UNDERSTANDING FDA STANDARDS WITH SMART LINK LOGISTICS

You’ve likely heard of FDA-certified products. But what exactly is the FDA? What do FDA standards entail? Let Smart Link Logistics guide you through these questions in this article.

1. What is the FDA?

The FDA, or the Food and Drug Administration, is a federal agency of the United States Department of Health and Human Services. Established in June 1906 when President Theodore Roosevelt signed the Food and Drug Act championed by Dr. Harvey Washington Wiley, the FDA has been a cornerstone of public health.

Initially known as the Bureau of Chemistry, its name was later changed to the Food, Drug, and Insecticide Administration (USDA), and eventually shortened to the Food and Drug Administration (FDA). Today, the FDA operates 223 offices and 13 laboratories across the United States, Virgin Islands, and Puerto Rico. Since 2008, the FDA has expanded internationally, opening offices in China, India, Costa Rica, Belgium, the UK, and several other countries.

2. What are FDA standards?

FDA standards are regulations set by the U.S. Food and Drug Administration to oversee the safety of products within its jurisdiction being marketed in the U.S. Any manufacturer aiming to enter this market must comply with these standards and obtain certification.

3. What do FDA standards include?

FDA standards are essential for any product looking to circulate in the U.S. market. Even if you are using services to send goods to the U.S., it is important to be aware of these standards.

FDA Standards for Food and Beverages:

Compliance with FDA regulations.
Adherence to HACCP standards for seafood and fruit juices.
Canned foods must have low acid content within standard limits.
Products must have complete labeling.
Labels must provide full information on ingredients and uses.
Product ingredients must be evaluated and notified to the FDA.
Compliance with cGMP requirements.
Certification of colors according to FDA requirements.
Determination of permissible EPA and FDA tolerances if the product is a pesticide.

FDA Standards for Dietary Supplements and Drugs:

Products must have complete labels detailing product information.
Registration at the Manufacturing Facility, complying with cGMP regulations.
Full disclosure of product structure and uses to the FDA.

FDA Standards for Cosmetics and Beauty Products:

Full compliance with product labeling regulations.
Complete evaluation of each product’s ingredients.

FDA Standards for Electronic and Radiological Devices:

Obtain an FDA entry number, comply with FDA electronic product reports.
Report and provide full effectiveness standards and certification requirements to the FDA.

Certain special goods are exempt from needing FDA certification, including:

Hand-made or individually produced foods.
Personal gifts sent to the U.S.
Goods considered under barter trade.

4. The Importance of Obtaining FDA Certification

When exporting goods to the U.S. or Canada, it is essential to have various documents and legal procedures to prove the origin, ingredients, quality control, and FDA certification of the products. Without these documents, your goods will be returned by U.S. Customs and cannot be re-exported, resulting in significant time and cost, mainly from warehousing fees.

Therefore, before exporting goods to the U.S., you need to carefully check the relevant information about the policies and requirements for that item.

These are the insights that Smart Link Logistics wants to share with you to help you better understand FDA standards. We hope this article will be useful in your import-export activities. Here at Smart Link, we provide services and solutions to help your goods reach the global market with dedicated support, standing by our customers. We pride ourselves on having over 13 years of experience in the logistics industry.

Hotline: + 84 935 766 039 to know more about our services

If you require assistance with international import and export of goods, please contact our team at Smartlink Logistics. We are available to provide you with professional guidance on our services and the necessary customs procedures.

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