When our camp doctors at Camp Celiac in Livermore, CA, try to determine whether a medication a child needs is gluten-free, they are stymied by a lack of information. Federal regulation is insufficient. Examining labels and package inserts, searching the Internet and calling drug manufacturers (if the doctor is lucky and it’s a weekday) may or may not produce an answer. Doctors, pharmacists and patients across the country experience the same challenges with gluten in medication. Public frustration with the Food and Drug Administration’s inaction on this issue is rising.
The Food and Drug Administration (FDA) regulates the gluten-free labeling of foods for health and safety, but in 2015 the agency declined to take actions that would provide comparable protection from gluten in medication. Proposals have included banning gluten from drugs or requiring labeling. The FDA stated that it would address the issue by publishing guidance for drug manufacturers, but did not offer a timeline [Update: FDA issued proposed guidance on December 13, 2017 – see timeline below]. Recent developments on the topic of gluten in medication indicate renewed pressure on the FDA to take action.
“This is an important issue that most healthcare providers don’t even realize exists,” said Amy Burkhart, MD, RD., who specializes in celiac disease and gluten-related disorders. “Most physicians assume the pharmacists are well versed in verifying that medications are gluten-free. The truth is that most pharmacists simply read the labels and don’t verify gluten-free status with the manufacturer. We need labeling regulations to streamline the process for pharmacists and ensure that patients on a strict gluten-free diet are able to take their medications without worry and adverse health consequences.”
U.S. Representatives Tim Ryan (D-OH) and Nita Lowey (D-NY) reintroduced legislation in September 2015 that would require medication to be labeled with a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient. The bill is titled Gluten in Medication Disclosure Act of 2015 (H.R. 3648) Similar legislation was introduced in 2012 and 2013, but died in Congress.
CITIZEN PETITION FROM NEW YORK RESIDENT
In June 2008, New York resident Michael Weber submitted a citizen petition asking that wheat gluten in medication be banned or appropriately labeled. Following a lawsuit by Public Citizen regarding the FDA’s “unreasonable delay,” the FDA replied to the petition with a 21-page letter last May.
The petition was “denied in part and granted in part.” The FDA denied the petition in part by declining to ban gluten in medication. It granted it in part with this statement: “Your labeling request is granted in that we affirm our preexisting expectation that any drug product containing wheat gluten as an inactive ingredient should be labeled to indicate its presence.” The FDA’s expectation that gluten be labeled does not carry the force and clarity of regulation and does not match the experience of gluten-free consumers and their medical providers.
The FDA stated that although it does not intend to issue new regulation, it recognizes misconceptions, frustration and anxiety on this topic. To address these concerns, the FDA plans to issue draft guidance for industry (directed at drug manufacturers) regarding gluten in drug products. The guidance would cover a range of topics: the labeling of ingredients using their “common or usual names”; paying attention to potential sources of gluten in drug formulations; making inactive ingredient labeling information readily available when a drug does contain gluten; and voluntary gluten-free labeling of drugs with steps to substantiate such labeling.
Michael Weber continued the dialogue by sending the FDA a reply letter in December 2015. The Celiac Community Foundation of Northern California collaborated with Mr. Weber in analyzing the FDA’s response to his petition. In his letter, Mr. Weber expressed appreciation for the FDA’s extensive analysis and welcomed its proposed actions, but disagreed with key points.
For example, Mr. Weber questioned the FDA’s assertion that Americans are already “adequately protected” from gluten in medication. As Mr. Weber countered, “If so, then the FDA should be urgently concerned that manufacturers, physicians, pharmacists and consumers alike are frequently mired in uncertainty about whether any one drug contains gluten.” Mr. Weber asked the agency to respond with a timeline for the actions it proposed on this topic, including its planned “broader analysis of gluten and publication of draft guidance.”
CITIZEN PETITION FROM CALIFORNIA RESIDENTS
A second citizen petition was filed in December 2015 by eight board members of the Celiac Support Group in Sacramento, California, following the FDA’s disappointing response to Mr. Weber’s petition. The group reviewed the history and scope of gluten in medication issues and, as individuals, filed a 19-page citizen petition to propose labeling medications when more than 20 ppm gluten is present. The petition argued that its proposed rule would “protect celiacs…without imposing burdens on medication manufacturers or the FDA.” On December 31, 2015, the FDA posted the petition and opened it for comments. (Enter “FDA-2015-P-5081” in the search bar here to access it.)
Gluten may be used as an inactive ingredient in medication (as a starch known as an excipient that binds medication), and the FDA does not currently require it to be labeled in prescription drugs. Gluten in medication is rare. However, without labeling and with a very low level of understanding of the issue among doctors, pharmacists, patients and even drug manufacturers, it is often difficult or impossible to tell if gluten is present in a medication.
The question of whether a medication contains gluten is often unresolved at key points in the supply chain and among patients: when a doctor prescribes a medication, when a pharmacist is considering contraindications, when an inquiry is made to the drug manufacturer, when a person with a gluten-related disorder needs to buy and take a medication, or when a parent needs it for their child. The information is unavailable, ambiguous, contradictory or so elusive that it requires extensive research beyond the resources of medical professionals or patients.
Gluten triggers an autoimmune reaction in people with celiac disease, causing short-term misery and long-term harm; it is poison to this segment of the population. Drug safety for all members of the public, including disease subpopulations, is a primary aspect of the FDA’s mission. The FDA requires a clear warning on medications that contain phenylalanine because it is toxic to the 14,500 Americans with the rare disorder phenylketonuria (PKU), while disregarding the needs of hundreds of thousands of Americans living with celiac disease and gluten-related disorders.
The proposed legislation and citizen petitions are asking the FDA to do its job in ensuring the safety of the drug supply for all Americans, including those with gluten-related disorders. National celiac organizations supporting the legislation are following the issue closely as it develops. Members of the public can take action in support of efforts to ban or label gluten in medication:
Citizen Petition: Public comments are carefully considered by the FDA, which often references and responds to comments in its final documents. In addition, comments are posted on the FDA website and contribute to the national discussion. The comment period for the first citizen petition is closed, but comments on the second one may be submitted until June 27, 2016. To comment, enter “FDA-2015-P-5081” in the search bar here to access the docket and click on the “Comment Now” button.
June 2008 – New York resident Michael Weber submitted a citizen petition to the FDA asking that wheat gluten in medication either be banned or labeled.
December 2011 – FDA requested comments and information in a Federal Register announcement on the topic of gluten in medication.
April 2012 – The Gluten in Medication Act of 2012 was introduced by Representatives Tim Ryan (D-OH) and Nita Lowey (D-NY).
May 2013 – Gluten in Medicine Disclosure Act (H.R. 2003) was introduced by Representatives Tim Ryan (D-OH) and Nita Lowey (D-NY). The bill would have required all drugs to disclose any gluten-containing ingredients.
September 2014 – Beyond Celiac (formerly National Foundation for Celiac Awareness) and research collaborators submitted preliminary research results to the FDA, highlighting the need for a large scale study identifying safe thresholds of gluten in medication, its impact on people with celiac disease, and the pervasiveness of gluten in binders and excipients. The research was funded by a 2011 grant the organization received from the FDA.
May 12, 2015 – FDA replied to Michael Weber’s citizen petition with a 21-page letter, granting his petition in part and denying it in part.
July 23, 2015 – Tricia Thompson, MS, RD, of Gluten Free Watchdog submitted a FOIA request to the FDA expressing concerns about flaws in the data in the Beyond Celiac study (see 2014 above) and requesting the raw data. As of July 2020, the FDA’s replies have noted delays and backlogs, and the agency has not fulfilled the FOIA request.
September 29, 2015 – U.S. Representatives Tim Ryan (D-OH) and Nita Lowey (D-NY) introduced Gluten in Medicine Disclosure Act of 2015 (H.R.3648).
December 2, 2015 – Michael Weber followed up the FDA’s response to his citizen petition with a letter that is publicly available here.
December 13, 2015 – Eight board members of the Celiac Support Association in Sacramento, CA, filed a citizen petition as individuals, asking the FDA to require labeling of medications when more than 20 ppm gluten is present.
December 31, 2015 – FDA posted the Sacramento group’s citizen petition and opened it for comments. Enter “FDA-2015-P-5081” in the search bar here to access it.
June 21, 2016 – FDA responded to the Sacramento group’s citizen petition with an Interim Response stating that it raises complex issues that require extensive review and analysis and a decision will be forthcoming. Public comments were reopened for the duration of this additional analysis.
December 13, 2017 – FDA issued draft guidance for industry titled “Gluten in Drug Products and Associated Labeling Recommendations,” encouraging drug companies to label for gluten but not requiring it. Public comments may be submitted to the FDA, which for unknown reasons has kept the docket open for years, despite the deadline for comments passing: https://www.regulations.gov/docket?D=FDA-2017-D-6352.
2019 – The Gluten in Medicine Disclosure Act of 2019 was introduced in Congress.
H.R.2074 – Introduced in the House by Rep. Tim Ryan (D-OH-13) on 04/03/2019
S.3021 – Introduced in the Senate by Sen. Richard Blumenthal (D-CT) on 12/11/2019
2020 – Like previous versions of this bill, the Gluten in Medicine Disclosure Act of 2019 is stalled in the early stages of the legislative process and does not have a high chance of being enacted. As of July 2020, H.R.2074 had 52 cosponsors and S.3021 did not have any cosponsors.
Pillbox: National Library of Medicine Identify pills by drug name, imprint, image, shape or color and find inactive ingredients
What has your experience been with gluten in medication?
Comments are welcome below.