FDA Certification for Exporting Food Products to America

FDA certification ensures that your food products comply with FDA regulations for sale in the American market.

From registration to the appointment of an FDA Agent, renewal of registration, label review, to the creation of nutrition facts: All the steps for FDA certification of food products intended for the American market and to be in compliance with the import regulations in America. 
 

Critical Aspects for FDA Certification of Certain Categories of Food Specialties

Overview of FDA Regulations for Compliance and Certification of Food Specialties

FDA standards apply to both producing companies and the food products themselves. Some food products, such as those with long shelf lives or those containing milk or eggs, require additional certification procedures or import permit applications. This page provides a comprehensive overview of all FDA requirements affecting both the players in the distribution chain (producers, importers) and the food products to be exported to the United States. The goal is to provide a checklist for both producer compliance and product compliance, to be used for selecting suppliers and food products to import and market in America.
 

FDA Standards for Food Producers and Exporters

There are three main requirements for exporting food to the United States that concern all producers and exporters regardless of the exported product.

FDA - https://www.fda.gov/

• 1) FDA Registration
  The first requirement for exporting food products to the United States is to register with the FDA and obtain a registration number that must be mentioned in all import procedures in America. Registration is mandatory for every establishment involved in the production, processing, packaging, or storage of food products intended for consumption in the United States.
• 2) Appointment of an FDA Agent
  During FDA registration, if the production establishment is outside the United States, the FDA requires the appointment of an FDA Agent, which is an agent representing the company with a domicile/headquarters in the United States. This is a formal (non-commercial) representation, serving as a liaison between the FDA and the producer to address any communication or issues that may arise.
• 3) FSMA Compliance
  Recently, the FDA introduced the FSMA, a legislative package impacting all food sector operators (from producers to importers) with the goal of ensuring the safety of food products sold in the USA. It applies to producers and production processes, as well as to importers who must implement a verification program on imported products.
  Below, we will provide a dedicated section on the FSMA summarizing the standard's contents; generally, since it is a relatively recent legislative package, we anticipate from experience that many producers—unless they export regularly and substantially to the USA—are not yet FSMA compliant and must undertake all compliance actions.

FDA Standards for Food Product Compliance for Export to the USA

Just as with producer compliance, there are also cross-cutting requirements that apply to all categories of food products, complemented by certain specific requirements that pertain only to certain products.

Except for certain processes requiring prior FDA approval, it is important to note that the processes listed below are NOT subject to prior FDA approval.

In other words, the FDA does not approve or review anything in advance but only sets the rules and leaves it up to the producer/exporter to ensure compliance. What the FDA can do is conduct inspections upon import to verify product compliance afterward. In the case of imported products, this inspection occurs as soon as the goods are cleared through customs in the USA. Here are the main requirements:

• 1) Label Content Review
  • Labels of food products sold in the United States must be designed according to FDA standards. These are very precise and specific standards concerning both the content and the form of the label, meaning they pertain to both WHAT is written on the label (in terms of content) and HOW it is written (in terms of size, position, etc.).
    An European/Italian label is generally NOT FDA compliant, first because it is not in English (mandatory requirement), and secondly because European regulations are very different from those of the FDA, which is why all labels must be reviewed and brought into compliance. The main areas to review and bring into compliance are:
    - Elements of the front part of the label (product name, net weight)
  • Ingredients
  • Allergens
  • Colorants and preservatives
  • Claims
  • Information about the producer/importer/distributor.
  • For each of these areas, FDA regulations are very extensive, so it's necessary to check each time to ensure that ingredients are authorized, that allergens are correctly indicated, that the product name is correct and permitted in the USA, etc. In particular, for certain products, the FDA has published a Standard of Identity, meaning it has established a definition and a name that must always be adhered to sell the food product for which a Standard of Identity has been promulgated. Therefore, it's always necessary to check if there is a Standard of Identity and, if so, to ensure the product complies with this standard to avoid it being deemed mislabeled. This applies to ALL products marketed in the USA, regardless of the category.
• 2) FDA Nutrition Facts
  The second requirement common to ALL products is the nutrition facts panel, the Nutrition Facts. Again, FDA regulations are very precise, especially concerning rounding and the identification of the reference RACC. It is indeed important to specify that, unlike in Italy where nutrition facts are established on 100g, in the USA, the Nutrition Facts are calculated based on the portion that, according to the FDA, is normally consumed for this type of product. As with label contents, there are also detailed rules for listing the mandatory nutritional values and how to present them graphically. It is important to note that in 2016, the FDA updated the Nutrition Facts, so anyone who had drafted the NF before this date must comply with the new format.

Other FDA Regulations Related to Certain Categories of Food Products for Sale in America

In addition to label review and nutrition facts, which apply across all products, there may be additional requirements that apply only to certain product categories.

FCE Registration and SID Procedure
The first category of products requiring an additional step beyond label and nutrition fact compliance is Acidified and Low-Acid Canned Food, which includes canned goods, vacuum-packed or low-acid products, and artificially acidified food products.

A low-acid food product is a food product [excluding wine and alcoholic beverages] with a final equilibrium pH above 4.6 or with an "activity water" greater than 0.85 [an example of a low-acid product but with an "activity water" below 0.85 is jam, where the high sugar content drastically reduces aw].

An artificially acidified food product is one that is naturally low-acid but whose final equilibrium pH has been reduced by the addition of acidifiers. Or a food product whose "activity water" level has been lowered to less than 0.85.

The FCE registration and SID procedure is the only case of pre-import and sales authorization procedure by the FDA. As mentioned earlier, for other products, the FDA merely dictates the rules and then checks, during the import procedure in America, that compliance is consistent with the rules issued by the FDA itself.

The control of the production process for the aforementioned product classes is related to the risk of botulism development, which, in the absence of oxygen and at acidity levels above a pH of 4.6, is very high.

In such cases, the Food and Drug Administration requires the producing company to register and obtain the so-called FCE [Food Canning Establishment - download the pdf document] number and, for each product class, obtain sterilization process certification. Once certified, the SID number is assigned and must always be included in customs documentation for import to the United States.

Thus, while the FCE registration number pertains to the company, the SID number is specific to the certified product family. The central element for granting SID certification is the validation of the autoclave [autoclaves] used to sterilize the product in question [canned goods, ready sauces, jams, peeled tomatoes, mushrooms or truffles, cheese creams, etc.]

Import Permit Request
For certain types of food products, it is necessary to request an import permit ["Import Permit"]. This is an authorization for import to the United States requested and issued by the USDA [United States Department of Agriculture]

The food specialties for which it is necessary to make an import permit request are those containing animal proteins such as milk, milk creams, powdered milk, eggs, or powdered eggs, when the animal protein is raw, meaning not fully cooked during the preparation process.

For this reason, it is necessary to evaluate the product's production process to determine whether it is subject to an Import Permit. For example, ice creams, cream cakes, frozen brioche preparations, etc., will be subject to an Import Permit.

If, on the other hand, animal proteins (powdered milk, eggs, powdered eggs, etc.) are cooked before import, it will suffice to attach to the customs documentation for import to the United States compliance declarations issued by the veterinarian of the ASL of the ingredient's country of origin.
 

FDA Compliance for Major Categories of Food Products

The table below identifies the FDA regulatory requirements that apply to certain categories of food products typically imported to the USA. All long-shelf-life products are slightly more complex because they require the autoclave validation process as well as FCE registration for the producing company and the SID procedure. For these products, the advice is to select suppliers who already export to the USA and are thus already in compliance in this regard.

Finally, meats and cold cuts are a problematic category to export to the USA because the compliance process is regulated by the USDA, and the requirements are so "prohibitive" and costly that very few Italian meat and cold cut producers are certified to export to the USA. For this type of product, the advice is to purchase directly on-site from distributors who already import Italian cold cuts and thus take care of all compliance activities.

In conclusion of this section, the comment is that FDA compliance—although a significant topic requiring a lot of attention—should not be seen as an obstacle but rather as an investment to make initially to standardize everything necessary, which, once completed, allows continuous export of food products to the United States. ExportUSA has always handled all FDA compliance activities and can assist you in all necessary steps for FDA compliance.