FDA Consulting for Compliance of Food Products, Cosmetics, and Dietary Supplements Intended for the United States of America

ExportUSA offers a consulting service on FDA procedures necessary to ensure compliance of food products, cosmetics, and dietary supplements intended for export to the American market. 

ATTENTION: New FDA Inspection Procedures Starting May 6, 2025

Important change for FDA inspections of foreign manufacturers: Starting May 6, 2025, FDA inspections will be conducted without prior notice.

The U.S. Food and Drug Administration (FDA) announced today, May 6, 2025, its intent to conduct surprise inspections without prior notice at foreign manufacturing facilities for food products, cosmetics, dietary supplements, and medical devices.

The initiative is based on the pilot program Foreign Unannounced Inspection by the Office of Inspection and Investigations active in India and China, aiming to ensure that foreign food production facilities are monitored equivalently to American manufacturers.

Analysis to Outline the Path to FDA Compliance

It often happens that it is not immediately clear what needs to be done to make a product FDA compliant for importation into the United States. Sometimes it is necessary to determine if the FDA allows the use of ingredients, or it may be necessary to review product labels to ensure they fall under cosmetics and not, for instance, drugs. A consultation on FDA regulations and procedures helps to understand what is required to make the product compliant for the United States, avoids potentially costly errors, and speeds up the time to enter the American market. 

ExportUSA also offers consulting services for the 510k procedure for compliance of Class II medical devices to be exported to the American market.

On this page of the ExportUSA website, we provide insights into Company Registration with the FDA and the Mandatory FDA Agent Service for importing food products into the United States.

The FDA Agent Has No Commercial Role

The FDA Agent acts solely as the recipient of every type of official communication from the FDA regarding the company's registration

The FDA Agent therefore does not have the authority to represent the company or to make any decisions that commit the company in any way. It is a convenience role to facilitate FDA communications with the exporting company. Imagine how problematic it would be for the FDA to have to communicate with food companies scattered all over the world, in every time zone, and having to communicate in dozens of different languages!

 

Export USA Offers FDA Agent Service at Competitive Prices with No Long-term Contractual Obligations

As an export consulting company based in New York, we are able to effectively respond to the needs of companies that must ensure compliance of food products to be imported into America. In particular, we refer to the necessity of renewing FDA registration biennially.

In this regard, we emphasize that Export USA, unlike what is practiced by other FDA consulting firms, does not bind its client companies to multi-year renewal plans and does not require signing contracts in this regard.

Your company remains free to continue the FDA agent relationship with us, or to terminate it at the end of each year. In addition, ExportUSA can boast the best prices on the market for FDA Agent services and food product certification services for importation into the United States. Below are the prices for the FDA agent service:

• FDA Agent Service for food exporters: $640 per year for the first year, and $480 per year for subsequent years. 
• FDA Agent Service for medical device exporters: $850 per year.

Contact us to learn about all the FDA services offered by Export USA

 

Importance of the FDA Agent Role for Importing and Selling Food Products in America

The FDA agent can be an individual or a legal entity residing in the United States, who acts as the representative of the exporter to the FDA. All non-American facilities producing, packaging, or storing food products, alcoholic and non-alcoholic beverages, and dietary supplements are legally required to appoint an FDA agent.

Moreover, all communications between the FDA and the exporter's facility occur through the FDA agent, who can intervene in case of bureaucratic issues. For example, it may happen that goods are stopped at customs. In such cases, the FDA does not contact the exporter but rather their customs agent. In these instances, the FDA Agent, being in America, can promptly intervene to assist with the clearance of goods. In summary, the importance of the FDA agent is twofold: it is legally mandatory, and it can provide prompt assistance for technicalities related to export and sales activities in the American market.

Documentation and Information Required for FDA Registration

To register your facility with the FDA, the following documentation and information must be provided:

• Facility information: address, phone number, email, contact name, business name, and type of activity conducted within the facility (whether production, packaging, or storage). 
• Mailing address of the legal entity.
• FDA agent details: if it is an individual, you must provide name, surname, address, phone number, and email. If the FDA agent is a legal entity, you must provide the business name, address, and email. 
• Product details: you must specify whether it is intended for animal or human consumption, and its technical characteristics.
• Applicant details for FDA registration. The applicant can be the FDA agent, the owner of the facility, or an authorized third party.
   

Registering with the FDA: Frequently Asked Questions

Below are some of the most frequently asked questions we receive from companies when they need to register their company with the FDA for importing into the United States.

1) How long does FDA registration last?
Two years.
2) How long does registration take?
Up to one week.
3) Do I need to apply for FDA registration?
It is mandatory for anyone who produces, packages, or stores food and beverages destined for the American market.
4) Can I ship after registration?
It depends on the product. As a general rule, the first step is FDA registration, after which product labels with nutritional values must be compliant. Additionally, for some products, additional information is required. For example, for dairy products, a veterinary certificate from the ULSS is required.
5) If production and labeling are done by different entities, which one needs to register?
Considering a scenario where a product passes through two facilities; if the second facility makes any modifications to the product, then only the second facility must register. Conversely, if the second facility only applies the label, both must register with the FDA.