As a premier Cosmetic Regulatory Company, we bring unparalleled expertise, precision, and commitment to ensuring your brand's Over-the-Counter (OTC) products meet and exceed global regulatory standards.
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📋 How We Handle OTC Compliance Review:
OTC Compliance: Our team of regulatory experts specializes in conducting thorough OTC compliance reviews. From active ingredient assessments to label claims scrutiny, we ensure your cosmetic OTC products align with the stringent requirements outlined by regulatory authorities, The FDA.
Proactive Regulatory Assurance: Regulatory compliance is a proactive commitment. We adopt a stance that goes beyond meeting standards to ensuring your cosmetic OTC products are in constant alignment with evolving regulatory landscapes, prioritizing consumer safety and satisfaction. Thorough Regulatory Assessments: Our meticulous process begins with a comprehensive assessment to identify the specific OTC requirements relevant to your cosmetic products. This forms the foundation for a tailored compliance plan. Precise Label Claims Verification: The accuracy of label claims is pivotal. We scrutinize label claims to ensure they align with regulatory requirements, providing consumers with transparent and trustworthy information about your OTC cosmetic products. |
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📋 What are OTC Requirements:
What is an OTC: A drug product that is available for consumers without a prescription. Some of the OTC products include acne treatments, SPFs, antiperspirants, dandruff control, hair growth/regrowth, scar care, anti-inflammatory and weight control. If your products claims sound like or similar to any of the items prior, seek regulatory assistance for Marketing Collateral Proficiency.
Where does the FDA come in: The US FDA is not approving the OTC products, but they are evaluating the ingredients and labeling of these products as part of the FDA OTC Drug Review Process. The designation between a cosmetic and OTC is the intended use of the product. This is done by assessing the products ingredients along with the brand's claims and consumer perception.
The US FDA is not pre-approving OTC Drug Labels marketed under OTC Monograph, but US FDA regulates all OTC Drug labeling of the primary packaging, secondary packaging, insert, labels etc. Packaging must include Drug Facts labeling and Principal Display Panel labeling. These regulations help to standardize the content and format of OTC Drug labeling, generally recognizing them as safe and effective, and not misbranded.
What is the difference between an OTC and a Cosmetic: The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a cosmetic by the intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. The FD&C Act defines a drug by the intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].
Products such as make-up, moisturizers, deodorants, and shampoos can be both cosmetic and a drug therefore labeling requirements are crucial as such products must comply with the requirements for both cosmetics and drugs.
Can FINY Help with the SPL files for:
FDA OTC Monographs: Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA [FD&C Act, sec. 505(a) and (b)], or comply with the appropriate monograph for an OTC drug
\/ - possibly get ride of the table
Where does the FDA come in: The US FDA is not approving the OTC products, but they are evaluating the ingredients and labeling of these products as part of the FDA OTC Drug Review Process. The designation between a cosmetic and OTC is the intended use of the product. This is done by assessing the products ingredients along with the brand's claims and consumer perception.
The US FDA is not pre-approving OTC Drug Labels marketed under OTC Monograph, but US FDA regulates all OTC Drug labeling of the primary packaging, secondary packaging, insert, labels etc. Packaging must include Drug Facts labeling and Principal Display Panel labeling. These regulations help to standardize the content and format of OTC Drug labeling, generally recognizing them as safe and effective, and not misbranded.
What is the difference between an OTC and a Cosmetic: The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a cosmetic by the intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. The FD&C Act defines a drug by the intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].
Products such as make-up, moisturizers, deodorants, and shampoos can be both cosmetic and a drug therefore labeling requirements are crucial as such products must comply with the requirements for both cosmetics and drugs.
Can FINY Help with the SPL files for:
- US FDA Drug Establishment Registration
- Drug Listing with US FDA
- NDC Labeler code request to US FDA
FDA OTC Monographs: Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA [FD&C Act, sec. 505(a) and (b)], or comply with the appropriate monograph for an OTC drug
\/ - possibly get ride of the table
FDA Fees for OTC Monograph Drug Facility Registration for 2023 Type of Registration / Application |
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OTC Monograph Drug MDF Facility Fee |
$ 26,153 |
OTC Monograph Drug CMO Facility Fee |
$ 17,435 |
OMOR Fee Tier 1 |
$ 517,381 |
OMOR Fee Tier 2 |
$ 103,476 |
