Cosmetics As OTC Drugs: The FDA has the authority to regulate personal care products that contain active ingredients that are Over-The-Counter (OTC) drugs. OTC drugs used in personal care products including cosmetics are subject to FDA approval. Generally, drugs must either receive pre-market approval by FDA or conform to final Federal regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain but not all 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 rules and 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) or comply with the appropriate Federal rules for an OTC 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”. The FD&C Act does not recognize any such category as “cosmeceuticals.” The main difference between cosmeceuticals and over-the-counter cosmetics is the concentration of active ingredients. Cosmeceuticals contain many more active ingredients and are in much higher concentrations. These active ingredients can therefore penetrate deeper into the dermis layer of the skin, which results in more visible, longer-term benefits. A product can be a drug, a cosmetic, or a combination of both, but the term cosmeceutical has no meaning under the law.
OTC drugs are often marketed side by side with cosmetics, and some products qualify both as cosmetics and as OTC drugs. This may happen when a product has two intended uses, with ingredients intended to do two different things. For instance, shampoo is a cosmetic, since its intended use is to cleanse the hair. An anti-dandruff 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 is a toothpaste that contains fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.
Cosmetic OTC drugs
Antidandruff agents (e.g. in Shampoos)
Dandruff occurs when skin cells on the scalp form too fast, meaning more skin cells are shed and become clumps that can be seen by the naked eye. This may be for a variety of reasons- a product built up in the hair like shampoo, conditioner, hair spray, gel, wax etc. that’s not washed and rinsed properly. A major reason is abnormally high levels of a fungus called Malassezia globose, which is a type of yeast and is always found on the scalp, even in those without dandruff. Inherent factors like diet, stress levels, weather conditions, hair type (oily hair type is more susceptible to dandruff) and even genetics play a role to some extent. An antidandruff shampoo can be used to break and wash away any product buildup in your hair to leave it clean. The anti-dandruff agents include zinc pyrithione, ketoconazole, selenium sulphide, coal tar, salicylic acid, tea tree oil etc. Although in non-medicated brands these are added in marginal amounts, it’s not advisable to use them every day (try alternate days) or leave them on the scalp for too long a period. Usually, 2-5 minutes should suffice. In medicated brands, the concentration of these active ingredients is usually high. The selection of antidandruff shampoo should be made wisely according to hair type. Where the one meant for dry hair will leave the hair moisturised, one meant for oily hair will strip most oils out of the hair. Additionally, these special formulations in anti-dandruff shampoos tend to temporarily re-balance the scalp’s pH balance. Most shampoos vary on the types as well as the strength of these ingredients; hence the pH balance effect does not usually last for long. Most shampoos take about 6-8 weeks of regular use to show results.
Fluorides (e.g. in Toothpastes)
Fluoride toothpastes make up more than 95% of all toothpaste sales. It is well recognized that the decline in the prevalence of dental caries recorded in most industrialized countries over the past 30 years can be attributed mainly to the widespread use of toothpaste that contains fluoride. Investigations into the effectiveness of adding fluoride to toothpaste have been carried out since 1945 and cover a wide range of active ingredients in various abrasive formulations. Fluoride compounds and their combinations which have been tested for the control of dental decay include sodium fluoride, stannous fluoride, sodium mono-fluoro-phosphate and amine fluoride. The amount of fluoride contained in fluoride toothpaste should be indicated on the toothpaste tube, although this information may sometimes be hard to locate. It may appear after the label “Active ingredient” or as a component under “Ingredients” on the toothpaste tube. Whereas previously fluoride content was given as a per cent of volume (% w/v) or weight (% w/w), it is now accepted that the most efficient method of informing people of the amount of fluoride in toothpaste is to give the “parts per million” fluoride (ppm F). Most manufacturers now give fluoride content in ppm F. Under EU Directive 76/768/EEC, toothpastes are classified as cosmetic products. EU Directives governing cosmetic products prohibit the marketing of cosmetic products (including toothpastes) with over-the-counter levels of fluoride greater than 1,500 ppm F. Fluoride toothpastes are more effective at preventing tooth decay at higher fluoride concentrations. If needed for therapeutic reasons, toothpastes containing more than 1,500 ppm F (e.g., 2,800 ppm F) are available but may be obtained only with a prescription.
Sun protecting agents (e.g. in Sunscreens)
Sunscreen, also known as suncream or sunblock, is a lotion, spray, gel or other topical product that absorbs or reflects some of the ultraviolet (UV) radiation and thus helps to protect against sunburn. Skin-lightening products have sunscreen to protect lightened skin because light skin is more susceptible to sun damage than darker skin. Depending on the mode of action, sunscreens can be classified into physical sunscreens (those that reflect the sunlight) or chemical sunscreens (those that absorb the UV light). In addition to moisturizers and other inactive ingredients, sunscreen formulations contain one or more of the following active ingredients, which are either chemical or mineral in nature:
- Organic compounds that absorb UV rays e.g. phenyl benzimidazole sulfonic acid, Ensulizole, Eusolex 232, PBSA, Parsol HS, Eusolex OCR, 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexylester, 2-Hydroxy-4-Methoxybenzophenone-5-sulphonic acid, 3-Benzoyl-4-hydroxy-6-methoxybenzenesulphonic acid, Benzophenone-4, Escalol 577.
- Inorganic particulates that reflect, scatter, and absorb UV light (such as titanium dioxide, zinc oxide, or a combination of both).
- Organic particulates mostly absorb UV light like organic chemical compounds but contain multiple chromophores that reflect and scatter a fraction of light like inorganic particulates. An example is Tinosorb M. The mode of action is about 90% by absorption and 10% by scattering.
Sunscreen agents are used in some hair care products such as shampoos, conditioners and styling agents to protect against protein degradation and colour loss. Currently, benzophenone-4 and ethylhexyl methoxycinnamate are the two sunscreens most commonly used in hair products. The common sunscreens used on skin are rarely used for hair products due to their texture and weight effects.
Antiperspirant Agents (e.g. in Deodorants)
Antiperspirants are personal hygiene products designed to control sweating and body odour. Antiperspirants contain ingredients that control sweat and body odour safely and effectively. They are readily available on the market as sprays (aerosol), sticks, creams or roll-ons. When an antiperspirant is applied to the skin surface, its antiperspirant ingredients – usually aluminium salts – dissolve in the sweat or moisture on the skin surface of the armpit. The dissolved substance forms a gel, which creates a small temporary ‘plug’ near the top of the sweat gland, significantly reducing the amount of sweat that is secreted to the skin surface. Bathing and washing will remove the antiperspirant gel. Re-application of antiperspirants can be beneficial to help to reduce sweating and keep fresh throughout the day. Antiperspirants reduce underarm sweating, but they do not impact the natural ability of the body to control its temperature (thermoregulation). Aluminium salts present in antiperspirants are natural antimicrobial agents, so they also kill bacteria on your skin. High efficacy deodorants (without aluminium salts) are available and rely on the use of specifically developed antimicrobial agents, such as triclosan or polyhexamethylene biguanide. Alcohol is also effective at killing bacteria, so deodorant and antiperspirant products that contain alcohol (or ethanol) can reduce body odour by combating the odour-forming bacteria.
There are several cosmetics like products that are classified as over-the-counter (OTC) drugs in the United States. The list of cosmetic/OTC products that are governed by an FDA monograph is detailed below:
1. Anti-acne products: This monograph describes 40 different ingredients that can be used for anti-acne. A rule was finalized in 1990 although there was some action in 2010 on Benzoyl Peroxide.
2. Toothpaste and anti-cavity products: This monograph gives a list of over 20 ingredients that can be used to fight cavities. The final rule was issued in 1995.
3. Topical anti-fungal: Products that are topically applied to places that need antifungal effects (diaper rash, feet, etc). The final rule was originally passed in 1993.
4. Anti-microbial products: There is a long list of ingredients that can be used for topical anti-microbial products. For most of the antimicrobial ingredients, the final rule has not yet been issued. It is suggested you follow the proposed rules when formulating.
5. Antiperspirant: This monograph is for products, that are designed to stop sweating. The final monograph was originally issued in 2003. It lists 26 active ingredients that you can use.
6. Astringents: These are classified as skin protectants. The final rule was originally issued in 2003.
7. Corn and Callus removers: A niche product, but some cosmetic companies might want to create these formulations.
8. Dandruff products: If you are planning to create an anti-dandruff shampoo, then you have to follow the rules of this monograph. The final monograph was issued in 1991 and revised in 1992.
9. Hair growth/ hair loss: The final monograph for these types of products was issued in 1989 and includes nothing that works. However, in 1994, minoxidil was switched from a prescription drug to an OTC. It remains the only non-prescription option.
10. Nail biting products: There is a monograph for products that are designed to stop people from biting their nails. The final monograph was issued in 1993.
11. Psoriasis: These products are designed to treat the condition of psoriasis. The tentative monograph was issued in 1986 and has yet to be finalized. Only a few active ingredients are allowed including coal tar and salicylic acid.
12. Skin bleaching: Skin lightening products are OTCs in the US. The tentative final monograph was issued in 1982, but it has yet to be finalized. There are only two active ingredients acceptable for skin lightening.
13. Sunscreen: It’s been a long time coming, but a final monograph on this topic was issued in 2011.
14. Topical analgesic: These products find a wide variety of applications and cover products such as those designed for diaper rash, cold sore treatments, poison ivy treatments, and others.
15. Wart remover: Products that are used to remove warts. The final monograph was issued in 1990 but updated in 1994. Thirteen active ingredients are listed.
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