The Food and Drug Administration requires food manufacturers to clearly label products that contain or have come in contact with food allergens. The same is not true for medicine, even though some of the same products are used in the manufacturing process.
U.S. Sen. Richard Blumenthal is looking to change that with a bill to add both prescription and over-the-counter medications to the requirement.
Officials at the University of Connecticut Health Center in Farmington said during a press conference Wednesday that without the requirement, prescribing can become a difficult and time-consuming process for some patients.
Clinical Pharmacist Jillian Carey said she sometimes even has to call the manufacturer directly and have to go through “several layers” to get an answer.
“A lot of times it’s a lot of automated systems before you get there. It does take a lot of time,” she said.
The FDA requires food and beverage manufacturers to identify if products contain one of nine major allergens — milk, eggs, wheat, soybeans, sesame, fish, crustacean shellfish, peanuts or tree nuts. In some cases, the company also has to identify the type of fish, tree nut or other allergens.
The same rules apply to businesses that prepare or package foods and beverages, even if items only come in contact with those allergens. Separately, cosmetic manufacturers are required to disclose when products contain latex, certain types of alcohol or other allergens.
Drug manufacturers only have to list active ingredients, or the substances that cause the desired effect of the medicine. They do not have to list inactive ingredients, even though allergens are sometimes used.
UConn Health Otolaryngologist Denis Lafreniere said companies sometimes use dairy or wheat to bind medicine together, for example, but don’t have to disclose that.
A study, performed in 2019 by researchers from Massachusetts Institute of Technology and Harvard University, estimated that 93% of medications contained at least one potential allergen.
“If our foods are labeled for allergens, then our medications need to be labeled as well,” Lafreniere said.
He added the bigger concern is with over-the-counter medicines, because lactose-intolerant consumers may not be aware that some toothpastes, for example, have dairy.
“My solution is pretty simple: just put it on the label,” Blumenthal said Wednesday.
He said the FDA could require the information be added to the label now, but he believes drug companies would convince a judge to halt the regulation because existing laws do not expressly give the agency the power.
“The fact is that it would be challenged, and probably successfully, by the industry,” Blumenthal said.
The FDA declined to comment, saying it does not discuss pending legislation. Johnson & Johnson, Pfizer, Eli Lilly & Co. and GlaxoSmithKline all did not respond to requests for comment Wednesday afternoon.
By mandating that the FDA require the information on the labels, Blumenthal said his proposal would address that legal hurdle.
Some companies volunteer the information already, but there’s no standard for what they need to disclose. This even includes the terminology used.
“Listing starch as a medication ingredient can mean potato, corn, tapioca or wheat starch, whereas it would mean cornstarch if it were on a food label,” Carey said.
The company can also decide where on the label to put the information. Blumenthal said this lack of consistency can lead consumers to wrongly think something is safe.
“Consumers will just assume ‘it’s not on the label, so it must be lactose free,’” he said.
Federal law also treats health supplements differently from food and drugs, greatly limiting the FDA’s ability to regulate the industry.
“Supplements really are the wild west,” he said. “There’s basically no regulation.”
Blumenthal has previously proposed legislation to change that, but did not include that in this bill. He said doing so would have invited a “torrent of opposition that we need not confront at this point.”
