“How can I look younger?” Few questions are so fundamental for people. Stories about the quest to look younger have been around for centuries including the Fountain of Youth and the Search for the Holy Grail. Anti-aging products often promise people will look younger, and what you need to know about manufacturing anti-aging products is that the success or failure of your product and what is involved in making it is all about the claims you make.
What do I mean, “the claims you make”? The law for products that claim to impact the effects of aging divides products into two categories, cosmetics and drugs. Before they’re on the market, drugs must have FDA approval for safety and effectiveness. Cosmetics must be safe when used as intended but don’t require approval before being sold.
“What claims determine whether my product is a drug or a cosmetic?” A drug is a product that is “intended to affect the structure or function of the body.” In the anti-aging market, a drug might be intended to increase the amount of collagen or remove wrinkles. A cosmetic would make wrinkles lines look better, less noticeable or to hide them. For example, a moisturizer isn’t changing how the body functions, it’s masking how the skin looks.
The FDA takes the difference between drugs or cosmetics seriously.
Being classified as a drug has a real impact on your product. Since it involves approval before going to market, the time and cost of getting a drug product to market are usually much higher than for a cosmetic product.
How the FDA knows which category a product fits into is by its intended use, both what it does and by what you claim it does! Products can get into serious legal jeopardy by merely making a claim inconsistent with being a cosmetic product. Any claims made, whether in advertising, on labeling, on the internet, or even in promotional material, can determine whether it’s a cosmetic or regulated as a drug.
Will your product reduce hair loss or relieve pain? That’s probably a drug. Hide varicose veins or lubricate the skin? Then it will probably be considered a cosmetic. Whether it’s a drug or cosmetic also includes what a consumer will reasonably expect the product to do or if it has specific ingredients that have therapeutic use.
All of this means that you have to consider all of these factors before bringing your product to market. If you don’t, the consequences could cost you a lot of money or even bring serious legal ramifications.
