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SITCSection 5
U.S. imports of mannitol (SITC 51224) totaled $3.0M in April 2026, traded with 5 countries.
Importers of Mannitol paid $485K in duties in April 2026 — an effective duty rate of 16% on $3.0M in dutiable value, based on actual customs collections rather than the published tariff schedule. Mannitol imports of $3.0M in April 2026 ran 11% above the year-to-date monthly average of $2.7M.
Last updated: April 2026 dataMannitol is a sugar alcohol produced primarily by hydrogenation of fructose or by extraction from seaweed, and it serves dual roles as a pharmaceutical excipient (lyophilization bulking agent, osmotic diuretic) and a food-grade sweetener. Because it enters pharmaceutical and food supply chains, FDA oversight applies to imported mannitol intended for those end uses, and suppliers must meet applicable USP or food-grade purity specifications. Classification can hinge on whether the product is presented in a form clearly intended for pharmaceutical versus industrial use.
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Pharmaceutical-grade mannitol imports generally require a certificate of analysis confirming USP or equivalent purity, documentation of the foreign manufacturer's GMP status, and may be subject to FDA prior notice requirements. Working with a licensed customs broker familiar with FDA-regulated chemicals is advisable.
Both grades typically fall under the same SITC heading, but the end-use grade affects which FDA regulatory pathway applies at entry. Importers should clearly declare the intended use and grade on entry documentation to avoid holds or sampling by FDA.
Monthly import values over time
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