The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant expansion of FDA authority over cosmetics since the Federal Food, Drug, and Cosmetic Act was first applied to the industry in 1938. Among its most consequential provisions is a mandate requiring FDA to issue regulations identifying fragrance allergens that must be disclosed on product labels—a requirement that will fundamentally alter how indie and startup brands formulate, label, and market their products.
For founders accustomed to protecting fragrance formulas as trade secrets, this shift demands careful legal and operational planning now, before the rule is finalized. Below are ten critical issues every cosmetic founder should understand.
1. Understand the Statutory Deadline FDA Is Operating Under
MoCRA directed FDA to issue a proposed rule identifying fragrance allergens requiring disclosure within 18 months of enactment, with a final rule to follow. While FDA has missed its original proposed-rule deadline, the statutory obligation remains in force. Founders should not assume the delay signals abandonment of the requirement. Regulatory history suggests that once FDA does publish, compliance windows are often shorter than companies anticipate. Treat this as a near-certain regulatory event, not a speculative one.
2. Know That the EU Allergen List Is the Likely Starting Point
FDA has signaled, through public statements and alignment with international harmonization efforts, that it will likely look to the European Union's list of 26 (recently expanded to include additional) fragrance allergens under the EU Cosmetics Regulation as a reference point. Brands already selling into the EU or UK have a head start, since their formulations may already undergo allergen screening. Founders selling only domestically should proactively audit fragrance components against the EU list now rather than waiting for FDA's final list.
3. Recognize That "Fragrance" Is No Longer a Safe Catch-All Term
Under current FDA labeling rules, "fragrance" or "parfum" can be listed as a single ingredient without disclosing its components, protecting proprietary blends. MoCRA's allergen disclosure mandate will carve out exceptions requiring specific allergens within that blend to be named individually once they exceed a yet-to-be-determined threshold concentration. Founders should not assume their current ingredient list format will remain compliant indefinitely.
4. Don't Confuse Fragrance Allergen Disclosure With General Ingredient Labeling
MoCRA also strengthened general cosmetic labeling and registration requirements—including facility registration, product listing, and adverse event reporting—that are already in effect or nearing enforcement. Founders sometimes conflate these obligations with the forthcoming allergen rule. They are legally distinct requirements with different timelines, and confusing them creates compliance gaps in both directions.
5. Audit Your Supplier Documentation Now
Most indie brands do not manufacture fragrance oils themselves; they purchase them from suppliers or fragrance houses. Those suppliers may treat exact allergen content as proprietary. Founders should begin requesting allergen disclosure statements or safety data sheets identifying known allergen components now, because renegotiating supplier transparency after a final rule is published—amid industry-wide compliance scrambles—will be slower and more expensive.
6. Understand That Reformulation May Be Necessary, Not Just Relabeling
Some founders assume compliance will simply mean adding text to a label. In reality, if a product contains allergens at concentrations requiring disclosure, the business decision may shift toward reformulation to avoid consumer-facing allergen warnings that could affect marketability—particularly for "clean beauty" or "sensitive skin" brands. Legal compliance and brand positioning must be evaluated together, not sequentially.
7. Don't Overlook Packaging and Label Real Estate Constraints
Small-batch and travel-size products often use compressed labeling formats. Adding individually named allergens—potentially a dozen or more per product—requires significant label space. Founders should begin consulting with packaging designers and legal counsel now about label redesigns, including consideration of the Precedent some brands have adopted internationally, such as QR-code-based digital disclosures, which MoCRA explicitly permits for electronic labeling in certain contexts.
8. Recognize the Interplay With MoCRA's Safety Substantiation Requirement
Separately, MoCRA requires cosmetic companies to maintain records substantiating the safety of their products. Fragrance allergens are a major component of safety substantiation because allergic sensitization is a well-recognized adverse reaction category. Founders should ensure their safety files already address known allergen risks, since this documentation will likely be examined alongside allergen labeling compliance during FDA inspections.
9. Avoid Assuming Small Business Exemptions Will Shield You
MoCRA includes limited exemptions for small businesses regarding certain facility registration and GMP requirements, based on revenue thresholds. However, founders frequently misunderstand the scope of these exemptions, assuming they extend to labeling and safety requirements broadly. Allergen disclosure, as currently contemplated, is tied to consumer safety and is unlikely to include broad small-business carve-outs. Relying on an assumed exemption without legal confirmation is a common and costly mistake.
10. Build Compliance Infrastructure Before the Rule Drops, Not After
The founders best positioned for this transition are not waiting for the final rule to act. They are:
- Auditing fragrance formulations against the EU allergen list
- Securing updated documentation from fragrance suppliers
- Reviewing label design flexibility for expanded disclosures
- Integrating allergen data into existing safety substantiation files
- Consulting counsel on phased compliance timelines tied to inventory and packaging cycles
FDA rulemaking timelines are notoriously difficult to predict, but the direction of travel is clear. Brands that treat this as a distant hypothetical risk reformulation and relabeling under time pressure, often at the worst possible moment—mid-production run or mid-fundraise.
Founders who engage proactively with experienced regulatory counsel now can turn this compliance obligation into a competitive advantage, signaling transparency and safety leadership to increasingly ingredient-conscious consumers.