Re: Is It a Cosmetic, a Drug, or Both Attn Dr Bashaar

[Guest guest]

Dear Dr Bashaar Thanks a lot for this information on medical uses of soap namely Opdeldoc for sprains. Soap for enema in constipation, and soap use in eczema. Soap is also present in toothpastes but here it is used for cleansing action and so, probably not a drug. Doctors prescribe soap enema, or liniment for sprains. But soaps like Dettol as medicines don't fall in any prescriptions that I have seen. However, they are being easily sold like medicines. Dettol is even endorsed by the Indian Medical Association and Colgate by Indian Dental Association. On what grounds? -Anupama"M.Bashaar Ulfat" <bashaarulfat@...> wrote: Dear Anupama, Thanks for your question, here we have some condtions where we used soap as a drug (when drug is added with soap ingredient or the drug is itself the active ingredient of soap) but itself the soap cant be a drug if there is no active ingredient of drug/medicine is there. Two preparations of hard soap (sodium oleate), made by acting on olive oil with caustic soda, are used in medicine: (1) Emplastrum saponis, made with lead plaster; (2) Pilula saponis cornposita, which contains one in five parts of opium. Soft or green soap (potassium oleate), made by acting on olive oil with caustic potash, is also used; its preparation (Linamentum saponis) is known as opodeldoc. Curd soap is also used, and is chiefly a stearate of sodium. The chief use of hard soap is in enemata, and as a suppository in children suffering from constipation; it also forms the basis of many pills; given in warm water it forms a ready emetic in cases of poisoning. Soft soap is used by dermatologists in the

treatment of chronic eczema, and opodeldoc is a domestic remedy for stiffness and sprains. Medicated soaps are made by adding the drug to either hard soap or curd soap in the desired proportions. Best Regards Bashaar Kabul, Afghanistan Is It a Cosmetic, a Drug, or Both? (or Is It Soap?) The legal difference between a cosmetic and a drug is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs. How does the law define a cosmetic? The Food, Drug, and Cosmetic Act (FD & C Act) defines cosmetics by their 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)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic

product. How does the law define a drug? The FD & C Act defines drugs, in part, by their 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)]. How can a product be both a cosmetic and a drug? Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs. What about "cosmeceuticals" ? The

FD & C Act does not recognize any such category as "cosmeceuticals. " A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law. How is a product's intended use established? Intended use may be established in a number of ways. Among them are: Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is

marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells. Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do. Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in

toothpaste. This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. How are the laws and regulations different for cosmetics and drugs? The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended

only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. You should direct questions regarding laws and regulations for drugs to CDER. How approval requirements are different FDA does not have a premarket approval system for cosmetic products or ingredients, with the important exception of color additives. Drugs, however, are subject to FDA

approval. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain -- but not all -- over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either - Be the subject of an approved New Drug Application (NDA) [FD & C Act, sec. 505(a) and (], or Comply with the appropriate monograph, or rule, for an OTC drug. What do these terms mean? · An NDA is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the U.S. FDA only approves an NDA after determining, for example, that the data are adequate to show the drug's safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new

ingredients entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system and their 'switch' to OTC status is approved via the NDA system. FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of non-prescription drugs, such as what ingredients may be used and for what intended use. Among the many non-prescription drug categories covered by OTC monographs are - acne medications treatments for dandruff, seborrheic dermatitis, and psoriasis sunscreens A note on "new drugs": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, no matter how ancient or "traditional" its use may be, once the agency has made a final determination on the status of 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. Where to learn more about NDAs and OTC monographs: If you have questions about NDAs and OTC monographs, you should address them to CDER. The CDER Handbook provides an introduction to the drug approval and OTC monograph processes. Other resources, also available on CDER's Web site, provide additional information on these subjects. How good manufacturing practice

requirements are different Good manufacturing practice (GMP) is an important factor in assuring that your cosmetic products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics. In contrast, 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)(

]. How registration requirements are different 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]. How labeling requirements are different A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling. 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. For example, the drug ingredients must be listed alphabetically as "Active Ingredients, " followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients. " And what if it's

"soap"? Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD & C Act because -- even though Section 201(i)(1) of the act includes "articles... for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic. How FDA defines "soap" Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when -- The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and The product is labeled, sold, and represented solely as soap [21 CFR 701.20]. If a cleanser does

not meet all of these criteria... If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example: If a product -- consists of detergents or primarily of alkali salts of fatty acids and is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing, it is regulated as a cosmetic. If a product -- consists of detergents or primarily of alkali salts of fatty acids and is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body, it is regulated as a drug. If a product -- is intended solely for cleansing the human body and has the characteristics consumers generally associate with

soap, does not consist primarily of alkali salts of fatty acids, it may be identified in labeling as soap, but it is regulated as a cosmetic. Source: United States FDA For More Information please click http://www.cfsan. fda.gov/~ dms/cos-toc. html Be a better friend, newshound, and know-it-all with Mobile. Try it now. Forgot the famous last words? Access your message archive online. Click here. Be a better friend, newshound, and know-it-all with Mobile. Try it now.

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[Guest guest]

Dear Anupama,

obliged for encouragment, in fact i wanted to put down some info about dettol, but you have raised, if we see it is very popular, even in Afghanistan the dettol soap which is imported from Pakistan, the people use dettol soap in summer since they have injected by this idea, that this soap is very effective to kill micorbes.

I am sure that we will more discussion on this issue till COB 07 May 08

Cheers

Bashaar

Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)

The legal difference between a cosmetic and a drug is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

How does the law define a cosmetic?

The Food, Drug, and Cosmetic Act (FD & C Act) defines cosmetics by their 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)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a

cosmetic product.

How does the law define a drug?

The FD & C Act defines drugs, in part, by their 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)].

How can a product be both a cosmetic and a drug?

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

What about "cosmeceuticals" ?

The FD & C Act does not recognize any such category as "cosmeceuticals. " A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.

How is a product's intended use established?

Intended use may be established in a number of ways. Among them are:

Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.

Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.

How are the laws and regulations different for cosmetics and drugs?

The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. You should direct questions regarding laws and regulations for drugs to CDER.

How approval requirements are different

FDA does not have a premarket approval system for cosmetic products or ingredients, with the important exception of color additives. Drugs, however, are subject to FDA approval. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain -- but not all -- over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending

publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either -

Be the subject of an approved New Drug Application (NDA) [FD & C Act, sec. 505(a) and (], or

Comply with the appropriate monograph, or rule, for an OTC drug.

What do these terms mean?

· An NDA is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the U.S. FDA only approves an NDA after determining, for example, that the data are adequate to show the drug's safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system and their 'switch' to OTC status is approved via the NDA

system.

FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of non-prescription drugs, such as what ingredients may be used and for what intended use. Among the many non-prescription drug categories covered by OTC monographs are -

acne medications

treatments for dandruff, seborrheic dermatitis, and psoriasis

sunscreens

A note on "new drugs": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, no matter how ancient or "traditional" its use may be, once the agency has made a final determination on the status of 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.

Where to learn more about NDAs and OTC monographs: If you have questions about NDAs and OTC monographs, you should address them to CDER. The CDER Handbook provides an introduction to the drug approval and OTC monograph processes. Other resources, also available on CDER's Web site, provide additional information on these subjects.

How good manufacturing practice requirements are different

Good manufacturing practice (GMP) is an important factor in assuring that your cosmetic products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics. In contrast, 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)( ].

How registration requirements are different

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].

How labeling requirements are different

A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling. 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. For example, the drug ingredients must be listed alphabetically as "Active Ingredients, " followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients. "

And what if it's "soap"?

Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD & C Act because -- even though Section 201(i)(1) of the act includes "articles... for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic.

How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when --

The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and

The product is labeled, sold, and represented solely as soap [21 CFR 701.20].

If a cleanser does not meet all of these criteria...

If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product --

consists of detergents or

primarily of alkali salts of fatty acids and

is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,

it is regulated as a cosmetic.

If a product --

consists of detergents or

primarily of alkali salts of fatty acids and

is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,

it is regulated as a drug.

If a product --

is intended solely for cleansing the human body and

has the characteristics consumers generally associate with soap,

does not consist primarily of alkali salts of fatty acids,

it may be identified in labeling as soap, but it is regulated as a cosmetic.

Source: United States FDA

For More Information please click http://www.cfsan. fda.gov/~ dms/cos-toc. html

Be a better friend, newshound, and know-it-all with Mobile. Try it now.

Forgot the famous last words? Access your message archive online. Click here.

Be a better friend, newshound, and know-it-all with Mobile. Try it now.

Did you know? You can CHAT without downloading messenger. Click here

Be a better friend, newshound, and know-it-all with Mobile. Try it now.

[Guest guest]

HI

Endorsement for money and nothing else. IMA also has endorsed a

water purifying system.Some justified criticism for endorsements has

led to slowdown in further business but I collected that many

companies are interested in getting their products endorsed by

IMA.Obvious that such endorsement delivers the returns!

Vijay

Is It a Cosmetic, a Drug, or Both? (or Is It Soap?) The legal

difference between a cosmetic and a drug is determined by a

product's intended use. Different laws and regulations apply to each

type of product. Firms sometimes violate the law by marketing a

cosmetic with a drug claim, or by marketing a drug as if it were a

cosmetic, without adhering to requirements for drugs.

> How does the law define a cosmetic? The Food, Drug, and

Cosmetic Act (FD & C Act) defines cosmetics by their 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)]. Among the products included in

this definition are skin moisturizers, perfumes, lipsticks,

fingernail polishes, eye and facial makeup preparations, shampoos,

permanent waves, hair colors, toothpastes, and deodorants, as well

as any material intended for use as a component of a cosmetic

product.

> How does the law define a drug? The FD & C Act defines drugs, in

part, by their 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)].

> How can a product be both a cosmetic and a drug? Some products

meet the definitions of both cosmetics and drugs. This may happen

when a product has two intended uses. For example, a shampoo is a

cosmetic because its intended use is to cleanse the hair. An

antidandruff treatment is a drug because its intended use is to

treat dandruff. Consequently, an antidandruff shampoo is both a

cosmetic and a drug. Among other cosmetic/drug combinations are

toothpastes that contain fluoride, deodorants that are also

antiperspirants, and moisturizers and makeup marketed with sun-

protection claims. Such products must comply with the requirements

for both cosmetics and drugs.

> What about " cosmeceuticals " ? The FD & C Act does not recognize

any such category as " cosmeceuticals. " A product can be a drug, a

cosmetic, or a combination of both, but the term " cosmeceutical " has

no meaning under the law.

> How is a product's intended use established? Intended use may

be established in a number of ways. Among them are:

>

> Claims stated on the product labeling, in advertising, on the

Internet, or in other promotional materials. Certain claims may

cause a product to be considered a drug, even if the product is

marketed as if it were a cosmetic. Such claims establish the product

as a drug because the intended use is to treat or prevent disease or

otherwise affect the structure or functions of the human body. Some

examples are claims that products will restore hair growth, reduce

cellulite, treat varicose veins, or revitalize cells.

> Consumer perception, which may be established through the

product's reputation. This means asking why the consumer is buying

it and what the consumer expects it to do.

> Ingredients that may cause a product to be considered a drug

because they have a well known (to the public and industry)

therapeutic use. An example is fluoride in toothpaste.

> This principle also holds true for essential oils in fragrance

products. A fragrance marketed for promoting attractiveness is a

cosmetic. But a fragrance marketed with certain " aromatherapy "

claims, such as assertions that the scent will help the consumer

sleep or quit smoking, meets the definition of a drug because of its

intended use.

> How are the laws and regulations different for cosmetics and

drugs? The following information is not a complete treatment of

cosmetic or drug laws and regulations. It is intended only to alert

you to some important differences between the laws and regulations

for cosmetics and drugs in the areas of approval, good manufacturing

practice, registration, and labeling. You should direct questions

regarding laws and regulations for drugs to CDER.

> How approval requirements are different FDA does not have a

premarket approval system for cosmetic products or ingredients, with

the important exception of color additives. Drugs, however, are

subject to FDA approval. Generally, drugs must either receive

premarket approval by FDA or conform to final regulations specifying

conditions whereby they are generally recognized as safe and

effective, and not misbranded. Currently, certain -- but not all --

over-the-counter (OTC) drugs (that is, non-prescription drugs) that

were marketed before the beginning of the OTC Drug Review (May 11,

1972) may be marketed without specific approval pending publication

of final regulations under the ongoing OTC Drug Review. Once a

regulation covering a specific class of OTC drugs is final, those

drugs must either -

>

> Be the subject of an approved New Drug Application (NDA) [FD & C

Act, sec. 505(a) and (], or

> Comply with the appropriate monograph, or rule, for an OTC

drug.

> What do these terms mean? · An NDA is the vehicle

through which drug sponsors formally propose that FDA approve a new

pharmaceutical for sale and marketing in the U.S. FDA only approves

an NDA after determining, for example, that the data are adequate to

show the drug's safety and effectiveness for its proposed use and

that its benefits outweigh the risks. The NDA system is also used

for new ingredients entering the OTC marketplace for the first time.

For example, the newer OTC products (previously available only by

prescription) are first approved through the NDA system and

their 'switch' to OTC status is approved via the NDA system.

>

> FDA has published monographs, or rules, for a number of OTC

drug categories. These monographs, which are published in the

Federal Register, state requirements for categories of non-

prescription drugs, such as what ingredients may be used and for

what intended use. Among the many non-prescription drug categories

covered by OTC monographs are -

> acne medications

> treatments for dandruff, seborrheic dermatitis, and

psoriasis

> sunscreens

>

> A note on " new drugs " : Despite the word " new, " a " new drug " may

have been in use for many years. If a product is intended for use as

a drug, no matter how ancient or " traditional " its use may be, once

the agency has made a final determination on the status of 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.

> Where to learn more about NDAs and OTC monographs: If you have

questions about NDAs and OTC monographs, you should address them to

CDER. The CDER Handbook provides an introduction to the drug

approval and OTC monograph processes. Other resources, also

available on CDER's Web site, provide additional information on

these subjects.

> How good manufacturing practice requirements are different Good

manufacturing practice (GMP) is an important factor in assuring that

your cosmetic products are neither adulterated nor misbranded.

However, no regulations set forth specific GMP requirements for

cosmetics. In contrast, 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)( ].

> How registration requirements are different 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].

> How labeling requirements are different A cosmetic product must

be labeled according to cosmetic labeling regulations. See the

Cosmetic Labeling Manual for guidance on cosmetic labeling. 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. For example, the drug ingredients must be

listed alphabetically as " Active Ingredients, " followed by cosmetic

ingredients, listed in order of predominance as " Inactive

Ingredients. "

> And what if it's " soap " ? Soap is a category that needs special

explanation. That's because the regulatory definition of " soap " is

different from the way in which people commonly use the word.

Products that meet the definition of " soap " are exempt from the

provisions of the FD & C Act because -- even though Section 201(i)(1)

of the act includes " articles... for cleansing " in the definition of

a cosmetic -- Section 201(i)(2) excludes soap from the definition of

a cosmetic.

> How FDA defines " soap " Not every product marketed as soap meets

FDA's definition of the term. FDA interprets the term " soap " to

apply only when --

>

> The bulk of the nonvolatile matter in the product consists of

an alkali salt of fatty acids and the product's detergent properties

are due to the alkali-fatty acid compounds, and

> The product is labeled, sold, and represented solely as soap

[21 CFR 701.20].

> If a cleanser does not meet all of these criteria... If a

product intended to cleanse the human body does not meet all the

criteria for soap, as listed above, it is either a cosmetic or a

drug. For example:

> If a product --

>

> consists of detergents or

> primarily of alkali salts of fatty acids and

> is intended not only for cleansing but also for other cosmetic

uses, such as beautifying or moisturizing,

> it is regulated as a cosmetic.

> If a product --

>

> consists of detergents or

> primarily of alkali salts of fatty acids and

> is intended not only for cleansing but also to cure, treat, or

prevent disease or to affect the structure or any function of the

human body,

> it is regulated as a drug.

> If a product --

>

> is intended solely for cleansing the human body and

> has the characteristics consumers generally associate with

soap,

> does not consist primarily of alkali salts of fatty acids,

> it may be identified in labeling as soap, but it is regulated as

a cosmetic.

>

> Source: United States FDA

>

> For More Information please click http://www.cfsan. fda.gov/~

dms/cos-toc. html

>

>

>

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