Why did the FDA require approval for PEPs?
• PEPs predate the passage of the 1938 Food, Drug, and Cosmetic Act. Over the years, the FDA has received reports of dosing discrepancies and adverse events associated with high doses of enzymes leading to narrowing of the digestive tract and claims that these drugs do not have the expected therapeutic effect potentially due to inactive ingredients or inadequate amounts of active drug in the capsules.
