Planning for FDA Regulations: What do Beauty Brands Need to Know?

Photo from Arthur Pereira on Unsplash

In the cosmetic industry, creativity and innovation are optional, but regulatory compliance is mandatory. With the FDA ramping up enforcement and new laws, such as the Modernization of Cosmetics Regulation Act (MoCRA), beauty brands must stay informed to remain compliant and competitive.

If you’re building a brand or launching a product, understanding the FDA’s role and requirements is critical. Here’s what you need to know to stay ahead of the curve.

Understanding the FDA’s Role in the Beauty Industry

The U.S. Food & Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, it’s important to understand the distinction between cosmetics and drugs:

• Cosmetics are products intended to cleanse, beautify, promote attractiveness, or alter appearance (e.g., moisturizers, lipsticks, shampoos).
  
  
• Drugs are intended to treat or prevent disease, or affect the structure or function of the body (e.g., acne treatments, dandruff shampoos, anti-aging serums that claim to “reverse wrinkles”).
  
  

If your product makes therapeutic claims—like “heals eczema” or “stimulates collagen production”—it may be considered a drug, even if it's sold in the beauty aisle. That distinction is key and will affect everything from how your product is tested to how it’s labeled.

Labeling Requirements: What Must Be on the Label

Proper cosmetic labeling isn’t just about the branding; it’s a legal requirement. The FDA has strict guidelines for what must appear on your product’s label, including:

• Statement of identity (what the product is)
  
  
• Net quantity of contents (amount of product)
  
  
• Name and address of the manufacturer, distributor, or packer
  
  
• Ingredient list, in descending order of predominance by weight, using INCI (International Nomenclature of Cosmetic Ingredients) names
  
  
• Warning statements if applicable (e.g., for products with certain AHAs, or aerosols)
  
  

Failing to meet these requirements could result in products being classified as misbranded and pulled from the market.

Claims and Compliance: Words Matter

Marketing language is one of the biggest pitfalls for new brands. While “hydrates skin” or “adds shine” are acceptable cosmetic claims, phrases like “treats rosacea,” “boosts collagen production,” or “reduces inflammation” can land your product in drug territory, which is under heavy FDA supervision.

Avoid drug-like claims unless you are prepared to go through the drug approval process. Stick to benefits that are legally allowed for cosmetics unless you’ve worked with a regulatory expert.

To protect your brand:

• Vet your product copy
  
  
• Substantiate your claims with proper testing
  
  

Work with a manufacturer or consultant who understands compliance language

Good Manufacturing Practices (GMPs): Your Compliance Foundation

Although the FDA does not currently mandate GMPs for cosmetics, it expects manufacturers to follow them, and this will change under MoCRA. GMPs ensure your products are:

• Free of contamination
  
  
• Properly documented and tracked
  
  
• Consistently produced across batches
  
  
• Made with verified, safe ingredients

Adverse Event Reporting: Your Responsibility Doesn’t End at Launch

Cosmetic brands must be prepared for post-market obligations, especially under MoCRA. As of 2023, serious adverse events (like infections, hospitalizations, or allergic reactions) must be reported to the FDA within 15 business days.

Brands must:

• Maintain records of all complaints and events for at least six years
  
  
• Report serious adverse events using the appropriate FDA forms
  
  
• Include a way for consumers to contact the responsible party on the product label

MoCRA: The New Cosmetic Regulation Era

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, marks a major shift in how the FDA oversees cosmetics. For the first time, cosmetics companies are required to comply with several mandates that were previously voluntary or loosely enforced.

Key Provisions Under MoCRA:

• Facility Registration:
  Cosmetic manufacturing and processing facilities must now be registered with the FDA. This includes domestic and foreign facilities that market in the U.S.
  
  
• Product Listings:
  Each marketed cosmetic product must be listed with the FDA, including key details like ingredients and intended use.
  
  
• Safety Substantiation:
  Brands must ensure that each cosmetic product has adequate safety substantiation—meaning documented proof that the product is safe for use under labeled or customary conditions.
  
  

• Adverse Event Reporting (AER):
  Serious adverse events must be reported to the FDA within 15 business days. Brands are also required to maintain detailed records for six years.
  
  
• GMP Requirements (Coming Soon):
  The FDA is developing mandatory Good Manufacturing Practices (GMPs) for cosmetics. While these aren’t finalized yet, beauty brands should be proactive about implementing GMP standards now.
  
  
• Fragrance Allergen Disclosure:
  A list of fragrance allergens will be required on product labels—something already standard in the EU, and soon to be U.S. law.
  
  

Key Dates to Watch:

• Facility registration and product listing deadlines: July 1, 2024 (original deadline), with extensions through 2025 for some companies.
  
  
• Additional rules on GMPs and fragrance allergens are expected to roll out by 2025–2026.
  
  

MoCRA represents a massive regulatory evolution, and brands that prepare now will be well-positioned to grow sustainably in a more transparent industry.

International Regulations: Going Global? Think Beyond the FDA

If you’re planning to sell internationally, FDA compliance is just the start. Each region has its own regulatory body:

• EU: Must comply with EU Regulation 1223/2009 and submit through the Cosmetic Products Notification Portal (CPNP).
  
  
• UK: Requires submission to the UK Office for Product Safety and Standards (OPSS).
  
  
• Canada: Governed by Health Canada, with mandatory cosmetic notification forms.
  
  

Working with a manufacturing partner who understands these requirements can save you time, money, and legal hassle.

How a Contract Manufacturer Helps You Stay Compliant

Navigating regulatory hurdles can be overwhelming, but you don’t have to do it alone. As a full-service contract manufacturer, we help brands:

• Develop compliant, high-performing formulations
  
  
• Ensure GMP standards in every production step
  
  
• Create labels that meet FDA and MoCRA standards
  
  
• Provide claim substantiation through clinical and stability testing
  
  
• Support FDA audits, facility registration, and MoCRA filings
  
  
• Monitor and manage adverse event reporting
  
  

Our job is to keep your brand safe, compliant, and market-ready—so you can focus on growth, not red tape.

Final Thoughts: Compliance is an Ongoing Investment in Your Brand

FDA compliance isn’t just about avoiding penalties, but it’s about building trust with your customers, your retailers, and your investors. With MoCRA bringing sweeping changes to the U.S. cosmetics landscape, brands that take a proactive, well-informed approach to regulation will lead the future of beauty.

Whether you’re just getting started or ready to scale, partnering with an experienced contract manufacturer can ensure you’re prepared for every phase of regulatory responsibility.

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