Understanding the FDA’s Stance on Nanomaterials in Skincare and Cosmetic Products

The Food and Drug Administration (FDA) works consistently with stakeholders to identify potential safety issues regarding cosmetic products. While the FDA does not intend to enact legislation regarding nanomaterials in cosmetic products immediately, the agency does make recommendations to the industry based on its observations and current thinking.

Describing Physicochemical Properties of Nanomaterials

To fully understand nanomaterials in cosmetic products and how they affect the body, the FDA requests that such materials be properly described:

• Identifiers like the name and Chemical Abstracts Service (CAS) number
• Structural formula and composition, including impurities or additives
• Particle size, shape, surface area, crystallinity, and distribution
• Surface chemistry
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The agency also recommends studying the details of the manufacturing process for a more thorough understanding, as additional impurities can arise during manufacturing.

The Toxicology of Nanomaterials

Testing of toxicology depends on the intended use of the product, exposure levels, and potential toxicity. The FDA identifies the following metrics for toxicology measurement:

• Location of Exposure. Most cosmetics are applied to the skin, but certain sprays can introduce the possibility of toxic inhalation. Other cosmetics might result in oral exposure as well.
• Absorption Tendency. How well can the nanomaterial pass through skin, cell membranes, and body barriers (such as the blood-brain barrier)? How soluble is the material? Soluble materials are less likely to be harmful since they break down into their molecular components, but insoluble ones can damage organs and cells.
• Testing. The FDA recommends testing for acute toxicity, skin and eye irritation, skin sensitization, and toxicity over repeated doses.

Other Considerations

Because nanomaterials can pass through physical barriers easily, they have immensely different effects on the human body than their larger counterparts of the same composition. The FDA seeks to analyze data and draw conclusions about the safety of products containing nanomaterials for this reason.

Safety assessments applied to products with nanomaterials should address several factors, including:

• Physicochemical characteristics
• Impurities and additives
• Potential for exposure

The FDA also encourages companies to work with the agency to determine potential short and long-term toxicity in new products. It also welcomes questions and comments regarding the use of nanomaterials in cosmetics.

Update Your Company’s Approach to Nanomaterials

With all these new developments in cosmetic safety, the Center for Professional Innovation & Education (CfPIE) encourages businesses to apply for cosmetic certification and training courses for their staff.

We offer several pharmaceutical and skin and cosmetic training courses that can help your organization understand how to maintain compliance with current FDA initiatives.

Are you interested in improving your knowledge of current best practices? Get in touch with CfPIE today by calling 1-610-648-7550 or by emailing [email protected].