NFCA Proposes FDA Gluten Labeling Requirements for Medications

If you’ve been on a gluten-free diet for a while, you’ve probably come to know many of the gluten-free foods that are safe to eat as well as which ones to avoid, through knowledge of what foods naturally contain gluten, familiarity with various food brands and companies, and the know-how of acquiring information regarding gluten content—usually by calling up companies or checking their websites. As important as this is, celiac patients need to understand that gluten can be found in many other products than one would at first imagine, and one product in particular which you may depend on for your health and physical well-being—medications. Unfortunately, even though prescription and over-the-counter drugs can contain this ingredient which can make 1 in 100 Americans seriously ill, no clear gluten labeling is required by the FDA by pharmaceutical companies, a fact which NFCA (the National Foundation for Celiac Awareness) is working hard to remedy.

Celiac disease is an autoimmune disorder caused by gluten, a protein found in wheat, barley, and rye. It’s estimated that three million Americans have the disease, which is genetic in origin and works by attacking the villi, the absorptive fingers of the lining of small intestines, preventing proper absorption of vital nutrients and resulting in a wide variety of painful physical and mental symptoms, such as chronic exhaustion, chronic diarrhea, migraines, severe stomach pain, and diarrhea.

The NFCA on behalf of the celiac community is working to get the FDA to implement labeling requirements for gluten in medication. 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 Alice Best, Founder and President of NFCA, and Loretta Jay, M.A., the Director of Program Development, in their docket to the Division of Dockets Management of the FDA, “The Safe Use Initiative’s emphasis on informational errors makes this project particularly important to people with celiac disease and gluten sensitivity.”

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.

In the end, the ramifications of lack of gluten labeling requirements can have serious results— what Best and Jay call “the almost certain potential for error and consequent grave harm to the celiac and gluten sensitive patient population.”

In the meantime, as the NFCA continues to address the FDA regarding this initiative for gluten labeling requirements, celiac patients and pharmacists will have to continue their diligent research on their own. Loretta Jay anticipates that there will be more activities in this area. “It will be a long road,” she says, but I suspect it will be a rewarding one.

Article Courtesy: Tina Turbin

Resources:

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