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The United States has the largest economy in the world and an extremely business-friendly environment. They offer a series of incentives for those who wish to undertake and invest in the country. The economic attractions and the possibility of operating in a country with a stronger currency motivate companies of various nationalities to seek ways to explore this market. For those who wish to do so through exports, in many cases, it is necessary to register products with the FDA – Food and Drug Administration.
The registration of products with the FDA is essential to ensure that exported goods are admitted into the country.
Each product category covered by the FDA has its own regulation, and therefore extensive knowledge is required to understand the necessary requirements before starting the registration procedure. This bureaucratic and complex aspect can represent a barrier for exporters interested in accessing this market, especially small and medium-sized companies.
UCA offers consulting services for product certification in the USA. Our consulting services for product registration with the FDA are complete. We assist companies of any nationality from the first steps toward FDA product registration and promote continuous learning about procedures.
The FDA Food Safety Modernization Act (FSMA) was passed by the US Congress in response to dramatic changes in the global food system. Another major motivation was the realization of the risks posed by foodborne illness and its consequences on public health, creating food insecurity, and, on the economy, creating barriers to international trade.
FSMA’s purpose is to transform the food safety system in the United States. Its goal is to combat contamination from foodborne diseases through a strategy of prevention.
To this end, the FDA has established rules for implementing the new legislation, which clarify the actions required at all points in the global supply chain to prevent contamination from foodborne illness.
The Food Safety Modernization Act enables voluntary certification (VQIP) of foreign suppliers, which is a prerequisite for importers who wish to expedite the admission of food exported to the US through customs. It adds to the objectives of the FDA’s product registration requirements, allowing for streamlined product compliance testing.
Having the FSMA – VQIP certification demonstrates that the US importer is in compliance with the established requirements and rules. Brazilian companies and companies of other nationalities can also obtain the certification, becoming certified as a foreign supplier.
FDA’s Voluntary Qualified Importer Program Certification (FSMA – VQIP) covers foreign suppliers. With it, Brazilian companies and companies of other nationalities have helped to understand what are and how to meet the requirements for certification of foreign suppliers required by U.S. companies.
The certification is a way to maintain serious measures for the safety and welfare of the population. The reason for this is that with globalization and the strengthening of international trade, the flow of people and products between countries has taken on ever greater proportions.
Consequently, the risks of people and organizations taking advantage of this volume of commercial flow to send illicit or improper products, outside of customs inspections, promoting trafficking, smuggling, laundering of drugs and weapons, money, among other criminal activities, have also increased. The FSMA – VQIP certification is a tool to streamline customs workflows, making them faster and also safer.
In practice, the certification attests that the transportation of products already certified in their country of origin is done within the FSMA norms, arriving in the United States in the necessary conditions to enter the country. This speeds up the goods admission process at customs, avoiding the need for the cargo to wait for clearance upon arrival at its destination.
Aiming to establish a connection between the Brazilian and U.S. markets, UCA offers full FDA product registration consulting services, which include planning and carrying out company accreditation in accordance with FSMA – VQIP requirements.
We have the following backing for this:
VQIP certification is issued to certify that not only does the manufacturing facility comply with the food safety requirements set for product registration with the FDA but the transportation of the goods as well.
VQIP certification is issued to attest that not only do the industrial facilities comply with the food safety requirements established for product registration with the FDA but also the transportation of the goods.
The UCA performs the mandatory regulatory audit, which can be supplemented by an optional consultative audit. Both cover all food safety regulations established for product registration with the FDA applicable to categories of foods that may be marketed for consumption in the United States.
The optional advisory audit is an audit that is a valuable exercise for foreign suppliers who want the experience of a full audit, but only for internal purposes. From it, a detailed report is generated that allows the company to check how close it is to becoming certified and to make necessary adjustments in preparation for the regulatory audit.
The regulatory audit is a successfully completed audit that leads to the issuance of the FSMA – VQIP certificate. Once granted, the certification is valid for 12 months and a follow-up audit is mandatory before it expires.
