Partner with FDA Entry Point for Seamless FDA Compliance and Market Access

Are you a dietary supplement manufacturer looking to enter or expand in the lucrative U.S. market? Navigating FDA regulations can be complex and time-consuming. FDA Entry Point is your trusted FDA-registered agent, providing comprehensive solutions to ensure your dietary supplement products meet all necessary requirements for compliant import and distribution in the United States.

Why Choose FDA Entry Point as Your FDA Registered Agent for Dietary Supplements?

Expert FDA Compliance Guidance: Our team of specialists possesses in-depth knowledge of FDA regulations pertaining to dietary supplements, including labeling requirements, DSHEA compliance, New Dietary Ingredient (NDI) notifications, Good Manufacturing Practices (cGMP), and adverse event reporting. We guide you through every step to ensure your products are fully compliant.

Streamlined Facility Registration: As your official U.S. agent, we facilitate your dietary supplement facility registration with the FDA, a mandatory requirement for foreign manufacturers, packers, and distributors. This ensures your operations are recognized and authorized by the FDA under the Bioterrorism Act and FSMA regulations.

Efficient U.S. Agent Representation: We serve as your official point of contact with the FDA, receiving communications, responding to inquiries, and facilitating inspections on your behalf. This simplifies communication and ensures timely responses to FDA requests, preventing costly delays at customs.

NDI Notification Support: If your product contains a New Dietary Ingredient, we provide expert guidance on whether an NDI notification is required and assist with the preparation and submission process to ensure FDA acceptance.

Serious Adverse Event Reporting (SAER) Assistance: We help you comply with mandatory serious adverse event reporting requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, ensuring proper documentation and timely FDA submission.

Structure/Function Claims Review: Our regulatory experts review your product labeling and marketing materials to ensure structure/function claims comply with FDA requirements and avoid prohibited disease claims that could trigger enforcement action.

Risk Mitigation & Peace of Mind: By partnering with FDA Entry Point, you significantly reduce the risk of costly delays, detentions, or rejections at the border due to non-compliance. Focus on your core business while we handle the regulatory complexities.

Market Access Acceleration: Our efficient processes and regulatory expertise help you get your dietary supplement products to the U.S. market faster, maximizing your sales potential and competitive advantage in this rapidly growing industry.

DUNS Number Registration Assistance: Navigate the application process with experts ready to facilitate your DUNS number registration, a requirement for FDA facility registration.

Our Dietary Supplement FDA Registered Agent Services Include:

FDA Food Facility Registration for Dietary Supplements
U.S. Agent Representation for Foreign Facilities
Prior Notice of Imported Food Shipments Guidance
New Dietary Ingredient (NDI) Notification Consulting
cGMP Compliance Assessment and Guidance
Dietary Supplement Labeling Review and Compliance
Structure/Function Claims Review
Serious Adverse Event Reporting (SAER) Assistance
Product Listing and Electronic Submission Support
Regulatory Updates and Compliance Alerts
Pre-Import Compliance Review
FDA Warning Letter Response Support

Understanding U.S. Dietary Supplement Regulations

The U.S. dietary supplement market represents over $50 billion in annual sales and continues to grow rapidly. However, the regulatory pathway requires careful navigation:

Dietary Supplement Health and Education Act (DSHEA): Defines dietary supplements and establishes specific labeling and safety requirements distinct from conventional foods and drugs.

Current Good Manufacturing Practices (cGMP): FDA requires all dietary supplement manufacturers to follow cGMP regulations (21 CFR Part 111) to ensure product quality, purity, and accurate labeling.

Food Facility Registration: Foreign facilities that manufacture, process, pack, or hold dietary supplements for U.S. consumption must register with FDA and designate a U.S. agent.

Import Requirements: All dietary supplement shipments must comply with Prior Notice requirements, and products may be subject to FDA inspection at ports of entry.

New Dietary Ingredients: Ingredients not marketed in the U.S. before October 15, 1994, may require pre-market notification to FDA demonstrating safety.

Common Compliance Challenges We Help You Avoid

Improper labeling leading to product detention
Missing or incomplete U.S. Agent designation
Failure to submit required Prior Notice for shipments
Non-compliant structure/function claims
cGMP violations during FDA facility inspections
Delayed response to FDA communications
Inadequate adverse event reporting systems
Import alerts and automatic detention

Industries We Serve

We support dietary supplement manufacturers across all categories:

Vitamins and minerals
Herbal and botanical products
Sports nutrition and performance supplements
Weight management products
Probiotics and digestive health
Omega-3 and essential fatty acids
Amino acids and protein supplements
Specialty and condition-specific formulations

Ready to ensure your dietary supplement products meet FDA standards and thrive in the U.S. market?

Contact FDA Entry Point today for a consultation and discover how our expert FDA registered agent services can simplify your path to compliance and success.

FDA Entry Point – Your Partner in Dietary Supplement FDA Compliance.

Frequently Asked Questions

Do I need a U.S. Agent if I manufacture dietary supplements outside the U.S.? Yes. Any foreign facility that manufactures, processes, packs, or holds food (including dietary supplements) for U.S. consumption must register with FDA and designate a U.S. Agent.

What is the difference between a U.S. Agent and an importer? A U.S. Agent serves as the official FDA communication point for the foreign facility and must be located in the U.S. An importer is the entity bringing the product into the U.S. and may be a different company.

How long does facility registration take? With FDA Entry Point’s assistance, facility registration can typically be completed within 1-2 business days once we have all required information.

What happens if my product contains a New Dietary Ingredient? You may need to submit an NDI notification to FDA at least 75 days before marketing. We can help you determine if this applies to your product and assist with the submission.

Can you help if my product is detained at customs? Yes. We can facilitate communication with FDA, help you understand the reason for detention, and assist with the response to resolve the issue quickly.