Are anti-aging skincare products drugs or cosmetics, and how does that matter? It turns out that it matters a whole lot-it influences how regulatory bodies scrutinize the product-or not.
What is the difference between a cosmetic and a drug?
Formal definitions vary from country to country, jurisdiction to jurisdiction, and the regulatory bodies that govern the approval of these products. In most countries, cosmetics and drugs are regulated differently-drugs are heavily scrutinized requiring studies with appropriate process and rigor to ensure safety and efficacy. Cosmetics are less rigorously regulated. In North America, cosmetic claims are not required to be substantiated through proper scientific studies.
Generally, a cosmetic is defined by what their claims are and how they are used. Products that are applied by being rubbed or sprayed to the skin to alter or improve appearance, cleansing, and generally beautifying fall under cosmetics. Typical examples of cosmetics include moisturizers, perfumes, lipsticks, make-up, shampoos and deodorants.
Drugs, on the other hand, affect either the body`s structure or function in some way. A product that claims to “reduce acne” or “reduce wrinkles” are therefore drug claims, and will be regulated as such. In the United States, the FDA regulates these products as pharmaceuticals-drugs proper, and therefore, these products have been approved by them.
What are cosmeceuticals?
Cosmeceutical is a recent and popular portmanteau taken from cosmetics and pharmaceuticals and combines aspects of both. If a topical product contains active ingredients that act beneficially, it is likely that the product is a cosmeceutical. Vitamins, peptides, antioxidants, essential oils, and enzymes are actives that are often associated with cosmeceuticals. The important thing to remember for consumers is that the term “cosmeceutical” is essentially a marketing term, not one that is recognized by regulatory bodies like Health Canada in Canada or the FDA in the United States. As far as regulations and government scrutiny go, there are only drugs and cosmetics; in terms of regulatory scrutiny, cosmeceuticals are cosmetics, not drugs.
Does it mean that cosmeceuticals don’t work?
Cosmeceuticals can have many benefits as can cosmetics. It is important for consumers to understand that cosmeceuticals are a marketing term, not a legal definition. Cosmeceuticals aren’t regulated with the same rigor that drugs are by governmental organizations like Health Canada and the FDA. Most of these products are not required to go through approval from these regulatory bodies unless they make drug claims-claims to alter how the body functions.
What is a cosmetic claim, and what is a drug claim exactly?
Laws vary from country to country, but in Canada, Health Canada considers claims of having a physiologic effect as a drug claim. Changes in appearances or scent or any other sensory claims are considered cosmetic.
Cosmetic (non-therapeutic) claims:
- Helps make the skin appear youthful
- Strengthens hair
- Reduces the appearance of age spots
Drug (Therapeutic) Claims:
- Makes the skin younger
- Stimulates Hair Growth
- Eliminates age spots
While the claims appear similar, the latter implies a physiologic change that occurs, making it a drug claim. The first is unverifiable, making it a cosmetic claim. By noting these subtle differences, consumers can better judge what claims are actually being made.
Dr. Stuart Maddin (Clinical Professor Emeritus, Department of Dermatology, University of British Columbia) is a well-known Canadian dermatologist who has been educating, practicing, and researching in the field of dermatology for the past 65 years.
