대한화장품산업연구원 손성민 연구원이 기능성 화장품의 화장품/OTC 등록에 관한 질문에 미국 FDA에서 회신한 내용입니다.

Some skin care products are regulated as cosmetics. Others are regulated as drugs, or as combination drug-cosmetic products. The examples you are wondering about may be considered drugs or combination drug-cosmetic products. Products that are both drugs and cosmetics must meet the requirements for both categories. We offer the following references and information to assist you in determining how to proceed. You can start with reading, How can I tell if my product is a cosmetic, a drug, or both?

Please review the regulatory definition of a drug, how the FDA defines and regulates a drug versus a cosmetic and what products do/do not require FDA approval. As you can see in how the regulations define a drug (first link provided in this paragraph), a product may be considered a drug based on its ingredients, and/or its intended use, and/or intended or actual effect on the structure or any function of the body of man or other animals.

• To determine whether any of the ingredients you will use in your product(s) are recognized as drug substances or drug products, you may choose to consult the United States Pharmacopeia/National Formulary (USP/NF), the drug compendium officially recognized in the United States.

• Information pertaining to the two examples of types of products you mentioned in your email (anti-wrinkle and skin whitening):  ◦Anti-wrinkle products may be regulated as drugs. Please review Wrinkle Treatments and other Anti-aging Products. Some firms have received warning letters about their products that they marketed as cosmetics but that may fit the regulatory definition of a drug based on the product claims and/or intended use.

◦ You should determine whether products you describe as skin whitening fit the definition of a drug, cosmetic, or both based on the active ingredient(s) and intended use. Below you will see a hyperlink to OTC drug rulemakings for skin bleaching drug products which may help you to determine if your skin brightening products may be considered skin bleaching products.

Drug products require FDA approval to be marketed legally in the United States. We will focus on the over-the-counter (OTC) approval pathways since your description of the products indicates you would intend it to be used without a prescription. All OTC drug products in compliance with FDA regulations are marketed in the U.S. in accordance with either an OTC Drug Monograph, or a New Drug Application (NDA)/Abbreviated New Drug Application (ANDA).

Please review the OTC Drug Product Review Process webpage and our webinar, Bringing an OTC to Market, to better understand how OTC drugs are regulated. You will need to determine whether the rulemakings apply to your product based on its characteristics including active ingredients. If, after reviewing these resources, you determine that your product fits the definition of a drug but does not conform to an OTC monograph, then the product would require review and approval by the FDA through a NDA.

• You may need to determine whether the products you describe as “whitening” could be considered skin bleaching products. Refer to the Rulemaking History for OTC Skin Bleaching Drug Products.

• Check the OTC Ingredient Status Report, which lists every active ingredient reviewed by the FDA for safety and effectiveness in the OTC drug review. This report lists the safety and effectiveness findings of each active ingredient by the OTC Monograph Advisory Review Panel (i.e., Category I, II, or III).

• There does not appear to be a monograph that covers anti-wrinkle products; therefore, such a product would require a NDA.

Please review the How Drugs are Developed and Approved to understand the drug approval process and NDAs.

The following are additional applicable regulations for drug products that are marketed in the U.S. that you may wish to review. Note that this is not intended to be an all-inclusive list:

• Registration of Producers of Drugs and Listing of Drugs In Commercial Distribution

◦ You may be interested in our CDER Small Business Webinar “Overview of the Drug Registration and Listing System (DRLS & eDRLS)”

◦ The Guidance for Industry document, Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing, is available to assist firms with submissions in electronic format.

• cGMP in manufacturing, processing, packing, or holding of drugs (21 CFR Part 210)

• cGMP for Finished Pharmaceuticals (21 CFR Part 211)

• Labeling of drug products (21 CFR Part 201)

Please note that the above discussion is not intended to be a complete review of any product.  Please be aware that the Agency does not provide “pre-clearance” or “pre-approval” for OTC products, nor do we have the resources to provide extensive consultative services. It is the responsibility of each person or firm marketing drug products to comply with all of the requirements of the Food, Drug, and Cosmetic Act and its implementing regulations, and to ensure that your drug products are safe and effective and do not violate the provisions of the Federal Food, Drug and Cosmetic Act. Should you have further questions concerning the manufacturing, labeling, approval requirements, etc. of any drug products that you are interested in marketing in the US, we strongly recommend that you retain the services of an attorney or consultant with expertise regarding the regulations. We are not able to provide a referral, but some have found the resources and professional services directory on the website for the Food and Drug Law Institute (www.fdli.org) helpful.

Review  our REdI: Prescription Drug Labeling Conference held on  November 1 -2 , 2017

Look at our  Extended Webinar: Electronic Drug Registration and Listing Using CDER Direct – held on October 5, 2017