Exporting food business from India to America is a highly profitable business, but with the necessity to adopt a strict adherence to the law, that is, of the United States Food and Drug Administration (FDA). For Indian companies with the intent to export Makhana (Fox Nuts or Lotus Seeds) to America, US FDA clearance for export of Makhana is necessary. We will guide you through the whole process of obtaining the US FDA certificate, standards, and clearing the American market entry hassle-free in this article.
Why is US FDA Approval Required for Makhana Export
US FDA approval for Makhana Export guarantees that:
- The product does not pose any human health risk.
- Your processing and packaging units are in compliance with safety and sanitation requirements.
- You eliminate rejection at export ports in America.
- Your company acquires a global reputation.
- You keep operating as per legal import protocols and do not have to pay the penalty.
Given the fact that demand for healthy food nuts such as Makhana continues to rise all across the globe, US FDA certification places Indian exporters in a position of maximum leverage.
Step-by-Step Instructions: How to Obtain US FDA Export Approval for Makhana
Register Your Food Facility with the FDA
The FDA requests that any foreign facility that grows, makes, packs, or stores food for consumption in the United States be registered with the FDA.
- Go to the FDA Unified Registration and Listing System (FURLS).
- Register your facility and create an account.
- You will need to designate a U.S. agent to whom FDA communications are to be addressed.
- Registration is free and is required to be renewed every two years.
Get a DUNS Number
- As of 2020, facility registration with the FDA requires a Data Universal Numbering System (DUNS) number. It is a nine-digit number issued by Dun & Bradstreet.
- Obtain a DUNS number through the internet.
- Have your firm’s contact information (name, address, phone) be a photocopy of that found in the FDA database.
Know FDA Food Safety Standards
To receive US FDA certification, your Makhana should adhere to the FDA’s Food Safety Modernization Act (FSMA) requirements. It deals with:
- Hazard Analysis and Risk-Based Preventive Controls (HARPC)
- Good Manufacturing Practices (GMP)
- Sanitation and pest control
- Employee hygiene training
- Having a third-party auditor or consultant on your team will see to it that your facility complies with these strict safety standards.
Labeling and Packaging Compliance
Labeling non-compliance is the most common cause of rejected shipments.
Your Makhana product label must have:
- Product name (e.g., Roasted Makhana)
- Net weight in ounces/grams
- List of ingredients
- Nutrition panel
- Manufacturer’s name and address
- Country of origin (“Product of India”)
- Declaration of allergens, if required
- Use the FDA Food Labeling Guide as a checklist while packaging your product.
Provide Prior Notice Prior to Shipments
- Before all food shipments to the U.S., there is a Prior Notice filing with the FDA.
- The notice has shipment data, quantity, description, and importer/exporter details.
- It must be submitted at least 2-4 hours prior to arrival in the case of air shipment and 24 hours prior to arrival in the case of sea shipment.
- Detention or rejection at the U.S. port in case of non-submission of PN.
Employ Voluntary Third-Party Certification
Although the FDA does not issue a “certificate of approval” as such, you may establish your credibility through third-party certifications like:
- ISO 22000 (Food Safety Management)
- HACCP (Hazard Analysis and Critical Control Point)
- FSSAI (India)
- USDA Organic (if exporting organic Makhana)
- They are not substitutes for FDA approval, but the U.S. importers and retailers welcome them.
Documents Needed for FDA Approval and Exporting Makhana
- FSSAI license (India)
- US FDA Food Facility Registration Certificate
- DUNS Number proof
- Certificate of Analysis (COA)
- Invoice and packing list
- Bill of lading or airway bill
- Product label sample
- Nutritional analysis report (optional but recommended)
- Prior Notice confirmation
Tips for a Seamless US FDA Approval Process for Makhana
- Use an FDA agent residing in the U.S. to aid with documentation and communication.
- Keep all documentation consistent and factual.
- Mock audits to determine loopholes in your processing or hygiene procedures.
- Train employees on hygiene and safety procedures.
- Keep current on FDA notifications or notices, particularly for foods.
Mistakes to Avoid
- Wrong Labeling – Poor compliance with font size, language, or display of nutrition facts.
- Late Prior Notice – Omission of this step will result in the rejection of your shipment.
- No U.S. Agent – Every food facility going to foreign countries ought to have one for FDA compliance.
- Bad Documentation – Documentation should be complete, correct, and current.
- Poorly Maintained Facilities – GMP non-compliance results in failure during inspection by the FDA.
How Long Does FDA Approval Take?
- Facility Registration- In an instant, through online submission (in 1 day)
- DUNS Number- 5 to 10 business days
- Labeling and Product Review- Whatever the consultant or Internal Calendar
- Prior Notice- May be submitted within hours.
- You can become exporting-ready and FDA-compliant in 2 to 4 weeks if done right.
Final Thoughts
It is not at all easy to obtain US FDA approval for Makhana Export, the key to one of the world’s biggest consumer markets. With higher awareness regarding the health benefits of Makhana in America, this superfood presents tremendous business potential.
FAQs
1. Is FDA approval necessary to export Makhana to the USA?
Yes. Foreign food establishments are mandated by the United States FDA to register and comply with food safety regulations before they can export any food item, including Makhana.
2. Does the FDA issue a certificate of approval?
The FDA does not give a “certificate” but verifies your facility’s registration and grants export based on adherence to its regulations. You’ll receive a registration number and can avail third-party certifications as support for your credentials.
3. How much does it cost to register with the US FDA?
Registration in the FDA food facility is free, but employing a U.S. agent, consultants, or label designers can be expensive.
4. Can I export organic Makhana to the U.S.?
Yes, but you will require USDA Organic Certification by an approved certifying agency in India on top of your FDA compliance.
5. What if my shipment of Makhana is rejected by the FDA?
In case of inspection failure or non-compliance (e.g., absence of Prior Notice), your shipment may be detained, refused, or destroyed. You may also incur penalties or suspension.
If you need further assistance or have any doubts, our experts are here to help you. Call us: 8881-069-069.
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