A cosmetic is any product “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 appearance” [FD&C Act, 201 (i)]. This definition includes skin moisturizers, perfumes, eye and facial makeup preparations, cleansing shampoos, hair colours, and deodorants.
A drug is any product “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” or any product “intended to affect the structure or any function of the body of man or other animals” [FD&C Act, 201 (g)(1)].
Some products have more than one intended use and fall in both categories. These products are then considered both a cosmetic and an OTC drug, and must comply with the regulatory requirements of both categories. A simple example of this is the intended use of shampoo. Shampoo is considered a cosmetic because of its intended use to cleanse hair. An antidandruff treatment is considered a drug because of its intended use to treat dandruff. An antidandruff shampoo is then considered to be both a cosmetic and a drug.
How to determine the nature of my product?
The key factor in deciding whether a product is an OTC or a Cosmetic (or both!) is its intended use. The intended use can be established in several ways.
The product's claims
A product’s claims are not just limited to any claims found on the product labelling. The intended use can also be determined based on advertising, information on the Internet, and other promotional materials. Some claims may establish a product as a drug, even if the product is marketed as if it were a cosmetic. The claims may define the intended use as treatment or prevention of disease or as affecting the structure or functions of the human body. This includes claims that products will treat varicose veins, restore hair growth, or regenerate cells.
The consumer's perception and the product's reputation
This requires understanding why the consumer is purchasing a specific product. A product may have “perceived claims” based on its reputation among consumers. For example, if a cosmetic product is perceived by consumers to prevent acne, then it must either be registered and fulfil the requirements of an OTC product or it must include a statement clarifying that it has not been proven to prevent acne.
The ingredients having a well-known therapeutic use
Certain ingredients that have a well-known therapeutic use will result in a product being considered a drug, even though it may have been intended as a cosmetic. This includes uses that are well-known to the public and to the industry. For example, toothpastes with fluoride are well known to prevent cavities, therefore toothpastes that contain fluoride are considered drugs regardless of whether specific anticaries claims are made.
Process differences between Cosmetics & OTC Drugs
Good Manufacturing Practices
Good Manufacturing Practices (GMP) are a very important factor in ensuring that your cosmetic products are not adulterated or misbranded. That being said, while the FDA provides guidelines for cosmetic GMP, there are no regulations that specify GMP requirements for cosmetics. In contrast, drug products (including OTCs) are required by law to adhere to strict GMP requirements. The FDA outlines the minimum current GMP requirements for drugs in Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211. Failing to meet the minimum GMP requirements can result in a drug product being considered adulterated.
Registration & Approval
Cosmetic products and ingredients (with the exception of colour additives) do not require FDA approval prior to going on the market. This means that the FDA does not require cosmetic companies to register their establishments or register their products. As a matter of fact, the FDA maintains a Voluntary Cosmetic Registration Program (VCRP), but, as the name indicates, this registration program is voluntary [21 CFR 710, 720].
Drugs must be proven to be safe and effective prior to entry on the market. Drug firms must register their establishments and list their products with the FDA.
Drug products can be registered using one of two pathways: New Drug Application or OTC Monograph.
