For cosmetic and personal care products marketed in the United States, ingredient compliance and safety are top priorities. The FDA requires that all ingredients used in cosmetics must be safe for consumer use and must not include substances that are prohibited or restricted under U.S. regulations. Failure to comply can lead to enforcement actions, product recalls, or import refusals.

The FDA does not pre-approve cosmetic ingredients (except for certain color additives). Instead, the responsibility lies with manufacturers, distributors, and importers to ensure their formulations are compliant and safe. This includes verifying that no restricted or banned substances are present and that ingredient concentrations fall within the allowable limits.

Another critical step is conducting toxicological safety assessments for new or innovative ingredients. These assessments help confirm that cosmetic products are not harmful under normal or expected use conditions. Companies must consider factors such as skin irritation, sensitization, long-term exposure, and vulnerable populations like children or pregnant women.

At XPRO America, we provide comprehensive FDA ingredient compliance and safety review services tailored for cosmetic brands, contract manufacturers, and international exporters. Our services include:

• Ingredient List Review – Checking all raw materials against the FDA restricted/prohibited substances database.
• Regulatory Compliance Check – Ensuring formulations meet U.S. cosmetic safety requirements.
• Toxicological Risk Assessments – Evaluating new or high-risk ingredients for consumer safety.
• Label & Safety Documentation Support – Preparing compliance records for FDA inspection readiness.
• Global Ingredient Cross-Checks – For brands exporting to the U.S. from international markets.

By working with XPRO America, cosmetic companies gain the assurance that their products are safe, compliant, and positioned for long-term success in the U.S. market. With regulatory scrutiny increasing under the Modernization of Cosmetics Regulation Act (MoCRA), proactive ingredient safety and compliance reviews are essential to building consumer trust and avoiding costly compliance issues.

XPRO America provides FDA ingredient compliance & safety review services for cosmetics, covering restricted substances, toxicology, and regulatory compliance.