Is your product a cosmetic or drug?

  07 April, 2021

Is your product
a cosmetic or drug?

Every year, country-specific health authorities refuse importation of cosmetic product shipments due to several factors - one major reason being “misbranded claims”. Whether any given product is a cosmetic or a drug under the law is determined by its intended use. There is a fine line that distinguishes it as a cosmetic, an over-the-counter (OTC) drug or both and different laws and regulations apply to each of them. Any discrepancies in product classification could lead to receipt of warning letters, recalls and huge loss of resources. If you are confused under which category your manufactured product falls, let us help you grasp a better understanding of it.

What is the legal definition of a cosmetic product?

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”. This includes moisturizers, shampoos, deodorants, hair dyes, hair setting agents, and colored cosmetics like lipsticks, eye makeup products etc.
Few health authorities also include accessories used for application of cosmetic products such as brushes and sponges under the cosmetic category whereas in certain markets, the aforementioned products are regulated as consumer goods.

What is the legal definition of a drug?

A drug is “any product that is used for diagnosis, cure, mitigation, treatment, or prevention of a disease.” This category also includes products that make anatomical, physiological, and morphological changes to the human body. In the consumer healthcare industry, products such as sunscreens, anti-acne products, anti-perspirants, toothpastes with fluorides, anti-dandruff shampoos etc., are also considered as drugs. However, in few region-specific markets, sunscreens are classified as cosmetics as per their respective regulatory authority. Even bath preparations and whitening products are categorized as ‘Special use cosmetics’ or quasi-drugs in specific markets.

Mentioned below are various product categories in the major regulated markets worldwide:

How to determine your product category?

Several markets across the world classify beauty and personal care products under multiple categories mentioned in the table above based on the ingredient(s) present in the formulation, or claims. But the key element that classifies any given product as cosmetic or an OTC drug is its intended use, which can be established by the following methodologies.

  • Thorough assessment of any public materials associated with the product, be it advertising, information on the internet, or any other promotional data
  • Market-research of consumer perception of the product while purchasing it
  • Careful evaluation of the list of ingredients that make up a product to rule out any discrepancy. For instance, the presence of a familiar therapeutic ingredient in a cosmetic product immediately classifies it into a drug.

Drugs and cosmetics not only have different legal definitions but there are major process differences too, right from product registration and approval to Good Manufacturing Practices (GMP) guidelines. Would you to like to know under which category your product falls to ensure timely approvals and prevent last minute confusion? At Athreva, our specialized team of cosmetic experts will help you navigate through the complex and time-consuming process of product classification as per regulations of the market of your choice.

The author of this blog Dr. Sravya is one of our in-house cosmetic regulatory experts. With hands-on experience in consulting for cosmetic manufacturing companies worldwide, her sharp eye for detail speaks for itself. You can find her on Linkedin.