FDA-Regulated

There is a lot of confusion over the role of the Food and Drug Administration (FDA) in the regulation of cosmetic products and ingredients. Many people do not understand the differences between FDA-regulated products and FDA-approved products. To understand the differences between the two, it is important to first understand how the FDA works.

How the FDA Works

The FDA is an agency that was created by the U.S. Congress to regulate the food and drug industry. Congress gives power to the FDA to create regulations that align with Congress laws and to enforce these regulations. For the cosmetic industry, the main laws that regulate this industry are the Federal Food, Drug and Cosmetic Act and the Fair Packaging and Labelling Act. These two laws are the basis for all regulations that the FDA enforces in the cosmetic industry.

Definition of Cosmetics

Under these laws, cosmetics are defined as articles that are meant to be applied on to the human body by rubbing, pouring, or spraying. It is important to note that soaps are not included in this category of products. This category of products also does not include any products that are used in the above ways but are meant for treatment purposes. In addition, the cream that your dermatologist prescribes to treat itchy skin symptoms is not considered cosmetics.

Law on Cosmetics

The law makes it illegal to sell adulterated or misbranded cosmetics in interstate trading. What this means is that products that include poisonous ingredients, dirty, or decomposed ingredients, or are prepared or packaged in unsanitary conditions can be harmful to the health of the users or can cause injury. All these and more are considered adulterated products and cannot be sold under these laws. This is the reason why cosmetic manufacturers invest in testing facilities or partner with organizations that help them test their products to ensure compliance.

Do Cosmetics Need FDA Approval?

This brings us to the main question of the article. The answer is no. The FDA does not approve cosmetic products apart from color additive ingredients. The FDA, however, can take action if a product in the market is not in compliance with any of the conditions we mentioned in the previous paragraph. Cosmetic manufacturers are free to use any ingredient in their products as long as it is safe (that is to say, it does not fall under the category of factors that the FDA considers as adulterated) and the product is properly labeled.

Under the law, cosmetics manufacturers have a legal responsibility to ensure that their products are safe. There are, however, no specific tests to demonstrate the safety of the products nor are manufacturers required to share safety information with the FDA. The FDA does not also function as a private testing laboratory for any cosmetics manufacturer. This is because it wishes to avoid the perception of being beholden to any one of the manufacturers out there. The FDA collects samples for routine testing and may sometimes conduct audits instead.