As we have previously discussed, the U.S. Food and Drug Administration does not approve cosmetic products and ingredients (other than colorants) before they are sold. Rather, the responsibility for product safety verification lies with Cosmetics Creators. The FDA requires that cosmetics be safe for consumers to use as expected or as labeled, but it’s largely up to the Cosmetics Creator to make sure of that. There’s no list of required tests.

As such, testing “is just one of the things a manufacturer might do to ensure the safety of a cosmetic product,” says the FDA website. When investigating safety concerns or conducting research, the FDA may test cosmetics; if the FDA can show that a product is not safe, it can take legal action.

So, as long as something is classified as a cosmetic but doesn’t also fall into the “drug” category, it’s up to the Cosmetic Creator whether or not to test. (You might be surprised what legally counts as a drug. Read this to learn more.)

But there are other resources.

Available safety data

A vast amount of data on ingredients and product formulations already exists. The FDA says that manufacturers can use this data to show a product’s safety. Ingredient suppliers often have safety data on products they sell. Scientific journals like PubMed and TOXNET also publish data. And the FDA states that it takes Cosmetic Ingredient Review (CIR) data into account when determining ingredient safety.

In addition to data on individual ingredients, if another manufacturer has already marketed a product that’s similar to yours, and there is safety data on that product, you can incorporate that data into your strategy to make sure your product is safe.

The Data Is Inconclusive. What Now?

If you’ve assessed the safety of all your ingredients, but there are still some questions, then you may have to work with a lab specializing in toxicology or other testing. You’ll need a bona fide scientific report showing the results of any tests that have to be performed.

By working with accredited laboratories, Creators will have reliable data that they can use to make decisions on development (i.e., regarding the safety of or necessary changes to the formulation) and around registration (i.e., for export into other markets, like the European Union).

Goldn is here to help. Our mission is to encourage cooperation between Cosmetics Creators and suppliers, including testing consultants. On Goldn, Cosmetic Creators will be able to find and work with specialized professionals and laboratories to securely test their ingredients and products. You can sign up to our Waitlist to be informed of when we launch.

Beyond Ingredient Toxicity: Contamination

Ingredient and formulation safety are non-negotiable, but there’s another thing Cosmetics Creators need to consider, and that’s contamination.

A cosmetic product must not contain any harmful germs. Manufacturing facilities and methods must be very clean, and Cosmetics Creators (whoever is handling the product during production and assembly) must ensure that no bad germs have the chance to contaminate products. Consultants can assist with this, and Goldn will be a great place to make connections with helpful partners.

A Word on Animal Testing

The FDA does not require cosmetics sold in the USA to be tested on animals, whether they’re made in America or imported. Animal testing is one of several tools available to companies, but not mandatory.

In fact, the FDA states: “We also believe that prior to use of animals, consideration should be given to the use of scientifically valid alternative methods to whole-animal testing. ... We will continue to be a strong advocate of methodologies for the refinement, reduction, and replacement of animal tests with alternative methodologies that do not employ the use of animals.” It also states its support for the most humane methods possible when animal testing is unavoidable.

With 13 other federal agencies, the FDA has formed a committee, called ICCVAM, and a center supporting it, called NICEATM. Their goal is to further alternative toxicology testing methods, and more information is available at their websites.

(In related news, the Leaping Bunny certification is one way that independent bodies are also attempting to further non-animal testing. For more information, click here.)

With Great Power Comes Great Responsibility

So, under the law, Cosmetics Creators have a lot of leeway in deciding whether and how to test, as long as they make absolutely certain that their products are safe when used as they should be.

That last part is key. As a Creator, you’re still responsible for product safety, even if testing isn’t mandatory. There are companies that specialize in this, and Goldn will be here to help you make those connections, so you can quickly and safely get your ideas from the drawing board into customers’ homes.