The Legal Truths
Simple….or not so much?
The active ingredients in a drug are ones that are doing all the heavy duty work. They are the stars of the show. They are compounds that change or influence the biochemistry of the body or skin in some way. When this pertains to OTC (over the counter drugs), the term ‘active’ ingredient is accurate as it closely follows FDA monograph guidelines where the actives are actually altering the biochemistry of the body or skin. But when the term ‘active’ ingredient is used in cosmetic preparations, the term is deemed inaccurate or even illegal as cosmetic preparations are not allowed to contain drugs.
Cosmetic preparations are limited to superficial and not therapeutic effects.
Basically when we see the term ‘active‘ ingredient in a cosmetic product, it’s usually more of a marketing gimmick and is a way of highlighting or focusing on the main ingredients. This shouldn’t happen and it’s best to label your products by simply stating ‘main’ or ‘star’, ‘focus’, or ‘major’ or better still ‘functional’ ingredients, so as to not enter into legal issues or confuse the consumer. And trust me when I say, that there are some big brands (no name dropping) that have faced some tough times because of this very issue. So my advice is, be informed from the start.
Making any sense?
So what is a cosmetic preparation?
Cosmetics are “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap” (Federal Food & Drug Act, 1938, p. 32).
Often a cosmetic product can be a combination of both drug and cosmetic. And if the cosmetic product exerts some kind of biological action, it will acquire a different legal status and different labelling approaches. A great example of a cosmetic-drug combo is an anti-dandruff shampoo or an acne lotion.
What are cosmeceuticals you ask?
This is a gray area and the jury is out on this subject. There are still no regulations passed on this group of products as yet. But this term is certainly confusing the consumers as the distinct line between drugs and cosmetics is now becoming somewhat blurred.
FDA states that the term “cosmeceutical” has no meaning under the law. While the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not recognize the term “cosmeceutical,” although the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits.
What is the best alternate term to ‘active’ ingredient in a cosmetic product?
That would be ‘functional’ ingredient. For example, in a Vitamin C serum, the functional ingredient will be Vitamin C with perhaps a few other additional ingredients that may work in synergy with the main ingredient to produce desirable benefits and optimal results when used.
In my 15 years of experience in the dermatology and skincare industry, I have come across thousands of cosmetic brands that claim to alleviate skin conditions like dark circles, boost collagen production, improve skin circulation, enhance cellular turnover, and the list goes on. When I assist start-ups as they embark on their journey through product evolution and branding, I always tell them the honest truths. These truths will save them from years of aggravation and stress down the road. When you claim that a certain product will exert biological influence over skin tissue, you must follow the rules and regulations and label it such, because now the product is acting like a drug and not purely as a cosmetic.
Important points to take away from this article?
When labelling and describing your cosmetic products, it’s best to focus on the beneficial results rather than the chemistry or inner workings of it. Results are what matter and what will define the efficacy and eventual success of your brand.
Make sure that you are strictly a cosmetic brand and not an in-between one that advertises fantastic claims, unless you are planning to introduce real ‘actives’ into the formulation.
Helping people through the process of brand-building, formulation, and product writing is my passion. Over-seeing the birth of a beneficial and effective brand is an extremely rewarding experience as it will help thousands of people look and feel confident and beautiful. But knowing the law is one aspect of the journey that cannot be forgotten.
I hope this article will shed some light on a few issues that the skincare industry faces on a daily basis.
Best of luck on your journey!
- Cosmetic Dermatology, Principles and Practice, Dr.Leslie Baumann, MD
- Clinical Applications of IPL- Dr.Ansul Khan MBBS, MSc Dermatology
- Treatment of Skin Disease- Comprehensive Therapeutic Strategies, Lebworth, Heymann, Berth-Jones, Coulan