In this third part of my series on cosmetics, drugs and cosmeceuticals, I will discuss the following:
• how a product's intended use is established
• various cosmeceutical products whose claims have caused them to run afoul of the law
• how approval requirements differs for drugs and cosmetics
• the definition of a new drug application
• the definition of a monograph (as it applies to over-the-counter drug categories such as sun blocks)
•definitions of new drugs.
Much of the technical data contained herein is directly summarized from FDA reviews of these subjects.1
Intended Use
United States law defines products not by their contents but by their claims, that is, the claims they make about a given product — known as “intended use.” A product is a drug essentially if it is intended to cure, treat or diagnose a disease.
As Table 1 shows, a product’s intended use may be established in three ways:1
1. Claims stated on its label and in marketing, including the Internet
2. consumer perception
3. ingredients.
Foods and Fragrances As Drugs
An article in the Archives of Dermatology reported that 44% of patients whose scalps were massaged daily with essential oils (thyme, rosemary, lavender, and cedar wood) in a mixture of carrier oils (jojoba and grape seed) showed improvement, compared with 5% in the control group treated with carrier oils.2
This combination of thyme, rosemary, lavender, and cedar wood oils in a mixture of carrier oils jojoba and grape seed drugs may seem to be a natural preparation but if it claims to be a treatment for a disease state such as alopecia areata, then it would be considered such according to the FDA rule. The same thing would apply to medical foods and foods for special dietary use that claim to treat or cure disorders.
Drug Requirements
Drugs must be approved by the FDA and can be on the market based on either on an FDA-approved new drug application (NDA) or through compliance with the appropriate monograph for an over-the-counter (OTC) drug.1 A list of monographs is attached (See List of FDA Monographs for OTC Drugs3 on page 27.) These monographs, which are published in the Federal Register, list requirements for categories of non-prescription drugs, such as the ingredients that may be used and for which intended use.1
An NDA is obtained by providing the FDA with clinical testing data and having the medication assessed by the FDA for safety and effectiveness.
New ingredients usually come to market based on NDAs rather than monographs. OTC drugs must be labeled according to OTC drug regulations whether on the market on the basis of an NDA or monograph.1
Crossing the Line
Sometimes a product sold as a cosmetic crosses the line to the extent that, from a claims standpoint, it is a drug.
An example that has come up in this regard involves eyelash lengthening products. The Age Intervention Eyelash product from Jan Marini contained bimatoprost, an ingredient in glaucoma medication. The FDA required Jan Marini to pull its ad for this product off the market because of the product’s claims.
At the same time, Allergan Inc., is in the process of developing a product that also contains bimatoprost, but it is developing it as a prescription product.
In another example, Brienza4 notes an FDA Warning Letter issued to a company for the seemingly innocuous claim “reduces redness.” However, the same company elsewhere claimed that its product was “intended for individuals with skin redness … often associated with conditions like eczema and rosacea,” which is a disease claim about treating abnormal conditions.
Another FDA Warning letter objected to a claim on a skin cream label that said it “helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin.”
Other anti-aging products that make “cell repair” claims are routinely, repeatedly provoke FDA sanction.3
Structure/Function Claims
Kawalek5 notes that in 1987, Daniel Michels, the director of the Office of Compliance for the FDA’s Center for Drugs and Biologics, issued warning letters to 23 cosmetics firms requesting that they cease making what he called “structure/function claims.” Claims about “cell rejuvenation,” for example, would no longer be tolerated because they promised to affect the structure of the skin.
In this case, the FDA required that those making such product claims rewrite brochures and text on packaging in addition to changing the products’ advertisements. Those failing to respond risked product seizures, injunctions against sales, and lawsuits. The companies complied, and the FDA had the funds and political backing to keep them in check — for a while.
Then, in January of 2005, the FDA sent one such letter to Basic Research, the marketer and distributor of StriVectin-SD and other products.2,6,7
“This letter is in reference to your firm’s marketing and distribution of StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-Apg, Mamralin-Ara, and TestroGel,” read the letter written by FDA District Director B. Belinda Collins.
Some of the drug claims referred to in the letter included, “Clinically Proven to Dramatically Reduce the Appearance of Existing Stretch Mark Length, Depth, Texture, and Discoloration” “Optimum Glycosa-minoglycan and Collagen Synthesis”; “Better than Botox?”; and “Superior wrinkle-reducing properties of a patented oligo-peptide . . . .”6,7
The list named nearly 40 other drug claims for Basic Research products, 11 of which pertained to StriVectin-SD.6,7 Yet StriVectin is still for sale despite the FDA warnings to the company that it is violating the Federal Food, Drug, and Cosmetic Act.
Cosmetics Requirements
Cosmetics are not subject to the same type of regulation as drugs. Color additives in cosmetics are subject to regulation. A list of approved color additives and sunblocks is attached as Table 2. It is interesting to note that some of these additives are also approved agents for sunblocks, specifically zinc oxide and titanium dioxide. (See special note below Table 2.)
Complex laws
The laws involving cosmetics and drugs are complex and do not provide for a separate category of cosmeceuticals. When dermatologist sell products, they must be aware of these laws so they can comply with their requirements.
Dr. Scheinfeld graduated from Harvard Law School in 1989 and from Yale Medical School in 1997. He’s currently an alternate on the Investigational Review Board at St. Luke’s-Roosevelt Hospital in New York City. He’s also an Assistant Clinical Professor at Columbia University.
In this third part of my series on cosmetics, drugs and cosmeceuticals, I will discuss the following:
• how a product's intended use is established
• various cosmeceutical products whose claims have caused them to run afoul of the law
• how approval requirements differs for drugs and cosmetics
• the definition of a new drug application
• the definition of a monograph (as it applies to over-the-counter drug categories such as sun blocks)
•definitions of new drugs.
Much of the technical data contained herein is directly summarized from FDA reviews of these subjects.1
Intended Use
United States law defines products not by their contents but by their claims, that is, the claims they make about a given product — known as “intended use.” A product is a drug essentially if it is intended to cure, treat or diagnose a disease.
As Table 1 shows, a product’s intended use may be established in three ways:1
1. Claims stated on its label and in marketing, including the Internet
2. consumer perception
3. ingredients.
Foods and Fragrances As Drugs
An article in the Archives of Dermatology reported that 44% of patients whose scalps were massaged daily with essential oils (thyme, rosemary, lavender, and cedar wood) in a mixture of carrier oils (jojoba and grape seed) showed improvement, compared with 5% in the control group treated with carrier oils.2
This combination of thyme, rosemary, lavender, and cedar wood oils in a mixture of carrier oils jojoba and grape seed drugs may seem to be a natural preparation but if it claims to be a treatment for a disease state such as alopecia areata, then it would be considered such according to the FDA rule. The same thing would apply to medical foods and foods for special dietary use that claim to treat or cure disorders.
Drug Requirements
Drugs must be approved by the FDA and can be on the market based on either on an FDA-approved new drug application (NDA) or through compliance with the appropriate monograph for an over-the-counter (OTC) drug.1 A list of monographs is attached (See List of FDA Monographs for OTC Drugs3 on page 27.) These monographs, which are published in the Federal Register, list requirements for categories of non-prescription drugs, such as the ingredients that may be used and for which intended use.1
An NDA is obtained by providing the FDA with clinical testing data and having the medication assessed by the FDA for safety and effectiveness.
New ingredients usually come to market based on NDAs rather than monographs. OTC drugs must be labeled according to OTC drug regulations whether on the market on the basis of an NDA or monograph.1
Crossing the Line
Sometimes a product sold as a cosmetic crosses the line to the extent that, from a claims standpoint, it is a drug.
An example that has come up in this regard involves eyelash lengthening products. The Age Intervention Eyelash product from Jan Marini contained bimatoprost, an ingredient in glaucoma medication. The FDA required Jan Marini to pull its ad for this product off the market because of the product’s claims.
At the same time, Allergan Inc., is in the process of developing a product that also contains bimatoprost, but it is developing it as a prescription product.
In another example, Brienza4 notes an FDA Warning Letter issued to a company for the seemingly innocuous claim “reduces redness.” However, the same company elsewhere claimed that its product was “intended for individuals with skin redness … often associated with conditions like eczema and rosacea,” which is a disease claim about treating abnormal conditions.
Another FDA Warning letter objected to a claim on a skin cream label that said it “helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin.”
Other anti-aging products that make “cell repair” claims are routinely, repeatedly provoke FDA sanction.3
Structure/Function Claims
Kawalek5 notes that in 1987, Daniel Michels, the director of the Office of Compliance for the FDA’s Center for Drugs and Biologics, issued warning letters to 23 cosmetics firms requesting that they cease making what he called “structure/function claims.” Claims about “cell rejuvenation,” for example, would no longer be tolerated because they promised to affect the structure of the skin.
In this case, the FDA required that those making such product claims rewrite brochures and text on packaging in addition to changing the products’ advertisements. Those failing to respond risked product seizures, injunctions against sales, and lawsuits. The companies complied, and the FDA had the funds and political backing to keep them in check — for a while.
Then, in January of 2005, the FDA sent one such letter to Basic Research, the marketer and distributor of StriVectin-SD and other products.2,6,7
“This letter is in reference to your firm’s marketing and distribution of StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-Apg, Mamralin-Ara, and TestroGel,” read the letter written by FDA District Director B. Belinda Collins.
Some of the drug claims referred to in the letter included, “Clinically Proven to Dramatically Reduce the Appearance of Existing Stretch Mark Length, Depth, Texture, and Discoloration” “Optimum Glycosa-minoglycan and Collagen Synthesis”; “Better than Botox?”; and “Superior wrinkle-reducing properties of a patented oligo-peptide . . . .”6,7
The list named nearly 40 other drug claims for Basic Research products, 11 of which pertained to StriVectin-SD.6,7 Yet StriVectin is still for sale despite the FDA warnings to the company that it is violating the Federal Food, Drug, and Cosmetic Act.
Cosmetics Requirements
Cosmetics are not subject to the same type of regulation as drugs. Color additives in cosmetics are subject to regulation. A list of approved color additives and sunblocks is attached as Table 2. It is interesting to note that some of these additives are also approved agents for sunblocks, specifically zinc oxide and titanium dioxide. (See special note below Table 2.)
Complex laws
The laws involving cosmetics and drugs are complex and do not provide for a separate category of cosmeceuticals. When dermatologist sell products, they must be aware of these laws so they can comply with their requirements.
Dr. Scheinfeld graduated from Harvard Law School in 1989 and from Yale Medical School in 1997. He’s currently an alternate on the Investigational Review Board at St. Luke’s-Roosevelt Hospital in New York City. He’s also an Assistant Clinical Professor at Columbia University.
In this third part of my series on cosmetics, drugs and cosmeceuticals, I will discuss the following:
• how a product's intended use is established
• various cosmeceutical products whose claims have caused them to run afoul of the law
• how approval requirements differs for drugs and cosmetics
• the definition of a new drug application
• the definition of a monograph (as it applies to over-the-counter drug categories such as sun blocks)
•definitions of new drugs.
Much of the technical data contained herein is directly summarized from FDA reviews of these subjects.1
Intended Use
United States law defines products not by their contents but by their claims, that is, the claims they make about a given product — known as “intended use.” A product is a drug essentially if it is intended to cure, treat or diagnose a disease.
As Table 1 shows, a product’s intended use may be established in three ways:1
1. Claims stated on its label and in marketing, including the Internet
2. consumer perception
3. ingredients.
Foods and Fragrances As Drugs
An article in the Archives of Dermatology reported that 44% of patients whose scalps were massaged daily with essential oils (thyme, rosemary, lavender, and cedar wood) in a mixture of carrier oils (jojoba and grape seed) showed improvement, compared with 5% in the control group treated with carrier oils.2
This combination of thyme, rosemary, lavender, and cedar wood oils in a mixture of carrier oils jojoba and grape seed drugs may seem to be a natural preparation but if it claims to be a treatment for a disease state such as alopecia areata, then it would be considered such according to the FDA rule. The same thing would apply to medical foods and foods for special dietary use that claim to treat or cure disorders.
Drug Requirements
Drugs must be approved by the FDA and can be on the market based on either on an FDA-approved new drug application (NDA) or through compliance with the appropriate monograph for an over-the-counter (OTC) drug.1 A list of monographs is attached (See List of FDA Monographs for OTC Drugs3 on page 27.) These monographs, which are published in the Federal Register, list requirements for categories of non-prescription drugs, such as the ingredients that may be used and for which intended use.1
An NDA is obtained by providing the FDA with clinical testing data and having the medication assessed by the FDA for safety and effectiveness.
New ingredients usually come to market based on NDAs rather than monographs. OTC drugs must be labeled according to OTC drug regulations whether on the market on the basis of an NDA or monograph.1
Crossing the Line
Sometimes a product sold as a cosmetic crosses the line to the extent that, from a claims standpoint, it is a drug.
An example that has come up in this regard involves eyelash lengthening products. The Age Intervention Eyelash product from Jan Marini contained bimatoprost, an ingredient in glaucoma medication. The FDA required Jan Marini to pull its ad for this product off the market because of the product’s claims.
At the same time, Allergan Inc., is in the process of developing a product that also contains bimatoprost, but it is developing it as a prescription product.
In another example, Brienza4 notes an FDA Warning Letter issued to a company for the seemingly innocuous claim “reduces redness.” However, the same company elsewhere claimed that its product was “intended for individuals with skin redness … often associated with conditions like eczema and rosacea,” which is a disease claim about treating abnormal conditions.
Another FDA Warning letter objected to a claim on a skin cream label that said it “helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin.”
Other anti-aging products that make “cell repair” claims are routinely, repeatedly provoke FDA sanction.3
Structure/Function Claims
Kawalek5 notes that in 1987, Daniel Michels, the director of the Office of Compliance for the FDA’s Center for Drugs and Biologics, issued warning letters to 23 cosmetics firms requesting that they cease making what he called “structure/function claims.” Claims about “cell rejuvenation,” for example, would no longer be tolerated because they promised to affect the structure of the skin.
In this case, the FDA required that those making such product claims rewrite brochures and text on packaging in addition to changing the products’ advertisements. Those failing to respond risked product seizures, injunctions against sales, and lawsuits. The companies complied, and the FDA had the funds and political backing to keep them in check — for a while.
Then, in January of 2005, the FDA sent one such letter to Basic Research, the marketer and distributor of StriVectin-SD and other products.2,6,7
“This letter is in reference to your firm’s marketing and distribution of StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-Apg, Mamralin-Ara, and TestroGel,” read the letter written by FDA District Director B. Belinda Collins.
Some of the drug claims referred to in the letter included, “Clinically Proven to Dramatically Reduce the Appearance of Existing Stretch Mark Length, Depth, Texture, and Discoloration” “Optimum Glycosa-minoglycan and Collagen Synthesis”; “Better than Botox?”; and “Superior wrinkle-reducing properties of a patented oligo-peptide . . . .”6,7
The list named nearly 40 other drug claims for Basic Research products, 11 of which pertained to StriVectin-SD.6,7 Yet StriVectin is still for sale despite the FDA warnings to the company that it is violating the Federal Food, Drug, and Cosmetic Act.
Cosmetics Requirements
Cosmetics are not subject to the same type of regulation as drugs. Color additives in cosmetics are subject to regulation. A list of approved color additives and sunblocks is attached as Table 2. It is interesting to note that some of these additives are also approved agents for sunblocks, specifically zinc oxide and titanium dioxide. (See special note below Table 2.)
Complex laws
The laws involving cosmetics and drugs are complex and do not provide for a separate category of cosmeceuticals. When dermatologist sell products, they must be aware of these laws so they can comply with their requirements.
Dr. Scheinfeld graduated from Harvard Law School in 1989 and from Yale Medical School in 1997. He’s currently an alternate on the Investigational Review Board at St. Luke’s-Roosevelt Hospital in New York City. He’s also an Assistant Clinical Professor at Columbia University.
