Both US domestic and foreign food facilities have been required to register with the FDA since 2003. The Food Safety Modernization act, which came into force in 2011, updated this requirement to include biennial renewals in order to keep the FDA’s registration database up-to-date.  Food facilities are now required to renew every even numbered year between October 1 and December 31. Foreign facilities must also designate a US agent to act as the intermediary between the supplier and the FDA and designated agents must be confirmed at the time of registration renewal. If registrations are not renewed, or the US agent is not confirmed, the FDA will consider registrations to be expired. Distributing food in the United States with an expired registration is a prohibited act and may lead to detention of products or other regulatory action by the FDA.

Figures released by the FDA to Registrar Corp under the Freedom of Information Act reveal that, following the last re-registration window, between October 1st. and December 31st. 2016 the number of UK food facilities registered with the FDA plunged by 43%, from 1865 to 1069.

However, the FDA’s 2017 figures show all of the major food exporting countries supplying products to the USA saw a large reduction in registered facilities after the last re-registration process at the end of 2016.

        January 2016        February 2017    Percentage change
JAPAN                13941                 9211                 -34%
FRANCE                10450                 7336                 -30%
ITALY                10125                 6169                 -39%
CHINA                  9667                 5236                 -46%
MEXICO                  9575                 4499                 -53%
CANADA                  6690                 4169                 -38%
SPAIN                  4688                 3208                 -32%
REP. OF KOREA                  3921                 2393                 -39%
INDIA                  3455                 1944                 -44%
UK                  1865                 1069                 -43%

Data Source: U.S. Food and Drug Administration. Image courtesy of FDA web site.

It’s clear that the UK is no better or worse than other countries, in terms of its effectiveness in responding to, and complying with, increasingly stringent FDA requirements. However, the figures do show that, despite its ongoing success in total global sales, the UK has a lot of catching up to do where US market share is concerned.

Perhaps, as the Americans like to say, this should be looked at as a challenge, rather than a problem.

EXPORT ACCESS is the Authorized Agent for UK & Ireland for REGISTRAR CORP, USA – the leading global provider of compliance services for goods entering the USA which are subject to regulation by the US Food & Drug Administration (FDA)