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