Food & Beverage
FDA food regulations reach all foods and all beverages distributed in interstate commerce in the U.S.A. except for products that are regulated exclusively by the U.S. Department of Agriculture (USDA). USDA food regulations govern meat (beef, lamb, pork), poultry, eggs, and products made from meat, poultry, and eggs.
FDA food regulations and FDA beverage regulations cover domestic and imported food safety, food adulteration, and food labeling. FDA’s food regulatory authority includes, for example: fresh produce (fresh fruits and vegetables), processed foods (dry goods, canned foods, acidified foods, prepared meals, etc.), dietary supplements and nutritional supplements, fruit and vegetable juices, carbonated drinks, functional beverages (such as energy drinks), bottled water, dairy products (cheeses, milk, milk products, yogurts, etc.), seafood products, food ingredients, food color additives, food contact surfaces (containers, utensils, food manufacturing surfaces, beverage containers and food containers), and some alcoholic beverages (beer, wine).
All food establishments that manufacture, pack and store food are subject to FDA Food Facility Registration. FDA Food Facility Registration must occur before the imported foods arrive in the U.S. for human or animal consumption.
Some food products are subject to special and additional regulations, including low acid canned foods (LACF), acidified foods (AF), pasteurized grade A dairy products, food colors, food contact surfaces, alcoholic beverages (although alcoholic beverages are permitted for sale in the U.S. by the Bureau of Alcohol Tobacco and Firearms, Tax and Trade Bureau (TTB)), etc.. FDA regulates imported foods differently by requiring some pre-market review or FDA approval prior to importing food for commercial distribution in the U.S.
Food labels must be correct or the foods are misbranded under U.S. law. That is, the food labels must bear all the required information in the correct formats using the correct fonts and information placements, and food labels may not bear labeling claims or statements that are not permitted by FDA regulation.
It is clear that there are many specific requirements for many different foods that must be met before foods are imported into the U.S. .
DIARY IMPORT LICENSING PROGRAM
Licenses permit the holder to import specified quantities of dairy products into the United States at the applicable in-quota rate of duty. If an importer has no license for an article subject to licensing, such importer will, with certain exceptions, be required to pay the applicable over-quota rate of duty.
Dairy products for which license is mandatory are:
Milk and cream, buttermilk, curdled milk and cream, yogurt, kefir, whey, butter and other fats and oils derived from milk, cheese and curd, margarine cheese, ice cream and casein.
To apply for any license, a person shall have in general:
- A business office, and be doing business, in the United States, and
- An agent in the United States for service of process, and
- An email address to be used for correspondence regarding licensing activities and reports.
Application for license shall be made on electronic forms designated for the purpose by the Licensing Authority. Individuals must apply annually for a license between Sept. 1 and Oct. 15 of the year preceding that for which license application is made.
If a licensee determines that it will not enter the entire amount of an article permitted under its license, such licensee shall surrender its license right to enter the amount that it does not intend to enter.
For each quota year, the Licensing Authority will, to the extent practicable, reallocate any amounts surrendered.
EXPORT OF PORK MEAT TO THE U.S.
FSIS / USDA and APHIS / USDA United States Authorities permit the export to the United States of the following pork products:
- cooked meat products, subjected to heat treatment which promotes the achievement of + 69 ° C at the core of the product (mortadella, cooked hams);
- sterilized products (cotechino);
- raw meat products (ham aged for over 400 days);
- raw meat products seasoned less than 400 days from slaughterhouses from other EU countries free of swine vesicular disease (SDV) and approved for export to the United States.
In order to be listed as authorized to export the establishments are subject to controls and monitoring by Ministry of Health inspectors; the slaughterhouse must also be recognized as suitable for export.Subsequently, companies are periodically inspected by FSIS officials who check the level of control measures ensured in the establishments.
Since 28 May 2013 some new Italian regions have been recognized as free from SVD; consequently, new procedures have been defined for obtaining approval to export pork meat products not heat treated and seasoned less than 400 days.
Currently, establishments from the so-called macro-regional area which includes Lombardy, Emilia-Romagna, Veneto, Piemonte, the autonomous provinces of Trento and Bolzano, Friuli, Liguria, Marche and Valle d'Aosta may request for being included in the list.
LOW ACID CANNED FOOD (LACF) / ACIDIFIED FOOD (AF)
The FDA’s Good Manufacturing Practice Regulations (21 CFR 113-114) prescribes that all operators of retorts, processing systems, aseptic processing and packaging systems and container closure inspector be under the operating supervision of a person who has satisfactorily completed a school of instruction in these matters.
Our professionals are accredited as Operating Supervisor at the Agriculture and Natural Resources, University of California, and we are able to support you in the registration procedures of your establishment and your ACIDIFIED (AF) and LOW ACID CANNED FOOD (LACF) for the exportation to the US.
COLOR ADDITIVES, FOOD INGREDIENTS AND PACKAGING - GRAS / FCS / FCN
Any substance that is reasonably expected to become a component of a food is a food additive and is subject to premarket approval by the FDA, unless the substance is generally recognized as safe (GRAS).
Any food additive that is intended to have a technical effect in the food is considered unsafe unless it either complies with the terms of a regulation prescribing its use or to an exemption for investigational use.
Similarly, any substance that is added to a food imparts color to the food is a color additive.
Any color additive in food is considered unsafe unless its use is either permitted by law or is exempt by regulation. Unlike the food additives, there is no GRAS exemption for color additives.
It is the responsibility of the manufacturer to ensure that all ingredients used comply with the specifications and limitations of the applicable authorizations.
To determine compliance, each authorization should be composed of three parts:
identity of the substance
specifications, including purity and physical properties
limitations on the conditions use
The individual substance that is reasonably expected to migrate to food because of its intended use in the food contact material shall be covered by one of the following specific regulatory framework:
a regulation listed in Title 21 Code of Federal Regulations
meeting the criteria for GRAS status
a prior sanction letter
a Threshold of Regulation (TOR) exemption request
or an effective Food Contact Substance Notification (FCN).
The Federal Food, Drug, and Cosmetic Act states that every FCN is effective for the manufacturer, the specific substance and the conditions of use identified in the notification and not effective for a similar or identical substance produced or prepared by a different manufacturer other than the manufacturer identified in the prior notification.
Alcoholic beverage imports, distribution, storage and wholesaling is regulated in the U.S. primarily by the Bureau of Alcohol Tobacco and Firearms (BATF). An agency of that bureau, the Alcohol and Tobacco Tax and Trade Bureau (TTB), primarily issues permits for companies to operate as alcoholic beverage businesses in the U.S. TTB also strictly regulates the labels that appear on all alcoholic beverages, whether the alcohol is produced domestically or in foreign processors. The various states and localities (counties and cities) also regulate alcoholic beverage distribution, importation, storage, wholesale and retail operations and issue permits that allow businesses to perform these business operations.
All imported articles are subject to Customs requirements and alcoholic beverages are also “foods” under the Food Drug and Cosmetic Act (FDCA). As a result, importing alcoholic beverages occurs under the watchful eyes of several different federal agencies.