A Fine Line Between SPF and Soufflé

The consumer-beauty/personal‐care sector is operating in what one might call a “regulatory + innovation squeeze”-zone. On one hand, major regulatory enforcement activity is underway — particularly from the FDA’s Center for Drug Evaluation and Research (CDER) — which signals heightened agency focus on non-traditional dosage forms, claims and cross-category blur. On the other hand, brand operators and formulators are chasing consumer demand for novel formats (think mousses, foams, whipped textures) and sensory triggers (food-inspired aesthetics) to differentiate. On top of this sits the broader backdrop: the OTC monograph world is changing under the OMUFA (Over-the-Counter Monograph User Fee Act) regime. While this reform is meant to speed up innovation and clarity, it also means user-fees, tighter pathways, and cost/resource implications — especially for smaller brands.

We’ll take a look here at (1) the recent FDA warning letters in the sunscreen space and what they tell us about format risk, (2) the “foodification” (or food-inspired) trend in beauty/personal care and attendant regulatory risk and (3) the OMUFA regime’s impact on innovation and competition, particularly for small and midsize enterprises (SMEs), and how to prepare.

FDA Warning Letters in the Sunscreen Space: Format Matters

In August 2025, the FDA issued warning letters to several firms for marketing sunscreens in apparently non-compliant formats. For example:

• The firm Kalani AB (dba “Kalani Sunwear”) received a warning letter for its “SUN MOUSSE SPF 50” labelled product, which was a mousse (foam) sunscreen. The FDA advised that no final administrative order under section 505G had been issued for sunscreens in mousse form, so the product did not fall within the OTC sunscreen monograph (M020) “dosage forms” list.

• Similarly, Vacation Inc. was cited for “Classic WHIP BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE / SHIMMER” marketed as a “whip” mousse. Again, the FDA flagged that mousse/whip forms are not authorized under the monograph.

• A further example: Fallien Cosmeceuticals Ltd. (dba Fallene) received a warning letter for its “TiZO SHEERFOAM Non-Tinted SPF 30 MINERAL SUNSCREEN” in mousse/foam form.

Key take-aways for companies:

• Format matters: Even if the active ingredients, SPF claims and efficacy data are aligned with expectations, the dosage form may be fatal to monograph compliance.

• The FDA appears sensitive not only to efficacy but also to packaging/format risks (e.g., mousse resembling edible whipped cream, risk of ingestion) and consumer application issues (does user apply enough product if it’s airy mousse?). For instance, products that are packaged like food can mislead consumers into mistaking the products for food. This presents particular concern as this increases the risk of accidental ingestion.

• The letters emphasize misbranding under section 502(ee) of the FDCA, as well as new‐drug issues if the product does not fall under the monograph.

Foodification” Risks in Beauty & Personal Care

Parallel to the format issues in sunscreens is a broader trend: the “foodification” of beauty/personal-care products, e.g. products that borrow from food imagery, textures, scents, or positioning (mocha body washes, whipped mousse sunscreens, dessert-inspired lotions, etc.).

Why this matters from a regulatory perspective:

• When beauty/personal-care products adopt packaging, textures or positioning that evoke food (desserts, snacks, mousse whipped form), those signals raise agency attention around safety (e.g., risk of ingestion) and product classification (cosmetic vs. drug vs. food).
• Brands might inadvertently position or claim benefits (e.g., “sun-mousse dessert for your skin”) that trigger drug classification (if claims of disease prevention or structure/function), or that may run afoul of cosmetic rules or even food/ingestion issues.
• This trend underlines the importance of cross‐category awareness: a product may look like a cosmetic, but the claims or format may push it into the OTC drug or even food/commodity regulatory sphere. For example, the sunscreen mousse letters emphasize ingestion risk because mousse/whip is without precedent in the monograph.
• Smaller companies chasing novelty must ensure compliance: formulation, packaging, claims, route of marketing. The risk of “novel format + food aesthetic” is that regulators may view the product as outside the safe haven of the monograph or cosmetic rules.

Risk mitigation suggestions:

• Conduct a “regulatory classification” audit early: what is the intended indication? Does the format fall within an established monograph (for OTC drugs) or is it a cosmetic?

• Benchmark packaging/textures: would a reasonable consumer mistake it for a food or ingestible? Are there disclaimers, markings, labeling risks?

• If moving into novel format territory (e.g., mousse, foam, or food-inspired product), prepare for incremental regulatory review: evidence of safety, user behavior (do consumers apply sufficient dose?), product stability, clear claims.

• Monitor and plan for future agency scrutiny: as the sunscreen example shows, novelty formats invite enforcement.
  
  

OMUFA, Innovation & Competition in the OTC Space

The regulatory landscape for OTC monograph drugs has undergone significant overhaul under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) — in particular through section 505G and the User Fee Program known as OMUFA (Over-the-Counter Monograph Drug User Fee Act).

What is OMUFA? Briefly:

• OMUFA authorizes the FDA to collect user‐fees (facility fees, Order Request (“OMOR”) fees) from firms engaged in OTC monograph drug activities.
• It replaces the slow rule-making paradigm for monograph changes with a more nimble “administrative order” process under section 505G.
• OMUFA’s first authorization expires September 30, 2025; reauthorization (“OMUFA II”) is currently under negotiation for FY 2026-2030.
  
  

Implications of OMUFA for innovation & competition:

• By streamlining monograph amendment pathways, OMUFA potentially enables faster introduction of new OTC active ingredients or formats — thereby supporting innovation.
• However, the user‐fee burden and the “facility fees” may create fixed costs that disproportionately affect smaller companies. For FY 2025, facility fees for a full OTC monograph drug facility (“MDF”) are set at $37,556; for a contract manufacturing organization (CMO) fee at $25,037.
• OMOR fees for ordering a monograph change are substantial (Tier 1: ~$559,777; Tier 2: ~$111,955 in FY 2025) — representing a high barrier for smaller entrants to alter or expand monograph conditions.
• For small businesses, this means that while the procedural pathway is improved, cost-and-resource burdens remain significant — potentially favoring larger incumbents unless companies plan accordingly.
• From a competition angle, faster monograph changes (if effective) could reduce “monograph lag” and enable brands to bring novel dosage forms or ingredients to market more quickly — but only if they can navigate format/labeling and pay the fees.
• Also, OMUFA revival discussions emphasize clarifying the “Generally Recognized as Safe and Effective” (GRAS/E) standard, non-animal testing methods, and modernization of topical and sunscreen monographs.
  
  

Action items for companies (especially SMEs):

• Build regulatory/proof-of‐concept plans early: If your innovation involves a new dosage form (e.g., mousse, foam, spray, patch) or new active ingredient, assess whether the existing monograph covers it or whether an OMOR request will be required.
• Budget for fees: For small companies the fixed fees may necessitate partner/collaborator models or outsourced manufacturing arrangements to share cost burden.
• Monitor monograph forecast: The FDA publishes annual “monograph forecasts”—staying ahead of potential changes (for example, the sunscreen monograph) enables proactive planning.
• Evaluate competitive advantages: If you anticipate that large incumbents may dominate the “monograph upgrade” process, smaller firms might carve niche via format innovation, claims tweaks, or speed-to-market but must ensure regulatory compliance front-loaded.
• Consider regulatory defense costs: Unapproved format risk (as the sunscreen example) may lead to warning letters, misbranding liability, product withdrawal — so compliance infrastructure is not optional.
  
  

Concluding Note

The regulatory environment for sun-care, beauty and personal-care products has entered a new phase. Novel formats (mousse, whip), food-inspired aesthetics, and hybrid product positioning (cosmetic + functional benefit) have huge market appeal — but they also attract regulatory scrutiny. The FDA’s recent warning letters in the sunscreen space illustrate that format and dosage form eligibility under the monograph can be a critical vulnerability.

At the same time, the OMUFA regime promises a more modern, responsive OTC monograph system — but also brings user-fees and competition implications that companies must plan for. In this hybrid regulatory-innovation landscape, companies that proactively align product design, regulatory strategy and business planning will be best placed to both innovate and stay compliant.

For questions on FDA compliance and enforcement, including for cosmetics and OTC drugs, please contact us at info@garg-law.com.