FDA: Keys to exporting to the U.S.A.

FDA: Claves para exportar a EE.UU.


FDA , the U.S. Food and Drug Administration, is the government agency responsible for overseeing the regulation of food, human and animal drugs, cosmetic products, medical biologics (including blood derivatives) and vaccines, among others.


FDA Functions

The FDA’s responsibilities are as follows:


  • Safeguard public health in the United States through oversight of human and animal drugs, vaccines and other biological products, medical devices, cosmetics, and radiation-emitting articles.
  • Promote public health by encouraging innovation.
  • Provide the public with accurate, science-based information to enable them to use drugs, medical devices and foods (including novel foods or production methods) safely and effectively.
  • Responsible for regulating the production, sale and distribution of tobacco products, with the aim of protecting public health and reducing underage consumption.

FDA: Claves para exportar a EE.UU.

What does the FDA regulate?


In general terms, the FDA oversees:

  • Foods, covering: dietary supplements, bottled water, food additives, infant formulas and other food products. It should be noted that the U.S. Department of Agriculture has a major role in regulating certain aspects of meat, poultry and egg products.
  • Drugs, which include: prescription drugs (both brand name and generic) and over-the-counter drugs.
  • Biological Products, which include: human vaccines, blood and blood products, cell and gene therapies, tissue and tissue products, and allergens.
  • Medical Devices, which range from simple items such as tongue depressors and chamber pots, to advanced technologies such as pacemakers, dental devices, surgical implants and prosthetics.
  • Electronic products that emit radiation, such as: microwaves, X-ray equipment, laser products, ultrasonic therapy devices, mercury vapor lamps and sun lamps.
  • Cosmetics, including: color additives in makeup and other personal care products, skin moisturizers and cleansers, nail polishes and perfumes.
  • Veterinary Products, covering: livestock feed, pet food, veterinary drugs and devices.
  • Tobacco Products, such as: cigarettes, cigarette tobacco, rolling tobacco and smokeless tobacco.

Meaning of FDA product approval


As previously mentioned, the FDA is responsible for overseeing and approving certain products that have undergone various phases of studies to ensure their safety and suitability for human and animal consumption.

However, not all products on the market require prior approval. In some cases, the agency focuses on regulating products after they are launched on the market.

This practice is dictated by the U.S. Congress, which defines FDA’s authority. Even in situations where prior approval is not required, the FDA has the power to intervene if safety issues arise with products already on the market.

How does your export influence the U.S.?

The FDA plays a fundamental role in the process of exporting to the United States. The following highlights the importance of the FDA and its impact on exports to the United States:


Regulatory compliance

The FDA requires products such as food, drugs, cosmetics and medical devices to meet specific standards before they can be marketed. By ensuring that products comply with FDA requirements, exporters can guarantee their acceptance in the U.S. market.


Public health protection

The FDA is responsible for protecting public health in the United States by rigorously evaluating products and monitoring their safety. This prevents the marketing of potentially dangerous or unsafe products, ensuring that U.S. consumers have access to safe, high-quality products.

For exporters, obtaining FDA approval demonstrates that their products meet the standards necessary to protect the health of consumers, thereby increasing confidence in exported products.

Access to a large market

The United States, one of the largest markets in the world, has a significant demand for products from a variety of industries. Obtaining FDA approval allows exporters to access this vast market and take advantage of the commercial opportunities available.

By complying with FDA requirements, exporters can ensure that their products are in compliance with the standards necessary to enter and compete in the U.S. market.

Credibility and reputation

Recognized internationally as a rigorous and reliable regulatory authority, the FDA’s endorsement indicates that products have been thoroughly evaluated and meet established standards. This not only enhances the reputation of the exporting company, but also facilitates product acceptance by distributors, retailers and consumers in the United States.

In short, obtaining FDA approval not only allows entry into one of the largest markets in the world, but also enhances the reputation and credibility of exporting companies. The FDA’s influence is crucial to ensure the quality and safety of exported products, protecting public health and facilitating commercial success in the United States.