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Let's Talk FDA

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If you are a food company hoping to begin business or distribution in the US, the FDA approval process should be very high on your list of priorities. It can be an extensive process if not handled properly. The first steps should include having a full understanding of the requirements as well as the necessary specific approvals.

What is the FDA? The Food and Drug Administration is the department responsible for protecting public health and regulating all consumable products in order to maintain the safest level of public health in the US. Before a new food product or consumable product can enter the borders of US from a foreign country, it must first be approved by the FDA.


Why Registering Your Business is a Must. If you are interested in exporting in the U.S. the first thing to do is to get yourself familiar with the FDA website as it provides critical information for successfully completing the process. As a first step, you are required to register your company on the FDA Portal. In this case, it is important to highlight all units/establishments of your business involved at any level (production, transformation, packaging or storage) in the process of making the good, all of which must be registered.


Once your company starts the registration process, it is required to indicate an individual, called FDA Agent, that will work as an intermediary between the company and the FDA for urgent communications. Once the FDA Agent is approved and the registration process is completed, the FDA will give you a “Registration number” which, from that point on, will have to be present in any invoices or company communications with the FDA.


The Food Safety Plan. As of September 16, 2016 the "Final Rules" required by the FDA's "Food Safety Modernization Act" (FSMA) became mandatory. All companies producing US market goods must submit their Food Safety Plan validated by the Preventive Controls Qualified Individual (PCQI). The “Final Rules” are equally valid for United States based companies and foreign-based businesses and they mainly concern the “Preventive Controls for Human Food”. There are two main systems/measures of preventive control based on risk analysis. The HARPC (Hazard Analysis and Risk Based Preventive Controls) and the HACCP (Hazard Analysis and Critical Control Points) which is also mandatory in the European Union. The Food Safety Plan must be developed by using these two measures. The elaboration and validation of the Food Safety Plan will be a responsibility of a new key figure called Preventive Controls Qualified Individual (PCQI) who will be responsible for the food company for the total implementation of the internal control system. The PCQI, whose presence is mandatory, can be a person inside the company or an external consultant but must carry out a specific training and obtain a special diploma issued by a recognized organization, the Food Safety Prevention Controls Alliance (FSPCA).


Labels, Ingredients and Prior Notice. Another fundamental aspect that is very relevant is the revision of the labels according to the FDA legislation which, with the last update, has made substantial changes in particular to the nutritional values label.


There are some ingredients prohibited by the FDA, in particular dyes and additives. It is essential to check your recipe by consulting the FDA website and in particular the "Overview of food ingredients, additives & colors" available at this link: https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm094211.htm


For each shipment of products intended for human consumption in the United States, it is mandatory to send an advance notification ("Prior Notice") from the FDA website. The information requested is: FDA number, summary description of the products, data of the importer, contact person and any additional details on the type of transport. For more information visit the FDA portal: https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm2006836.htm


Other Certifications. Producers must also evaluate the need for further certification to export its product to the United States. These include the FCE (Food Canning Establishment) and the prior import authorization (SID procedure) relating to canned and long-life products such as sauces, tuna in oil, truffles and preserves.

Conclusion. For further FDA information be sure to check out the official FDA website or with a law firm who is an expert in the food industry. Remember, this information is a vital step in entering the US market, so make sure you are very familiar with FDA requirements.