What you must know about FDA Regulations

What is the FDA?

The FDA or Food and Drug Administration is a government agency responsible for protecting the general public of the United States’ safety and health through the implementation of regulations and standards regarding medications, medical devices, cosmetics, food, vaccinations, tobacco and dietary supplements. As a result of this seemingly all-encompassing regulatory responsibility, the FDA imposes various regulations in a number of areas.

From FDA regulations concerning the packaging of products to the administration of safe drugs, all FDA regulations must be satisfied by the producers and manufacturers of food, cosmetics, drugs, vaccines, medical supplies and various other consumer products in the United States. Failure to comply with these FDA regulations will result in felony charges (placed on the producer, distributor or manufacturer of the aforementioned goods) or the institution of an FDA product recall.

Examples of FDA Regulations:

FDA Regulations concerning Commercial Cutting and Produce:

The United States Food and Drug Administration regulates the national food supply, including how food is harvested and distributed from local farms. More specifically, the fashion in how and which food is cut and transported are regulated by the FDA.

For example, the FDA stipulates that knives utilized to cut produce, such as lettuce, must be sanitized regularly. Furthermore, after an item is cut, the exposed surface of the produce should not touch the soil to prevent contamination. To further prevent the spread of disease or contamination, FDA regulations will extend to the practice of hand-harvesting; workers must adhere to FDA regulations regarding hand washing and glove use.

FDA Labeling Regulations for Restaurants:

The FDA imposes regulations on how restaurant menus label nutritional information; such FDA regulations must be adhered to in order to help consumers identify health options. This effort is instituted to reduce diet-related diseases, such as diabetes or obesity, by informing consumers to the caloric intake of their meal choices. The FDA determined that all food chains (those restaurants with 20 or more locations throughout the United States) must label their menu items so that consumers can choose dishes that are lower in calories or in general, make them more aware as to their caloric intake.

FDA regulations concerning labeling require the restaurant to notify the consumer of the meal’s total fat, which includes transfat, saturated fat, sodium, protein and carbohydrate counts. This information must be reported on the menus or made available upon the request of the diner; in essence however, the FDA regulations over labeling are primarily concerning with calorie information.

FDA Import Regulations:

The FDA published new regulations designed to keep the American public safe from foreign food threats. These FDA regulations allow the government to keep a close watch on food entering the United States, for imported foods are typically more vulnerable to contamination or terrorist threats. As of October 2003, the FDA requires all foreign and domestic food facilities to register with the agency.

Following registration, all foreign facilities must appoint an agent who either resides in the U.S. or maintains a place of business there. The agent will then act as the intermediary between the FDA and the foreign establishment to inform the United States government concerning matters involving new shipments and the quantity of such loads.