Perrigo’s New Gluten-Free “claim” on Drugs

By Shandra Martinez

ALLEGAN — Perrigo Co.’sannouncement Monday it will be the first manufacturer in the United States to label more than 200 of its over-the-counter drugs gluten free is drawing mixed reactions.

The problem is the Food and Drug Administration has not come out with a standard for what is considered gluten free, said Elaine Monarch, executive director of the Celiac Disease Foundation in Studio City, Calif.

“It’s not as cut and dry as people think it is,” she said, adding people can have different tolerances to even a small amount of gluten.

But two local allergists call the announcement a step in the right direction.

“When a patient is really looking at everything they are consuming, it’s nice to know that a product doesn’t have wheat in it,” said Dr. James Bishop, who treats respiratory and food allergies in his Holland practice. “I really applaud them for increasing awareness.

“You can argue both sides of it, but what harm is it in labeling it?”

Perrigo says its program is based on gluten thresholds of less than 20 parts per million, the same standard under consideration by the FDA.

The new initiative will include all of Perrigo’s best-selling categories, such as pain relievers, cold and allergy, and antacids. The company already has more than 200 dietary supplements that are part of a similar labeling program.

It’s not the medicine that’s the concern, but the filler, capsule or coating that might contain the gluten, said Dr. Sara Uekert, of Grand Rapids Allergy PC.

“The drawback is that until there is an awareness of what is an acceptable threshold, it’s a moot point,” Uekert said. “Just because it’s on the label doesn’t mean it might not be problematic for more sensitive individuals with lower thresholds.

“It’s Perrigo putting its own limits, but at least it is a step in the right direction.”

Perrigo spent almost three years working through its manufacturing process and supply chains to establish that the products met the new standard.

“It’s an assurance program,” said company spokesman Art Shannon.

Perrigo initiated the labeling program in response to an increasing market demand for gluten-free products. Consumer questions about the gluten content of Perrigo-manufactured products have recently ranked among the company’s top call center inquiries.

Perrigo supplies products carried by many retailers as store brands — although its name is not on the packaging.

“We are excited about the program,” Shannon said. “We believe we are the first manufacturer in the U.S. to do this.”

Gluten is a protein found in wheat, barley and rye. In this country, an estimated one in seven people have a gluten intolerance, and 3 million suffer from celiac disease. Those with the disease cannot eat gluten because it creates an immune-mediated toxic reaction that damages the small intestine and does not allow food to be properly absorbed, according to the foundation’s Web site.

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