Key takeaways
- FDA does not approve or certify finished tableware. Compliance rests on every food contact component being authorized for its use, and on the ware not leaching unsafe substances.
- Coatings, lacquers, resins and plastics must match a listing in 21 CFR 174–178, a GRAS or prior sanction, a threshold of regulation exemption, or a food contact notification held by the supplier.
- Ceramic ware is judged against FDA action levels for leachable lead and cadmium. Decorative ware that looks usable for food must carry the 21 CFR 109.16 marking.
- No FDA regulation authorizes lead as a cookware component. FDA warned in 2025 against certain imported aluminum, brass and alloy cookware, much of it made in India.
- An inspection can check materials, markings, labels and supplier documents; leach and migration results come only from an accredited lab.
How FDA regulates food contact materials
Under the Federal Food, Drug, and Cosmetic Act, a substance that can reasonably be expected to migrate into food from a plate, bowl, pan or coating is regulated like a food additive unless it is exempt. FDA calls these food contact substances: substances used in materials for making, packing, transporting or holding food, with no technical effect in the food (section 409(h)(6)). The rules sit in 21 CFR Parts 170 to 189.
| Route to lawful use | Where it is found | What it means for an importer |
|---|---|---|
| Indirect food additive regulation | 21 CFR 174 (general), 175 (adhesives and coatings), 176 (paper), 177 (polymers), 178 (adjuvants and production aids) | The substance must meet the listed specifications, limits and conditions of use. |
| Generally recognized as safe (GRAS) | 21 CFR 182, 184, 186, or a GRAS notice | Covers the specific use described, not any use. |
| Prior sanction | 21 CFR 181 | Uses approved by FDA or USDA letter before 1958. |
| Threshold of regulation exemption | 21 CFR 170.39 | Granted by FDA for uses with very low dietary exposure. |
| Food contact notification (FCN) | Section 409(h); FDA inventory of effective FCNs | Effective only for the notifier's substance and the stated use, so the material must come from that manufacturer. |
FDA places responsibility on the manufacturer of each food contact substance. Suppliers may give customers a guaranty under section 303(c)(2) of the Act. There is no FDA certificate, registration or mark for finished tableware, so any “FDA approved” claim on a plate or pan should be treated with care.
What applies to tableware and kitchenware from India
| Material | Main FDA reference | Typical risk to check |
|---|---|---|
| Glazed ceramics and stoneware (Khurja, Jaipur blue pottery) | CPG Sec. 545.450 (lead), CPG Sec. 545.400 (cadmium), 21 CFR 109.16 | Lead and cadmium leaching from glazes and decorations; missing “Not for food use” marking on decorative pieces |
| Aluminum, brass and alloy cookware (Hindalium, Indalium) | Adulteration provisions of the Act; FDA warning, August 2025 | Lead leaching from the metal or alloy |
| Wood bowls, boards and servers | Coatings: 21 CFR 175.300 (resinous and polymeric coatings); wood preservatives: 21 CFR 178.3800 | Lacquers, oils, stains or preservatives with no authorization for food contact |
| Coated metal, enamel-look and nonstick finishes | 21 CFR 175.300; 21 CFR 177.1550 (perfluorocarbon resins) | Coating not covered for the food type or temperature |
| Melamine and other plastic parts | 21 CFR 177 (for example 177.1460, melamine-formaldehyde molded articles) | Unlisted resins, fillers or colorants |
Metal cookware. In August 2025 FDA warned retailers and consumers not to sell or use certain imported aluminum, brass and alloy cookware, including pots, kadai and handi-style vessels, after tests under food-contact conditions showed it could leach lead. Many of the listed products named manufacturers in India. FDA states that no regulation authorizes lead as a component of cookware. The list was last updated in December 2025.
Lacquered and painted ware. Decorative lacquer, paint or resin on the food surface of a bowl or tray must be authorized for food contact. If it is not, the item should be sold and labeled as decorative only, with no food-contact surface finish.
Lead and cadmium in ceramics
FDA judges glazed ceramics against action levels for leachable lead (CPG Sec. 545.450) and cadmium (CPG Sec. 545.400), measured on six units with a 4% acetic acid leach. For lead, the levels range from 3.0 µg/mL for flatware (average of six) down to 0.5 µg/mL for cups, mugs and pitchers (any one unit). Ware above the level is treated as adulterated and can be detained at import. Full tables and the test method are on our page on lead and cadmium in ceramics.
Decorative ceramics that look usable for food are presumed to be for food unless they carry both a conspicuous stick-on label and a permanent statement molded or fired onto the base, such as “Not for Food Use. May Poison Food”, or have a hole bored through the food surface (21 CFR 109.16). FDA also advises that ceramics with any extractable lead should not be labeled “lead free”.
California Proposition 65 overlap
Goods sold in California also fall under Proposition 65. Lead and cadmium are on the Prop 65 list, so tableware or cookware that exposes users to them above the safe harbor levels needs a clear and reasonable warning. For ceramic tableware, the levels used in practice come from court-approved settlements rather than from an OEHHA regulation, and they are separate from FDA's action levels. Many US retailers write a Prop 65 leach limit into their purchase terms; confirm the exact figures with your buyer before you test.
What inspection can check, and what needs a lab
| An inspector at the factory can check | Needs lab testing |
|---|---|
| Materials, glazes, coatings and finishes match the approved sample and bill of materials | Leachable lead and cadmium from ceramics (ASTM C738 or AOAC 973.32, as cited by FDA) |
| Supplier statements or guaranties for coatings, resins and lacquers, and that the named supplier is the one actually used | Lead leaching from metal cookware under food-contact conditions |
| Decorative pieces carry the 21 CFR 109.16 label and the permanent base marking, or a bored hole | Migration tests on coatings, plastics and melamine |
| Labels and cartons carry the buyer's Prop 65 warning where required | Composition checks, such as lead content of brass or solder |
| Chipped glazes, crazing, exposed base metal or damaged coatings on sampled units |
Visual checks cannot show whether a glaze or alloy leaches lead. They can show whether the goods are what was tested, which is what makes a lab report meaningful.
How Clear To Load checks this in India
On a home décor and handicrafts inspection in India, the inspector compares glazes, finishes and materials with the approved sample, photographs base markings and labels, and checks the supplier documents you list in the checklist. Where you need leach or migration results, we pull and seal samples for an ISO/IEC 17025-accredited lab of your choice through lab testing coordination (US$99 per order) and check the report against the goods.
Reports arrive within 24 hours of the inspection with a verdict of Cleared to load, Hold or Not cleared. An inspection does not make goods FDA compliant; it checks that the goods match the evidence. To add these checks, book an inspection.
Sources
- 21 CFR Chapter I, Subchapter B, Parts 170–189 (eCFR)
- FDA: Determining the Regulatory Status of Components of a Food Contact Material
- FDA: Regulatory Background of the Food Contact Substance Notification Program
- FDA CPG Sec. 545.450, Pottery (Ceramics); Import and Domestic – Lead Contamination
- 21 CFR 109.16, Ornamental and decorative ceramicware (eCFR)
- FDA: Warning about imported cookware that may leach lead (August 2025, updated Dec 2025)