USA
Cosmetics - MoCRA
FDA MoCRA Product Listing
The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetics Act (FDCA) of 1938. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority over cosmetic products in the United States since the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938. The recent changes in Modernization of Cosmetics Regulation Act (MoCRA) has brought significant changes to the cosmetic industry, requiring manufacturers, packers, and distributors to comply with updated safety and regulatory standards. Among these changes is the introduction of mandatory cosmetic product listing with the U.S. Food and Drug Administration (FDA).
Each product manufactured or imported in the US is subject to a mandatory cosmetic product listing that details everything from the ingredients, including fragrance or flavor, and responsible party to the facility of manufacture and its location.
At FG, our team of experts can guide you through every step of this process.
FDA MoCRA Facility Registration
Manufacturers and processors must register their facilities with FDA and renew their registration every two years. FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
Our experts specialize in helping your business comply with the requirements of the MoCRA, which mandates registration of cosmetic facilities and product listings with the U.S. Food and Drug Administration (FDA).
Dietary supplements
FDA- Facility Registration & Renewal
Stay Compliant. Stay Market-Ready!!
If you manufacture, pack, or store dietary supplements for the U.S. market, FDA facility registration is a mandatory regulatory requirement under the Federal Food, Drug, and Cosmetic Act (FDCA). Whether you’re a U.S.-based company or a foreign facility exporting to the U.S., compliance begins with registering your facility.
Who Must Register?
All domestic and foreign facilities that manufacture, process, pack, or hold dietary supplements for consumption in the U.S. must:
- Register with the FDA before beginning operations
- Renew registration every even-numbered year (e.g., 2024, 2026)
- Appoint a U.S. agent (for foreign facilities)
US FDA Agent & Other Services
We assist you in meeting all FDA requirements for dietary supplement facility registration:
- New Facility Registration: We guide you through the step-by-step process of submitting an initial registration through the FDA’s Food Facility Registration Module (FURLS).
- Biennial Renewal: We ensure your registration is renewed accurately and on time, avoiding costly penalties or import delays.
- U.S. agent Service (for Foreign Facilities): Foreign facilities must appoint a U.S.-based agent for communication with the FDA. We act as your official U.S. agent to fulfill this legal obligation.
- Registration Updates: Facility address or contact details changed? We handle amendments and updates as required by the FDA.
- Compliance Support: We help you understand your ongoing responsibilities under the Dietary Supplement Health and Education Act (DSHEA) and FDA regulations.
Why Facility Registration Matters?
Failing to register can result in:
- Detained imports at the U.S. border
- Warning letters or enforcement action from the FDA
- Loss of business opportunities and market credibility
Need Help with FDA Registration?
Whether you’re launching a new dietary supplement or expanding into the U.S. market, we make sure your facility is fully compliant and FDA-registered.
Let our regulatory experts take care of the paperwork—so you can focus on growing your brand.
Contact us today to get started.
Label Review
Ensure Your Label Meets FDA Requirements – Before You Go to Market
Labeling errors are one of the top reasons for FDA warning letters and product recalls in the dietary supplement industry. If you’re selling dietary supplements in the United States, your product labels must comply with the FDA’s labeling regulations under 21 CFR 101.36 and the Dietary Supplement Health and Education Act (DSHEA).
Our expert label review service helps ensure your product labels are fully compliant—so you can launch with confidence and avoid regulatory risk.
What We Review
Our comprehensive U.S. label compliance review covers:
Supplement Facts Panel
- Format, font size, line thickness, nutrient units
- Correct daily values and serving size declarations
Ingredient Listing
- Order and naming of active and other ingredients
- Use of appropriate common or usual names
Claims Review
- Structure/function claims compliance
- Proper use of FDA disclaimers
- Evaluation of health, disease, or drug claims (not permitted)
Mandatory Label Elements
- Statement of identity
- Net quantity of contents
- Directions for use
- Name and place of business (including U.S. address)
- Contact information for adverse event reporting
Allergen & Warning Statements
- Compliance with Food Allergen Labeling and Consumer Protection Act (FALCPA)
- Required warning statements for specific ingredients (e.g., iron, caffeine)
What You Receive
- A detailed compliance report highlighting required corrections
- A marked-up label with clear comments and suggested edits
- Guidance on permissible claims and marketing language
- Support for FDA inspection readiness and market launch
Common Labeling Mistakes We Help You Avoid
- Improper or misleading structure/function claims
- Missing FDA disclaimers
- Incorrect Supplement Facts formatting
- Missing manufacturer/distributor contact details
- Noncompliance with font size and placement rules
Who Needs This Service?
- U.S. supplement brands preparing for market launch
- Foreign companies exporting to the U.S.
- Amazon sellers needing compliant labels to avoid delisting
- Private label or contract manufacturers seeking compliance assurance
Why Choose Us?
- Deep understanding of FDA and FTC regulations
- Experience with over 250+ supplement labels across categories
- Fast turnaround and responsive support
Optional add-ons: formulation review, claims substantiation, ingredient safety
Ready to Launch with Confidence?
Let us help you meet FDA dietary supplement labeling requirements the first time.
Contact us today for a free quote or to schedule your label review.