Guide to Doing Business with US
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 July 2006

 2.3 Product Safety

 A. Consumer Products

Any consumer product offered for importation will be refused admission if it (a) fails to comply with an applicable product safety standard or regulation or with a specified labelling or certification requirement, or (b) is determined to present a substantial product hazard. These requirements are administered by the CPSC.

In order to improve consumer product safety compliance rates, the CPSC strongly recommends that manufacturers fully comply with both CPSC mandatory standards and private sector voluntary standards. Although private sector standards are conceived as voluntary requirements, products that fail to comply with them are nonetheless regarded as substandard in design and may be considered to present a "substantial product hazard" for that reason alone. Any product that presents a substantial product hazard will be refused entry into the US and, if the product is already in circulation, subject to a CPSC recall.

Manufacturers should also take advantage of certification programmes where available. In the absence of certification, the CPSC recommends that representative samples be tested by a laboratory accredited to the ISO/IEC 17025 standard by a recognised accreditation body. Manufacturers should also ensure that the selected testing laboratory is technically competent to test for the specific product safety standards. There are many advantages to having a product certified, including the identification of all applicable product standards and the enhancement of mechanisms for quality control through factory inspections, pre-market production sample testing and post-market testing.

Additional Information

a) Toys and Children's Articles

Toys and other children's articles cannot be imported into the US if they fail to comply with applicable regulations issued under the Federal Hazardous Substances Act (FHSA). Regulations stipulate that toys intended for children under three years of age cannot have small parts that present choking hazards to small children. The Child Safety Protection Act (an amendment to the FHSA) and its implementing regulations require warning labeling on toys for children who are at least three years of age but less than six years of age that present choking hazards from small parts. These regulations also cover balloons, small balls (small balls for children under age three are banned), and marbles. Electric toys, rattles, pacifiers and cribs are also subject to specific safety regulations. The CPSC's regulations contain tests used to define hazardous sharp edges and points on toys and other children's articles. Lawn darts are banned.

b) Lead in Paint

Paint and other similar surface-coating materials intended for consumer use are banned if they contain more than 0.06% lead. This ban also applies to paint used on furniture as well as toys or other articles intended for use by children. Such products cannot be admitted into the US. Although this ban applies to "surface coatings", the CPSC can take action under the FHSA against other lead-containing products if the lead content results in a substantial risk of injury or illness.

c) Bicycles and Bicycle Helmets

Bicycles cannot be admitted into the US unless they comply with the FHSA regulations. Bicycle helmets cannot be admitted into the US unless they meet the safety standard for bicycle helmets and are accompanied by a certificate of compliance. The safety standard establishes strict performance and construction requirements for the brakes, wheels, steering system and frame. Bicycles require reflectors on the front, back, sides and pedals to make them visible at night; require elimination of uncovered sharp edges and jutting parts; and require brakes on bicycles with seat height of 22 inches or more.

d) Fireworks

FHSA regulations set labelling requirements and technical specifications for consumer fireworks. Large fireworks, such as cherry bombs and M-80s, are banned for consumer use. Large re-loadable mortar shell fireworks are banned, and large multiple-tube mine and shell fireworks are subject to specific requirement to prevent tip-over. Fireworks not meeting any of these requirements cannot be imported into the US.

As of 1 June 2005, a total of five states (Delaware, Massachusetts, New Jersey, New York and Rhode Island) banned all consumer fireworks, including those allowed by federal law. Arizona only allowed novelty fireworks as of that date, while Illinois, Iowa, Maine, Ohio and Vermont allowed only sparklers and/or other novelties.

e) Flammable Fabrics

Any article of wearing apparel, fabric or interior furnishing cannot be imported into the US if it fails to conform to an applicable flammability standard issued under the Flammable Fabrics Act. These standards cover general wearing apparel, children's sleepwear, mattresses (including futons), and carpets and rugs. Certain products can be imported into the US for the purpose of finishing or processing to render such products not so highly flammable as to be dangerous when worn by individuals, provided that the exporter states on the invoice or other paper relating to the shipment that it is being made for that purpose.

On 16 February 2006, the CPSC adopted a new mandatory flammability standard for mattresses, effective from 1 July 2007. The new standard addresses mattress fires ignited by open flame sources, including matches, candles, lighters and other related scenarios. Cigarette ignition will continue to be regulated by a separate standard.

f) Art Materials

Art materials cannot be imported into the US unless they meet the requirements of the Labeling of Hazardous Art Materials Act (LHAMA). The LHAMA requires that chronically hazardous art materials carry the warning labelling specified in industry standard ASTM D-4236. This standard also requires that art materials carry a label certifying that they have been reviewed by a toxicologist and identifying any known hazards.

g) Cigarette Lighters

Disposable and novelty cigarette lighters cannot be admitted into the US unless they meet a safety standard that requires them to be child-resistant. All non-refillable lighters, and refillable lighters whose customs value is less than US$2.00 and that use gas as a fuel, are considered to be "disposable lighters" and are covered by the standard. Novelty lighters are lighters (using any type of fuel) which have entertaining audio or visual effects or that depict articles commonly recognised as intended for use by children under five years of age. Manufacturers must test lighters, keep records and report the results to the CPSC. A certificate of compliance must accompany each shipping unit of the product or otherwise be furnished to the distributor or retailer to whom the product is delivered by the manufacturer, private labeller or importer.

h) Other Consumer Products Regulated by the CPSC

The CPSC has also issued safety standards and regulations that apply to the following.

  • Architectural glazing
  • Matchbooks
  • CB base station antennas and TV antennas
  • Walk-behind power lawn mowers
  • Swimming pool slides
  • Cellulose insulation
  • Automatic residential garage door operators
  • Unstable refuse bins
  • Flammable contact adhesives
  • Consumer patching compounds containing respirable free-form asbestos
  • Emberizing materials (ash and embers) containing respirable free-form asbestos
  • Household chemicals
  • Refrigerator doors
  • Poison Prevention Packaging Act (requires child-resistant packaging of certain drugs and household chemicals)

i) Other Miscellaneous Merchandise

The importation of white or yellow phosphorus matches, pepper shells and switchblade knives is prohibited.

B. Electronic Products

Radiation-producing Products, Including Sonic Radiation

The Radiation Control for Health and Safety Act (RCHSA) establishes standards for electronic products in order to control radiation emitted by those products. Every manufacturer of an electronic product for which an applicable standard is in effect must furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards. Unless otherwise provided, the certification must be in the form of a label or tag permanently affixed to or inscribed on the product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags must be in English. Certification must be based on a test, in accordance with the standard, of the individual article to which it is attached or upon a testing programme that is in accordance with good manufacturing practices.

Some of the more relevant specific requirements established by the RCHSA are as follows.

  • Television receivers. Radiation exposure rates produced by a television receiver must not exceed 0.5 milliroentgens per hour at a distance of five centimetres from any point on the external surface of the receiver.

  • Cold-cathode discharge tubes. Radiation exposure rates produced by cold-cathode gas discharge tubes must not exceed 10mR/hr at a distance of 30 centimetres from any point on the external surface of the tube.

  • Microwave ovens. Microwave ovens must meet applicable requirements regarding power density and must have a minimum of two operative safety interlocks with certain characteristics.

There are also extensive regulations for diagnostic x-ray systems and their major components, radiographic equipment, fluoroscopic equipment, computed tomography equipment, cabinet x-ray systems, laser products, sunlamp products and ultraviolet lamps intended for use in sunlamp products, high-intensity mercury vapour discharge lamps, ultrasonic therapy products, CD players, CD-ROMs, cellular and cordless telephones, and other electronic products for which there are radiation performance standards.

C. Food, Drugs, Cosmetics and Medical Devices

a) Foods, Cosmetics, etc.

The importation into the US of food, drugs, medical devices and cosmetics is governed by the provisions of the FFDCA, which is administered by the FDA. These regulations prohibit the importation of articles that are adulterated or misbranded, including products that are defective, unsafe, filthy or produced under unsanitary conditions. The term "misbranded" includes statements, designs or pictures in labelling that are false or misleading or that fail to provide required information in labelling. The importation of pharmaceuticals that have not been approved by the FDA for admission into the US is also prohibited.

Imported products regulated by the FDA are subject to inspection at the time of entry. Shipments found not to comply with applicable laws and regulations are subject to refusal. They must be brought into compliance, destroyed, or re-exported. At the discretion of the FDA, an importer may be permitted to bring a non-conforming importation into compliance if it is possible to do so. Any sorting, re-processing or re-labelling must be supervised by the FDA at the importer's expense.

Various imported foods such as confectionery, dairy products, poultry, eggs and egg products, meats, fruits, nuts and vegetables are also subject to the requirements of other agencies, as discussed in this guide. In addition, certain aquatic species may be subject to the requirements of the National Marine Fisheries Service of the DOC's National Oceanic and Atmospheric Administration.

The importation of alcoholic beverages is also subject to the specific requirements of the FDA. Certain plant materials, when used for bottle jackets for wine or other liquids, are subject to special restrictions under the USDA's plant quarantine regulations. All bottle jackets made of dried or un-manufactured plant materials are subject to inspection upon arrival and are referred to the USDA.

b) Biological Drugs

The requirements that regulate the manufacture and importation of biological products for human consumption are overseen by the FDA. Domestic and foreign manufacturers of such products must obtain a US licence for both the manufacturing establishment and the product intended to be produced or imported. Licensing information may be obtained from the FDA or online at

The regulations for biological drugs for animals are administered by the USDA. The importation of viruses, serums, toxins and analogous products, and organisms and vectors for use in the treatment of domestic animals is prohibited unless the importer holds a permit from the USDA covering the specific product. These importations are also subject to special labelling requirements.

The importation of any drug or medicine designed to cause an unlawful abortion is prohibited unless otherwise authorised by the FDA.

c) Biological Materials and Vectors

The importation into the US for sale, barter or exchange of any virus, therapeutic serum, toxin, antitoxin, or analogous products, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), except materials to be used in research experiments, applicable to the prevention, treatment or cure of human diseases or injuries, is prohibited unless these products have been propagated or prepared at an establishment holding an un-suspended and un-revoked licence for such manufacturing issued by the Secretary, Department of Health and Human Services.

A permit from the CDC is required for shipments of any etiological agent or insect, animal or plant vector of human disease, or exotic living insect, animal or plant capable of being a vector human disease. See for additional information on obtaining a permit.

d) Narcotic Drugs and Derivatives

The importation of controlled substances, including narcotics, marijuana and other dangerous drugs, is prohibited except when imported in compliance with the regulations of the Department of Justice's Drug Enforcement Administration (DEA). Examples of prohibited controlled substances are amphetamines; barbiturates; coca leaves and derivatives such as cocaine; hallucinogenic substances such as LSD, mescaline, peyote, marijuana, and other forms of cannabis; opiates, including methadone; opium, including opium derivatives such as morphine and heroin; synthetic substitutes for narcotic drugs; and anabolic steroids.

e) Drug Paraphernalia

Items of drug paraphernalia are prohibited from importation or exportation. The term "drug paraphernalia" means any equipment, product or material of any kind that is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling or otherwise introducing into the human body a controlled substance, the possession of which is unlawful under the Controlled Substances Act.

Items of drug paraphernalia include, but are not limited to, the following: (1) metal, wooden, acrylic, glass, stone, plastic or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls; (2) water pipes; (3) carburetion tubes and devices; (4) smoking and carburetion masks; (5) roach clips, meaning objects used to hold burning material, such as a marijuana cigarette, that has become too small or too short to be held in the hand; (6) miniature spoons with level capacities of one-tenth cubic centimetre or less; (7) chamber pipes; (8) carburettor pipes; (9) electric pipes; (10) air-driven pipes; (11) chillums; (12) bongs; (13) ice pipes or chillers; (14) wired cigarette papers; and (15) cocaine freebase kits.

D. Motor Vehicles and Boats

a) Motor Vehicles

As a general rule, all imported motor vehicles less than 25 years old and items of motor vehicle equipment must comply with all applicable federal motor vehicle safety standards (FMVSS) in effect when these vehicles or items were manufactured. A CBP inspection at the time of entry will determine such compliance, which is verified by the original manufacturer's certification permanently affixed to the vehicle or merchandise. An entry declaration form, HS-7, must be filed when motor vehicles or items of motor vehicle equipment are entered. An HS-7 can be obtained from customs brokers, ports of entry or at

A vehicle without a certification label cannot be imported as a conforming vehicle. In this case, the importer must contract with a registered importer (RI) to modify the vehicle and post a DOT conformance bond in an amount equivalent to one and a half times the vehicle's dutiable value. This bond is in addition to the normal CBP entry bond. Copies of the DOT conformance bond and the contract with an RI must be attached to the HS-7 form. Furthermore, the vehicle model and model year must be determined to be eligible for importation.

Under the contract, the RI will modify the vehicle and certify that it conforms to all applicable FMVSS requirements. Before an RI can modify a vehicle, the DOT's National Highway Traffic Safety Administration (NHTSA) must have determined that the vehicle is eligible for importation based on its capability of being modified to conform to all applicable FMVSS. If no determination has been made, the RI must petition the NHTSA to determine whether the vehicle is eligible for importation. If the petitioned vehicle is not similar to one sold in the US, this process can be complex and costly. A list of vehicles that have been determined eligible for importation can be found on NHTSA's web site at

Certain temporary importations may be exempt from the requirements for conformance if written approval is obtained in advance from both the DOT and the Environmental Protection Agency (EPA). This includes vehicles brought in for research, demonstrations, investigation, studies, testing or competitive events. EPA form 3520-1 and DOT form HS-7 must be submitted to CBP at the time entry is made for such vehicles.

Modifications necessary to bring a nonconforming vehicle into conformity with the safety, bumper or vehicle emissions standards may require extensive engineering and be impractical or impossible, and the labour and materials may be unduly expensive. It is highly recommended that these modifications be investigated before a vehicle is purchased for importation.

Additional Information

b) Boat Standards and Restrictions

Imported boats and associated equipment are subject to US Coast Guard safety regulations or standards. Products subject to standards must have a compliance certification label affixed to them. Certain hulls also require a hull identification number to be affixed. A Coast Guard import declaration is required to be filed with entries of nonconforming boats. Additional information may be obtained online at

Vessels that are foreign-built or of foreign registry may be used in the US for pleasure purposes and in the foreign trade of the US. However, federal law prohibits the use of such vessels in the coastwise trade; i.e., the transportation of passengers or merchandise between points in the US, including carrying fishing parties for hire.

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