Adina Togal is the inspiration for a bill that would require labeling of the top 9 food allergens and gluten on prescription and over-the-counter medications. “I’m changing lives,” the 12-year-old from Minneapolis told her parents when the Allergen Disclosure in Non-Food Articles (ADINA) Act was introduced in June 2023.
Adina experienced firsthand the need for transparency about medication ingredients when she suffered a serious reaction after taking an antibiotic that lacked clear allergen information. The Togal family began their efforts to change drug labeling within days of her reaction.
Minnesota Rep. Dean Phillips, the Togals’ local representative, expressed surprise and concern after hearing about Adina’s experience. Her mom Jennifer Togal says he jumped on board, working to create the bill that would amend the Food Allergen Labeling and Consumer Protection Act (FALCPA).
On June 21, 2023, Phillips introduced the bipartisan legislation to the U.S. House of Representatives.
“All consumers have a right to know what they ingest,” says Jason Linde, senior vice president for advocacy for the nonprofit Food Allergy Research and Education (FARE). “Parents have a right to know that the medicine they’re giving their children will help them, not hurt them.”
Allergens can be present in a drug’s inactive ingredients, which are often used to help absorption or serve as fillers, binders or pill coating. For example, the blood pressure drug Tekturna has two active medical ingredients. But lactose and wheat show up in its inactive ingredients.
Nancy Ginter, director of administration for Beyond Celiac, says legislation requiring clear drug labeling is also essential for the celiac community and others who must avoid gluten.
“Ingredient transparency enables individuals to make informed choices when selecting medications. This information empowers them to manage their condition effectively and avoid unnecessary risks,” Ginter says.
Frustration Fuels Action
Adina was at sleep-away camp in Wisconsin in July 2022 when she developed strep throat, and required medicine.
The camp’s nurse contacted the Togals to find out if the antibiotic she wanted to give to their daughter was suitable. Adina is allergic to dairy and has celiac disease and eosinophilic esophagitis, which is triggered by gluten and other foods.
Her father Seth Togal recalls the struggle to find out. As it was the weekend, Adina’s parents had little luck getting information from pharmacies and couldn’t reach the manufacturer. Her dad also tried in vain searching the antibiotic’s ingredient names online.
“We were stressed and frustrated,” Seth says. Her parents ultimately decided that Adina should take the medication, so strep treatment could begin.
Over the next days, the 11-year-old camper began experiencing symptoms consistent with her reactions to gluten. They included dropping blood pressure, brief loss of consciousness, vomiting and other gastrointestinal symptoms. As Adina’s blood pressure began to dip dangerously low, one night at 2 a.m., she was rushed to the hospital.
The Togals suspect the medication contained or had cross-contact with gluten. But Adina’s dad was livid that they couldn’t get clear answers on ingredients. Once Adina was home recovering, the Togals started contacting lawmakers to seek change in drug labeling.
“Without proper labeling, taking medication for a simple illness could have detrimental or even deadly side effects for people living with severe food allergies,” Phillips says in the release that announced his bill.
Allergens, Gluten in Your Medication?
The Togals quickly realized that they were not alone in their frustration with the lack of allergen transparency with drug labeling. They’ve now heard several stories similar to Adina’s and created a Facebook group, called Citizens for Allergen Safe Medication Labeling.
Finding information on allergens or gluten in drugs is challenging. But it is also not straightforward to estimate how many medications either contain allergens and gluten or present a cross-contact risk.
Gluten and top allergens such as milk or soy can show up as inactive ingredients. The names of those ingredients are often incomprehensible to a non-healthcare professional or are vague, such as “starch”. Starch could be derived from various sources, including corn, potato or wheat, notes Steven Plogsted, a former clinical pharmacist at Nationwide Children’s Hospital in Ohio.
Plogsted runs the website Glutenfreedrugs.com to help patients determine whether medications are safe for them. His experience researching ingredients in drugs since the nineties shows that likely 40 percent of oral pills and capsules contain potential allergens. Corn is the most common such food-related ingredient, he says. As well, different manufacturers producing the same type of medication will vary the inactive ingredients.
Researchers at the Massachusetts Institute of Technology and Brigham and Women’s Hospital conducted a study on inactive drug ingredients in 2019. They found that 93 percent of drugs could contain an ingredient such as lactose, dyes and peanut oil. (While lactose is a milk sugar, it’s difficult to discover whether there is cross-contact with milk protein.)
Drug Labeling Frustration
In 2014, scientists published research on the presence of lactose in dry-powder corticosteroid inhalers to treat asthma. The researchers noted that medical information does not always clearly reference the risk for patients with milk allergy. An earlier study about milk proteins in these inhalers also noted the lack of allergy information on package inserts.
Scientists say there needs to be more research on how common allergens and gluten are in medication. Research conducted by Beyond Celiac into gluten in medications also pointed to insufficient means of testing for the presence of gluten.
Plogsted empathizes with the frustration that comes with trying to decipher a typical medication label that has a list of ingredients “a mile long”. Plus, “people have emergencies on weekends and holidays when it is especially hard to get information.”
He recommends that patients consult the DailyMed website in addition to reading medication package inserts. The National Library of Medicine site is a searchable database of labeling information for prescription and nonprescription drugs.
Legislative Push for ADINA Act
The goal of the ADINA Act is to make sure that patients know what top allergen or gluten-derived ingredients are in their medications. It addresses both prescribed and over-the-counter drugs.
Beyond Celiac, which has long lobbied for medication labeling for gluten, is among 14 celiac and food allergy advocacy groups endorsing the ADINA Act. Beyond Celiac previously supported a legislative effort called the Gluten in Medicine Disclosure Act. However, that 2019 bill did not get past the introduction stage. Ginter notes that “the legislative processes can be complex.”
With the ADINA Act encompassing allergens and gluten, Ginter says there could be challenges managing the diverse needs of different patient groups. She notes that it’s also important to ensure labeling requirements are feasible and enforceable.
However, aligning the celiac and food allergy communities to push for the ADINA Act could help its chances of passing. Broader support can bring “greater strength in numbers,” Ginter tells Allergic Living.
FARE’s Linde agrees there are challenges. But he is hopeful that the large number of people impacted will help the ADINA Act to succeed. “When you grow an audience, it magnifies and elevates the importance of the bill,” he says.
How Allergy Community Can Help
Linde reminds food allergy families that it is important to share their stories with their representatives. They can set up a meeting with their representatives during the August break when the lawmakers are back in their home states.
FARE says it is making the ADINA Act a legislative priority. The organization has set up a link where consumers can send letters to lawmakers, asking them to cosponsor the bill. There’s a form to fill in with your name and address and, based on your location, a letter will be sent to the correct lawmaker. The letter outlines the ADINA Act and the medical issues that arise without clear drug ingredient labeling. It concludes:
“Given that more than 100 million Americans have life-threatening food allergies, intolerances, celiac disease, or a gluten-sensitivity, we need a fast and simple solution, which is why I am asking you to support this bill to help protect my family and other American food allergy families.”
Readers can also find their elected officials on the House of Representatives website, and use the contact information to email letters or call to support the ADINA Act.
Ginter notes that the collective voice of those sharing personal stories about the challenges of lacking ingredient transparency is impactful. “By engaging with policymakers, citizens can contribute to the push for transparent medication labeling and improved patient safety.”
As for Adina, she is busily engaging, sharing her story and explaining the issue of medication transparency to schoolmates and friends. As her mom notes, “you can stand up for the things that matter, and you can make a difference in your community.”