What is FDA? What do FDA standards require?

So what is FDA, and what special requirements do products that meet FDA standards have? Let's find out with Vietnam Cleanroom equipment right here.

What is FDA?

FDA stands for the Food and Drug Administration, which is the regulatory agency for food and pharmaceuticals in the United States. It is part of the U.S. Department of Health and Human Services and is headquartered in Washington DC, USA.

The FDA was established in June 1906. It is an organization responsible for protecting and promoting public health through regulation and supervision of products such as food, pharmaceuticals, tobacco, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation, veterinary products, and more. Additionally, the FDA enforces various other regulations of U.S. law, particularly those outlined in Section 361 of the Public Health Service Act and associated regulations.

This agency was formerly known as the Food, Drug, and Insecticide Administration (abbreviated as USDA). It was later streamlined to its current name, the Food and Drug Administration (FDA). Currently, the agency has more than 223 offices and 13 laboratories in the United States, the Virgin Islands, and Puerto Rico. Particularly, since 2008, the FDA has opened additional offices in countries such as the United Kingdom, Belgium, China, Costa Rica, India, and more.

What is FDA standard?

The FDA standards are regulations set by the FDA to oversee the safety and quality of products within its jurisdiction, and these standards are applicable in the U.S. market.

Any entity wishing to market its products in the U.S. must comply with FDA standards, which means obtaining FDA certification. This is a goal that businesses in Vietnam aspire to achieve when introducing their products to the U.S. market.

What does the FDA standard regulation include?

The U.S. Food and Drug Administration (FDA) regulates and oversees most foo and pharmaceutical products circulating in the U.S. market. Therefore, if a Vietnamese business wants to export its products to this market, it must comply with the regulations of the FDA. Some basic requirements for various industries to obtain this certification include:

FDA Standards for Food and Beverages

Food and beverages are closely regulated by the U.S. FDA, and the following are the requirements that need to be adhered to:

• Ensure compliance with FDA regulations.
• Ensure compliance with the Seafood and Juice HACCP standards.
• Acid levels in canned foods must be within specified limits.
• All ingredients in the product must be assessed and notified to the FDA.
• Familiarize yourself with cGMP (Current Good Manufacturing Practice) standards.
• Ensure color certifications meet FDA requirements.
• For insect repellent products, determine the allowable margin of error set by the EPA and FDA.
• All products must have complete labeling.
• Labels must contain sufficient information about the product's ingredients and functions.

Read more: What is HACCP?

FDA Standards for Drugs and Dietary Supplements

Drugs and dietary supplements have significant impacts on human health, and the FDA requires the following:

• Registration at the Manufacturing Facility is required.
• Compliance with cGMP (Current Good Manufacturing Practice) standards is mandatory.
• Information on the structure and function of the product must be submitted to the FDA.
• Products must have labels that provide complete detailed information about the product.

Read more: GMP standards for functional foods

FDA Standards for Cosmetics and Beauty Pharmaceuticals

• Compliance with product labeling regulations as per FDA requirements is essential.
• Ensure full compliance with ingredient evaluations for each product as specified.

FDA Standards for Electronic Radiation Devices

For products classified as electronic radiation devices, manufacturers need to adhere to:

• Apply for an FDA accession number.
• Ensure full compliance with FDA electronic product reports.
• Provide and report standards of effectiveness and authentication to the FDA.

Furthermore, certain types of commodities are exempt from requiring FDA certification without the need for an application, including:

• Products as personal gifts sent to the United States.
• Handcrafted or homemade foods made by an individual.
• Commodities classified as samples for trade.

Scope of FDA Activities

The FDA regulates most food and drug products, but not all. Let's find out what those are.

Primary FDA-regulated products

It includes:

• Pharmaceuticals and biologics
• Medical devices
• Human tissues and cells
• Blood transfusions
• Tobacco products
• Veterinary drugs
• Food
• Color additives
• Products emitting electronic radiation

What does the FDA not regulate?

In addition to the above products, there are products that, if not clearly stated, we will not know that the FDA does not regulate them, below are those products:

• Cosmetics
• Medical food
• Dietary supplements
• Infant formula

If you want to learn more about why they are regulated, why not, and how the FDA regulates them, you can learn more here.

How to Get FDA Approval

Achieving FDA certification is not a simple task, especially considering the technological and societal differences between the United States and Vietnam, making it more challenging for domestic businesses. Here are some conditions and requirements from the U.S. Food and Drug Administration (FDA) that your business needs to meet:

• Products must have the correct levels of nutrients: Products falling under categories such as nutrients, fresh foods, dietary supplements, etc., intending to be marketed in the United States, need to undergo control and assessment of the required nutrient levels.
• Manufacturing facilities must meet standard requirements: The FDA has regulations regarding manufacturing facilities, machinery, and technology lines that must meet specific standards. It is crucial for your factory to comply with cGMP (Current Good Manufacturing Practice) standards.
• Highly skilled workforce: Employees involved in the research and production processes must have the appropriate professional qualifications as per the requirements.
• Effective product recall procedures: Manufacturers need to have efficient procedures for product recalls when defective products occur, as this is an inevitable part of the production process.

One thing to note is that to achieve FDA certification, you need to have a deep understanding of their regulations. If not, you should collaborate with competent consulting organizations to assist your business in the FDA certification process.

You may not be aware that for medical devices, you need to provide prior notice before marketing them in the U.S. through FDA 510k certification.

How important is FDA certification?

We have talked a lot about FDA regulations and know that they are not easy to comply with. So, what is the reason we need to go through the challenges to obtain this strict certification? Let's explore its benefits, drawbacks, and impact.

Benefits of FDA standards

The ultimate goal of the FDA is to protect the health of consumers. A business obtaining FDA certification means that their product ensures the right components and safety for users. The agency's scrutiny process helps filter and contribute to the creation of high-quality products. And we all know that products in the United States with this certification are highly regarded.

By regulating the components in drugs, devices, food, and other items, the FDA can contribute to community protection. This set of standards also provides a level of protection to try to prevent infectious diseases, prohibited substances, and counterfeit products. Failure to meet manufacturing requirements will likely result in product recalls.

For Vietnamese businesses, obtaining certification from the U.S. Food and Drug Administration (FDA) implies that their products will be distributed in the market of the land of the stars and stripes. It is an enormous market that every Vietnamese business aspires to enter.

In addition, the domestic manufacturing system will be enhanced, producing high-quality products for local consumers to use.

Consequences of Non-Compliance

The U.S. legal system clearly stipulates that goods imported into its market without FDA certification will violate regulations and may face prosecution. If imported goods do not meet FDA requirements, they will be held at the port under the management of both the FDA and CBP (Bureau of Customs and Border Protection). Importers will incur all associated costs for storage, relocation, disposal, or destruction of these products.

FDA Approval Process

So how do you get FDA certification for your product? Here are 4 basic steps you need to take:

Step 1: Prepare Documents

• Business registration certificate
• Manufacturing facility address
• HACCP or ISO 22000 certification (if available)
• Contact information for the U.S. representative office
• Information about the person working and responsible for FDA compliance
• Other necessary information

Step 2: Appoint an Agent in the U.S.

Step 3: Register the production facility, obtain a product code, and register an account, etc.

Here is the FDA registration timeline:

• Food: 1 to 2 days
• Cosmetics: 4 weeks
• Medical devices: 5-7 days

Step 4: FDA Approval

Regulations for Obtaining FDA Certification for Goods Exported to the U.S

When shipping goods to the U.S., FDA certification is an essential document. Certain types of goods such as shrimp, dried fish, drugs, jams, tea, confectionery, etc., all require this certification.

All items under FDA management must adhere to the strict regulations of the agency to obtain certification. Each FDA certificate is issued specifically for a particular type of product, with no limitation on quantity or weight. If you are sending two different types of products, you must obtain two separate certificates, regardless of the quantity.

For businesses in Vietnam looking to export to the U.S. market, it is necessary to register an account and obtain FDA certification in Vietnam.

Now you know what FDA standards are and the basic requirements of this agency to achieve their certification. Hopefully, this article can help you understand more about the FDA and the regulations they impose.