Prohibited ingredients in cosmetic manufacturing: What you need to know
Jun 15, 2021 · 4 min read
Cosmetic Creators have great freedom when choosing ingredients—but there are boundaries.
Under American law, as long as a cosmetic product cannot also be classified as a drug (more on that here), Creators may use almost any raw material they choose for ingredients. They may then market the product without getting prior approval from the Food and Drug Administration (FDA). But that doesn’t mean manufacturers can just do anything they want.
There are some specific ingredients that are not allowed in cosmetic products in the United States. Additionally, it is illegal to market a cosmetic that harms consumers when they use it according to the directions on the label, or “in the customary or expected way,” per the FDA’s website. That applies even if none of the specifically prohibited or restricted ingredients are in the product.
In other words: except for a few specific things, use what you want, as long as it doesn’t make your product a drug, legally speaking. And it’s your responsibility to make sure it is safe for consumers.
Now, what about those few prohibited ingredients? And are there any exceptions to the “no harmful ingredients” rule?
Ingredients prohibited or restricted by law
Under U.S. law, a few specific ingredients may not be used in cosmetic products. These are:
Bithionol, because it may cause users to have negative reactions to sunlight.
Chlorofluorocarbon propellants in cosmetic aerosol products intended for domestic consumption (e.g., hair spray).
Chloroform, because it is cancer-causing in animals and probably harmful to humans as well. The FDA “makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient.”
Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide), because they may cause serious skin disorders.
Hexachlorophene (HCP), because it is toxic and can penetrate human skin. If no other preservative has been shown to be as effective, HCP may be used, but concentration must not be higher than 0.1 percent, and it may not be used in products that you put on mucous membranes, such as the lips.
Mercury compounds, because they are absorbed through the skin, accumulate in the body, and may cause allergic reactions, skin irritation, or neurotoxicity. The following restrictions apply:
Limited to eye-area products at no more than 65 parts per million (0.0065 percent, calculated as the metal). Allowed only if no other safe, effective preservative is available.
All other cosmetics containing mercury are considered adulterated, meaning the FDA can take action, unless the mercury level is less than 1 part per million (0.0001 percent, calculated as the metal) and cannot be avoided under conditions of good manufacturing practice.
Methylene chloride, which is cancer-causing in animals and probably also harmful to human health.
Prohibited cattle materials. There is a detailed list of what parts of cattle may not be used. This is to protect against “mad cow disease,” or bovine spongiform encephalopathy (BSE). More information is available at this FDA web page, in the body text and footnotes.
It’s also not allowed to use material from nonambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef.
Sunscreens, unless they’re used to protect the products’ color, and labeled as such. Otherwise, the cosmetic may fall into the category of a “drug,” meaning more regulation requirements.
Vinyl chloride, because it causes cancer and other health problems.
Zirconium-containing complexes in aerosol cosmetic products, because they are toxic to animal respiratory tracts and are linked to the appearance of granulomas (a kind of growth) in human skin.
Cosmetic manufacturers may use color additives only if the FDA has approved the color for the specific use that the maker plans.
There are some additives that may be used only if they are from specific batches that the FDA has tested and certified.
Some colors have other restrictions, as well, like maximum concentrations allowed in finished products.
For more information, you can read the FDA color additive fact sheet.
Exceptions to the rule
There is exactly one exception to the “if it’s harmful, it is forbidden” rule: coal-tar hair dye.
The FDA cannot act against the manufacturer of a coal-tar hair dye for safety reasons, as long as the manufacturer follows certain guidelines.
These guidelines include a special warning on the label and directions for a skin test.
Also, it isn’t an exception, but cosmetic manufacturers need to realize that some cosmetics can be safe when used as intended but unsafe when used in some other way. (Hairspray in the eyes, for example.) Labeling should clearly indicate what use a product is intended for.
Freedom of choice
So: As long as you, as a Creator, follow good manufacturing practices (including avoiding the few banned ingredients), ensure that your product is safe, and ensure that packaging and labeling requirements are met, you have lots of freedom to develop formulations. To make extra sure you’re doing things the right way, it can also be a good idea to work with regulatory consultants.
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A Short List of Prohibited and Restricted Cosmetic Ingredients in the United States:
- Chlorofluorocarbon propellants
- Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide)
- Hexachlorophene (HCP)
- Mercury compounds: strictly limited
- Methylene chloride
- Prohibited cattle materials
- Sunscreens: particular regulations apply
- Vinyl chloride
- Zirconium-containing complexes
- Color additives: not banned, but restrictions apply
- Coal tar in hair dye: specific regulations and guidelines apply
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