacking the absorptive fingers which line the small intestines, called villi, damaging them so that vital nutrients can’t be absorbed. What results is a wide variety of painful physical and mental symptoms, such as chronic diarrhea, chronic exhaustion, stomach problems, and migraines. Even though prescription and over-the-counter drugs can contain this ingredient that can make 1 in 100 Americans seriously ill, no clear gluten labeling laws exist, a fact which NFCA (the National Foundation for Celiac Awareness) is working hard to remedy.
The FDA has already launched a Safe Use Initiative, in which the FDA “seeks to partner and collaborate with relevant stakeholders to measurably reduce preventable harm from medications, thereby improving patient health,” according to the FDA’s website. Alice Best, Founder and President of NFCA, and Loretta Jay, M.A., the Director of Program Development, have teamed together to get the FDA to expand the initiative’s scope on behalf of the celiac community. “The Safe Use Initiative’s emphasis on informational errors makes this project particularly important to people with celiac disease and gluten sensitivity,” they wrote to the FDA.
According to Best and Jay, without labeling requirements for medications, “although few medications do contain gluten, every medication must be investigated to verify its gluten-free status.” The current situation requires that pharmacists and patients contact the pharmaceutical manufacturers themselves to inquire about gluten content. “Answers are not available after regular business hours, and sometimes manufacturers are not prepared with the responses when contacted during the day,” Best and Jay write. Furthermore, this information can change easily as pharmaceuticals are manufactured differently. Whereas time-consuming research can be inconvenient for celiac patients when it comes to food products, it can be a health-threatening matter when dealing with medication.
Clearly, this lack of gluten labeling requirements can put celiac patients at risk and result in what Best and Jay call “the almost certain potential for error and consequent grave harm to the celiac and gluten sensitive patient population.” Thankfully, we have the NFCA working on our behalf. In the meantime, celiac patients and pharmacists will have to continue their diligent research on their own. “It will be a long road,” Jay says, but with perseverance I think we can look forward to future gluten labeling on our medications.
FDA: FDA’s Safe Use Initiative http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188961.pdf
Regulations.gov: National Foundation for Celiac Awareness (NFCA) http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480b0e253
From our home to yours, Tina Turbin.