Compliance Guide Clarifies Rules for Iron Products

The document, published for small businesses, spells out how to comply with the new regulations for packaging drugs and supplements containing iron.

The Center for Food Safety and Nutrition (CFSAN) has published a compliance document for small businesses struggling to understand FDA's requirements for labeling and packaging products containing iron. The document, Iron-Containing Supplements and Drugs: Label Warning and Unit-Dose Packaging Small-Entity Compliance Guide, restates in plain language the legal requirements set forth in the current regulation.

The document was prepared by FDA under section 212 of the Small Business Regulatory Enforcement Fairness Act (P.L. 104-121). Unlike a Federal Register notice, the guidance document does not bind FDA or the public.

&As stated in the final rule of January 15, 1997 (62 FR 2218), packages of iron-containing dietary supplement and drug products in solid dosage form (e.g., tablets, capsules, or caplets) must be labeled with warnings to prevent accidental, potentially fatal poisonings of children. The regulation also requires the following warning statement:

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

In addition, the regulation requires that those iron-containing products with 30 mg or more of iron per dosage unit (tablet, capsule, caplet, etc.) be packaged in unit-dose packaging such as a blister pack, pouch, or other nonreusable container.

The regulation temporarily exempts products that contain 30 mg or more of an elemental form of iron, which is called carbonyl iron, from the unit-dose packaging requirements. Preliminary data indicate that this form of iron may be so much less toxic than iron salts that accidental overdose of these products is unlikely to result in serious injury or death. If, during the one-year temporary exemption period, FDA receives data clearly establishing that this is the case, the agency will consider permanently exempting carbonyl iron from the unit-dose packaging requirements of this regulation.

For products with less than 30 mg of iron per dosage unit that are not packaged in unit-dose packaging, the regulation requires that the warning statement appear prominently and conspicuously on the information panel of the immediate container label. When a bottle with an iron-containing product is placed within a separate box for retail sale, the warning statement must appear prominently and conspicuously on the information panel of both the bottle label and the outer box label. In addition, the warning statement must appear on any labeling, including inserts, that contain other product warnings. The warning statement that appears on the immediate container and outer box labels must be set off in a printed boxed area.

For unit-dose packaging, if the blister pack, pouch, or other nonreusable container bears any printed material, the warning statement must also appear prominently and conspicuously on this packaging.

A warning statement must be placed on the unit-dose packaging in a way that maximizes the likelihood that it can be read until all the individual dosage units are used. For example, multiple copies of the warning statement may be printed on the unit-dose packaging to increase the chances that at least one complete warning statement will remain intact until all of the individual units are used.

The guidance document can be viewed at CFSAN's Web site (http: //

Manufacturers of iron products should contact both FDA and the Consumer Product Safety Commission about packaging their products. Both agencies have regulations that must be met before products can be put on the shelf.

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