Are Your Cosmetics FDA Approved?

fda approval

We’re obviously dedicated to bringing you cosmetic products that are safe and effective but we also strive to offer reliable information about the health and cosmetic industries. This month’s question from the FDA cosmetics quiz is a little more nitty-gritty than we’ve written about before—this time, the laws surrounding the industry are involved.
The FDA is dedicated to making sure that what we put in and on our bodies is safe for consumption. This is a great objective, but they can only go so far, so today we want to talk a little about that. Here’s the first question on the quiz; True or False: FDA must approve all cosmetics before they go on the market?

Here’s their answer:

The law treats cosmetics differently from drugs. Unlike drug companies, cosmetic companies may use almost any ingredient they choose, with these exceptions:

1. There are a few substances that are not allowed to be used in cosmetics, and there are limits on using some others.

2. Color additives must be approved for their intended use. For example, a particular color additive may only be used in an eye shadow if it is approved for cosmetic use, including the area of the eyes. Many colors even have to be “certified” by FDA. That means that samples from each batch must pass special testing for purity in FDA's own labs before they may be used.

3. Cosmetic products and ingredients must be safe when used as intended. Cosmetic companies are responsible for making sure their products and ingredients are safe when people use them as intended. FDA can take action against unsafe cosmetics on the market.

What does FDA approval mean?

The FDA has a two-fold operation when it comes to cosmetics. The first is making sure that the cosmetic ingredients that companies are using are safe—that’s why they have to approve the color additives, not everything that creates pigment is safe—and the other is to distinguish between what is a cosmetic product and what is a drug. Since they have more authority over drug regulation, they have to make sure that manufacturers aren’t selling drugs under the guise of cosmetics.

This is because when it comes to anything classified as a cosmetic, the FDA doesn’t require approval before a product goes on the market but when it comes to anything classified as a drug, it does—which makes the distinction between a cosmetic and a drug very important. To muddy the matter just a little more, the definitions of both ‘cosmetics’ and ‘drugs’ are entirely use and intent dependent so the language around a product is at the very crux of this issue.

What is a Cosmetic; What is a Drug?

The law defines a cosmetic product as something for cleansing, beautifying, promoting attractiveness, or altering appearance. This means that it doesn’t affect the structure or the function of the body and it is meant solely for the purposes of vanity. This definition applies to finished products and all of the ingredients in it.

A drug is considered anything that is created with the intent to mitigate or cure disease. That means if a product is used to change the structure or function of the physical body, the finished product and the active ingredients do have to be approved by the FDA.

Some products, (like dandruff shampoo or fluoride toothpaste) are considered both cosmetics and drugs because they’re meant to beautify but they are formulated to create structural changes or to solve an ailment. These types of products have to meet the standards for both drugs and cosmetics.

How the FDA Tells Them Apart

In most cases it’s pretty easy to tell the difference between a drug and cosmetic (ie. lipstick is for making your lips a different color and aspirin is for a headache) but there are a lot of products that fall into the grey area. That’s where language and intent comes to play—and a lot of it has to do with marketing.

A product, like a moisturizer, that is marketed to make your skin more radiant and beautiful is a cosmetic but if that same moisturizer is marketed to soothe irritation from rosacea, it crosses into the territory of being a drug because of the claim that it can heal. See the distinction? Anything that heals is a considered a ‘drug’ and therefore has to go through a much more rigorous certification and approval process from the FDA.

Another thing that the FDA looks at is the customers’ perception of how a product works. If the overwhelming amount of reviews or comments on a cosmetic product’s page have claims of amazing structural or function changes, the FDA may investigate it to see if people treat it like a drug or believe that it acts like one.

Because cosmetics are only created to help with appearance and they don’t change or heal the body, cosmetic companies have to be FDA compliant rather than FDA approved. That distinction makes all the difference.

So how does the FDA find companies to investigate?

Here’s something that I wondered about when I started researching the FDA guidelines for cosmetics: if a company can just put a new product on the market without approval from the government agency that dictates the safety of what we put in and on our bodies, how does the FDA know who to investigate? Luckily, they have awesome resources on their website so I was able to find out that there are several different ways:

Voluntary registration—a company can register their own products and ingredients on the FDA database.
Random Inspections—this applies more often with products coming in from other countries. The FDA works with customs or border protection to make sure that the products coming into the USA are safe. They also have random inspections of USA based manufacturers but it’s less frequent because they do have limited resources.
Surveys—Sometimes the FDA actually purchases products and runs their own analysis on them to make sure that all of their ingredients are listed and compliant.
Independent panels—the larger cosmetic industry funds a series of third-party panels that purchase products and run analysis on them.
Consumer reviews—this is where a consumer, like you or I, writes in to the FDA with information about a company for them to look into. Typically this happens when someone buys a product, has an adverse reaction, and is concerned that the ingredients in the formula are unsafe.

Although there are a lot of avenues for the FDA to find potentially hazardous cosmetics, they are always found after these products are already on the market. The FDA can take legal action against companies that are using hazardous ingredients or making claims about what they sell, but they do have to give notice—like asking the company to recall a product or sending a letter suggesting changes to the marketing language.

What does this mean for us?

We are dedicated to being FDA compliant but because there isn't an approval process for cosmetics that we can adhere to, our products are not “FDA approved.” Our products are wonderful but they certainly aren’t drugs and we don’t claim that they can be used for healing anything. Since adhering to the FDA’s rules we have had to change some of our product names and enhance some of our language, but we’re on board and glad to know that the FDA is watching out for consumers in our country.

What does worry us is that because the FDA doesn’t regulate cosmetic products before they go onto the market, they have to trust the manufacturer until they hear otherwise. This means that there isn’t a solid way to know exactly how much of a preservative or filler chemical is in the products on the shelves. Yikes! We don’t love having to assume that typical manufacturers are listing every ingredient, testing those ingredients (hopefully not on animals), and using safe levels of those ingredients in their products. We happen to know that when it comes to companies that use synthetic ingredients and are solely focused on the bottom line, that’s a pretty tall order.

Of course this unregulated chemical concern is a driving factor about why Annmarie Skin Care was created to begin with. That’s where the “Honest” in our Wild. Beautiful. Mantra comes from, why we write articles like this one, and why we research potential harmful effects of chemicals for our ingredient watch list. Our ingredients come from our Earth and have been tried and tested over time to be safe and effective. We list everything we use right on our labels (and on the website, and the boxes, and the brochures—if there’s blank space, we’re listing ingredients), it’s what we were founded on and that will never change.

What FDA questions would you like to read about? Let us know in the comments!


Center for Food Safety and Applied Nutrition. “Consumers – Cosmetics Safety Q&A: Personal Care Products.” U S Food and Drug Administration Home Page. Center for Food Safety and Applied Nutrition, n.d. Web. 24 Apr. 2017.

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