What is the FDA’s role in cosmetic approvals?

The US Food, Drug and Cosmetic Act states that the law requires every personal care and cosmetic product and its ingredients to be validated for safety before entering the marketplace and that they must not contain any prohibited ingredients.


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Cosmetic companies take the safety of their products very seriously, and many firms surpass legal requirements by including additional safety measures on behalf of consumers. It is imperative that consumers have confidence in their cosmetics and that claims that products lighten age spots and plump skin, for example, are substantiated. The FDA is quick to issue a warning to any company that cannot prove these claims.

Scientific research

Many personal care products and cosmetic companies invest heavily into safety processes and scientific research in order to certify the safety of their products. They employ and work alongside thousands of biologists, chemists, toxicologists, environmental scientists and other professionals to appraise the safety of the product before it is released to the market.

FDA’s safest product category

As a result, almost 11 billion cosmetic and personal care products are sold each year in America, and very few cause adverse reactions as reported to the FDA. Among those cases that are reported, the majority are related to allergies and rashes. The strong commitments to safety that the cosmetic companies demonstrate has meant that personal care products and cosmetics are the safest product category currently regulated by the FDA.

FDA 510k clearance process

All cosmetics should be submitted for 510k FDA approval before entering the market. The FDA attempts to review and respond to all 510k submissions within 90 days. However, this goal is not always achieved. In fact, it can often take up to six months to complete the process.

Many cosmetic manufacturers consider this too long, and companies such as http://www.fdathirdpartyreview.com/ can help accelerate the process for cosmetic approval by expediting submissions, cutting down the time it takes to get to market by up to 100 days. This fast-tracking of approval allows companies to get their products to the market quicker than their competitors, thereby increasing their business success.

In a competitive market, a cosmetic company’s top priority is the safety of its products. By gaining FDA approval, a brand demonstrates commitment, responsibility and awareness of this, giving the consumer greater confidence in its products.