Article Summary
- The history of cosmetic regulations
- How the FDA regulates cosmetics vs drugs
- FDA approval vs clearance
- New regulations
Cosmetics in the US are often portrayed as the Wild West, a lawless land free from regulations and brimming with toxic chemicals.
But while business is booming for the clean beauty industry and its promise of non-toxic skincare that is free of chemicals, there is a huge difference between not requiring premarket approval and being completely unregulated.
Let’s get to the bottom of how cosmetics are regulated, when FDA approval is needed, and what the newest legislation means for skincare.
The History of Cosmetic Regulations
The most common myth surrounding cosmetics
regulation is that a lack of FDA approval means there is no regulation at all.
In 1938, the US Congress passed the Federal Food, Drug and Cosmetic Act (FDCA)1. This gave the Food and Drug Administration (FDA) the authority to protect consumers and regulate food, drugs, and cosmetics - a power it still holds today. Before this, it truly was a Wild West as manufacturers weren’t held to clear quality standards, required to test for safety, or even subject to any authority at all… which led to consumers being harmed.
Bonus Trivia: before the landmark 1938, brands could sell supposed treatments for disease without having done any kind of testing to show that they work - or that they’re safe2. Banbar, for example, was an oral “cure” for diabetes made with horsetail that resulted in people dying from diabetes during a time when insulin was available. Or there was Koremlu, a product that claimed to remove unwanted hair but was actually a rodenticide.
The FDA has many responsibilities but a few of the important tasks it performs are as follows:
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Create and enforce quality standards for food, medicine, and cosmetics
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Require drug manufacturers to establish the safety and efficacy of all medications and submit these results to the FDA before bringing them to market
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Inspect any and all facilities that produce cosmetics, medications, food, and other similar products
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Approve any new medications or medical devices
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Regulate the labeling of cosmetics, food, and drugs as well as responsible advertising of medications
While this act was first passed almost a century ago, there have been a number of amendments over the years to reflect the changing times and ensure that the FDA has the authority it needs to keep us safe. But in 2022, a new piece of legislation passed called the Modernization of Cosmetic Regulation Act (MoCR)3 which has been the most significant expansion of the FDA’s reach to date. More on that later.
How the FDA Regulates Cosmetics
It’s true that cosmetics don’t need to be approved before being sold to the public. FDA approval is saved for medications and medical devices that carry the potential for significant risk. But it’s important to understand that while they’re not FDA approved, they’re still FDA regulated.
The definition of a cosmetic:
The FDA defines cosmetic products as anything applied to the human body for the purpose of “cleansing, beautifying, promoting attractiveness, or altering the appearance.” 4 Examples include skincare like moisturizers, lipsticks and other makeup products, perfume, and hair care.
Cosmetics are different from drugs. They cannot change the structure of the skin or treat disease - nor can they make claims to that effect. Drugs are subject to stricter regulations as a result, whether they’re Over-the-Counter (OTC) or require a prescription. It is worth noting that a product can be both a cosmetic and also a drug5 if it has more than one intended use. For example, sunscreen agents are considered drugs so a moisturizer that offers sun protection can be both.
The FDA requires that brands be in compliance of the following:
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all products must be correctly labeled per the FDA guidelines on labeling
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the final product and its ingredients must be safe (and specifically for the conditions under which it will be used)
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no cosmetic may be adulterated or misbranded
The FDA also has the right to conduct inspections and do other research to check for compliance. If a cosmetics company is found to not be in compliance, the FDA has a number of actions it can take which may include requesting a recall, seizure, or using the legal system to request a restraining order to stop distribution. Brands can also be at risk of litigation from consumers.
The most important takeaway here is that the FDA does have regulations brands must follow as well as the power to ensure that they’re compliant. Brands do have a lot of leeway in that they can utilize existing safety data in addition to conducting their own testing and they don’t have to file these results with the FDA. But this also places a lot of responsibility on brands as they are liable if they don’t sell safe products and this risk creates a huge incentive to ensure safety.
FDA Approval VS Clearance
FDA approval is often held out as the ideal when it comes to safety and efficacy. If you’re someone who is a fan of beauty devices, you may have even heard that FDA cleared is inferior and undesirable in comparison. Let’s dig further into this.
The FDA organizes medical devices (which can include beauty devices) into categories based upon potential risk6:
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Class 1. Very low risk to consumers and don’t require any approval or even approval by the FDA. Brands will often just register them so the FDA knows they’re selling the product and be done with it.
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Class 2. This is your low to moderate risk category. If a brand can show that there’s a substantially similar product on the market, they can obtain FDA clearance for their device.
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Class 3. These medical devices carry the most potential risk but because they offer invaluable benefits for supporting life or treating disease, they can undergo FDA approval to be sold. An example would be a defibrillator or pacemaker.
So is FDA approval better? While it’s true that the FDA approval process is more rigorous, this is because these devices carry more risk. If you’re wanting to sell a beauty device that is low risk like most cosmetics, there is no need for FDA approval. And it's an extremely expensive, time consuming process to boot.
FDA clearance also isn’t anything to sneeze at. Whether you go through the more common 510(k) submission or instead undergo the DeNovo classification process, you’re going to have to prove that your device is safe. This usually involves a clinical study amongst other things.
Cosmetics don’t require FDA clearance or FDA approval because the risk is so low but brands are legally required to ensure they’re safe. Meanwhile, beauty devices are generally FDA cleared - not because that’s inferior to FDA approval, but because that’s what is appropriate for the level of risk.
New Cosmetic Regulations
There are some changes on the horizon with the 2022 Modernization of Cosmetic Regulation Act (MoCRA) that went into effect at the end of 2023. MoCRA was tacked onto a larger bill that was passed and essentially expands and strengthens the FDA’s authority. While it’s a good thing, it’s important to stress that it doesn’t mean cosmetics weren’t safe before too.
The main changes that will take effect include:
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Mandatory recall authority. Previously, the FDA could request recalls and then take legal action if a brand didn’t comply. Now the FDA can order the recall when appropriate.
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Serious adverse event reports. Companies have 15 days to submit a serious adverse event report after receiving one.
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Good manufacturing processes. Good manufacturing processes (GMP) have been used elsewhere like pharmaceuticals and will be expanded.
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Safety records. Rules for record keeping in regards to safety substantiation and records inspection by the FDA have been expanded.
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Talc and PFAs. Further researches and testing of asbestos in talc and PFAs will be conducted.
At the end of the day, it’s always good to address any potential gaps when it comes to regulating cosmetics and keeping consumers safe. MoCRA is still being rolled out and we will have to wait and see how it impacts the industry - and if there’s any kinks along the way. But it should be a positive like the previous amendments to the FDA’s authority. At the end of the day, the cosmetics industry is ever evolving and regulations need to evolve alongside it.
The takeaway: while cosmetics don’t carry enough risk to require premarket approval, that does not mean that the cosmetics industry is unregulated.
References
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https://www.fda.gov/about-fda/fda-history-exhibits/80-years-federal-food-drug-and-cosmetic-act
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https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Both
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https://www.goodrx.com/classes/medical-supplies-and-devices/fda-approval-vs-fda-clearance
Mira is a skincare educator, blogger, and the content creator behind Skin Science by Mira and The Skincare Forum on Facebook. While skincare keeps her busy, she’s also pursuing her degree in Nursing and loves to spend her free time hiking. As a content writer for Stratia Skin, Mira shares her evidence-based approach to skincare topics and a passion for making science accessible.