Addressing PFAS Liability: Navigating Emerging MoCRA Safety Substantiation Standards

The Convergence of PFAS Scrutiny and MoCRA Compliance

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) fundamentally altered the compliance landscape for cosmetic manufacturers, distributors, and private-label brands. Among its most consequential provisions is the requirement that responsible persons maintain "adequate substantiation" of product safety, supported by data sufficient to demonstrate that a cosmetic product is safe under conditions of customary or reasonably foreseeable use.

That obligation has taken on new urgency as the FDA has intensified its scrutiny of per- and polyfluoroalkyl substances (PFAS) in cosmetic formulations. FDA-commissioned testing and independent academic studies have identified PFAS compounds—used historically for water resistance and texture enhancement in products such as foundations, lip products, and eye cosmetics—at detectable levels in a meaningful percentage of tested products, including some marketed as "PFAS-free."

For legal and compliance officers, this is not merely a scientific development. It is a regulatory and litigation inflection point that intersects directly with MoCRA's safety substantiation mandate, the FDA's expanding enforcement posture, and a rapidly evolving state-level patchwork of PFAS restrictions.

Why PFAS Findings Create Distinct MoCRA Exposure

MoCRA does not name PFAS as a prohibited or restricted category of ingredients. However, the statute's safety substantiation requirement operates independently of any specific chemical prohibition. A responsible person's dossier must reflect current scientific understanding, and the FDA's own findings on PFAS occurrence in cosmetics now constitute part of that understanding.

This creates three overlapping risk vectors:

• Substantiation adequacy risk. A safety file compiled before recent PFAS testing data emerged may no longer represent an adequate assessment of a product's safety profile, particularly for formulations containing fluoropolymers, fluorinated surfactants, or ingredients with known potential for PFAS contamination during manufacturing.

• Misrepresentation and labeling risk. Products marketed as "clean," "non-toxic," or "PFAS-free" face heightened exposure if independent testing contradicts those claims. FDA enforcement authority under the Federal Food, Drug, and Cosmetic Act, as amended by MoCRA, extends to misbranding theories that do not require proof of actual harm.

• Civil litigation risk. Plaintiffs' counsel have already demonstrated a pattern of pursuing consumer protection and false advertising claims against cosmetic manufacturers over PFAS content, often independent of any FDA enforcement action. A deficient or outdated substantiation file becomes a central discovery target in such litigation.

Reassessing the Safety Substantiation Dossier

Companies that treat MoCRA compliance as a static, one-time exercise are exposed. The statute's language—and the FDA's evolving guidance—supports an interpretation that substantiation must be revisited as new safety-relevant data becomes available. PFAS findings are precisely this type of data.

A defensible substantiation framework should include the following components:

• Ingredient-level PFAS risk mapping. Cross-reference full formulations, including trace contaminants and processing aids, against known PFAS classes and analogues rather than relying solely on intentionally added ingredient lists.

• Supply chain certifications. Obtain and retain updated certificates of analysis and PFAS-specific attestations from raw material suppliers, with contractual indemnification provisions where appropriate.

• Independent analytical testing. Where feasible, commission third-party laboratory testing using validated methods capable of detecting total organic fluorine or targeted PFAS analytes, rather than relying exclusively on supplier representations.

• Documented risk assessment methodology. Ensure the safety substantiation file articulates a clear, scientifically grounded rationale for why the product is safe under its intended use, referencing current toxicological literature rather than outdated industry consensus.

• Version control and audit trail. Maintain a documented history of substantiation updates, reflecting when and why the file was revised in response to emerging PFAS data, to demonstrate ongoing diligence rather than reactive compliance.

Labeling Claims Require Independent Legal Review

Marketing and legal teams frequently operate in silos, with claims language finalized before substantiation is fully reconciled. Given the reputational and legal stakes associated with PFAS-related claims, that sequence should be reversed.

Any "PFAS-free" or comparable claim should be approved only after:

• Analytical testing supports the absence of PFAS at levels consistent with the claim's plain meaning to a reasonable consumer;
• Legal counsel has reviewed the claim against current FTC Green Guides principles and analogous state advertising statutes; and
• The substantiation file explicitly documents the basis for the claim, insulating the company from allegations that the representation was aspirational rather than evidence-based.

Anticipating the Regulatory Trajectory

The FDA has signaled continued interest in PFAS occurrence data, and several states have already enacted or proposed outright bans on intentionally added PFAS in cosmetics. This trajectory suggests that federal MoCRA substantiation expectations will likely converge with, or be informed by, state regulatory standards over time.

Companies that proactively align their substantiation practices with the most stringent applicable standard—rather than the minimum federal requirement—will be better positioned to avoid a fragmented, jurisdiction-by-jurisdiction compliance posture.

Practical Next Steps for Responsible Persons

• Conduct an immediate audit of existing safety substantiation files against current PFAS testing literature and FDA findings.
• Prioritize product lines with historical use of fluorinated ingredients or known PFAS-adjacent chemistries.
• Engage regulatory counsel early to assess whether existing claims and substantiation documentation would withstand FDA inquiry or civil discovery.
• Establish a recurring substantiation review cycle tied to emerging scientific literature, not merely product reformulation events.

MoCRA's substantiation requirement was designed to be dynamic, not a static compliance checkbox. As PFAS science continues to develop, responsible persons who treat their safety files as living documents—continuously updated, rigorously documented, and independently verified—will be far better positioned to withstand both regulatory scrutiny and the litigation risk that increasingly follows it.