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Saturday, December 12, 2009
Follow up to Perrigo's Press Release
On Wednesday, I posted a press release from Perrigo Company announcing that they will begin labeling their over-the-counter drugs as gluten-free (if applicable). It looks like there is some skepticism about Perrigo's actions since the FDA currently does not set standards for gluten in products.

Critics question value of Perrigo's new 'gluten free' claim on drugs
By Shandra Martinez | The Grand Rapids Press

ALLEGAN -- Perrigo Co.'s announcement 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.

E-mail Shandra Martinez: smartinez@grpress.com

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Wednesday, December 9, 2009
Perrigo Company Launches Labeling Initiative to Identify Gluten-free Products
FOR IMMEDIATE RELEASE

Perrigo Company Launches Labeling Initiative to Identify Gluten-free Products
Gluten-free labeling program an industry-first for over-the-counter pharmaceuticals

ALLEGAN, Mich., Dec. 7 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced it will implement a labeling program to help consumers more clearly identify more than 200 of the company's over-the-counter store-brand pharmaceuticals that are gluten-free, starting in January 2010. Previously, the only way a consumer could verify a pharmaceutical product as "gluten-free" was to call Perrigo directly. Now, consumers will be able to identify whether a Perrigo-supplied product is "gluten-free" simply by reading the product label.

Perrigo will be the first manufacturer to offer its customers the ability to place gluten-free statements on a wide range of over-the-counter pharmaceutical products. 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.

To support the gluten-free labeling initiative, Perrigo has instituted a gluten-free assurance program. Perrigo's program is based on the acceptable thresholds of gluten (less than 20 parts per million) identified by the FDA for the food industry. It is comprised of a gluten testing methodology for raw materials and products, as well as ongoing quality assurance for ingredient and formula changes.

Perrigo initiated the labeling program specifically in response to an increasing market demand for gluten-free products. Questions from consumers regarding the gluten content of Perrigo-manufactured products have recently ranked among the company's top call center inquiries.

Perrigo's Chairman and CEO Joseph C. Papa stated, "Our retail customers can continue to rely on Perrigo to pinpoint and act on consumer trends. This includes the growing list of individuals who need to know whether or not a product is gluten-free."

Gluten is a protein found in wheat, barley and rye. It is estimated that in the United States, one in seven people have a gluten intolerance, and three million people suffer from celiac disease – when it is medically necessary to consume only food and medicines that are gluten-free.(1) In addition to those diagnosed with celiac disease, millions more Americans, an estimated 15 percent, suffer from varying levels of gluten intolerance.(2)

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet (http://www.perrigo.com).

Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 27, 2009, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

(1) Celiac Disease Facts and Figures. www.CeliacDisease.net. Aug. 2005. University of Chicago. 28 May 2009.
(2) www.foodintol.com. 11 May 2009. http://foodintol.com/celiac.asp.

CONTACT: Arthur J. Shannon, Vice President, Investor Relations and Communication, +1-269-686-1709, ajshannon@perrigo.com; Daniel B. Willard, Manager, Investor Relations and Communication, +1-269-686-1597, dbwillard@ perrigo.com, both for Perrigo Company

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