HTSBase
FDAUnited StatesFood containers

Do food containers need FDA approval?

Updated

Short answer

No. There is no FDA approval or certificate for a finished container.

FDA regulates the substances in food contact articles, not the finished container. Every component that can reasonably be expected to migrate into food must be lawful for that use: listed in the indirect food additive regulations in 21 CFR 174 to 179, generally recognized as safe, prior sanctioned, exempt under the threshold of regulation, or covered by an effective Food Contact Notification (FCN). FDA places the duty on the manufacturer and does not issue "FDA approved" certificates for containers.

What changes the answer

  • Conditions of use. Most authorizations are limited by food type and temperature. A polymer cleared for room temperature dry food may not be cleared for hot fatty foods or microwave use.
  • FCNs are proprietary. An FCN covers the substance from the notifier named in it. A resin that copies a notified polymer from another supplier is not covered.
  • Polymer regulations. Common plastics have their own sections, such as olefin polymers in 21 CFR 177.1520 and rubber articles, including many silicones, in 177.2600. Each sets composition and extraction limits.
  • Ceramics and glazes. FDA has separate action levels for lead and cadmium leaching from ceramic ware. California Prop 65 can require a warning for the same exposure.
  • State laws. Several states restrict PFAS or BPA in some food packaging. These are in addition to FDA rules.

What to do

  1. Get a letter of guaranty or declaration of compliance from the resin or material supplier naming the regulation or FCN for each component and the permitted conditions of use.
  2. Have a lab run the extraction or migration tests the regulation specifies for your food types and temperatures.
  3. Keep a compliance file per SKU: formulas, supplier letters, test reports and the use conditions you market.
  4. Do not use "FDA approved" on packaging or listings. "Made with materials that comply with FDA food contact regulations" is accurate when your file supports it.
HTS lines for food containers
  • 3924.10.40.00

    3924: Tableware, kitchenware, other household articles and hygienic or toilet articles, of plastics

    Tableware and kitchenware / Other

    Plastic tableware and kitchenware, other, including many food storage containers.

    General rate
    3.4%
    Free or reduced under 17 programs
  • 7615.10.71.25

    7615: Table, kitchen or other household articles and parts thereof, of aluminum; pot scourers and scouring or polishing pads, gloves and the like, of aluminum; sanitary ware and parts thereof, of aluminum

    Cooking and kitchen ware / Not enameled or glazed and not containing nonstick interior finishes / Containers suitable for food preparation, baking, reheating or storage, 0.04 mm or more but not over 0.22 mm in thickness

    Aluminum containers suitable for food preparation, baking, reheating or storage.

    General rate
    3.1%
    Free or reduced under 17 programs

Next steps

Frequently asked questions

Is "BPA free" required?
No federal rule requires a BPA-free claim. If you make the claim, it must be true. BPA is on the Prop 65 list, so it matters for California warnings.
Does FDA register food container importers?
Food contact articles are not food, so the food facility registration rule does not apply to a plain container business. Containers that are sold with food are a different case.
Is a supplier's LFGB or EU test report enough?
No. EU tests follow EU rules. The U.S. analysis is whether each substance is authorized under 21 CFR or an FCN for your conditions of use. Some test data can overlap, but the legal basis differs.

Sources

  1. Determining the Regulatory Status of Components of a Food Contact Material, U.S. Food and Drug Administration
  2. 21 CFR part 177, Indirect food additives: polymers, eCFR, National Archives
  3. 21 CFR part 174, Indirect food additives: general, eCFR, National Archives
  4. List of Proposition 65 chemicals, California OEHHA

This is general information drawn from the official sources linked above. It is not legal advice. Rules change and often turn on the facts of your product, so confirm your test plan with an accredited lab and your obligations with qualified counsel before you import or sell.