FDA

 

Registration / Certification / Approval of FDA

• FDA (Food and Drug Administration) is a U.S. Governmental Agency under the U.S. Department of Health & Human Services and is one of the most trusted and powerful consumer protection agencies to protect public health by managing the safety and production/distribution/sales of foods and health products in U.S.A.
• Cosmetics, Medicines, Quasi-Drugs, Medical Devices, Food and regulated products imported into the United States must be registered, certified, or approved by FDA on Product Registration and Facility Registration for consumer safety, depending on product ingredients and degree of risk.
• In order to further strengthen consumer health protection on Cosmetics, the Modernization of the Cosmetics Regulation Act (MoCRA) has been enacted in the United States in 2022, requiring (1) facility and product registration (2) demonstrating safety (3) integrated GMP guidelines.
• Therefore, it is necessary to prepare (1) labeling requirements, (2) report allergy-induced and adverse effects, (3) safety of asbestos standards including Talc, (4) clinical results, and (5) GMP in order to safely export products to the United States and effectively cope with FDA regulations,
• The exported product may be detained or returned by the US Customs and may be subject to FDA penalty in case of Product Misclassification or lack of FDA registration, certification, or approval.

Advantages of Registration of FDA

1. Safely export to the United States.

1. The exporter can prevent product classification errors, labelling problems, and delays in the US customs clearance.

2. Effectively Response to FDA Regulations.

1. The exporter can respond quickly to new FDA regulatory measures since FDA is tightening regulations in terms of safety in order to protect the health of U.S. consumers.

3. Increase of Market Share.

1. The exporter can rapidly increase the US market share by improving consumer recognition and participating in U.S. public procurement bids. In addition, the exporter would secure price competitiveness when expanding to other countries.

Categories of FDA Registration/Certification/Approval

• Products related to consumer health and hygiene must be registered, certified or approved by FDA, which are Medicines, Quasi-Drugs, Medical Devices, Cosmetics, Hygiene products, and foods regulated.
• OTC Registration is not required for General Cosmetics, General Foods, Additives, Low Grade Medical Devices, and Sanitary Products that are required Facility Registration and Product Registration only.
• The criteria for classification of products that must be registered, certified or approved by the FDA are (1) Intended for Use (2) Active Ingredients (3) Potential Risks, and Functional Cosmetics for medical purpose or skin protection such as sunscreen and skin regeneration are classified as OTC drug (Over The Counter) and must be registered in FDA OTC.
• Common Requirements for FDA registration
  • 1. Facility Registration
    Company Registration, Manufacturing Facility Registration, DUNS
  • 2. Product Registration
    Name, Weight, Ingredients, Manufacturer, Address, Origin, Label, etc
  • 3. Safety Evaluation Data
    Test Analysis Data verified by official evaluation agencies

FOODS

General Foods, Health Supplements, Health Functional Foods, heat- Processed Low-Acid Foods (pH 4.6 higher), and Acidic Foods (pH 4.6 lower) must be registered, and safety evaluation data must be submitted.

	FDA 등록 사항
Facility Registration	FCE or SID
Label Registration	Ingredients 100%
Safety Evaluation Data	Test Analysis Data
GMP Registration	Exempted for small size companies
FDA Audition	Surveillance Inspection

[Remark]
1. Facility Registration includes Company Registration and DUNS in accordance with LACF Regulation.
2. FCE (Food Canning Establishment) : Registration of Heat-processed food manufacturing plant.
3. SID (Submission Identifier) : Registration of Processed Food + Sterilization Process Registration.
4. Label Registration : Name, Weight, Ingredients, Manufacturer, Origin, etc.
5. GMP : Good Manufacturing Practice.
6. FDA Audition : Surveillance Inspection for 1 year -2 year.

COSMETICS

• Any cosmetics products must be registered as OTC if the labels contains phrases of physical functions such as anti-wrinkle, regeneration, etc.
• Products in drug stores are generally required to be registered for OTC, such as sunscreen products, acne products, toothpaste, atopic treatment lotion, and dandruff shampoo, etc.
• While Zinc oxide and titanium dioxide are allowed for Sunscreens, oxy-benzone and octinoxate are banned.
• Safety evaluation data for the safety and functionality should be submitted.

Facility Registration	Manufacturing Facility and Manufacturer
Ingredient Registration	Ingredients 100%
Label Registration	NDC Labeller Code
Safety Evaluation Data	Test Analysis Data
GMP Registration	Exempted for small size companies
FDA Audition	Surveillance Inspection

[Remark]
1. Facility Registration includes Company Registration and DUNS.
2. Ingredient Registration must be 100% including Active Ingredients.
3. Labels must contain NDC Labeller Code, Name, Weight, Ingredient, Manufacturer, Origin, etc.
4. FDA Audition : Surveillance Inspection for 1 year – 2 year.

[Remark]
(1) A warning must be affixed on packages for California in accordance with the Proposition 65 of the OEHHA regulations.
(2) Be sure to write a warning that contains harmful toxic substances above the standard or that there are potential risks such as rash, hives, etc.

Medical Devices

• The Grades are classified to Class I, Class II, and Class III according to their potential risk, and are subject to general controls, special controls, PMN (Premarket Notification 510(k)) or Premarket Approvals (PMA) or two or more regulations.
• However, PMA (Promotion Authorization) and Clinical Data & Safe Claim (Clinical Data & Safety Data) are exempted for R&D and clinical
  experimental medical devices under IDE (Investigational Device Exception) and HDE (Humanitarian Device Exception).

1. Class I

1. General Medical Devices exempt from PMN (Premarket Notification) and GMP due to no potential risk.

2. Class II

1. Medical Devices required PMN (Premarket Notification 510(k)) to demonstrate ‘Substantial Equivalence of Devices’.

3. Class III

1. Medical Devices having a significant impact on the human body required PMA (Premarket Approval) & Clinical Data & Safe Claim.

Medical Devices for FDA Registration/Certification/Approval

	Class I	Class II	Class III
Facility Registration	○	○	○
Product Registration	○	○	○
Label Registration	○	○	○
Safety Evaluation Data	○	○	○
510(k)	X	○	○
GMP Registration	X	○	○
PMA	X	X	○
FDA Audition	○	○	○

[Remark]
1. Facility Registration includes Company Registration and DUNS.
2. Product Registration includes Class, Name, Drawings, Materials, etc.
3. Labels must contain NDC Labeller Code, Name, Weight, Ingredient, Manufacturer, Origin, etc.
4. FDA Audition : Surveillance Inspection for 1 year – 2 year.

DRUGS

• OTC registration is required for products for diagnosing, alleviating, treating, or preventing diseases or for affecting on the function or structure of the body.
• Quasi Drugs are also generally required to be registered as Over-The- Counter drugs (OTC).

1. New Drugs :

1. NDA (New Drug Application) required.

2. Generic Drugs : Reproduced Drugs

1. It is know as copy drugs that duplicate original drugs with expired patents and has biological equivalence in formulation, safety, content, performance characteristics, and applications.

3. Over-the-Counter ; OTC

1. It is a safe and effective drug that can be used in a drug store without a prescription and must be registered as OTC.
2. OTC products are considered “GRASE” (Generally Recognized as Safe and Effective) and are recognized as pharmaceuticals having proven stability and efficacy under conditions such as ingredients, dosage, usage, etc.

	Registration of OTC
Facility Registration	Manufacturing Facility and Manufacturer
Ingredient Registration	Ingredients 100%
Label Registration	NDC Labeller Code
Safety Evaluation Data	Test Analysis Data
GMP Registration	Exempted for small size companies
FDA OTC Audition	Surveillance Inspection

[Remark]
1. Facility Registration includes Company Registration and DUNS.
2. Product Registration includes Class, Name, Drawings, Materials, etc.
3. Labels must contain NDC Labeller Code, Name, Weight, Ingredient, Manufacturer, Origin, etc.
4. FDA Audition : Surveillance Inspection for 1 year – 2 year.

Animal Feed & Animal Drugs

1. Similar to human products, and the “FD & ACT” rule is applied.
2. Required Analysis of Ingredients of animal feed and additives as well as safety and efficacy tests of animal drugs.

Radiation-Emitting Products

1. Applied to Performance Standard Regulations.
2. Safety tests such as radiation emission tests are required.

Food Containers & Food Contact Substances

1. Applied to Regulations of the potential risks of the degree to which food containers, packaging materials, and food contact materials react with the contents and are absorbed into the human body.
2. safety assessment data is required.

OTC for Drugs and Functional Cosmetics

• Drugs , Quasi-Drugs and Functional Cosmetics for medical purpose or skin protection are classified as OTC drug (Over The Counter).
• The OTC monograph provides the information on the safety, effectiveness, and labeling of active ingredients and contains active ingredients for which OTC registration is required.
• There are about 100 OTC monographs, and the total number of activeingredients is about 1,700 depending on the purpose of use.

FDA 등록 절차

일반적인 FDA 등록 절차이며, 특별 성분 또는 안전성 위해 제품은 안전성 입증 서류, FDA 시험, 임상결과 등의 추가 절차가 진행됩니다.

Registration Fees of FDA

The FDA registration fee below is based on 2024 year and must be paid annually, and the renewal period is September-December each year.

	등록비용	비고
Facility Registration	US$ 6,493 / year	Not included DUNS
OTC MDF	US$26,153 / year	Manufacturer
OTC CMO	US$17,435 / year	OEM or contracter

Q & A

We want to sell Suncreens in AMAZON. Do we need to register in FDA in advance ?

1. General cosmetics can be exported to the USA with Facility Registration in FDA. However, Sunscreens regarded as OTC products are required to the OTC Registration of FDA for US Export.

Our Cosmetics Products contain ingredients that improve wrinkles and skin elasticity. Do we need to register with the FDA?

1. If your cosmetic products contains any functional ingredients for wrinkle improvement, anti-wrinkle, regeneration, skin elasticity or the skin and body functions, your cosmetics products must be registered in FDA’s OTC in order to pass US Custom Clearance.

Check Points for FDA OTC

1. Accurate Product Classification

Product Classification must be done after checking and identifying purpose of use, active ingredients, and medical purposes or functionality in OTC Mnograph. In case of wrong or mis-classification, those mis-classified products may be held in US Custom and be subject to sales regulations by the FDA.

2. Compliance with Labeling Requirements.

Labeling requirements must be accurately followed to review the risks of allergic induction and side effects and to demonstrate safety.

3. Attaching a warning

A warning of potential physical hazards must be affixed if hazardous substances are detected, suspected, which are below the standard level.

Inquiry of the Certification of CE / KFDA

DaeHan Public Administrative Attorney’s Office has specialized in the Certification on KFDA/CE/FDA/, Foreign Invested Corporations (FIC)
including Branches and Liaison Offices, Immigration on Public Bond Investment and Real Estate Investment, and has provided Immigration & Investment Solutions, Consulting on D8, D7 Visa, Tax and Marketing. We submit applications for licenses or permits on the behalf of clients.

Please contact us for the following issues. (1) Certification on KFDA/CE/ FDA (2) Establishment of FIC, Branches & Liaison Offices (3) Immigration on Public Bond Investment and Real Estate Investment (4) Visa Consulting on D8, D7, F5, F2, F1 (5) M&A & Technology Outsourcing (6) Stock Market Investment (8) Marketing & Tax Consulting.