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The FDA’s regulatory landscape for cosmetics continues to evolve, and 2025 has already brought significant developments under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For contract manufacturers and brand owners, staying informed isn’t just about compliance—it’s about staying competitive.

Here’s a breakdown of the most recent updates and what they mean for your business.

1. Mandatory Registration and Listing: The Numbers Are In

As of January 1, 2025, the FDA has received:

9,528 active facility registrations

589,762 unique product listings

This marks a dramatic increase from the previous Voluntary Cosmetic Registration Program (VCRP), which had only 5,176 facility registrations and 35,102 product listings. The shift from voluntary to mandatory registration has significantly expanded the FDA’s oversight.

What it means for you:
If you haven’t registered your facility or listed your products, you’re already behind. These are now legal requirements under MoCRA, and non-compliance could lead to enforcement actions.

2. Increased Transparency and Public Data Access

The FDA has made registration and listing data publicly available, including:

Facility locations by state and country

Product listing volumes

Submission methods (e.g., Cosmetics Direct, ESG, SPL)

What it means for you:
Your registration status is now part of the public record. This transparency can affect your reputation with retailers, partners, and consumers.

3. Enforcement Trends Under the New Administration

Despite broader political shifts, MoCRA remains in full effect. The FDA is actively monitoring compliance and has signaled that enforcement will continue to ramp up.

What it means for you:
Don’t assume regulatory leniency. The FDA is watching—and the data shows they’re prepared to act.

4. How to Adapt: Legal and Strategic Recommendations

To stay ahead of these changes, contract manufacturers and brand owners should:

✅ Audit your registration and product listings to ensure accuracy and completeness.

✅ Review your labeling and marketing claims to avoid misbranding.

✅ Update Quality Agreements to reflect MoCRA responsibilities.

✅ Maintain documentation for safety substantiation and adverse event reporting.

How I Can Help

As an attorney focused on FDA regulatory compliance, I help clients:

Navigate MoCRA registration and listing

Draft and review Quality Agreements

Prepare for FDA inspections

Respond to enforcement actions

📩 Need help adapting to the latest FDA changes?
Let’s talk. I offer tailored legal support for contract manufacturers and brand owners navigating the evolving regulatory landscape.

The U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) have initiated a comprehensive review of infant formula nutrients, marking the first major reassessment in over two decades. This regulatory shift will impact manufacturers, suppliers, and contract formulators, requiring them to align with potential new standards for ingredient composition, testing, and transparency.

Why Is the FDA Conducting This Review?

The FDA currently mandates 30 essential nutrients in infant formula. However, recent advancements in nutritional science and public health research have raised concerns about:

🔹 Heavy metals and contaminants detected in some formulas
🔹 High sugar content in existing formulations
🔹 Potential nutrient gaps based on updated dietary research

As a result, the FDA aims to determine whether existing requirements need to be updated, paving the way for stricter manufacturing protocols.

Key Industry Implications

✅ Ingredient Adjustments May Be Required
Manufacturers may need to reformulate products to align with updated minimum and maximum nutrient levels once FDA guidance is finalized.

✅ Enhanced Quality Control & Testing
Expect increased testing requirements for contaminants, including heavy metals and nutrient absorption studies to validate efficacy.

✅ Labeling & Transparency Mandates
Stricter labeling regulations may be introduced to improve consumer clarity on nutrient content, requiring manufacturers to adjust packaging and disclosures.

✅ Supply Chain Impact
New sourcing requirements could affect raw material procurement, necessitating additional supplier audits and documentation compliance.

Next Steps for Manufacturers

📝 Monitor FDA Updates & Participate in Public Comment Period
Manufacturers can submit scientific data and industry insights before September 11, 2025, to help shape regulatory decisions.

🔍 Conduct Internal Compliance Audits
Review current formulations, supplier agreements, and testing protocols to anticipate potential adjustments in manufacturing requirements.

🤝 Engage with Regulatory Consultants
Partner with compliance experts to assess risk exposure and proactively align with evolving FDA expectations.

Final Thoughts

This regulatory review signals a major shift in infant formula oversight, with long-term implications for manufacturers and supply chains. Staying ahead of compliance changes will be critical to maintaining market access, ensuring consumer trust, and minimizing enforcement risks.

Would you like assistance drafting supplier agreements or compliance audits to prepare for these regulatory updates? Let me know how I can support your industry strategy!

Private labeling offers a fast track to launching a cosmetic brand—but it also comes with regulatory responsibilities that many new brand owners overlook. Whether you’re an influencer launching a skincare line or a contract manufacturer supporting multiple brands, understanding FDA compliance is essential for long-term success.

As an attorney focused on FDA regulatory compliance, I’ve outlined key tips and common pitfalls to help private labelers stay compliant and competitive.

1. Understand Your Role as the “Responsible Person”

Under the Modernization of Cosmetics Regulation Act (MoCRA), the “responsible person” is the entity listed on the product label—typically the brand owner. This person is legally accountable for:

Ensuring product safety

Submitting product listings to the FDA

Reporting serious adverse events

Maintaining records for six years

Even if you outsource manufacturing, you are still responsible for compliance.

2. Avoid Drug Claims on Cosmetic Products

One of the most common pitfalls is making marketing claims that classify your product as a drug. For example:

❌ “Treats acne”

❌ “Heals eczema”

❌ “Reduces inflammation”

These claims imply therapeutic use and may trigger FDA enforcement unless the product is approved as an over-the-counter (OTC) drug.

Stick to cosmetic claims like:

✅ “Improves the appearance of skin”

✅ “Moisturizes and softens”

✅ “Enhances natural glow”

3. Labeling Must Be Clear, Accurate, and Compliant

FDA labeling requirements include:

Product identity and net quantity on the front (Principal Display Panel)

Ingredient list in descending order of predominance

Name and address of the responsible person

Warning statements where applicable

Labels must be legible and not misleading. Avoid vague or exaggerated claims that could be interpreted as deceptive.

4. Vet Your Contract Manufacturer

Even though you’re not producing the product yourself, you’re still liable for its safety and compliance. Make sure your manufacturer:

Follows Good Manufacturing Practices (GMPs)

Provides Certificates of Analysis (COAs)

Has a track record of FDA compliance

Consider using a Quality Agreement to define roles and responsibilities clearly.

5. Keep Documentation Ready

MoCRA requires that you maintain:

Safety substantiation for each product

Adverse event records

Product listing updates

Having this documentation organized and accessible is critical in the event of an FDA inspection or inquiry.

How I Can Help

As an attorney specializing in FDA regulatory compliance, I help private labelers and brand owners:

Draft compliant labels and marketing claims

Navigate MoCRA registration and reporting

Review contracts with manufacturers

Respond to FDA enforcement actions

📩 Need help launching or scaling your private label brand with confidence?
Let’s talk. I offer tailored legal support to help you stay compliant and competitive.

Why the Shift to Natural Colors?

For decades, synthetic food dyes have been widely used to enhance the appearance of processed foods. However, growing concerns about potential health risks—such as allergic reactions and behavioral effects—have led regulators and manufacturers to explore natural alternatives.

The Newly Approved Natural Colors

The FDA has granted approval for three new color additives sourced from natural ingredients:

Galdieria Extract Blue – Derived from the unicellular red algae Galdieria sulphuraria, this vibrant blue color is now permitted for use in beverages, dairy products, candies, and frozen desserts.

Butterfly Pea Flower Extract – Extracted from the petals of the butterfly pea plant, this additive provides a range of blue and purple hues for drinks, confections, and dairy-based products.

Calcium Phosphate – A white color additive approved for use in ready-to-eat chicken products, candy melts, and sugar coatings.

These approvals expand the options available to food manufacturers seeking natural, FDA-compliant colorants.

Impact on the Food Industry

The transition to natural food colors is expected to reshape product formulations. While synthetic dyes offer bright, stable colors, natural alternatives may require adjustments in processing and packaging to maintain vibrancy. Additionally, sourcing natural pigments can be more expensive, potentially influencing product pricing.

Despite these challenges, many food brands are embracing the shift, recognizing the consumer demand for cleaner labels and health-conscious choices.

Looking Ahead

The FDA’s approval of these natural colors is part of a broader movement toward reducing synthetic additives in the food supply. As research continues, more natural colorants may emerge, further expanding options for manufacturers and consumers alike.

Dietary supplements are products intended to supplement the diet and provide nutrients that may be missing or insufficient in one’s regular diet. They can come in various forms, such as vitamins, minerals, herbs, botanicals, amino acids, and enzymes.

The regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act (DSHEA), passed in 1994. DSHEA defines dietary supplements and outlines the responsibilities of manufacturers, distributors, and the FDA in ensuring their safety.

The FDA plays a crucial role in overseeing dietary supplements to protect public health. While DSHEA allows supplements to be marketed without FDA pre-approval, the agency still enforces specific regulations to ensure product safety, proper labeling, and appropriate marketing claims.

In the next blogs, we’ll dive deeper into key FDA regulations for dietary supplements, understanding claims and marketing practices, and more. Stay tuned!

An AV Preeminent-Rated attorney, she represents startups to Fortune 500 companies.

Lisa Capote has been honored as one of Florida Trend’s Legal Elite Up and Comers for 2018. Visit Florida Trend’s Legal Elite Digital Edition for a full list of the awardees.

Los granos de café en la determinación final se producen a partir de granos de café verde crudo importados a Canadá o a los Estados Unidos en su estado natural. Una vez en Canadá o en los Estados Unidos, los frijoles se tuestan y envasan. La CBP dictaminó que “tostar granos de café verde transforma sustancialmente los granos en un nuevo y diferente artículo de comercio”. La agencia emite resoluciones de país de origen “con el propósito de otorgar exenciones de ciertas restricciones de ‘Compre estadounidense’ en las leyes de los Estados Unidos o práctica “para la contratación pública.

Once in Canada or the US the beans are roasted and packaged. CBP ruled that “roasting green coffee beans substantially transforms the beans into a new and different article of commerce.” The agency issues country-of-origin rulings “for the purpose of granting waivers of certain ‘Buy American’ restrictions in United States law or practice” for government procurement.

Being issued a warning letter is stressful, but when you take the right steps, it can be far from detrimental.

Identify What Issues the FDA Has with Your Product

An FDA warning letter gives detail about alleged violations your company has made regarding your product(s), your marketing, your product label(s), etc. The first step to handling a warning letter is to break it down and determine what exactly your alleged violations were.

Determine What Needs to Change to Meet FDA Regulations

Sooner rather than later, you’ll need to hold a meeting with any key players in your business to determine what might need to change about the design or manufacture of your product, the marketing of your product, or anything else the FDA stated was violated in the warning letter. Some of these things could be simple changes like updating a label, while others could take time and resources. You’ll need to have an idea of exactly what it will take to meet regulations.

Write a Response to The Warning Letter

Once you’ve identified what you plan to do to satisfy the requirements set forth by the FDA, you’ll need to craft a well-thought-out response. Generally speaking, the more comprehensive the response, the more you’ll illustrate that your company is taking the FDA’s concerns seriously.

You want to avoid being confrontational in the letter and be sure to address each point of contention with an appropriate response about what you plan to change, how long it will take, and what additional steps you may be taking to resolve the issue. Often, a warning letter response requires the help of an experienced FDA lawyer.

Be Ready for A Follow-Up

Be prepared for a follow-up inspection by the FDA to ensure that you have indeed made the changes necessary to meet FDA regulations. Stick to the time frame you provided to them in your response and make sure to have any and all changes completed by that time.

Contact Us Today

If you received an FDA warning letter, don’t wait to take action. Get legal help today by calling our office.