You’ve likely encountered the term FDA, especially when investigating products that comply with U.S. quality standards. So, what is FDA, and what specific requirements do products meeting FDA standards have? Let’s delve deeper into this with GOL in the following article!

1. What is the FDA?

FDA stands for the Food and Drug Administration, is the regulatory body for food and pharmaceuticals in the United States. It operates under the Department of Health and Human Services and is headquartered in Washington DC, USA.

Established in June 1906, the FDA is tasked with protecting and promoting public health through regulatory oversight of various products, including food, pharmaceuticals, tobacco, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation, veterinary products, and more. Additionally, the FDA enforces other U.S. laws, notably Section 361 of the Public Health Service Act and its associated regulations.

Initially known as the Food, Drug, and Insecticide Administration (abbreviated as USDA), it later evolved into its current form as the Food and Drug Administration (FDA). The agency currently operates over 223 offices and 13 laboratories in the United States, the Virgin Islands, and Puerto Rico. Notably, since 2008, the FDA has expanded its presence globally, establishing offices in countries such as the United Kingdom, Belgium, China, Costa Rica, India, and others.

2. What Does the FDA Do?

The FDA oversees certain foods, medications, and medical devices, regulating their production processes. It ensures that these products and their manufacturers adhere to safety regulations. Additionally, the FDA informs the public about associated risks, similar to how it handles cigarette warnings.

When the FDA regulates a product, such as medication, it mandates approval before it can be marketed. The agency monitors products to ensure ongoing safety and efficacy. This includes inspecting facilities that produce food and drugs and conducting sample checks to verify compliance with regulations. Moreover, the FDA intervenes post-market if products are inaccurately marketed, such as falsely claiming to treat medical conditions without evidence or in response to consumer complaints.

Tobacco products are regulated by the FDA. However, the agency does not approve them for safety or effectiveness. Instead, it ensures that manufacturers comply with regulations and provide warnings about the risks associated with these items.

3. What are FDA standards?

FDA standards are regulations set forth by the Food and Drug Administration to monitor the safety and quality of products within its regulatory scope, and these standards apply to products circulated in the U.S. market.

Any entity intending to distribute its products in the U.S. market must adhere to FDA standards, implying the necessity for FDA registration. This is a goal that businesses aspire to achieve when entering the U.S. market.

4. FDA regulations

The U.S. Food and Drug Administration regulates and oversees the majority of food and pharmaceutical products circulating in the U.S. market. Therefore, if businesses wish to export their products to this market, they must comply with the regulations of the U.S. FDA. Some basic requirements for various industries to obtain this FDA include:

4.1 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. The latest rule is FSMA. The FSMA (Food Safety Modernization Act) is one of the significant regulations of the United States Food and Drug Administration (FDA) related to food safety. Signed into law in 2011, the primary goal of FSMA is to enhance the food safety system in the United States.
• Implement compliance with HACCP standards for Seafood and Juice.
• Limit the acidity levels for canned foods.
• All ingredients in the product must be assessed and reported to the FDA.
• Familiarize with requirements from cGMP (Current Good Manufacturing Practice) standards.
• Ensure color registration meet FDA requirements.
• For insect repellents, determine the acceptable 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 nutrition value.

4.2 FDA Standards for Drugs and Dietary Supplements

Both drugs and dietary supplements significantly impact human health, and the FDA requires the following:

• Must have registration at the Manufacturing Facility.
• Adhere to regulations from cGMP standards.
• Information about the product’s structure and function must be submitted to the FDA.
• Products must have labels containing detailed information about the product.

4.3 FDA Standards for Cosmetics and Beauty Pharmaceuticals

Prior to the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, FDA registration for cosmetic businesses was optional. However, MoCRA now mandates establishment registration and product listing with the FDA, along with adherence to Good Manufacturing Practices (GMP) and adverse event reporting requirements.

Cosmetic facilities have until July 1, 2024, to complete registration and product listing.

MoCRA empowers the FDA with:

• Record Access: To copy records of potentially adulterated cosmetics posing a serious health risk, based on reasonable belief.
• Safety Substantiation: Manufacturers/distributors remain responsible for ensuring product safety before market, as the FDA doesn’t pre-approve cosmetics.
• Regulation Development: Upcoming regulations by the FDA will cover GMP, fragrance allergen labeling, and Talc testing methods. Companies are expected to comply.
• Serious Adverse Event Reporting: Responsible persons must report such events within 15 business days and maintain records for six years.
• Cosmetic Facility Registration: Mandatory every two years, with potential suspension if products pose serious health risks.
• Product Listing: Annual updates required for each marketed product, including ingredients.
• Recall Authority: The FDA can order mandatory recalls if companies refuse voluntary recalls for adulterated or misbranded cosmetics posing serious health risks.
• Labeling Requirements: Labels must comply with FDA regulations, disclose fragrance allergens, and provide contact information for adverse event reporting.

4.4 FDA Standards for Electromagnetic Radiation-Emitting Devices

For products falling under electromagnetic radiation-emitting devices, manufacturers need to adhere to:

• Obtain a unique identifier from the FDA.
• Ensure complete compliance with FDA’s electronic product reports.
• Provide and report to the FDA on efficacy standards and authentication requirements.

Additionally, certain specific categories of merchandise are exempt from requiring FDA registration, such as:

• Personal gift items sent to the United States.
• Food produced manually or made by an individual.
• Goods measured under trade customs.

5.  The scope of the FDA’s regulation

The FDA is tasked with safeguarding public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. Additionally, the FDA is responsible for overseeing the safety of the nation’s food supply (both human and animal), cosmetics, and products that emit radiation.

5.1 The main activities of the FDA

The United States Food and Drug Administration (FDA) plays a crucial role in safeguarding public health by ensuring the safety, efficacy, and quality of a wide range of products that directly impact us. Here is a detailed list of product categories that FDA requires strict compliance with regulations to ensure consumer safety:

• Drugs and biologics: Including prescription drugs, over-the-counter drugs, vaccines, serums, genes, and advanced cell therapies. The FDA closely monitors all stages, from research and development to manufacturing, distribution, and use of drugs, ensuring they meet rigorous safety and efficacy standards.
• Medical devices: From small medical bandages to complex devices like MRI machines, all fall under the FDA’s purview. The goal is to ensure the safety and effectiveness of devices in diagnosing, treating diseases, and supporting bodily functions.
• Human cells and tissues: Transplantation and use of human cells and tissues require FDA’s stringent oversight to prevent disease transmission and ensure clear cell quality and origin.
• Blood: The FDA sets strict standards for the donation, screening, storage, and transfusion of blood to ensure safety for both donors and recipients.
• Tobacco products: Not limited to cigarettes, but also includes smokeless tobacco, cigars, e-cigarettes, and emerging tobacco products. The FDA aims to limit exposure to harmful substances in tobacco, minimizing health risks to the community.

• Veterinary drugs: Similar to drugs for humans, veterinary drugs undergo a rigorous approval process to ensure safety and effectiveness for animals while preventing the transmission of diseases from animals to humans.
• Food: From fresh produce to processed foods, the FDA closely monitors the entire food supply chain, ensuring food safety and preventing the risk of foodborne illness or contamination.
• Color additives: The FDA sets standards for the safety and appropriateness of color additives used in food, cosmetics, and pharmaceuticals to protect consumers from potential hazards.
• Products emitting electromagnetic radiation: Mobile phones, microwave ovens, and other electronic devices emit electromagnetic radiation. The FDA is responsible for ensuring safe radiation levels for users, preventing long-term health effects.

Therefore, the FDA plays a crucial role in ensuring the safety of a wide range of products that directly impact our daily lives. The strict regulations imposed by the FDA contribute to protecting consumer health and maintaining trust in the quality and safety of products in the market.

5.2 Items exempted by the FDA

Additionally, there are still items exempted from FDA standards during transportation, such as:

• Food produced by individuals
• Goods sent to the U.S. as personal gifts
• Personal items sent to individuals in the form of non-commercial samples
• Non-consumable food samples with a value under $200 USD. These are items that need to prove they are sample goods sent to food production facilities or laboratories.

6. Why is the FDA needed?

The Food and Drug Administration (FDA) of the United States plays a crucial role in safeguarding public health, and its necessity stems from various important reasons:

Preventing risks from the use of hazardous products:

• Before the establishment of the FDA, the market for food, drugs, and medical devices was often chaotic, with substandard and even life-threatening products.
• The FDA was created to standardize regulations, ensuring products meet safety and efficacy criteria before circulation.
• Stringent regulations on clinical testing, quality control, and manufacturing processes significantly reduce risks for consumers.

Protecting consumers from misleading information:

• Some manufacturers may provide false claims about the functions or health benefits of their products with the intention of deceiving consumers.
• The FDA regulates statements on labels, advertisements, and marketing materials, preventing misleading information that could cause misunderstandings among consumers.

Updating regulations based on new scientific findings:

• The healthcare and nutrition industries continuously evolve with new innovations.
• The FDA is responsible for updating regulations based on the latest scientific research, ensuring newly introduced products meet safety and efficacy standards.

Building consumer trust:

• The FDA’s presence provides consumers with a level of confidence in the quality and safety of products on the market.

Fostering and promoting healthcare innovation:

• The FDA not only ensures safety but also supports the development and approval of new drugs, medical devices, and treatment therapies.
• By providing guidance and assistance to researchers and developers, the FDA contributes to advancing healthcare, bringing more effective treatment methods for patients.

6. Requirements to obtain FDA registration

Achieving FDA registration is no simple task, especially considering the technological and societal differences between the United States and other countries worldwide. This makes it more challenging for global businesses. Here are some conditions and requirements set by the U.S. Food and Drug Administration (FDA) that your business needs to meet:

• Correct Nutrient Levels:
  • Products falling under categories such as nutrients, fresh foods, dietary supplements, etc., intending to circulate in the U.S. market, must undergo control and assessment of the required nutrient levels.
• Compliance with Manufacturing Standards:
  • FDA has regulations regarding manufacturing facilities, machinery, equipment, and technological processes that must meet specific standards.
  • Ensuring your factory complies with Current Good Manufacturing Practice (cGMP) standards when applicable. 

• Highly Skilled Workforce:
  • Employees involved in the research and production processes must have appropriate expertise as per the requirements.
• Effective Product Recall Procedures:
  • Manufacturers need to have effective procedures in place to address product defects promptly, as encountering defective products is inevitable in the manufacturing process.

Meeting these conditions is essential for any business looking to export products to the U.S. market and obtain FDA registration. The rigorous standards aim to ensure the safety, quality, and efficacy of products consumed by the American public.

7. Steps for FDA registration

So, how can you register with the FDA for your product? Here are 4 basic steps you need to follow:

Step 1: Prepare Documentation

• Business registration registration
• Manufacturing facility address
• HACCP or ISO 22000 certificate (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 Product Facility, Obtain Code, Create Account, etc.

Below are the FDA registration times:

• Food: 01 to 02 days
• Cosmetics: 04 weeks
• Medical devices: 03 – 06 months 

Step 4: FDA registration

When shipping goods to the U.S., FDA registration is essential. Certain goods like shrimp, dried fish, medicines, jams, tea, confectionery, etc., all require this registration.

All products under FDA management must comply with the strict regulations to obtain registration. Each FDA registration is specific to a particular type of product, without limitations on quantity or weight. If you are sending two types of products, you need two registration, regardless of the quantity.

For businesses wanting to export to the U.S., it is necessary to register an account and obtain FDA registration. Now that you know what FDA standards are and the basic requirements for their registration, this information should help you understand more about FDA and the regulations they impose.

8. Effortless FDA Registration with GOL

Navigating the intricate regulations of FDA registration (FDA food facility registration; FDA Medical Device Registration;….) is a critical step for anyone exporting goods to the U.S. The complexity of the process can often be overwhelming, but that’s where GOL comes in. 

Let us simplify your FDA journey, ensuring a smooth entry into the U.S. market. Our team of experienced professionals is ready to guide you through every step of the FDA registration process, guaranteeing compliance with all applicable regulations. 

• We conduct a thorough assessment of your products and facilities, identifying potential compliance gaps and developing tailored solutions. 
• Handling all the necessary paperwork and submissions on your behalf, we save you time and effort. 
• Our commitment doesn’t end with registration – we provide ongoing support to maintain your FDA compliance, keeping you informed about regulatory changes and best practices. 

Contact GOL today, and let us be your trusted partner in navigating the FDA registration process with confidence. Don’t let FDA compliance stand in the way of your U.S. market expansion!

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