The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
The FDA has even implemented a new and broad reaching amendment to their requirements under the Modernization of Cosmetics Regulations Act (MoCRA), mandating that all cosmetics entering the U.S. be registered with the FDA. A departure from the past regulations of labeling and voluntary submission.
Some of these products are easily identifiable but even small items like dental floss or sunglasses are regulated by the FDA. Even cosmetics are now mandatorily required to be registered with the FDA and in order to do so a U.S. Agent must be assigned. TradeHaus Consulting can help register you or your supplier with the FDA for Food, Medical Devices and Cosmetics.
https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
https://www.fda.gov/food
A plethora of Federal U.S. Agencies (and others around the world) monitor, publish rules and enforce compliance on consumer products in the United States, plus many individual state local governments. With the FTC, FDA, CPSC, USDA, CBP, EPA, FCC and on; every product is subject to some level of compliance and the acronyms can be daunting. We can simplify this process to confirm exactly what testing, certification, labeling or requirements must be met to effectively bring your products to the market. Whether it’s Toys or Textiles or anything in-between. And if your product requires registration or permits as licensed U.S. Customs brokers, we can help attain them for you.
Additionally, it never hurts to perform a full audit on your import activities. Under the U.S. Customs Modernization Act originally passed in 1993 and amended in 2023, importers have a responsibility to exercise “reasonable care” in all activities. This means that regardless of what the shipping company or customs broker filed with U.S. Customs the fines, penalties and fault lay with you, the importer. This makes it essential to check small things like HTS codes but also audit your broker to ensure that the data you’ve provided is being entered correctly. We help perform risk assessments, customs audits, and compliance reviews for small and large companies to make sure you wont be surprised by any unknown risks.
https://www.cpsc.gov/Business--Manufacturing/Small-Business-Resources
https://www.ftc.gov/business-guidance/resources/threading-your-way-through-labeling-requirements-under-textile-wool-acts
https://oehha.ca.gov/proposition-65
The Harmonized System (HS) is used by more than 200 countries and economies as a basis for their Customs tariffs and for the collection of international trade statistics. It is also used for many other purposes, including for the monitoring of controlled goods, as a basis of rules of origin and for trade negotiations, and it is a vital element of core Customs controls and procedures. Meaning if your product is misclassified you may not only be responsible for the incorrect duty amount but also subject to incorrect licensing, permitting or import requirements. Goods must be classified in accordance with the rules created by the World Trade Organization (WTO), and as licensed Customs Brokers we know these rules well and can classify your product quickly so that you know exactly what your landed cost will be.
https://www.cbp.gov/
https://www.cbp.gov/trade/rulings/informed-compliance-publications
https://hts.usitc.gov/
The Environmental Protection Agency (EPA) protects people and the environment from significant health risks, sponsors and conducts research, and develops and enforces environmental regulations. This means chemicals, yes, however the EPA also regulates and enforces products that mitigate pests. A simple mouse trap is required to be produced in an EPA registered facility. Seems ridiculous but true. TradeHaus Consulting acts as the authorized agent and contact point for dozens of foreign establishments producing everything from disinfectants to bird netting. With the EPA being one of the most stringent U.S. agencies capable of assessing millions in fines or penalties we can help make sure your product, producer and labeling is compliant.
https://www.epa.gov/pesticides/pesticide-devices-guide-consumers
https://www.epa.gov/pesticide-registration/how-register-pesticide-guide-applicants-new-process