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How Does the FDA Regulate Cosmetics?

FDA Regulated -- Not FDA Approved

Perhaps the most critical takeaway for cosmetics brands is that the FDA does not currently offer approval for cosmetics or any kind of aesthetic skincare products (for example, false-eyelash glue.) Instead, the FDA lays out specific regulations cosmetics brands must meet when manufacturing their formulas.

The primary regulations center around the ideas of adulteration and misbranding, both of which we’ll unpack in depth. Beyond these requirements, cosmetics brands must also meet general sanitation and hygiene standards when formulating, packaging, and distributing their product within the US.

Adulteration of Cosmetic Products

Adulteration of cosmetics under FDA regulations refers to any contaminant or incorporated ingredient that is harmful to consumer health. These include any ingredients that are poisonous or otherwise dangerous, such as non-skin-safe solvents or solutions that have been proven to cause adverse reactions.

Adulteration can also come into play during the actual production and packaging of the product. During these stages, any exposure to a hazardous material is defined as adulteration. This is why cosmetics brands must be particularly careful in the handling of their products even post-formulation.

Misbranding of Cosmetic Products

As the name suggests, misbranding is any branding that is falsified or in any way misleading to the consumer. Cosmetics products must clearly state their ingredients list in order to concentration (i.e., if the product is a powder, talc, or the substance making up the bulk of the formula must come first in the ingredients list so that consumers can assess concentrations.)

Cosmetics products also cannot use the size of their packaging to mislead consumers about the quantity of a product enclosed. However, this is more difficult to regulate and many large cosmetics brands still employ these tactics in order to mislead consumers. The FDA does require the net weight to be printed on cosmetics packages in an attempt to address this.

Requirements for Color Additives in Cosmetics

Color additives are one of the only specific ingredients that are strictly regulated by the FDA, as there are certain colorants that have proven to be carcinogenic or otherwise harmful to human health even when applied topically in small doses. Given this, the FDA specifically prohibits the use of any color additive which has been proven to put consumers at risk -- similar to the idea of adulteration, but with specific color materials being either approved or prohibited.

You can learn more about the FDA’s specific regulations around color additives in cosmetics, here.

The Takeaway for Cosmetics Brands

While the FDA does not offer approval for cosmetics products, it does regulate them on the basis of adulteration, misbranding, and specific color additives. It is vital for even small, independent cosmetics brands to understand the regulations that apply to them before formulating their products.

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