HTSBase
CPSC children'sUnited StatesBaby teethers

Do baby teethers need a CPC?

Updated

Short answer

Usually yes. Medical claims can make it an FDA device instead.

A teether sold as a baby product is a children's product and a child care article: 16 CFR 1307.2 covers products that help children 3 and younger with sucking or teething, and CPSC lists teethers by name. It needs tests at a CPSC-accepted lab, tracking labels and a Children's Product Certificate (CPC) eFiled with the entry. The exception is a teething ring intended for a medical purpose, which FDA classifies as a device in 21 CFR 872.5550.

What changes the answer

  • FDA device or consumer product. FDA's rule covers a teething ring "intended for use by infants for medical purposes to soothe gums": Class I if it has no fluid, Class II if fluid-filled, both exempt from 510(k). Devices are outside CPSC's jurisdiction and need FDA establishment registration and listing instead. Pain relief claims push a product toward FDA; a teether sold as a toy stays with CPSC. Where your claims fall is a fact question, so get an opinion before launch.
  • Small parts. The small parts ban in 16 CFR 1501 names teethers among articles for children under 3. No part may fit the small parts cylinder, before or after use-and-abuse tests.
  • Phthalates. The eight phthalates in 16 CFR 1307 are limited to 0.1% in each accessible plasticized part. Silicone, TPE and PVC need testing. Untreated wood and natural latex are on CPSC's no-testing list but must still comply.
  • Toy standard. ASTM F963-23, mandatory under 16 CFR 1250, has requirements for teethers and squeeze toys, and teethers with rattle features also fall under 16 CFR 1510.
  • Teething jewelry. FDA warned in 2018 against teething necklaces and bracelets because of strangulation and choking deaths.

What to do

  1. Decide the regulatory route from your claims and marketing, and keep the claims consistent across packaging and listings.
  2. For a CPSC teether, test at a CPSC-accepted lab to ASTM F963-23, 16 CFR 1501, 16 CFR 1510 if it rattles, lead content, lead in coatings and the eight phthalates.
  3. Issue a CPC listing each rule and the lab, eFile it with the entry, and put tracking information on the teether where practicable and on the package.
  4. For an FDA teething ring, register the establishment and list the device under 21 CFR part 807, with a U.S. agent if the manufacturer is foreign.
HTS lines used for teethers
  • 9503.00.00.71

    9503: Tricycles, scooters, pedal cars and similar wheeled toys; dolls' carriages; dolls, other toys; reduced-scale ("scale") models and similar recreational models, working or not; puzzles of all kinds; parts and accessories thereof

    "Children's products" as defined in 15 U.S.C. § 2052 / Labeled or determined by importer as intended for use by persons / Under 3 years of age

    Toys for children under 3. Many teethers are entered as toys.

    General rate
    Free
  • 3924.90.56.50

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

    Other

    Other household articles of plastics. Some rulings place non-toy plastic or silicone teethers here.

    General rate
    3.4%
    Free or reduced under 17 programs

Next steps

Frequently asked questions

Do silicone teethers need phthalate testing?
Silicone is not on CPSC's list of materials exempt from phthalate testing, so test it or use component test results for the exact compound under 16 CFR part 1109.
Does a wooden teether need testing?
Untreated, unfinished wood is determined not to exceed the lead limit and needs no phthalate testing. Finishes, paints and any plastic or textile parts still need testing, and the small parts and F963 tests always apply.
Is a water-filled teething ring a toy?
FDA classifies fluid-filled teething rings intended to soothe gums as Class II devices under 21 CFR 872.5550. If you sell one, check FDA status before relying on a CPSC test plan.

Sources

  1. 16 CFR 1307.2, Definitions of children's toy and child care article, eCFR, National Archives
  2. 21 CFR 872.5550, Teething ring, eCFR, National Archives
  3. 16 CFR 1501.2, Small parts regulation scope, eCFR, National Archives
  4. Phthalates FAQ, U.S. Consumer Product Safety Commission
  5. FDA warns against use of teething necklaces, bracelets and other jewelry, U.S. Food and Drug Administration
  6. Certificates of Compliance final rule (eFiling), published January 8, 2025, Federal Register

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.