UNITED STATES OF AMERICA

Due to the size of its economy, the USA is, understandably, high up on the list of target markets for exporters. However, although there are tremendous opportunities, there are considerable obstacles and challenges standing in the way of successful market entry.

The US Food & Drug Administration (FDA) regulates around 12 per cent of all products entering the US market, including Foods & Beverages, Dietary Supplements, Pharmaceuticals, Medical Devices, Cosmetics, Biologics, Radiation-Emitting Devices, Veterinary Products, Alcohol & Tobacco

FDA regulations are very complex but, at the same time, are strictly enforced and before marketing or distributing any of the above mentioned products in the USA for the first time, it’s very important to make sure you identify and understand FDA regulations that apply to companies in the supply chain and to products.

Some products, like Medical Devices and Pharmaceuticals require pre-market approval by the FDA. On the other hand, the FDA doesn’t approve foods, beverages, supplements or cosmetics. However, whatever the product, the FDA will always want to identify, register and regulate products and companies in the supply chain, to make sure that products are safe, before they are exported.

Even if you have been exporting to the USA for some time, you should be aware that the FDA requires companies to periodically renew registrations and to report changes to companies, products and processes. Also, FDA regulations evolve and change over time, so it’s wise to continually monitor your compliance status.

EXPORT ACCESS is the Official Representative Office in the UK & Ireland for Registrar Corp USA

REGISTRAR CORP USA is the leading global provider of FDA compliance assistance services. Over the last 15 years the company has helped more than 30,000 companies in 160 countries achieve ongoing compliance with FDA regulations. The company provides comprehensive, easy to access and cost-effective compliance assistance services to exporters of the following products to the USA: