To successfully trade from one place to another, especially between countries, you must ensure that you follow each of the customs requirements.  

Whether submitting certain documents, inspections, or guarantees like a customs bond, your cooperation helps the U.S. Customs and Border Protection (CBP) protect its territory, population, and commercial alliances.

Although the CBP is not the only one that looks after the population’s wellbeing, there is also the federal agency of the United States Department of Health and Human Services (HHS), the FDA (Food and Drug Administration).

This agency doesn’t ask for a bill of lading, certificate of origin, or commercial invoice for the same logistics reasons as the CPB. Yet, their impact on the import process is quite significant. Find out why the FDA plays such an important role in all importation activities. 

What is the FDA?

The FDA, or the Food and Drug Administration, is the federal regulatory agency responsible for protecting public health by ensuring that all food, drugs, biologics, medical, cosmetics, veterinary, tobacco, and electronics products entering and being distributed in the country meet all quality and safety requirements.  

This type of requirement covers both products imported into the United States for sale and distribution purposes, as well as products for personal use. 

If you plan to import any items that fall under the jurisdiction of the FDA, a mexican custom broker will help you file any documents that would speed up the customs process and ensure that your goods meet all FDA requirements.

FDA functions on importation processes 

So far, you know that the FDA regulates the entry and sale of certain products. For importers, this means a loss of investment if they fail to pass the review process. Hence, it is important to rely on the advice of your custom brokers in Manzanillo as well as the guidelines provided by the FDA.  

What other functions does the FDA have that may affect your business’s importation processes? We will explain a few of them.

1.- Determines admissibility

If the importer declares goods at the CBP and the Harmonized Tariff Schedule (HTS) code indicates that some or all of the items fall under FDA-regulated products, the officials in charge will immediately transfer the goods to the FDA agents for the entry review process. 

During this inspection, the importer or their mexican custom broker must submit an entry that includes the product code and descriptions, country code identifying where the product was produced, name and address of manufacturers, affirmation of compliance codes, and other physical evidence depending on the situation. 

If the importer fails to submit this documentation or if the products appear to be adulterated, misbranded or are among the prohibited and restricted items for consumption and sale in the U.S, then the FDA would take actions to detain, refuse entry, or destroy the products. 

In severe cases, for example, if the products are counterfeit, or have been intentionally mislabeled to deceive and harm consumers, the FDA may also pursue legal action against the importer, including fines or other penalties, ultimately affecting their business reputation.

2.- Oversees the protection of public health 

Overall, the reason why the FDA applies such strict requirements to all products imported to the U.S. is to protect public health and safety. This stringent regulation ensures that all imported products, from food and electronics to medical devices and cosmetics, meet the highest standard necessary to safeguard consumers.  

However, the FDA work continues once the goods leave customs. Their mission is to monitor these products to ensure that they continue to meet safety and quality standards as they reach consumers. 

The FDA conducts post-market surveillance, which includes inspecting manufacturing facilities, monitoring adverse event reports, and testing products in the marketplace. This ongoing oversight is essential to protect public health and maintain consumer confidence in the safety and efficacy of products available in the U.S.

3.- Provides accessible information  

Another way the FDA protects the public is by sharing information with them about potentially dangerous or severely regulated products. They may issue public alerts, safety warnings, guidance and educational resources to help consumers make informed decisions about their products. 

This transparency promotes a culture of awareness of the risk of unsafe products to the public.

For the importers, this means they must be diligent in ensuring that their products meet all FDA requirements before they reach the U.S. market. This information and the help of their custom brokers in Nuevo Laredo will make it possible for them to comply and enjoy the trade benefits.  

4.- Conducts continuous research 

FDA also plays a significant role in developing scientific advances that make the identification of adulterated products more efficient, especially those needed for medical purposes.  

These investigations also serve as a defense mechanism, where in the event that any health threat arises in the population due to an item previously identified as “acceptable”, the FDA scientists have the necessary tools to address this risk before it becomes more serious. 

As an importer, you must always be aware of any changes in FDA regulations, guidelines and safety standards. This way, you will foster a healthy relationship between your business, partners, customs and future clients. 

Benefits of compliance with FDA regulations 

“FDA approved” is not a simple label, it’s a guarantee that your business has made the effort to meet all the FDA safety requirements, and that you care more about the health and wellbeing of your consumers over potential sales of your products.

Building this trust will allow you to expand your business into horizons that you might not have considered possible years ago. Therefore, we encourage you to continue learning more about the subject and to consult with your mexican custom broker if you have any specific questions.