6 replies to this topic

[Eva Victoria]

After reading things like: "OTC means non-prescription and, literally, "over the counter." Anything that you can get in a retail store without a prescription or special process is considered OTC. Oral syringes are OTC, cosmetic products are OTC, OTC drugs are OTC. Clearly umbrellas and handbags are also OTC, but it is redundant to say so since one would never need a prescription for them. OTC cosmetic products are referred to as such because in the US there are also prescription/doctor-applied cosmetic products: botox, benzoyl peroxide 6%, retin-A, nizoral 2%..."


I decided there was clearly a need to clear up the confusion about the definition of Prescription Drugs (RX), Over the Counter Drugs (OTC) and Cosmetics according to the FDA.

(For other parts of the world please view the attached file.


OTC drug products are those drugs that are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks.

OTC drugs generally have these characteristics:

• their benefits outweigh their risks
• the potential for misuse and abuse is low
• consumer can use them for self-diagnosed conditions
• they can be adequately labeled
• health practitioners are not needed for the safe and effective use of the product

http://www.fda.gov/c...otc/default.htm



http://www.medscape....warticle/464201



The U.S. Food and Drug Administration (FDA) determines whether medicines are prescription or nonprescription. The term prescription (Rx) refers to medicines that are safe and effective when used under a doctor's care. Nonprescription or OTC drugs are medicines FDA decides are safe and effective for use without a doctor's prescription.

http://www.fda.gov/b...RightForYou.htm



FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.

http://www.cfsan.fda...ms/cos-206.html

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.

http://www.cfsan.fda...ms/cos-218.html




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 (b)], or
• Comply with the appropriate monograph, or rule, for an OTC drug.

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."





The Fine Line Between Cosmetics and Drugs

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. This definition includes skin-care creams, lotions, powders and sprays, perfumes, lipsticks, fingernail polishes, eye and facial makeup, permanent waves, hair colors, deodorants, baby products, bath oils, bubble baths, and mouthwashes, as well as any material intended for use as a component of a cosmetic product.

Products that intend to treat or prevent disease, or otherwise affect structure or function of the human body are considered drugs. Cosmetics that make therapeutic claims are regulated as drugs and cosmetics, and must meet the labeling requirements for both. A good way to tell if you're buying a cosmetic that is also regulated as a drug is to see if the first ingredient listed is an "active ingredient." The active ingredient is the chemical that makes the product effective, and the manufacturer must have proof that it's safe for its intended use. For products that are both drugs and cosmetics, the regulations require that active ingredients be listed first on these products, followed by the list of cosmetic ingredients in order of decreasing predominance.

Examples of products that are both cosmetics and drugs are dandruff shampoos, fluoride toothpastes, antiperspirant deodorants, and foundations and tanning preparations that contain sunscreen.

http://www.fda.gov/F...8/398_cosm.html

Further reading:


http://www.cfsan.fda...ms/cos-toc.html



http://www.cfsan.fda...ms/cos-217.html



http://www.fda.gov/C...rug/default.htm

The CDER Handbook:

http://www.fda.gov/c...ok/startpag.htm

Attached Files

•  Regulations_Worldwide.pdf   1.25MB   80 downloads
•  EU_2007_Cosmetic_directory.pdf   384.44KB   47 downloads

Edited by Eva Victoria, 07 November 2008 - 08:52 PM.

[Mind]

The line between OTC and RX will continue to blur and this could become a problem for immortalists. FDA and other regulatory bodies around the world are typically slow to act a far behind the knowledge curve on latest research. I am afraid the default option will be to ban many new poorly understood products.

[conwict]

Hello,

I am going to respond to clarify the topic for anyone reading as well as to clarify my statement that Eva Victoria has (and I say this respectfully) misquoted and conflated with his or her own confusions regarding the definitions of OTC, OTC drug, et al.

Let me first say that in the United States, as well as in the rest of the world to my knowledge, the government absolutely does not have exclusive prerogative to defining any phrases.  Respectfully, that sounds like something from Orwell's 1984.  While the FDA and such agencies have huge clout and do set legal standards and definitions, those legal standards and definitions are neither singular nor exclusive.  I submit, again respectfully, that a fundamental difference in Eva Victoria's thinking and my own is that I understand and believe that etymology is a democratic process.  Simply because a governmental agency co-opts a phrase does not suddenly invalidate other usages of that phrase.  Again, the logical (if extreme) end-point of granting your government such power would not be so far off from Orwell's "doublespeak."

Now, here is a transcript of a conversation between Eva Victoria and myself:

Thanks for your kindness to clear up the term OTC.
However, in the US OTC drugs are considered to be Over the counter Drugs that have active pharmaceutical ingredients like hydroquinone, sodium fluoride (like in toothpaste!), all sunscreens (even though they are classified as cosmetics in the EU) in less concentration than RX (prescription) drugs. (Like Hydroquinone at the strength of up to 2% can be bought OTC/without need for prescription but at 4% concentration it is an RX -prescription needed drug.) So handbags as you kindly put it not OTC drugs (at least not yet).
Cosmetics are a completely different category of products without any ingredients classified as
actives or Active Ingredients.
Should you have any further questions about these three very important terms please read the
attached document on the thread where I wrote this post).

Please, have the decency to check your answers before you post them. You'll spare a lot of
embarrassment for yourself.

Cheers!

Hi,

OTC in and of itself is a colloquialism rather than a technical term. "OTC drug" is a technical term that quite literally has a cluster-****ed definition put in place (in the US obviously) by the FDA.

The problem is that in your original post, you simply said "OTC," not "OTC drug." You are correct in surmising that OTC drug and prescription drug and cosmetic have specific regional technical definitions. However, in the US and the UK, OTC is used colloquially and somewhat discretely from "OTC drug" to refer to something that is available without any special licensure or a doctor visit or something that is traded between two parties with no required licensure. This is significant because it is a conscious differentiation in usage rather than a corruption; in fact, the technical term "OTC drug" is actually derived from the more general (yet now colloquial as opposed to technical) turn of phrase "over the counter," not the other way around.

I don't need to check anything, because I hear it used that way frequently. Further, I think that ascribing my definition to some lack of "decency," as you said, simply because it differs from yours is quite beside the point - unless, of course, you have a different definition of decency from mine. Remember, a popular usage, even if it is a misusage, will always trump a technical or official definition. Doubly so when the technical definition is a derivative of the popular (or general) usage.

Conwict

Finally, a second private message Eva sent to me linking me to this thread:

Hi Conwict!

Thought you might enjoy reading this new topic about OTC,RX and Cosmetics.

http://www.imminst.o...showtopic=25615

Hope you'll not make the same mistake after reading this and say that "cosmetics are OTC drugs like umbrellas and handbags". Which I found quite entertaining

Anyone who has the inclination (not very likely) can feel free to do a post search and see whether I posted the above statement.  I did not.

Now, rather than frame this as what's sometimes called a "pissing contest," let me state that I find searching for common communicative ground one of the most ennobling and frustrating things about being a human being.  My intent is by no means aimed at proving Eva wrong or making him/her look bad.

I do agree with the above poster that this entire issue, not to mention the power the FDA wields, is a huge headache.

Conwict

Edited by conwict, 09 November 2008 - 01:42 AM.

[Ben]

The line between OTC and RX will continue to blur and this could become a problem for immortalists. FDA and other regulatory bodies around the world are typically slow to act a far behind the knowledge curve on latest research. I am afraid the default option will be to ban many new poorly understood products.

This is a major problem in Australia. Example: Piracetam was first synthesised in the 1960's. When did the Australian government first asses it? 2003.

[Eva Victoria]

Hello,

I am going to respond to clarify the topic for anyone reading as well as to clarify my statement that Eva Victoria has (and I say this respectfully) misquoted and conflated with his or her own confusions regarding the definitions of OTC, OTC drug, et al.

Let me first say that in the United States, as well as in the rest of the world to my knowledge, the government absolutely does not have exclusive prerogative to defining any phrases. Respectfully, that sounds like something from Orwell's 1984. While the FDA and such agencies have huge clout and do set legal standards and definitions, those legal standards and definitions are neither singular nor exclusive. I submit, again respectfully, that a fundamental difference in Eva Victoria's thinking and my own is that I understand and believe that etymology is a democratic process. Simply because a governmental agency co-opts a phrase does not suddenly invalidate other usages of that phrase. Again, the logical (if extreme) end-point of granting your government such power would not be so far off from Orwell's "doublespeak."

Now, here is a transcript of a conversation between Eva Victoria and myself:

Thanks for your kindness to clear up the term OTC.
However, in the US OTC drugs are considered to be Over the counter Drugs that have active pharmaceutical ingredients like hydroquinone, sodium fluoride (like in toothpaste!), all sunscreens (even though they are classified as cosmetics in the EU) in less concentration than RX (prescription) drugs. (Like Hydroquinone at the strength of up to 2% can be bought OTC/without need for prescription but at 4% concentration it is an RX -prescription needed drug.) So handbags as you kindly put it not OTC drugs (at least not yet).
Cosmetics are a completely different category of products without any ingredients classified as
actives or Active Ingredients.
Should you have any further questions about these three very important terms please read the
attached document on the thread where I wrote this post).

Please, have the decency to check your answers before you post them. You'll spare a lot of
embarrassment for yourself.

Cheers!

Hi,

OTC in and of itself is a colloquialism rather than a technical term. "OTC drug" is a technical term that quite literally has a cluster-****ed definition put in place (in the US obviously) by the FDA.

The problem is that in your original post, you simply said "OTC," not "OTC drug." You are correct in surmising that OTC drug and prescription drug and cosmetic have specific regional technical definitions. However, in the US and the UK, OTC is used colloquially and somewhat discretely from "OTC drug" to refer to something that is available without any special licensure or a doctor visit or something that is traded between two parties with no required licensure. This is significant because it is a conscious differentiation in usage rather than a corruption; in fact, the technical term "OTC drug" is actually derived from the more general (yet now colloquial as opposed to technical) turn of phrase "over the counter," not the other way around.

I don't need to check anything, because I hear it used that way frequently. Further, I think that ascribing my definition to some lack of "decency," as you said, simply because it differs from yours is quite beside the point - unless, of course, you have a different definition of decency from mine. Remember, a popular usage, even if it is a misusage, will always trump a technical or official definition. Doubly so when the technical definition is a derivative of the popular (or general) usage.

Conwict

Finally, a second private message Eva sent to me linking me to this thread:

Hi Conwict!

Thought you might enjoy reading this new topic about OTC,RX and Cosmetics.

http://www.imminst.o...showtopic=25615

Hope you'll not make the same mistake after reading this and say that "cosmetics are OTC drugs like umbrellas and handbags". Which I found quite entertaining

Anyone who has the inclination (not very likely) can feel free to do a post search and see whether I posted the above statement. I did not.

Now, rather than frame this as what's sometimes called a "pissing contest," let me state that I find searching for common communicative ground one of the most ennobling and frustrating things about being a human being. My intent is by no means aimed at proving Eva wrong or making him/her look bad.

I do agree with the above poster that this entire issue, not to mention the power the FDA wields, is a huge headache.

Conwict

Hi Conwict!

Here is exactly what you posted in the thread of Ben-Aus:

http://www.imminst.o...o...30&start=30

"conwict View Member Profile Add as Friend Send Message Find Member's Topics Find Member's Posts ipsmenu.register( "post-member-275505", '', 'popmenubutton-new', 'popmenubutton-new-out' ); 6-Nov 2008, 05:34 AM

Post #50

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Joined: 6-Nov 2008 Posts: 6

Eva,

You're still confused about the phrase "OTC."

OTC means non-prescription and, literally, "over the counter." Anything that you can get in a retail store without a prescription or special process is considered OTC.

Oral syringes are OTC, cosmetic products are OTC, OTC drugs are OTC.

Clearly umbrellas and handbags are also OTC, but it is redundant to say so since one would never need a prescription for them.

OTC cosmetic products are referred to as such because in the US there are also prescription/doctor-applied cosmetic products: botox, benzoyl peroxide 6%, retin-A, nizoral 2%..."

[conwict]

"OTC means non-prescription and, literally, 'over the counter.' Anything that you can get in a retail store without a prescription or special process is considered OTC.
..Clearly umbrellas and handbags are also OTC, but it is redundant to say so since one would never need a prescription for them."

≠

"cosmetics are OTC drugs like umbrellas and handbags"

If you don't speak English as a first language I can understand the confusion, but why spend so much time fixating on this? You yourself said you were totally unfamiliar with the term until reading the "thread of Ben Aus," so why bother debating the nuances and finer points of the English language when you just learned the meaning of a word? As I said in my above post, I assure you that the FDA does not have proprietary rights to American English.

If this is because you perceived a combative tone in my initial post, I offer my apology for not taking more care in moderating my tone. Starting an argument was not my intention.

Edited by conwict, 10 November 2008 - 08:05 PM.

[Eva Victoria]

"OTC means non-prescription and, literally, 'over the counter.' Anything that you can get in a retail store without a prescription or special process is considered OTC.
..Clearly umbrellas and handbags are also OTC, but it is redundant to say so since one would never need a prescription for them."

≠

"cosmetics are OTC drugs like umbrellas and handbags"

If you don't speak English as a first language I can understand the confusion, but why spend so much time fixating on this? You yourself said you were totally unfamiliar with the term until reading the "thread of Ben Aus," so why bother debating the nuances and finer points of the English language when you just learned the meaning of a word? As I said in my above post, I assure you that the FDA does not have proprietary rights to American English.

If this is because you perceived a combative tone in my initial post, I offer my apology for not taking more care in moderating my tone. Starting an argument was not my intention.

Hi Conwict!

I did not learn the term OTC drug from the thread Ben-Aus started. _{(It was ironically meant about the Avene cream, because it is classified as cosmetics in the EU so I was very surprised that it could be classified as OTC drug in the US, hence the question mark)}.The term OTC I learnt about 25 years ago I am a formulator of among others cosmetics but mainly sunscreens. So as you know I should be familiar with the term OTC drug defined by the FDA since sunscreen agents do fall in this category in the US (while they are classified as cosmetics in the EU).

Second I started this thread for clarifying this misunderstanding. There are many people who do not understand the difference between RX, OTC drugs and Cosmetics. So thank you for giving me the idea!

On this forum when people speak/write about OTC (drugs) they do refer to the FDA defined term not the colloquial English usage about over the counter.
As you have seen most people talk about topical treatments on the Skin Health forum.

I don't take this as an argument. I think it was a very good idea really to write about this topic.

Hope you'll enjoy being on this forum!

Edited by Eva Victoria, 10 November 2008 - 09:07 PM.