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Home > Cosmetics Knowledge > Cosmetics & OTC drugs
Cosmetics & OTC drugs

DrugsUnlike drugs, which are used to treat or prevent disease in the body, cosmetics do not change or affect the bodys structure or functions. The legal difference between a cosmetic and a drug is determined by a products 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. The Food, Drug & Cosmetic 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 bodys structure or functions. Among the products included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, 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 the structure or functions of the human body, are considered drugs. Over-the-counter drugs are drugs that can be purchased without a doctors prescription. Examples of products that are over-the-counter drugs are fluoride toothpastes, hormone creams, sunscreen preparations, antiperspirants, and antidandruff shampoos.

Over-the-counter drugs should be used primarily for the temporary relief of minor symptoms.

A growing number of nonprescription, over the counter (OTC) medicines are available to treat an expanding range of ailments. OTC medicines can relieve many minor aches, pains and itches. Some can prevent diseases like tooth decay, cure diseases like athletes foot and, with a doctors guidance, help manage recurring conditions like arthritis.

The FDA determines whether medicines are prescription or nonprescription. The term prescription (Rx) refers to medicines that are safe and effective when used under a doctors order. Nonprescription (OTC) drugs are medicines FDA decides are safe and effective for use without a doctors prescription. The FDA also decides when a prescription drug is safe enough to be sold directly to consumers over the counter.

According to the US Food and Drug Administration (FDA) some products qualify as both a cosmetic and an over-the-counter drug. The distinction between cosmetics and drugs is sometimes vague. According to FDA guidelines, products claiming to offer medical benefits or physiological effects were over-the-counter (OTC) drugs. Examples of items with controversial classifications included antiperspirants, which were classified as OTC drugs in the late 1970s, sunscreen products that listed a Sun Protection Factor (SPF) number, hair care products claiming to protect or restore hair, and shampoos professing to cure or remove dandruff. If the FDA deemed a cosmetic product to be an OTC drug, it was regulated as a new drug. The manufacturer was then required to demonstrate product safety and efficacy to gain FDA approval. Cosmetics are defined as products "intended to be [applied] ...to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance", whereas drugs are defined as articles (other than food) "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.....Or intended to affect the structure or any function of the body of man or other animals." Under these definitions, some products, such as deodorants, flouride toothpastes, AHAs, etc. have intended uses as both cosmetics and drugs, and hence must comply with requirements for both.

Cosmetics are put on the body to:
cleanse it
make it beautiful
make it attractive
change its appearance or the way it looks

Cosmetic products include:
skin creams
lotions
perfumes
lipsticks
fingernail polishes
eye and face make-up products
permanent waves
hair dyes
toothpastes
deodorants

Under the Food, Drug, and Cosmetics Act, the Food and Drug Administration (FDC) of the United States has the authority to regulate foods, prescription (Rx) drugs, over-the-counter (OTC) drugs, and cosmetics. The FDA also administers a second statute, the Fair Packaging and Labeling Act. In order to administer this complex task, the FDA depends on the legalistic and statutory definitions of drug and cosmetics in the FDCA. Nevertheless, the publics interpretation of what constitutes a drug or a cosmetic may differ somewhat from that of regulatory agencies. Philosophically and historically, a cosmetic is a product that helps improve external appearance and has the ability to hide, or at least distract from, unwanted stigmata or skin defects.

A product that changes the color of hair is a cosmetic, as is a product intended to increase the skins tendency to tan by exposure to sun. This traditional view remains ingrained in the consumers mind but may not be judicially valid. A change in hair color, for example, can be effected by the following: 1) a wig, which might be viewed as an article of clothing; 2) a variety of dyeing processes, which are properly identified as cosmetic changes; and 3) possibly by a variety of ingested or topically applied substances that gradually alter the hair follicles ability to synthesize melanin, which should be classified as a drug effect. The common goal of these three approaches is to effect a change in appearance, the key objective of all cosmetics. The method by which this goal is achieved differentiates the three hair "coloring" processes and makes a product a drug or a cosmetic. This can create some confusion, as is demonstrated by a consideration of sunscreen products. Sunburn prevention by topical products was for years considered within the scope of cosmetics, even though ultraviolet-B (UV-B) light absorbers were incorporated into these "cosmetics." The cosmetic industry responded rather calmly when the FDAs review of OTC drugs included suntan preparations and sunburn preventives. What for years had been a cosmetic suddenly became a drug by legislative or administrative fiat. The FDAs rationale is justifiably based on the concept that sunburn prevention is prevention of disease. The user would view adding an ingredient that enhances the ability of melanocytes to produce melanin in the skin as a cosmetic. The FDA is likely to accept cosmetic (color change, appearance) claims for such a product, but a definition of a drug would become mandatory if the melanin were claimed to protect against sunburn. The implication that a parasol intended to prevent exposure to sun is a medical device has not been judicially examined.

One must recognize that the differentiation between cosmetics and drugs is complex and is blurred by the interplay of consumer perception, commercial interest, and statutory interpretation by regulatory agencies, with the ultimate decision in the hands of the judiciary.

The Food, Drug & Cosmetic 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 bodys structure or functions. Among the products included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, 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 the structure or functions of the human body, are considered drugs. Over-the-counter drugs are drugs that can be purchased without a doctors prescription. Examples of products that are over-the-counter drugs are fluoride toothpastes, hormone creams, sunscreen preparations, antiperspirants, and antidandruff shampoos.

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