Courts Revoke FDA's Regulatory Oversight of Iron Supplement Packaging

NEW YORK--The U.S. Court of Appeals for the Second Circuit ruled against the Food and Drug Administration's (FDA) assertion that it has a say in packaging iron-containing dietary supplements or drugs.

Decades ago, before the era of childproof caps, FDA went before Congress and asked for poison prevention 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.

FDA, however, in the interest of limiting children's access to products containing more than 30 mg of iron per serving, decided that under its power to prevent injurious health, FDA would 1) require iron warnings on dietary supplements containing iron and 2) require the product to be sold as blister packs if there was 30 mg or more of iron per unit (tablet, capsule, etc.).

Today, these warning labels are on iron-containing supplements, but the regulations regarding poison prevention packaging are what concerned the National Health Alliance (NHA)--a consumer-oriented educational association--that filed action against FDA for overstepping its regulatory boundaries. NHA argued that the agency's promulgation of these blister pack requirements for dietary supplements and drugs was beyond the agency's statutory authority. But in 2000, the U.S. District Court for the Eastern District of New York decided in favor of FDA. NHA persevered and appealed the decision, taking the case to the 2nd Circuit that, on Jan. 21, decided the lower court was wrong.

"Number one, the Food and Drug Act is clear in that FDA's authority is limited to adulteration, not poison prevention packaging," said Steven Shapiro of Ullman, Shapiro & Ullman, a New York-based firm and the plaintiffs' counsel. "Because the packaging in question is not intended to prevent people from adulterating the product, this argument is `nonsensical,' according to the court. Number two, the PPP Act rests with CPSC, not FDA. If CPSC is prevented from prescribing a particular type of packaging, FDA should not be able to have the power to go around them and regulate the type of packaging to their liking.

FDA argued that it had the ability to regulate packaging against adulteration. But, requiring blister packs to keep children from iron-containing products is not an action that falls under adulteration but rather poison prevention--which falls under CPSC.

As a result, the 2nd circuit court has ordered the lower court (which had ruled in favor of FDA) to revoke the two FDA regulations that require unit dose packaging for iron products containing 30 mg or more per unit.

According to Bob Ullman, one of the principal counsels for the plaintiffs, the decision took so long 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."