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What is FDA (Food and Drug Administration)? Role and Benefits

FDA is a federal agency in the USA that regulates the quality of certain foods, drugs, cosmetics, and medical products. Learn more about its role in exporting food from India.

Authorities across the world strive to ensure evidence-based entry of food, drugs, and other consumable products into their countries. In the United States, the Food and Drug Administration (FDA) plays a pivotal role in this process by protecting public health through rigorous checks and regulations.¹The FDA ensures that imported products are safe, effective, and secure, preventing any harmful items from entering the market. For Indian exporters targeting the US market, understanding and complying with FDA regulations is crucial for successful and safe trade. In this blog post, we will discuss the FDA’s roles, functions, and registration process, and understand which product categories come under FDA regulations.

What is the Food and Drug Administration (FDA)?

The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in the U.S. federal government. Although it adopted its current name in 1930, the FDA's regulatory functions began with the Pure Food and Drugs Act of 1906. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, as well as the safety of the nation's food supply, cosmetics, and products that emit radiation. To prevent the entry of violative products, the FDA regulates compliance and provides guidance to exporters and the industry through educational materials and certification programs.²

Role and functions of FDA in exporting to the USA

The United States is one of the largest markets in the world, with considerable demand for products from a variety of industries. Indian exporters wishing to export products to the US must declare their products to U.S. Customs and Border Protection (CBP), which refers all FDA-regulated products to the FDA for review. All imported shipments of FDA-regulated products are reviewed by the FDA and must comply with the same standards as domestic products. The FDA determines whether products are admissible into the country and may refuse entry to any that violate any provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).³

For Indian exporters, the Office of Global Policy and Strategy's (OGPS) India Office (INO) serves as the lead FDA on-site presence in 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 US from India.⁴

Products under 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 FDA:

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

Cosmetics

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

Veterinary products

• Pet food
• Veterinary drugs and devices

Radiation-emitting electronic products

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

Medical devices

• 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^.5

Benefits of Food and Drug Administration (FDA) approval

The following are some of the advantages of receiving FDA approval:

1. Gain access to foreign markets

When the FDA approves your product, you receive a Certificate of Foreign Government Approval, enabling you to expand your reach and sell products internationally.

2. Enhance brand credibility

FDA approval signifies that your product has undergone rigorous quality testing and various enhancement techniques, which boosts its credibility.

3. Increase product demand

With FDA approval, consumers recognize that your product is safe and trustworthy, significantly increasing its appeal and demand.⁶

Documents required for FDA certification

Some of the documents required for FDA certification are as follows:

1. Essential documents:

A. Bill of Lading (BOL)
B. Airway Bill (AWB)
C. Invoice
D. Purchase order

2. Commodity-specific documents (as applicable):

A. Packing list/growers list
B. Copies of labeling
C. Documentation stating who is the actual manufacturer of the product
D. Certificate of analysis
E. Intended use statement/end use statement that states the product's purpose⁷.

FDA registration process for imports

FDA-regulated products that are exported from other countries to the US are subject to FDA review upon entry. The FDA electronically reviews all entries submitted through U.S. Customs and Border Protection (CBP) to ensure compliance with US laws and regulations. Although entry requirements vary based on product category and intended use, the following process provides a general overview of the steps involved in securing FDA approval for imports into the US:

Step 1:

Ensure compliance with U.S. Customs and Border Protection (CBP) rules and processes. Information about the importation process with CBP can be found on their website.

Step 2:

Provide detailed entry information to CBP, including Harmonized Tariff Schedule (HTS) codes. HTS codes contain indicators which determine whether a product category falls under FDA regulation.

Step 3:

If the HTS code indicates that the product is FDA-regulated, you must submit information to the FDA. Include commodity details, product code, manufacturer information, estimated arrival date, etc.

Step 4:

Submit any additional documentation or information requested by the FDA promptly to avoid delays in the approval process.⁸

What are the FDA labeling requirements?

Following are some of the crucial labeling requirements for different types of FDA-regulated products.

Food, beverage, and dietary supplements

The FDA requires information on calories, daily values, serving sizes, and nutrition charts.⁹

Medical devices

The device label must have instructions for use, servicing instructions, warning statements, and other information important for its end users.¹⁰

Cosmetics labeling

Information on cosmetic labeling, including claims, needs to be truthful and not misleading, and the label should also contain the expiry date.¹¹

India is one of the largest exporters of drugs and biologics to the United States and is also the global leader in the export of spices. Considering this, the FDA office in India has been primarily set up to ensure the safety, quality, and effectiveness of food and medical products exported to the United States. With the rising opportunity to export in the US, Indian exporters can use the services of e-commerce export programs to diversify their business abroad. Ecommerce export programs like Amazon Global Selling help exporters take their products from India to the world by listing them on international marketplaces.

Export from India to the USA with Amazon Global Selling

Starting an export journey can be intimidating for Indian businesses and MSMEs, and that is where Amazon Global Selling can help. If you are a business owner and you want to sell your products to the world, Amazon Global Selling enables you to list and sell ‘Made in India’ products on 18 Amazon global marketplaces. As an e-commerce exports program, Amazon Global Selling provides support and guidance at every step of your exports journey – documents and licenses, shipping, payments, advertising, and more.

Registered sellers can choose to ship their products by themselves through Merchant Fulfilled Network (MFN) or they can opt for Fulfillment by Amazon (FBA) and outsource order fulfillment to Amazon including packing, storage, delivery, and returns. Amazon Global Selling simplifies the process of international shipping to the world, helping businesses navigate customs and reach a vast audience.

Here’s a guide to exporting with Amazon Global Selling

Visit Exports Compliance dashboard to view and obtain FDA requirements

Frequently Asked Questions

What does FDA approval mean?

FDA approval means that a product has been thoroughly evaluated and deemed safe, effective, and secure for public use based on scientific evidence. This approval ensures the product meets the stringent standards set by the FDA for quality and safety.

What is the FDA in India?

The Office of Global Policy and Strategy's (OGPS) India Office (INO) serves as the lead FDA on-site presence in New Delhi, 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 US from India.

What does it mean to be FDA cleared?

FDA-cleared means that a product has been reviewed and authorized for marketing based on substantial equivalence to a legally marketed device, typically for medical devices. The difference between FDA-approved and FDA-cleared is that FDA approval requires a thorough evaluation of clinical testing results to determine that the product's benefits outweigh its risks, while FDA clearance requires proof of substantial equivalence to an existing approved product.¹²

Published on May 16, 2022.

Sources:
1. https://www.fda.gov/about-fda/fda-history
2. https://www.fda.gov/about-fda/what-we-do
3. https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/import-basics
4. https://www.fda.gov/about-fda/office-global-operations/india-office
5. https://www.fda.gov/about-fda/what-we-do/what-does-fda-regulate
6. https://www.bizadvisors.io/fda-certification#
7. https://www.fda.gov/industry/entry-review/documents-required-status
8. https://www.fda.gov/industry/fda-import-process/entry-submission
9. https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list
10. https://www.fda.gov/industry/fda-esubmitter/radiological-health-program
11. https://www.fda.gov/food/nutrition-facts-label/whats-nutrition-facts-label
12. https://www.cnet.com/health/fda-approved-vs-fda-cleared-whats-the-difference/

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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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