What is the US FDA?

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What is the FDA?

The FDA (Food and Drug Administration) is a Federal Agency under the Department of Health and Human Services (Department of Health and Human Services), one of the US Federal Executive Offices.

The Agency was established in 1862 and regulates food, cosmetics, medicines and medical devices through testing and research. It is the equivalent of Anvisa in Brazil, for example.

What is the purpose of the FDA?

The purpose of this regulatory authority is totally broad in its responsibilities towards the government and is linked to aspects of several other government agencies. Because it is based on many technical terms and rules, it becomes a little confusing and difficult at first, and that's why it's important to have a consultation and knowledge of the rules during the process.

As responsibilities are tied to various regulatory government agencies, confusion often arises when identifying which agency is appropriate to contact.

FDA has also the purpose of regulating and ensuring the safety of marketing foods that are fit for consumption and within safety standards.

What is FDA is responsible for?

• Protecting public health by ensuring that foods (with the exception of beef, chicken and some egg products, which are regulated by the Department of Agriculture) are safe and properly labeled;

• Ensuring that human and veterinary medicines, vaccines and other biological products intended for human use are safe and effective;

• Protect the public from radiation emitted by electronic products;

• Ensuring that cosmetics and food supplements are safe and properly labeled;

• Regulate tobacco products;

• Promoting public health by helping to accelerate product innovations.

All FDA responsibilities extend to the 50 US states, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and any other US territories and possessions.

Characteristics for Imports

The FDA controls all American and imported products to be sold in the United States, and the company and products that are not properly regulated by the FDA will not be able to enter the giant American market. It is the FDA's job to prevent consumers from being harmed, harmed, or even harmed.

US importers are responsible for actions that include:

• Determining known or reasonably foreseeable hazards with each food;

• Assess the risk posed by a food, based on risk analysis and the performance of the foreign supplier;

• Use that assessment of the risk posed by an imported food and supplier performance to approve suppliers and determine appropriate supplier verification activities;

• Carry out supplier verification activities;

• Carry out corrective actions;

• Comply with the requirements of the supply chain program in accordance with the rules of preventive controls;

• Implement preventive controls for risks in food in accordance with the requirements in the preventive control rules; or they are not required to implement preventive controls in accordance with these rules in certain specific circumstances;

Examples of such circumstances include the type of food such as coffee beans that could not be consumed without the application of preventive control, or when the customer is significantly minimizing or avoiding identified risks and they comply with requirements for disclosures and written assurances.

There is also a risk analysis that includes:

• Biological hazards, including diseases caused by parasites and bacteria

• Chemical hazards, including radiological hazards, pesticides and drug residues, natural toxins, food decomposition, unapproved foods or dyes, and food allergens

• Physical hazards , such as glass

• Food formulation of Condition, function and design of the establishment and equipment of a typical entity producing the food.

• Raw materials and other ingredients o Transport practices o Harvesting, growing, production, processing and packaging procedures.

• Packaging and labeling activities of Storage and distribution.

• Reasonable intended or intended use of Sanitation, including employee hygiene.

Overview

The regulation, however compromised it may be, cannot verify and evaluate all products before they are marketed. As a result, the FDA often focuses on focusing enforcement on products that are already on the market and under whistleblowing. In this case, they act assertively, correcting possible product safety irregularities.

In summary, the FDA does not monitor production on a day-to-day basis, but specifically of the category itself, making it important to standardize all merchandise that has already undergone a previous inspection. It is up to companies to be attentive to norms and standards so that there are no health-related problems, labeling errors, complete product category specifications, and ensure that they are marketed correctly within the sector that encompasses them.

How to get the FDA?

In order to obtain FDA registration, it is necessary that the owners of companies that wish to start marketing their products and that fall within the FDA inspection funnel have an agent in the United States that represents the company in the United States.

“US Agents” may be a private company or an individual residing in the US and, as such, are subject to US law. Foreign companies must provide details of their US agent to the FDA, including their address and telephone number. The authorized agent acts as an intermediary between the FDA and the foreign company. FDA contacts the US agent directly for registration-related updates for registration approval.

If your company wants to export to the United States and is in one of the aforementioned sectors, you must hire an experienced Agent who will be responsible for communicating directly with the FDA on your behalf, responding quickly and in an organized manner, ensuring a smooth flow between your company and the American agency.

B2USA has an office in Miami and is an agent suitable for this representation. The company also has a structure in Brazil to serve companies that wish to enter the American market, enabling work on all the necessary fronts to adapt to standards, registration processes and export regulations.

Contact our Traders, professionals responsible for the registration and documentation processes and request a quote for your FDA registration and agency in the United States. Start exporting safely now.