What is the U.S. Food & Drug Administration (FDA)?

What is the FDA? | Food & Drug Administration

You may think of the U.S. FDA as just another American government agency adding even more paperwork to your life as a food and beverage importer or exporter. However, the US. FDA adds value to consumers and plays a large role in how you run your business. In this article, we look at the role of the U.S. FDA and why you should care.

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Background

The U.S. FDA, U.S. Food and Drug Administration, is the American agency that regulates consumable products in the United States. The agency’s main responsibility is advocating for and maintaining public health and safety. Their reach extends beyond deciding on the types of French cheeses allowed into the U.S. or if German Kinder eggs are hazardous to children. In fact, its regulatory capacity stretches to the following domains:

Food and drugs
Medical devices
Radiation-emitting products
Vaccines, blood, and biologics
Animal and veterinary products
Cosmetics
Tobacco products

The FDA is the oldest consumer protection agency in the U.S. government and is actually part of the U.S. Department of Health and Human Services. Its regulatory duties came into place in 1906 with the passage of the Pure Food and Drug Act. Since then, the FDA has been thoroughly involved in the protection and safety of consumables on American soil.

Not only does the FDA oversee the consumption and use of products, but is an active party in anti-counterterrorism efforts. For instance, if a terrorist organization attempts to poison those on US grounds through consumable products, the FDA is present to prevent and deal with the situation. As this is a large and complex undertaking, the FDA frequently works with other governmental agencies such as the U.S. Customs and Border Protection.

During the COVID-19 pandemic, the FDA has been in the spotlight with its involvement in COVID vaccinations. The FDA sets vaccine testing standards, sets expectations for a vaccine’s safety and effectiveness which vaccine manufacturers must meet, and approves emergency use of new COVID vaccinations and boosters. Experts in the FDA review data from drug manufacture’s trials to evaluate the effectiveness and potential side effects, and make decisions about the drug’s release.

Why Food Exporters/Importers Should Care

Government departments and bureaucracy are in every country. So why should you care about the U.S. FDA?

With your involvement in international food and beverage food importing and exporting, it is critical you understand the requirements of the U.S. FDA if you wish to work with customers in the United States. Failure to understand and comply with FDA requirements can result in your consumable product shipment being delayed or even confiscated.

Allowed/Not Allowed

The first thing to be aware of is what is and what is not allowed in the United States. The FDA is just one of several U.S. government agencies, such as the U.S. Customs and Border Protection and the U.S. Department of Agriculture, that has input into what is allowed into the U.S. The FDA also identifies ingredients of consumables that are allowed and not allowed into the US. Generally, the food or beverage you produce, sell, or export to the U.S. must be safe, produced in a hygienic environment, and approved for entry to the U.S.

The FDA issues also issues recall and safety alerts once it is aware of any danger a consumable may pose. To maintain vigilance, the FDA works closely with the U.S. Department of Agriculture, USDA, in identifying food issues.

Ingredients/Labeling

Another thing the FDA is involved in is requirements related to ingredients and labeling. To keep those on U.S. soil safe, the FDA is active in deciding which ingredients are allowed in food allowed into the U.S. As for labeling, there are guidelines that producers and sellers of prepared foods must abide by to meet FDA requirements. Making sure that nutrition, health, and ingredient claims are accurate and transparent is of great importance to the FDA.

Food Manufacturing Registration

Under its Food Safety Modernization Act of January 2011, the FDA is responsible for overseeing the safety of food processing facilities. Food producers wishing to sell food in the United States must submit additional information about the manufacturing facilities where the food was produced to the FDA.

In fact, any “owner, operator or agency” either already in or outside of the United States that works in the “manufacturing/processing, packing, or holding of food for human or animal consumption in the United States” must register with the FDA.

This registration provides the FDA with additional information about the processing facility, the right to inspect the facility, and the right to suspend the facility’s right to export its goods to the U.S.

Prior Notices

Another extremely important part of the FDA’s involvement in food and beverage is prior notices. Before food and drink are imported into the United States, prior notice must be provided to the FDA by electronic notification. Before the shipment of food and drink into the United States can be accepted, prior notification must be received, confirmed, and approved.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires an advanced notice of imported food and drink. To protect American citizens from potentially harmful foods and drinks, the Bioterrorism Act mandates specific actions from the Food and Drug Administration.

Automating FDA Prior Notices

If you sell or distribute international food and beverages to clients in the United States, you are aware of how time-consuming and taxing the US regulatory procedure can be, particularly the manual completion of prior notices. But did you know that there is an app that can complete this task in a few seconds?

PriorNotify is the app specifically designed for e-commerce that streamlines and automates the US FDA Prior Notice documentation. PriorNotify easily facilitates the sale and shipment of food and beverages from abroad to customers in the United States.

PriorNotify was also designed to facilitate communication between manufacturers of food and drink, as well as retailers, wholesalers, drop shippers, and logistics companies. Companies from all around the world can now ship their consumable goods to buyers in the United States.

PriorNotify integrates with a wide range of e-commerce platforms, including Shopify, WordPress (WooCommerce), Magento, PrestaShop, and WiX, allowing for prior notices to be completed automatically upon an online sale. You can also use PriorNotify with any order management software or marketplace, including Amazon.

For instance, whenever a producer of food or drink makes a purchase from a company that sells their product, the prior notice is automatically generated and completed. Drop shippers can use PriorNotify to instantly notify manufacturers of orders and finish the required regulatory steps for each order placed. When a consumer makes a purchase, the shipping or postal company can use PriorNotify to automatically complete the regulatory process.

For more information and to obtain a free trial, visit PriorNotify.com.

Final Words

The U.S. FDA is not a government agency to ignore. With your role in food and beverage imports/exports, the U.S. FDA directs much of your business activity. It is important to understand the U.S. FDA’s policies, procedures, and continued updates. For more information about the FDA, visit the U.S. FDA website. For more information about food and beverage imports and exports, visit RudiCoder’s Insights Page. And for more information about automating U.S. FDA prior notices, visit PriorNotify.com .