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What is FDA: Overview and its role in exporting products to the USA

FDA stands for Food and Drug Administration – a federal agency in the United States of America, which regulates certain food, drugs, cosmetics, medical products, etc. Here’s a guide to understanding the registration process for exporters and role of FDA in exporting from India to the USA.

Authorities across the world strive to ensure evidence-based entry of food, drugs and other consumable products into the country. While importing, it becomes important for checks and regulations to ensure that the products are not harmful. The Government of USA established Food and Drug Administration (FDA) in 1906 to protect public health by ensuring the safety, efficacy and security of certain products. It holds the responsibility to provide accurate and scientific information to public about all the food and medical products being imported.

The Office of Global Policy and Strategy's (OGPS) India Office (INO) serves as the lead FDA on-site presence in New Delhi, India. The India Office addresses operational and policy matters concerning FDA-regulated products in collaboration with the Government of India. In line with the FDA's mission, the INO's primary focus is ensuring the safety, quality and effectiveness of food and medical products exported to the USA from India¹. The India Office advances the FDA's mission to protect and promote public health by:

Conducting commodity-specific inspections to meet the requirements of FDA-specific legislative mandates.

Building strong coalitions and partnerships with regulatory authorities, industry, academia, multilateral organizations, non-governmental organizations and other relevant institutions to increase FDA’s understanding of India’s regulatory framework and processes.

Enhancing FDA’s knowledge of India’s legal requirements and oversight capacity of India's regulatory agencies. Indian businesses that manufacture or export products are subject to FDA’s jurisdiction.

Expanding upon and building better quality data to inform FDA’s regulatory decisions and actions.

Role of the FDA in exporting to the USA

FDA regulates compliances to prevent the entry of violative products, giving guidance to exporters and the industry with education materials and certification programs. Following are the key roles of FDA²:

• FDA develops rules regarding clinical tests to be done on new medications before being marketed to individuals.
• It oversees divisions involving food, drugs, cosmetics, animal food, dietary supplements, biological goods and medical devices.
• FDA aims to protect public health by inspecting and reviewing food and drugs.
• It has the power to inspect products in the market for safety or other reasons.

What products are under the FDA regulations?

A range of products fall under the scope of regulation by the FDA when being exported from India to the USA. Below is a list of some of the products regulated by the FDA³:

Food products

• Dietary supplements
• Bottled water
• Food additives
• Infant food formulas
• Other food items (except the meat, poultry, and egg products)

Drugs

• Prescribed drugs (both branded and generic)
• Non-prescribed (over-the-counter) drugs

Biological products

• Vaccines for human consumption
• Gene therapy products
• Allergenics

Cosmetics

• Colour added in makeup and other products
• Skin moisturizer
• Perfumes and nail polishes

Veterinary products

• Livestock feeds
• Pet food
• Veterinary drugs and devices

Radiation-emitting electronic products

• Microwave oven
• Laser devices
• Mercury vapour lamps
• X-ray equipment
• Ultrasonic therapy machines

Medical devices

• High-end devices like heart pacemakers
• Dental devices
• Surgical implants and prosthetics

While exporting to the USA, food and chemical products are subject to review by the FDA. The FDA electronically reviews all the entries submitted by the US Customs and Border Protection (CBP) to check if they comply with the FDA’s laws and regulations. The products that do not comply with the US requirements at the time of import are not permitted to be exported.

What are the FDA labeling requirements?

The food packaging must contain information about nutrition and its content with other specific requirements. The FDA has set standards and rules for labeling of the food products under the Federal Food, Drug and Cosmetic Act. Manufacturers of food products must understand the applicable laws and regulations to minimize any legal action or delays while exporting. Following are some of the crucial labeling requirements in different types of the FDA regulated products⁴:

Food, beverage, and dietary supplements

The FDA requires information on daily consumption values, serving sizes, and nutrition chart.

Medical devices

The device label must have instructions for use, servicing instructions, warning statements, and other information important for its end users.

Drugs labeling

The list of active ingredients, warning statements and dosage instructions are required to be mentioned.

Cosmetics labeling

Cosmetic products must have genuine labeling claims with information on chemicals used (if any), among others.

Easy e-commerce exports from India to the USA with Amazon Global Selling

With e-commerce exports, Indian exporters can now sell internationally in an easy and seamless manner. Amazon Global Selling helps exporters take their products from India to the world by listing on international marketplaces.

With access to millions of customers shopping on Amazon international marketplaces across 200+ countries and territories, Amazon Global Selling also provides latest tools and programs that simplify the process of obtaining export documents, shipping and delivering products to the customer in the USA, UK, UAE, Australia or any other country. With FBA (Fulfillment by Amazon), all that sellers or exporters are required to do is ship their products to Amazon warehouses. Amazon packs and delivers the order to the customer.

Here’s a guide to exporting with Amazon Global Selling

Visit Exports Compliance dashboard to view and obtain FDA requirements

Frequently Asked Questions

What is FDA approved mean?

FDA approved means that the particular product is safe and the information given on the packaging has been reviewed by the Center for Drug Evaluation and Research (CDER).

What is FDA in India?

There is an Office of Global Policy and Strategy (OGPS) in India Office (INO) serving as the lead FDA on-site presence in New Delhi, India. Established in November 2008, this office addresses all matters on FDA-regulated export products.

What does it mean FDA cleared?

FDA cleared means that the manufacturer can say that their product is equivalent to another already-cleared or approved product called a predicate. For instance, Samsung wants to create a smartwatch that has same features as the one that already exists. The FDA declares this one as “Cleared”.

How to register with FDA?

The Food and Drug Administration Act of 2007 states that all the registration and listing of products should be submitted electronically. Depending on the product category, the registration process might differ.

Published on May 16, 2022.

Sources:
1. https://www.fda.gov/about-fda/fda-history/history-fdas-enforcement-work
2. https://www.fda.gov/about-fda/office-global-operations/india-office
3. https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate
4. https://www.registrarcorp.com/fda-labeling/
5. https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list#3
6. https://www.fda.gov/drugs/development-approval-process-drugs#:~:text=Developed%20and%20Approved.-,FDA%20Approval%3A%20What%20it%20means,risks%20for%20the%20intended%20population.

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*Map not to scale. The map has been used for design and representational purpose only, it does not depict the geographical boundaries of the country. These do not conform to the external boundaries of India recognized by the Survey of India.

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