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FDA Certification: The mandatory certification for exporting goods to the U.S.

Posted on by adminmettifda
19
Jul

When businesses hear the term “FDA Hoa Kỳ” (U.S. FDA), they often associate it with complicated procedures, high costs, and lengthy approval processes. However, a clear understanding of the FDA can help companies not only overcome these legal “barriers” but also unlock long-term opportunities in one of the world’s most demanding markets.

FDA Certification: The mandatory certification for exporting goods to the U.S.
FDA Certification: The mandatory certification for exporting goods to the U.S.

What is FDAcCertification?

The FDA (short for Food and Drug Administration) is a U.S. federal agency under the Department of Health and Human Services (HHS). Its mission is to protect public health by regulating:

  • The safety of food and beverages

  • The quality of pharmaceuticals, vaccines, and medical devices

  • The oversight of cosmetics, dietary supplements, and biologically-derived products

Additionally, the FDA monitors product labeling, advertising, and manufacturing practices to ensure consumers are not misled or exposed to substandard products.

What is FDAcCertification?
What is FDAcCertification?

Is FDA certification required for exporting to the U.S.?

Yes and no — it depends on your product category.

1. Products that must be registered with the FDA:

According to U.S. law, the following categories are under FDA regulation:

  • Food and beverages (including dietary supplements)

  • Pharmaceuticals (both OTC and prescription drugs)

  • Medical devices (e.g., test kits, surgical tools)

  • Cosmetics

  • Biological products and vaccines

If your business fails to register your manufacturing facility and products with the FDA, your goods may be refused entry at U.S. ports.

2. Products outside of FDA’s jurisdiction:

The FDA does not regulate products such as:

  • Raw agricultural goods (overseen by USDA)

  • Alcoholic beverages (under ATF)

  • Live animal-derived foods (under USDA/APHIS)

Thus, determining your product’s correct classification is essential to know whether FDA compliance is required.

Is FDA certification required for exporting to the U.S.?
Is FDA certification required for exporting to the U.S.?

The true meaning of “FDA Certification”

It’s crucial to understand that the FDA does not issue traditional “certificates.” Instead, businesses:

  • Register their facility and products

  • Comply with all applicable labeling and formulation requirements

  • May be subject to surprise inspections or port-of-entry reviews

Only after fulfilling these obligations can a product be “accepted” into the U.S. — effectively an unofficial form of FDA certification.

The true meaning of “FDA Certification”
The true meaning of “FDA Certification”

Critical notes for Vietnamese exporters

Many Vietnamese businesses have faced rejections or warnings due to misunderstandings of FDA regulations — particularly in labeling, active ingredient declarations, or lack of a U.S.-based representative.

Simply submitting information to the FDA website is not enough. A comprehensive compliance strategy is needed to avoid being placed on Import Alert lists.

Critical notes for Vietnamese exporters
Critical notes for Vietnamese exporters

-> Learn more: FDA approves natural food coloring: A clean label trend for Vietnam’s F&B industry

Partner with MettiFDA – Your FDA compliance expert in Vietnam

MettiFDA is a legal and regulatory consultancy specializing in FDA compliance. Our mission is to help Vietnamese enterprises systematically access and grow in the U.S. market. We assist businesses in determining whether their products fall under FDA jurisdiction and provide end-to-end compliance solutions.

MettiFDA supports you with proper documentation, FDA-standard labeling, U.S. representation services, and guidance in dealing with alerts or import refusals. With extensive experience in pharmaceuticals, medical devices, cosmetics, and supplements, we are your reliable partner on the path to conquering the U.S. market.

Partner with MettiFDA – Your FDA compliance expert in Vietnam
Partner with MettiFDA – Your FDA compliance expert in Vietnam

Conclusion

FDA Hoa Kỳ is not just a “license to sell” — it’s a vital quality assurance that drives sustainable success in the U.S. Understanding and complying with FDA standards helps businesses mitigate risk, enhance credibility, and unlock international growth.

If you’re exporting — or planning to export — to the U.S., start by learning the FDA inside out and choose a trusted advisor to ensure you’re on the right track from day one.

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