What specific labeling or health claim violations does the FDA cite for iron products?
Executive summary
The FDA requires a very specific boxed warning on solid oral iron-containing dietary supplements and drugs: "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6." The rule, first issued in 1997, also included unit-dose packaging for products ≥30 mg elemental iron per dosage unit, but the agency later removed its unit-dose packaging requirement after a court ruling in 2003 [1] [2].
1. What the FDA explicitly requires: the exact warning text and format
The agency’s regulations mandate that any dietary supplement or drug in solid oral dosage form that contains iron and is intended to supplement or provide therapeutic iron must carry the precise warning statement: "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6." The rule further requires that the statement appear prominently on the immediate container’s information panel, be set off in a printed boxed area, and be placed on any labeling that contains other product warnings; if an outer package exists the warning must appear there as well [1] [3] [4].
2. The now-removed packaging mandate and the court’s impact
The original 1997 final rule did two things: require the warning and require unit‑dose packaging for iron products that contain 30 mg or more of elemental iron per dosage unit. In 2003, following Nutritional Health Alliance v. FDA, the agency removed its regulatory requirement for unit‑dose packaging because the court concluded the FD&C Act did not authorize FDA to mandate unit‑dose packaging for poison‑prevention purposes [1] [2] [5].
3. Which products are in scope — and which are not
The labeling requirements apply to iron-containing products in solid oral dosage form (tablets, capsules) that add iron for supplementation or therapeutic purposes; the regulations do not apply to liquid or powder forms [1] [3]. FDA guidance reiterates that the warning is required when iron is added to a dietary supplement for supplementation or if the product is represented as a supplement [4] [6].
4. Related labeling obligations that can trigger enforcement
Beyond the iron-specific warning, dietary supplement labels must meet broader statutory requirements: a statement of identity (e.g., "dietary supplement" or "iron supplement"), the manufacturer’s name and place of business, a Supplement Facts panel (when applicable), an ingredient list for non‑declared ingredients, and net quantity of contents. FDA and FTC share oversight for labeling and promotion; certain claims (e.g., health claims) may need premarket review or authorization [7] [6].
5. Enforcement and practical compliance timelines
While the iron warning requirement dates to the 1997 rule and related small entity compliance guidance, FDA continues to issue uniform compliance dates for new food labeling rules (e.g., a 2028 uniform compliance date for food labeling regulations published in 2025–2026). Available sources do not say that the 2028 uniform compliance date changes the longstanding iron warning requirement; that requirement remains set out in the earlier rule and guidance [8] [9].
6. Where ambiguity and contention remain
The major contested element historically was unit‑dose packaging, which FDA lost authority to mandate in court [2]. Sources show FDA retained the authority to require the warning language but lacked authority to force packaging design for poison prevention [2] [5]. Available sources do not mention current FDA plans to reintroduce a packaging requirement or to broaden the warning language beyond the specified text [2] [1].
7. Why this matters — public health and industry tradeoffs
FDA framed the warning requirement as a child‑safety measure because accidental pediatric iron overdoses were a leading cause of fatal poisoning in young children, prompting the exact warning box and placement rules [1]. The court decision removing packaging mandates highlights a tension between regulators’ public‑health goals and the statutory limits of FDA authority; industry compliance is therefore focused on label wording and placement rather than mandated unit‑dose packaging [2] [5].
Limitations and sourcing note: This analysis draws only on FDA guidance, the 1997 final rule and the 2003 Federal Register action removing the unit‑dose mandate, and related FDA labeling guidance provided in the search results [1] [3] [2] [5] [7] [6] [4] [8]. If you want direct quotes from the Federal Register text or the exact CFR citations, I can pull those passages from the listed FDA and Federal Register links.