FDA Amends Iron Blister Pack Guidelines 37517

FDA Amends Iron Blister Pack Guidelines

WASHINGTONThe Food and DrugAdministration (FDA) amended certain provisions regarding the regulation ofiron-containing supplements and drugs. The U.S. appellate ruled FDA oversteppedits regulatory boundaries when it required unit-dose packaging for supplementsand drug products containing 30 mg or more of iron per dosage unit. As a result,the agency filed public notice in the Oct. 17 Federal Register; thenotice, which would have this guideline no longer apply to manufacturers,becomes effective immediately.

When FDA submitted the final rule in 1997, the NutritionalHealth Alliance (NHA) contested it soon after, arguing the agencyspromulgation of blister pack requirements for dietary supplements and drugs wasbeyond the agencys statutory authority. In 2000, the U.S. District Court forthe Eastern District of New York ruled in favor of FDA, a decision NHA appealed.In June 2003, the U.S. Court of Appeals for the Second Circuit reversed the 2000judgment, ruling the Federal Food, Drug and Cosmetic Act does not provide FDAwith the regulatory power to require manufacturers of iron-containingsupplements or drugs to use dose-unit packaging for poison prevention purposes.

However, the reversal will not affect FDAs guideline thatall iron-containing drugs have a warning label, nor the guideline to keepironcontaining supplements and drugs in childresistant packaging.

In 1970, Congress enacted the Poison Prevention Packaging(PPP) Act, which enabled FDA to require poison prevention packaging. However, the agency was not given the power to regulate thetype of packaging used. Therefore, in 1972, Congress created the ConsumerProduct Safety Commission (CPSC). All of the power under PPP transferred toCPSC, and it fell on the commissions shoulders to regulate poison preventionpackaging.

When the appellate court decision was made, one of theprincipal counselors to NHA, Bob Ullman, told INSIDER the courts took solong deciding because the safety of children was involved. But the reversalof the 2000 decision was inevitable, Ullman said. This shows FDA that itcant enforce regulations that are not under its jurisdiction.