Pancreatic enzyme products (PEPs) have been used for decades to improve digestion in patients with insufficient pancreatic enzyme production, such as those with cystic fibrosis. All porcine-derived PEPs contain a mixture of amylases, lipases and proteases. Since use of PEPs preceded the Federal Food, Drug and Cosmetic Act of 1938, they have been marketed without formal FDA approval,1 and major differences have been reported between the actual enzyme content in the product and the amount indicated on the label.2 In 1991, the FDA announced that all manufacturers of PEPs would be required to...

Pancreatic enzyme replacement products have been used for years to improve digestion in patients with exocrine pancreatic insufficiency (EPI). These products were initially marketed before formal FDA approval was required; in 1991, however, the FDA told all manufacturers of pancreatic enzyme replacement products that they would have to submit a new drug application by April 2010 in order to keep their products on the market.EPI is a chronic disorder characterized by a deficiency of exocrine pancreatic enzymes, which results in malabsorption, steatorrhea, and weight loss. Irreversible EPI is...