Sectoral chapters, including Chapter 12, on FDA-regulated products have not been considered in most previous trade agreements, including NAFTA. Therefore, the inclusion of these annexes by the USMCA is an innovation not only in U.S. trade policy, but also for international public health. In addition to its work with the WTO, the United States has concluded trade agreements with 20 countries that cover a number of issues, ranging from tariffs on goods and access to the agricultural market to intellectual property and the environment. For the FDA, the specific themes are chapters of agreements on regulatory issues such as SPS measures, OBTs and good regulatory practices – as well as sector chapters on cosmetics, medical devices and drugs, if any. The FDA helps develop negotiation proposals in the United States and the FDA is actively involved in trade negotiations with U.S. trading partners. In summary, the USMCA contains many provisions that advance public health and FDA regulatory approaches. Now that the agreement has come into effect, we will continue to follow what it means for the FDA, for public health and for our regulated industries. On July 17, 2017, the United States released a summary of the negotiating objectives for the renegotiation of NAFTA. U.S. objectives include deficit reduction, the inclusion of a chapter on the digital economy, and the inclusion and strengthening of labour and environmental commitments currently included in NAFTA`s ancillary agreements. In addition, there is a provision that the agreement itself must be reviewed every six years by the three nations, with a 16-year forfeiture clause.
The contract may be renewed for a period of 16 years during the six-year review period.  The introduction of the Sunset clause gives more control in the organization of the future of the USMCA in the hands of national governments. However, there is concern that this could lead to greater uncertainty. Sectors such as automotive require significant investment in cross-border supply chains.  Given the dominant position of the U.S. consumer market, it is likely that this will put pressure on companies to establish more production in the United States, with a higher probability of higher production costs for these vehicles.  This agreement is the result of a renegotiation between member states of the North American Free Trade Agreement between 2017 and 2018, which formally approved the terms of the new agreement on 30 September 2018 and 1 October.  The USMCA was proposed by U.S. President Donald Trump and signed on November 30, 2018 by Trump, Mexican President Enrique Pea Nieto and Canadian Prime Minister Justin Trudeau as a secondary event of the 2018 G20 summit in Buenos Aires. A revised version was signed on December 10, 2019 and ratified by the three countries, with final ratification (Canada) taking place on March 13, 2020 just before the Canadian Parliament adjourned due to the COVID-19 pandemic. Under the leadership of President Donald J.
Trump, the United States renegotiated the North American Free Trade Agreement and replaced it with an updated and balanced agreement that works much better for North America, the U.S.-Mexico-Canada Agreement (USMCA), which came into effect on July 1, 2020.