Food packaging regulations in the United States do not approve a cup, a clamshell or a fork as a finished product. FDA regulates the substances the article is made of: the resin, the paper chemistry, the coating, the ink on the food side, the adhesive in the seam. Each of those has to fit one of a short list of legal routes, and the finished article is lawful only when every component that can migrate into food does.
For importers of foodservice disposables and food packaging, that structure puts the compliance work upstream. There is no FDA certificate that travels with the container, and a supplier statement that says “FDA approved” means nothing on its own. What protects the importer is knowing which route covers each material, holding documents that tie the shipped article to that route, and knowing where the article sits in the tariff schedule, because a paper cup, a plastic plate and a molded fiber tray carry very different duty.
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How FDA Clears a Food Contact Substance: GRAS, Prior Sanction, Regulation or FCN
The statute defines a food contact substance as any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food, where the use is not intended to have a technical effect in the food (FFDCA section 409(h)(6), 21 U.S.C. 348(h)(6)). If a substance that migrates into food is not covered by a valid route, the food it touches is adulterated under 21 U.S.C. 342(a)(2)(C), and 342(a)(6) separately covers containers made of a poisonous or deleterious substance that may render the contents injurious to health.
21 CFR 174.5(d) lists the main routes that make a component lawful under good manufacturing practice, and 21 CFR 170.39 adds a threshold of regulation exemption. Every material in an imported disposable has to fit one of them.
- GRAS: substances generally recognized as safe in or on food, or generally recognized as safe for their intended use in food packaging.
- Prior sanction: an explicit approval granted by FDA or USDA before September 6, 1958 (21 CFR 170.3(l)).
- Regulation: a listing in 21 CFR parts 174 to 178 (or 179.45), used within the conditions, limits and specifications the section sets.
- Food contact notification (FCN): an effective premarket notification under section 409(h). FDA has 120 days to object; if it does not, the FCN becomes effective (21 CFR 170.104(a)).
- Threshold of regulation: an exemption under 21 CFR 170.39 for substances whose use results in dietary concentrations at or below 0.5 parts per billion, with no carcinogenicity concern and no technical effect in food.
Why an FCN Number on a Spec Sheet Is Not Enough
The FCN route has a feature importers routinely miss. Under 21 U.S.C. 348(h)(2)(C), an FCN covers the substance made by the manufacturer identified in the notification and does not include a similar or identical substance made by anyone else. A factory that cites a resin maker’s FCN is only covered if it actually buys that resin maker’s material, which is a purchasing fact the importer should be able to document, not a chemistry fact.
Regulations work the other way: a listing in part 177 is generic and covers any manufacturer whose material meets the section’s specifications. Even then, 21 CFR 174.5(b) says a listing does not relieve the article from the rest of the FFDCA, so a compliant resin that gives food an off-odor or taste can still render it unfit.
21 CFR Parts 174 to 178 by Material: Paper, Plastics, Coatings and Adhesives
The indirect additive regulations are organized by what the substance is, which maps closely onto the bill of materials of a disposable. Part 174 sets general provisions, including the good manufacturing practice limits in 174.5(a): no more of a substance than is reasonably required for its technical effect in the article, and purity suitable for the use.
The practical step is to break each SKU into its food-contact layers and assign a section to each. A double-wall paper cup has paperboard, a polyethylene or other barrier coating, an adhesive in the side seam and possibly ink on the rim. A polystyrene clamshell is one resin plus colorants and processing aids. A plastic fork is resin plus colorant.
| Material or component | Typical section | What the section covers |
|---|---|---|
| Paper and paperboard, wet or fatty food | 21 CFR 176.170 | Components of paper and paperboard in contact with aqueous and fatty foods, with extractives limits by food type and temperature |
| Paper and paperboard, dry food | 21 CFR 176.180 | Components of paper and paperboard in contact with dry food (Type VIII) |
| Recycled fiber | 21 CFR 176.260 | Pulp from reclaimed fiber, with limits on retained poisonous or deleterious substances |
| Polyethylene and polypropylene | 21 CFR 177.1520 | Olefin polymers, with density, extractables and use-condition specifications |
| PET cups and lids | 21 CFR 177.1630 | Polyethylene phthalate polymers |
| Polystyrene cups, clamshells and cutlery | 21 CFR 177.1640 | Polystyrene and rubber-modified polystyrene |
| Barrier and decorative coatings | 21 CFR 175.300, 175.320 | Resinous and polymeric coatings, including coatings for polyolefin films |
| Seam and label adhesives | 21 CFR 175.105, 175.125 | Adhesives and pressure-sensitive adhesives |
| Colorants, stabilizers, plasticizers | 21 CFR 178.3297, 178.2010, 178.3740 | Adjuvants used in polymers |
Conditions of Use Matter as Much as the Section
Most sections clear a substance for defined conditions: food type (aqueous, acidic, fatty, alcoholic, dry) and temperature range, from frozen storage to hot-fill or microwave reheating. A resin cleared for room-temperature dry food is not automatically cleared for a hot soup container. When the product brief says “hot and cold” or “microwavable,” the compliance file has to show the material was evaluated for those conditions, usually through migration testing under the section’s extraction method.
Paper is a common gap. Section 176.170 exempts paper from its extractives limits only when every food-contact component is GRAS, prior-sanctioned or regulated without limits; otherwise the paper must meet the extraction limits in paragraph (c). A cup stock with a sizing agent, wet-strength resin or grease barrier needs evidence for each of those additives.
What an Importer of Foodservice Disposables Should Hold Before Shipment
Food contact substances are carved out of two FDA import procedures. The definition of food used for prior notice excludes food contact substances (21 CFR 1.276(b)(5)(i)(A)), and so does the definition used for food facility registration (21 CFR 1.227). A factory that only makes cups and containers is not registered on that basis, and a shipment of empty disposables is not the subject of FDA prior notice. Supplier verification for the food itself under FSVP is also a separate program; it does not cover the packaging.
Those carve-outs do not take the article out of FDA’s reach. FDA can refuse admission to an article that appears adulterated under 21 U.S.C. 381(a), and an unsafe food additive in packaging is adulteration. If a sample shows a problem, the outcome looks like any other FDA detention, with the importer carrying the storage and the burden of proof. The defense is a file assembled before the goods ship.
- A bill of materials per SKU listing every food-contact layer: base resin or fiber, coatings, adhesives, inks on food-contact surfaces, colorants and processing aids.
- For each layer, the route relied on (GRAS, prior sanction, a named 21 CFR section, an FCN number, or a threshold of regulation exemption) and the conditions of use it covers.
- For any FCN, evidence that the material came from the notifier named in the FCN: resin supplier invoices or certificates of analysis that match the trade name.
- A supplier compliance statement or letter of guaranty that names the SKU, the sections relied on, the food types and the temperature limits, signed by someone accountable at the factory.
- Migration or extraction test reports where the section sets extractives limits, from a lab that names the method, simulants, time and temperature.
- A PFAS statement covering intentionally added fluorinated chemicals, needed for the state rules discussed below.
- A change-control clause in the purchase order that obliges the factory to notify before switching resin grade, coating, adhesive or ink supplier.
Who Carries the Risk
The importer of record is the party in front of CBP and FDA when an entry is held, and usually the party a distributor or chain account turns to when a food-contact question comes up. Chain customers increasingly ask for the same file in their vendor onboarding. Importers serving food and beverage logistics programs or hospitality OS&E buyers should expect the request per SKU, and should treat a factory’s reluctance to name its resin supplier as a red flag rather than a confidentiality preference.
State PFAS Bans on Food Packaging
At the federal level, PFAS grease-proofing agents for paper and paperboard have left the market. FDA announced in February 2024 that grease-proofing substances containing PFAS were no longer being sold for food contact use in the United States, and in a January 6, 2025 notice (90 FR 653) it determined that the related food contact notifications were no longer effective, based on the manufacturers’ abandonment, with a June 30, 2025 compliance date for existing stocks of the substances listed in the notice’s second table. FDA lists the 35 FCNs affected. PFAS remain authorized in other food-contact uses such as non-stick cookware coatings and sealing gaskets in food processing equipment.
State law goes further and is written around the package, not the substance. Minnesota Statutes section 325F.075 prohibits manufacturing, knowingly selling or distributing in Minnesota a food package that contains intentionally added PFAS, and defines food package broadly enough to cover cups, plates, bowls, trays, wrappers, bags and tubs, plus coatings, closures, inks and labels. Washington’s RCW 70A.222.070 prohibits intentionally added PFAS in food packaging application by application, once the Department of Ecology has found safer alternatives for that application.
Other states have their own versions, with different scopes, dates and fluorine thresholds, and the list changes every legislative session. For an importer selling nationally, the workable standard is a written supplier declaration of no intentionally added PFAS for every food-contact layer, backed by fluorine testing where a buyer or certifier requires it. Imported goods that move through national distribution end up in states with these laws whether the importer planned for it or not.
Tariff Lines and Duty for Cups, Containers, Cutlery and Plates
Classification follows material and form. Paper and paperboard tableware sits in heading 4823, cartons in 4819, plastic tableware in 3924 and plastic packing containers in 3923. The table shows candidate lines with MFN and additional duties for China and Vietnam as of October 28, 2026. Most China lines here are on Section 301 List 3 at 25 percent; plastic plates and cups under 3924.10.20 are on List 4A at 7.5 percent; plastic cutlery under 3924.10.40 is listed only under the suspended List 4B. Both origins also pay the 12.5 percent Section 301 forced labor tariffs on these lines.
| HTS | Product | MFN | China additional | China total | Vietnam total (MFN + 12.5%) |
|---|---|---|---|---|---|
| 4823.69.0020 | Paper cups and round nested food containers | Free | 37.5% (List 3 + forced labor) | 37.5% | 12.5% |
| 4823.69.0040 | Paper plates, trays and dishes (paper plates also subject to AD/CVD orders) | Free | 37.5% | 37.5% + AD/CVD | 12.5% + AD/CVD |
| 4819.20.0020 | Folding cartons of non-corrugated paperboard, sanitary food and beverage containers | Free | 37.5% | 37.5% | 12.5% |
| 3924.10.2000 | Plastic plates, cups, bowls and serving dishes | 6.5% | 20% (List 4A + forced labor) | 26.5% | 19% |
| 3924.10.4000 | Other plastic tableware, including cutlery | 3.4% | 12.5% (forced labor only) | 15.9% | 15.9% |
| 3923.10.9000 | Plastic boxes and containers for packing goods (some clamshells; depends on the product) | 3% | 37.5% | 40.5% | 15.5% |
Notes on the Table
Totals are ad valorem on customs value and do not include Section 301 product exclusions or antidumping and countervailing duties. Three sets of orders matter in this category. Thermoformed molded fiber products from China and Vietnam (plates, bowls, clamshells, trays and lids, including bagasse) are under antidumping duty orders published January 27, 2026 (91 FR 3431) and countervailing duty orders (91 FR 3437), mainly under 4823.70.0020 and 4823.70.0040. Paper plates from China, Thailand and Vietnam are under antidumping duty orders published March 20, 2025 (90 FR 13139), with countervailing duty orders on China and Vietnam (90 FR 13135); the scope covers plates of any paper, including bamboo and bagasse, and excludes plates molded or pressed directly from paper pulp. Disposable aluminum containers, pans, trays and lids from China are under antidumping and countervailing duty orders published May 8, 2025 (90 FR 19467). Check scope with antidumping and countervailing duties in mind before quoting a landed cost.
The line between 3923 (articles for the conveyance or packing of goods) and 3924 (tableware) for clamshells and takeout containers depends on the article’s design and use, so confirm it per SKU. To price a specific code, run it through the China to US tariff calculator.
Frequently Asked Questions
Does FDA approve food packaging before import?
No. FDA does not approve finished cups, containers or cutlery. It regulates the substances in them, which must be GRAS, prior-sanctioned, listed in 21 CFR parts 174 to 178, covered by an effective food contact notification, or exempt under the threshold of regulation. The importer is expected to know which route covers each component.
What does "FDA compliant" mean on a supplier's packaging spec?
It should mean that every food-contact component is covered by a named route, such as 21 CFR 177.1520 for polypropylene or a specific FCN number, for stated food types and temperatures. A statement that does not name the sections or conditions of use is a marketing claim, not evidence.
Can my factory rely on another company's food contact notification?
Only if it uses that company’s material. Under 21 U.S.C. 348(h)(2)(C), an FCN covers the substance made by the manufacturer named in the notification, not an identical substance made by someone else. The importer should hold invoices or certificates showing the resin or additive came from the notifier.
Do imported food containers need FDA prior notice or facility registration?
No. Food contact substances are excluded from the definition of food used for prior notice (21 CFR 1.276) and for food facility registration (21 CFR 1.227). FDA can still refuse admission to packaging that appears adulterated under 21 U.S.C. 381(a).
Are PFAS banned in food packaging in the United States?
Not by a single federal ban. PFAS grease-proofing agents for paper have been withdrawn and FDA declared 35 related food contact notifications no longer effective as of January 6, 2025. Several states, including Minnesota, prohibit intentionally added PFAS in food packaging sold in the state, so national sellers usually require a no-intentionally-added-PFAS declaration from every supplier.
What duty do paper cups from China pay?
As of October 28, 2026, paper cups under HTS 4823.69.0020 are MFN free but pay 25% under Section 301 List 3 and 12.5% under the Section 301 forced labor action, for 37.5% on customs value. Paper plates in the same heading are also subject to antidumping and countervailing duty orders.
Are molded fiber plates covered by the paper plate antidumping orders?
Not by the paper plate orders, which exclude plates molded or pressed directly from paper pulp (HTS 4823.70.0020). But thermoformed molded fiber plates from China and Vietnam are covered by separate antidumping and countervailing duty orders published January 27, 2026 (91 FR 3431 and 91 FR 3437). Pressed paper plates, including those made from bamboo or bagasse paper, are within the paper plate orders.
