FDA Amends Iron Blister Pack Guidelines

WASHINGTON--The Food and Drug Administration (FDA) amended certain provisions regarding the regulation of iron-containing supplements and drugs. The U.S. appellate ruled FDA overstepped its regulatory boundaries when it required unit-dose packaging for supplements and 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; the notice, which would have this guideline no longer apply to manufacturers, becomes effective immediately.

When FDA submitted the final rule in 1997, the Nutritional Health Alliance (NHA) contested it soon after, arguing the agency's promulgation of blister pack requirements for dietary supplements and drugs was beyond the agency's statutory authority. In 2000, the U.S. District Court for the 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 2000 judgment, ruling the Federal Food, Drug and Cosmetic Act does not provide FDA with the regulatory power to require manufacturers of iron-containing supplements or drugs to use dose-unit packaging for poison prevention purposes.

However, the reversal will not affect FDA's guideline that all iron-containing drugs have a warning label, nor the guideline to keep iron-containing supplements and drugs in child-resistant 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 the type of packaging used. Therefore, in 1972, Congress created the Consumer Product Safety Commission (CPSC). All of the power under PPP transferred to CPSC, and it fell on the commission's shoulders to regulate poison prevention packaging.

When the appellate court decision was made, one of the principal counsels for NHA, Bob Ullman, told INSIDER the courts took so long deciding because the safety of children was involved. "But the reversal of the 2000 decision was inevitable," Ullman said. "This shows FDA that it can't enforce regulations that are not under its jurisdiction."