In this second part of my series on cosmetic, drug and cosmeceutical claims, I review the criteria that lead to the classification of a product as either a drug or cosmetic, and how products and ingredients — and even soap — are defined for regulatory purposes.
Intended Use of a Product1
This principle of intended use may lead to the “cosmetic” designation of one fragrant oil to be conventionally marketed and perceived as intended to promote attractiveness, while another fragrant oil is designated as a drug with claims of “aromatherapeutic” benefits such as promoting relaxation or aiding weight loss or smoking cessation.
Intended use may be established in a number of ways. Among them are product claims, consumer perception, and ingredients.
Product claims. Certain claims found either on labeling or promotional materials may establish the product as a drug rather than a cosmetic because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Claims that a product would make cells or skin younger, eliminate veins, increase hair growth, eliminate cellulite would not be allowed for a cosmetic.
Consumer perception. This aspect of intended use is more subtle, as it deals with expectations, that is, the reason the product is being purchased and what the consumer expects it to do.
Ingredients. Certain ingredients determine whether a product is a cosmetic or drug. Many ingredients, including fluoride in toothpaste, are widely known to be for therapeutic use and for that reason cause a product to be considered a drug.
If It’s a Drug1
While, with the exception of color additives, the FDA does not have a pre-market approval system for cosmetic products or ingredients, drugs must either receive pre-market approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and are not misbranded.
OTC Drug Review
Some exceptions to this are some over-the-counter (OTC) drugs marketed before the beginning of the OTC Drug Review in May, 1972. Such products may be marketed without specific approval, pending publication of final regulations under the ongoing OTC Drug Review. However, once a regulation covering a specific class of OTC drugs is final, those drugs must either: (1) be the subject of an approved New Drug Application (NDA) [FD&C Act, sec. 505(a) and (b)], or (2)comply with the appropriate monograph, or rule, for an OTC drug.
New Drug Applications
A New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the United States. It is designed to establish the safety and efficacy of a drug for its proposed use and that its benefits outweigh the risks. This system is also used for new ingredients entering the OTC marketplace for the first time.
Monographs1
FDA has published rules, for a number of OTC drug categories. Called monographs, these rules, which are published in the Federal Register, specify requirements for categories of non-prescription drugs, such as the ingredients that may be used and the use for which they are intended. Among the many non-prescription drug categories covered by OTC monographs are: sunscreens; acne medications; and treatments for psoriasis, dandruff, and seborrheic dermatitis.
Marketing “New” Drugs
No matter how long it has been around, if a product is intended for use as a drug once the agency has made a final determination on its status as an OTC drug product, it must have an approved NDA or comply with the appropriate OTC monograph to be marketed legally in interstate commerce. Certain OTC drugs may remain on the market without NDA approval pending final regulations covering the appropriate class of drugs.
Different Requirements For Drugs vs. Cosmetics
Whether a product is designated a drug or cosmetic is indeed a big deal when it comes to hurdles such as meeting labeling and registration requirements.
Good Manufacturing Practice Requirements1
Good manufacturing practice (GMP) is an important factor in assuring that cosmetic products are neither adulterated nor misbranded. However, there are no regulations establishing specific GMP requirements for cosmetics, only for drugs. The law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].
Registration Requirements
FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].
Labeling Requirements
A cosmetic product must be labeled according to cosmetic labeling regulations, which can be found in the
FDA’s Cosmetic Labeling Manual (https://www.cfsan.fda.gov/~dms/cos-lab1.html). OTC drugs must be labeled according to OTC drug regulations, including the “Drug Facts” labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling in which drug ingredients are listed first alphabetically as “active ingredients,” then cosmetic ingredients are listed in order of predominance as “inactive ingredients.”
So What Does It All Mean?
It is clear from the foregoing discussion that there is no legal category for cosmeceuticals. If a product labeled “cosmeceutical” is really only a cosmetic, the claims that can be attached to such a product are limited. A “cosmeceutical” cannot legally claim it is the equal of Botox, silicon breast implants, Juvéderm, laser resurfacing, or liposuction. While these claims may be defended as merely figurative or metaphorical, they still are illegal. A product without approved ingredients for UV protection cannot claim to have photo-protective effects. (See Table 1 for allowed and prohibited claims for “cosmeceuticals.”2) If a product penetrates the skin and alters its structure and function or alters cellular function — e.g., thickens the skin, increases cellular turnover, or alters collagen production — this product is a drug. While claims to enhance appearance can be licit, they must be backed by data that are evidenced and experimentally based. Even vague claims without such data transgress Federal Trade Commission regulations rendering the over-promiser liable for civil and monetary sanction.
In this second part of my series on cosmetic, drug and cosmeceutical claims, I review the criteria that lead to the classification of a product as either a drug or cosmetic, and how products and ingredients — and even soap — are defined for regulatory purposes.
Intended Use of a Product1
This principle of intended use may lead to the “cosmetic” designation of one fragrant oil to be conventionally marketed and perceived as intended to promote attractiveness, while another fragrant oil is designated as a drug with claims of “aromatherapeutic” benefits such as promoting relaxation or aiding weight loss or smoking cessation.
Intended use may be established in a number of ways. Among them are product claims, consumer perception, and ingredients.
Product claims. Certain claims found either on labeling or promotional materials may establish the product as a drug rather than a cosmetic because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Claims that a product would make cells or skin younger, eliminate veins, increase hair growth, eliminate cellulite would not be allowed for a cosmetic.
Consumer perception. This aspect of intended use is more subtle, as it deals with expectations, that is, the reason the product is being purchased and what the consumer expects it to do.
Ingredients. Certain ingredients determine whether a product is a cosmetic or drug. Many ingredients, including fluoride in toothpaste, are widely known to be for therapeutic use and for that reason cause a product to be considered a drug.
If It’s a Drug1
While, with the exception of color additives, the FDA does not have a pre-market approval system for cosmetic products or ingredients, drugs must either receive pre-market approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and are not misbranded.
OTC Drug Review
Some exceptions to this are some over-the-counter (OTC) drugs marketed before the beginning of the OTC Drug Review in May, 1972. Such products may be marketed without specific approval, pending publication of final regulations under the ongoing OTC Drug Review. However, once a regulation covering a specific class of OTC drugs is final, those drugs must either: (1) be the subject of an approved New Drug Application (NDA) [FD&C Act, sec. 505(a) and (b)], or (2)comply with the appropriate monograph, or rule, for an OTC drug.
New Drug Applications
A New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the United States. It is designed to establish the safety and efficacy of a drug for its proposed use and that its benefits outweigh the risks. This system is also used for new ingredients entering the OTC marketplace for the first time.
Monographs1
FDA has published rules, for a number of OTC drug categories. Called monographs, these rules, which are published in the Federal Register, specify requirements for categories of non-prescription drugs, such as the ingredients that may be used and the use for which they are intended. Among the many non-prescription drug categories covered by OTC monographs are: sunscreens; acne medications; and treatments for psoriasis, dandruff, and seborrheic dermatitis.
Marketing “New” Drugs
No matter how long it has been around, if a product is intended for use as a drug once the agency has made a final determination on its status as an OTC drug product, it must have an approved NDA or comply with the appropriate OTC monograph to be marketed legally in interstate commerce. Certain OTC drugs may remain on the market without NDA approval pending final regulations covering the appropriate class of drugs.
Different Requirements For Drugs vs. Cosmetics
Whether a product is designated a drug or cosmetic is indeed a big deal when it comes to hurdles such as meeting labeling and registration requirements.
Good Manufacturing Practice Requirements1
Good manufacturing practice (GMP) is an important factor in assuring that cosmetic products are neither adulterated nor misbranded. However, there are no regulations establishing specific GMP requirements for cosmetics, only for drugs. The law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].
Registration Requirements
FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].
Labeling Requirements
A cosmetic product must be labeled according to cosmetic labeling regulations, which can be found in the
FDA’s Cosmetic Labeling Manual (https://www.cfsan.fda.gov/~dms/cos-lab1.html). OTC drugs must be labeled according to OTC drug regulations, including the “Drug Facts” labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling in which drug ingredients are listed first alphabetically as “active ingredients,” then cosmetic ingredients are listed in order of predominance as “inactive ingredients.”
So What Does It All Mean?
It is clear from the foregoing discussion that there is no legal category for cosmeceuticals. If a product labeled “cosmeceutical” is really only a cosmetic, the claims that can be attached to such a product are limited. A “cosmeceutical” cannot legally claim it is the equal of Botox, silicon breast implants, Juvéderm, laser resurfacing, or liposuction. While these claims may be defended as merely figurative or metaphorical, they still are illegal. A product without approved ingredients for UV protection cannot claim to have photo-protective effects. (See Table 1 for allowed and prohibited claims for “cosmeceuticals.”2) If a product penetrates the skin and alters its structure and function or alters cellular function — e.g., thickens the skin, increases cellular turnover, or alters collagen production — this product is a drug. While claims to enhance appearance can be licit, they must be backed by data that are evidenced and experimentally based. Even vague claims without such data transgress Federal Trade Commission regulations rendering the over-promiser liable for civil and monetary sanction.
In this second part of my series on cosmetic, drug and cosmeceutical claims, I review the criteria that lead to the classification of a product as either a drug or cosmetic, and how products and ingredients — and even soap — are defined for regulatory purposes.
Intended Use of a Product1
This principle of intended use may lead to the “cosmetic” designation of one fragrant oil to be conventionally marketed and perceived as intended to promote attractiveness, while another fragrant oil is designated as a drug with claims of “aromatherapeutic” benefits such as promoting relaxation or aiding weight loss or smoking cessation.
Intended use may be established in a number of ways. Among them are product claims, consumer perception, and ingredients.
Product claims. Certain claims found either on labeling or promotional materials may establish the product as a drug rather than a cosmetic because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Claims that a product would make cells or skin younger, eliminate veins, increase hair growth, eliminate cellulite would not be allowed for a cosmetic.
Consumer perception. This aspect of intended use is more subtle, as it deals with expectations, that is, the reason the product is being purchased and what the consumer expects it to do.
Ingredients. Certain ingredients determine whether a product is a cosmetic or drug. Many ingredients, including fluoride in toothpaste, are widely known to be for therapeutic use and for that reason cause a product to be considered a drug.
If It’s a Drug1
While, with the exception of color additives, the FDA does not have a pre-market approval system for cosmetic products or ingredients, drugs must either receive pre-market approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and are not misbranded.
OTC Drug Review
Some exceptions to this are some over-the-counter (OTC) drugs marketed before the beginning of the OTC Drug Review in May, 1972. Such products may be marketed without specific approval, pending publication of final regulations under the ongoing OTC Drug Review. However, once a regulation covering a specific class of OTC drugs is final, those drugs must either: (1) be the subject of an approved New Drug Application (NDA) [FD&C Act, sec. 505(a) and (b)], or (2)comply with the appropriate monograph, or rule, for an OTC drug.
New Drug Applications
A New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the United States. It is designed to establish the safety and efficacy of a drug for its proposed use and that its benefits outweigh the risks. This system is also used for new ingredients entering the OTC marketplace for the first time.
Monographs1
FDA has published rules, for a number of OTC drug categories. Called monographs, these rules, which are published in the Federal Register, specify requirements for categories of non-prescription drugs, such as the ingredients that may be used and the use for which they are intended. Among the many non-prescription drug categories covered by OTC monographs are: sunscreens; acne medications; and treatments for psoriasis, dandruff, and seborrheic dermatitis.
Marketing “New” Drugs
No matter how long it has been around, if a product is intended for use as a drug once the agency has made a final determination on its status as an OTC drug product, it must have an approved NDA or comply with the appropriate OTC monograph to be marketed legally in interstate commerce. Certain OTC drugs may remain on the market without NDA approval pending final regulations covering the appropriate class of drugs.
Different Requirements For Drugs vs. Cosmetics
Whether a product is designated a drug or cosmetic is indeed a big deal when it comes to hurdles such as meeting labeling and registration requirements.
Good Manufacturing Practice Requirements1
Good manufacturing practice (GMP) is an important factor in assuring that cosmetic products are neither adulterated nor misbranded. However, there are no regulations establishing specific GMP requirements for cosmetics, only for drugs. The law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].
Registration Requirements
FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].
Labeling Requirements
A cosmetic product must be labeled according to cosmetic labeling regulations, which can be found in the
FDA’s Cosmetic Labeling Manual (https://www.cfsan.fda.gov/~dms/cos-lab1.html). OTC drugs must be labeled according to OTC drug regulations, including the “Drug Facts” labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling in which drug ingredients are listed first alphabetically as “active ingredients,” then cosmetic ingredients are listed in order of predominance as “inactive ingredients.”
So What Does It All Mean?
It is clear from the foregoing discussion that there is no legal category for cosmeceuticals. If a product labeled “cosmeceutical” is really only a cosmetic, the claims that can be attached to such a product are limited. A “cosmeceutical” cannot legally claim it is the equal of Botox, silicon breast implants, Juvéderm, laser resurfacing, or liposuction. While these claims may be defended as merely figurative or metaphorical, they still are illegal. A product without approved ingredients for UV protection cannot claim to have photo-protective effects. (See Table 1 for allowed and prohibited claims for “cosmeceuticals.”2) If a product penetrates the skin and alters its structure and function or alters cellular function — e.g., thickens the skin, increases cellular turnover, or alters collagen production — this product is a drug. While claims to enhance appearance can be licit, they must be backed by data that are evidenced and experimentally based. Even vague claims without such data transgress Federal Trade Commission regulations rendering the over-promiser liable for civil and monetary sanction.
