Cosmetics vs. OTC Drugs - What You Need to Know!
Hello
there!
Today,
we are here for some technical and scientific knowledge about cosmetics and
over-the-counter (OTC) drugs. Let us first begin by addressing the difference
between them.
According
to the Food, Drug, and Cosmetic Act (FDA), drugs are made to diagnose,
mitigate, and/or treat a disease that affects the function of the body. Cosmetics
are defined as the ingredients that are used for beauty enhancement. The
FDA states that both drugs and cosmetics fall under The Federal Food, Drug, and
Cosmetic Act which was enacted in 1938. This law established quality standards
for food, drugs, medical devices, and cosmetics manufactured and sold in the
United States. Under this influential act, the FDA made sure that the products
we use meet certain safety standards. While both OTC drugs and cosmetics
contribute to our well-being, this act draws a significant difference as they
play distinct roles in our skincare journey. Now, we will be looking into some
detailed differences between OTC drugs and cosmetics.
So,
How does the FDA define a cosmetic product?
As
we know, the FDA is here to ensure our safety and well-being. Have you ever
wondered how this act defines cosmetic and other products in this category? Well,
they are defined as products applied to our bodies to beautify our skin. From
moisturizers to toners, perfumes to lipsticks, nail polishes to eye makeup,
hair shampoos to hair colors, all these products are intended to enhance the
appearance. Notably, except for the color additives, the FDA does not demand
any prior approval before being launched in the market for the aforementioned
products.
Special mention: The soaps which we use for our body fall under a unique category for this law. Although soaps are primarily used as cleansing products, FDA recognize them as a category comprised of alkali salts and fatty acids. If there are synthetic ingredients, they are then classified as "cosmetic.” If a soap claims to not only cleanse but moisturize the skin, it is not a true soap, and soaps are regulated by Consumer Product Safety Commission rather than the FDA.
How does the FDA define a drug?
Any
product that is intended to be used to cure a disease is qualified to be a
drug. Unlike cosmetic products, drugs must pass through a premarket testing
phase, in order to be launched in the market. The FDA has to provide an
approval through the New Drug Application Process or conform to a "monograph”
as established by the FDA’s over-the-counter (OTC) drug review. A monograph is
a detailed study on a particular subject. OTC monographs are like a rule
book with different set of conditions to follow, under which there are certain
ingredients considered safe and effective.
Do you know that monographs can actually be found on the FDA’s website? The website is appropriately organized according to different categories and is easy to navigate and locate. Each monograph contains established conditions from active ingredients to dosages, labeling to testing protocols --you name it! Whether you are interested in acne care, sun protectants, sunscreen for these sunny days, or maybe just a hand sanitizer, OTC monographs can be that go-to resource. Isn’t it pretty cool?
Have
you ever seen a drug facts box on your sunscreen or a medicine for cold? Yes,
that is the box that contains important information like active ingredients,
purposes, uses, warnings, directions of use, inactive ingredients, and other
questions.
How is the intended use established?
There
are several factors considered by the FDA to define the intended use. They look
at the product labels, online promotion (if any), advertising standards, and
any other information related to the product. Sometimes, a cosmetic product can
also be classified as a drug according to the FDA. There are certain set of
claims that this law is stringent about, so what are they? Well, if there is a
product that can restore hair growth, reduce cellulite, treat varicose veins,
or even regenerate cells, it can be classified as a drug. As these claims are
meant to treat diseases that disturb the body’s functions, the FDA addresses it
as a drug, interesting right?
Secondly,
the FDA looks through the consumer perception of a product. It is basically a
study of consumers and their expectations before buying a product. Here’s
another interesting insight: ingredients or products can be classified as drugs
due to their therapeutic properties. For example, fluoride in toothpaste or
salicylic acid in acne products are classified as drugs due to their medicinal
properties.
Thirdly, brands need to be mindful about their cosmetic product claims, making them truthful and not misleading. If a product claims to make wrinkles less noticeable by moisturizing skin, then it is classified as a cosmetic claim. But, if it states that it can completely remove the wrinkles, it is seen as altering the structure of the skin, making it fall under the drug category by the FDA. Therefore, brands are supposed to be careful of the language and terminology used when it comes to claims. Otherwise, they might encounter dealing with the violation of the FDA regulations.
Remember,
honesty is the best policy even when it comes to making claims about cosmetic
products!
Can a product be both a cosmetic and a drug?
Sometimes,
there are certain products that can be both a cosmetic and a drug. It usually
happens when a product is intended for multipurpose use. For example, a shampoo
is a cosmetic because its primary purpose of creation is for hair cleansing, while
an anti-dandruff treatment is a drug because its main purpose is very specific
to treating dandruff. If a product is an anti-dandruff shampoo, then it is both
a cosmetic and a drug as it serves both purposes.
Another example, is when a deodorant that acts also as an antiperspirant, moisturizer, or makeup that also provides sun protection are some cosmetic-drugs.
Now you may be wondering where cosmeceuticals fit in. A cosmeceutical is the term that dates back to 1984 by Albert Kligman, which is used to describe the combination of cosmetic and pharmaceutical. It is when a cosmetic product provides medicinal or drug-like benefits. These cosmeceuticals contain biologically active ingredients. However, it is important to note that the FD&A Act does not officially recognize the category of cosmeceuticals. So, this term does not have any legal meaning according to the FDA.
In
conclusion, the FDA is the primary law governing cosmetic products in the
United States which receives important updates through the Modernization of
Cosmetics Regulation Act (MoCRA). These amendments have established stricter
rules and obligations for beauty brands since the original Act in 1938. With
MoCRA in place, us consumers can confidently purchase cosmetic products for our
everyday use as they come to us after undergoing various rigorous safety
regulations. Also, brands need to ensure compliance and provide consumers with
products that meet the necessary standards.
We
hope you enjoyed reading this finalale of Masterclass series and have gained some
scientific knowledge behind the skin and skincare products. On this note, we
would like to announce that we will be back with yet another season of this
series very soon.
FDA Website: https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/historical-status-otc-rulemakings
To get more insights on this topic, tune in to Active Concepts YouTube channel
https://www.youtube.com/watch?v=qF0BzOJXuGs
Happy shopping!