FOOD, DRUGS & COSMETICS FDA     USDA

PRODUCTS COVERED Food       Drugs       Cosmetics

FOOD

Labeling | Health and Safety Issues | Bioterrorism | Sanctions | Registration Requirements | Organic Products

The FDA and the USDA jointly regulate importations of food products into the United States.  The USDA regulates meat products and related items, while the FDA regulates most other food products.  The specific regulations that control are, in large part, product specific.  However, a number of FDA requirements have near universal application including Food Nutrition Labeling Requirements, Food Information labeling and Food Phyto-Sanitary requirements.  Importers of food products and foreign manufacturers of food products should make sure that they are aware of any and all issues that face their specific market sector.

Two recent changes with a relatively significant impact on the importation of food products are the Food Allergen Labeling and the Bioterrorism Act.

The Food Allergen Labeling Act greatly expands on information which must be provided on the product label.  It includes specific declarations for products containing any of a number of ingredients, including tree nuts, dairy, and wheat.  This declaration also includes sub products derived from these ingredients.  Products not marked in accordance with this regulation are subject to seizure and the importer and manufacturer will potentially face significant penalties and a recall of their food products.

The Bioterrorism Act imposes a responsibility on both U.S. importers and their foreign producers.  Every domestic producer, every importer, every entity that holds food for distribution, and every foreign producer into the United States MUST PAY CLOSE ATTENTION to the requirements imposed by this law.    This requirement includes pre-registration of the manufacturer with the FDA and detailed record keeping requirements.

Labeling

Food

The FDA requires specific information on food and food packaging including the identification of the source of the food, the standard name (if any) of the food, the weight and ingredients of the product, and the nutrition information.   The FDA has set forth detailed guidelines for each of these requirements.

Product Identification

The FDA has issued standards of identify for a number of food products.  These specific names can only be used if the food product meets the standard of identity.   If the food is not subject to a standard of identity, then the name of the product should be the ordinary name of the food.

Nutrition

The FDA requires the inclusion of nutrition facts information on most food packages.   This information must be calculated based on FDA designated serving sizes and must meet certain other requirements.  

Weights & Ingredients

The FDA requires a declaration of the ingredients in a food product and that the product be labeled with its size or weight.   

Allergen Information

The Food Allergen Labeling Act greatly expands on information which must be provided on the product label.  It includes specific declarations for products containing any of a number of ingredients, including tree nuts, dairy, and wheat.  This declaration also includes sub products derived from these ingredients.  Products not marked in accordance with this regulation are subject to seizure and the importer and manufacturer will potentially face significant penalties and a recall of their food products.

Special Products

The FDA carefully regulates any health claims made on food packaging and only recognizes a limited number of claims.   In addition, the FDA also controls, or limits, other claims on food packages.   Prior to making any claim about a food product, the legality of the claim should be examined.

Health & Safety Issues

Manufacturing Practices

The FDA has specific manufacturer standards and production processes which must be used for certain types of food products.   These standards must be met even if the product is not produced in the US if the product is to be sold for consumption in the US.

Recalls

When a problem is discovered with a particular batch of food products, a company can engage in either a voluntary or mandatory recall of the specific food product.   In a voluntary recall the company works with the distributors and retailers to recover the food from the market and to destroy or rehabilitate the food.   Although this is a voluntary action, it is normally done in conjunction with the FDA.  In a mandatory recall the company is ordered by the FDA to recall the product.  Mandatory recalls normally occur where either the company has refused to engage in an appropriate voluntary recall or where the threat to the health and safety of the users of the food product is high.

Material Ingredients

The FDA has specific standards for certain ingredients used in food products.  For example, if a colorant is used, it must either fall within a group of natural food colorants or must be one of a limited number of approved chemical colors or lakes approved for use in food products by the FDA and must come from a batch of colorant certified by the FDA for use in food products.

Bioterrorism

The Bioterrorism Act imposes a responsibility on both U.S. importers and their foreign producers.  Every domestic producer, every importer, every entity that holds food for distribution, and every foreign producer into the United States MUST PAY CLOSE ATTENTION to the requirements imposed by this law.    This requirement includes pre-registration of the manufacturer with the FDA and detailed record keeping requirements.

Registration – Domestic

All U.S. entities that produce, manufacture, pack, or hold food for consumption in the United States must register with the FDA and obtain a bioterrorism registration number for each such facility.  In addition, every entity must maintain records which will enable the facility to trace all sales and purchases of food product.       

Registration – Foreign

All foreign entities that produce, manufacture, pack, or hold food for consumption in the United States must register with the FDA and obtain a bioterrorism registration number for each such facility.  These foreign entities must also designate a U.S. agent to serve as a point of contact for the FDA.  In addition, every entity must maintain records which will enable the facility to trace all sales and purchases of food product sold for consumption in the United States. 

Pre-notification of Importations

All importers of food products must now provide pre-importation notice of food products shipped to the United States.  If pre-notification is not provided, the product is subject to seizure or detention. 

Sanctions

Administrative Detention

Administrative detention is the process in which the FDA notifies a facility that it is not able to sell or ship product due to FDA concerns about the wholesomeness or safety of the product.  

Recalls

When a problem is discovered with a particular batch of food products, a company can engage in either a voluntary or mandatory recall of the specific food product.   In a voluntary recall the company works with the distributors and retailers to recover the food from the market and to destroy or rehabilitate the food.   Although this is a voluntary action, it is normally done in conjunction with the FDA.  In a mandatory recall the company is ordered by the FDA to recall the product.  Mandatory recalls normally occur where either the company has refused to engage in an appropriate voluntary recall or where the threat to the health and safety of the users of the food product is high.

 Fines

Liquidated damages

In certain cases, the U.S. government and a food producer or importer may enter into a contractual agreement in which the producer or importer agrees to take some particular action.  If the producer or importer does not so act, the U.S. government can imposed liquidated damages.  These liquidated damages are considered Acontractual@ in nature and are normally at amounts fixed by the Acontract@.    

Criminal Sanctions

Denial of Import Privileges

If a company engages in criminal acts involving the importation of food products, it is possible that it will lose its import privileges.  In such case, the company will no longer be able to import food.   This is a very serious sanction which is normally only imposed as a last resort.

Registration Requirements

Federal Canning Establishment (FCE)

The FDA requires the registration of all facilities, both foreign and domestic, engaged in the canning of certain types of food products sold in the US.   This is intended to ensure the health and safety of canned foods sold in the US and ensure that only acceptable canning technology is used. 

Bioterrorism

The Bioterrorism Act imposes a responsibility on both U.S. importers and their foreign producers.  Every domestic producer, every importer, every entity that holds food for distribution, and every foreign producer into the United States MUST PAY CLOSE ATTENTION to the requirements imposed by this law.    This requirement includes pre-registration of the manufacturer with the FDA and detailed record keeping requirements.

Organic Products

National Organic Program

The National Organic Program (NOP) establishes Federal standards for organic products.   It replaces the ad hoc set of state and local laws and regulations which previously provided conflicting standards as to what constituted an organic product. 

Qualifications

In order to qualify as organic under the NOP a product must be produced to certain standards and certified by a recognized certifying authority.  

Labeling

Product which is qualified as organic under the NOP may be marked with a seal and otherwise described as organic.   This is a voluntary seal and identification and product which is organic does not need to be marked as organic.