Definition of Cosmetics as per Indian Regulations: As per Section 3(aaa) of the Drugs and Cosmetics Act 1940 and Rules 1945, Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part of the body for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. Whether a product is a cosmetic or a drug under the law, is determined by a product’s 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. Cosmetics are regulated in India under the provisions of the Drugs and Cosmetic Act 1940 and Rules 1945 vide Gazette notification G.S.R 426(E).
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, 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 is a toothpaste that contains 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. The scope of effects/efficacies of general cosmetic products is listed in blow.
The scope of effects/efficacies of general cosmetic products
- To clean hair and scalp.
- To reduce bad odor from hair and scalp by using aroma.
- To maintain the health of hair and scalp.
- To increase bounce and resilience of hair.
- To increase the moisture of hair and scalp.
- To maintain the moisture of hair and scalp.
- To increase the suppleness of hair.
- To make hair combing easier.
- To maintain the gloss of hair.
- To increase the gloss of hair.
- To remove dandruff and itching.
- To reduce dandruff and itching.
- To replenish and maintain moisture and oil of hair.
- To prevent split ends, breakage, or damaged hair.
- To dress hair and maintain a hairstyle.
- To prevent electrostatic charges in hair.
- To clean skin (by removing dirt).
- (Facial cleaners) To prevent pimples and prickly heat (by washing).
- To condition skin.
- To improve skin texture.
- To maintain the health of the skin.
- To prevent skin roughness.
- To tighten skin.
- To increase the moisture of the skin.
- To replenish and maintain moisture and oil of the skin.
- To maintain suppleness of the skin.
- To protect the skin.
- To prevent dry skin.
- To soften skin.
- To increase bounce of skin.
- To increase the gloss of skin.
- To smoothen skin.
- To make shaving easier.
- To condition skin after shaving.
- To prevent prickly heat (applying powder).
- To prevent sunburn.
- To prevent spots or freckles due to sunburn.
- To impart aroma.
- To protect nails.
- To maintain the health of nails.
- To increase the moisture of nails.
- To prevent chapped lips.
- To improve the texture of lips.
- To increase the moisture of lips.
- To maintain the health of lips.
- To protect lips and prevent dry lips.
- To prevent stiff lips due to dryness.
- To smoothen lips.
- To prevent cavities (toothpaste, etc., for brushing teeth).
- To whiten teeth (toothpaste, etc., for brushing teeth).
Establishing Product’s Intended Use
The intended use of a product may be established in several ways. The following are some examples:
- Claims are stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered as a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.
- Consumer perception may be established through the product’s reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
- Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.
This principle also holds for “essential oils.” For example, a fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil, that is simply intended to lubricate the skin and impart fragrance is cosmetic, but if the product is intended for therapeutic use, such as relieving muscle pain, it’s a drug.
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