Exporting products to the United States requires compliance with strict regulations, including FDA registration and label accuracy. Understanding the scope of the FDA’s responsibilities and ensuring your products meet U.S. standards are crucial steps for successful market entry.
At Pankesum, we specialize in making this process smooth and efficient for businesses exporting food, cosmetics, and apparel from Thailand.
What Does the FDA Regulate?
The FDA (Food and Drug Administration) oversees a wide range of products to protect public health and safety. For businesses aiming to export to the U.S., understanding FDA regulations is essential. Here’s a quick overview of the key categories the FDA regulates:
- Food and Beverages: Fresh, packaged, and processed foods. Products must meet labeling and safety requirements.
- Drugs: Both prescription and over-the-counter medications.
- Medical Devices: Simple tools like thermometers to advanced devices like pacemakers.
- Biologics: Vaccines, blood products, and gene therapy items.
- Radiation-Emitting Products: X-ray machines and microwave ovens.
- Cosmetics: Ensures safety and proper labeling for cosmetics.
- Veterinary Products: Includes pet foods, medications, and devices for animals.
- Tobacco Products: Compliance with safety and labeling laws.
Knowing these categories helps businesses determine their compliance needs before entering the U.S. market.
FDA Registration: The First Step
FDA registration is a key requirement for manufacturers exporting goods to the U.S. While it doesn’t include product inspection, it ensures that the manufacturing facility is listed and compliant with U.S. regulations. At Pankesum, we specialize in registering products such as dried fruits, vegetables, herbs, and items without animal-derived ingredients.
Key Details About FDA Registration:
- Cost: 280 – 450 USD per year, renewable annually.
- Additional Fees: May apply for canned or bottled products containing preservatives.
- Processing Time: 1–2 weeks.
- Required Documents: Seller and factory details, product label, and relevant certifications.
Once registered, a unique USFDA registration number is issued. For OEM products, factory approval is required before registration. A storage facility address can also be used if the factory is already registered.
Label Checking Services
Ensuring your product labels meet U.S. import regulations is just as important as FDA registration. Pankesum offers professional label checking services to help businesses comply with these requirements.
Label Compliance Requirements for Food Products:
- Net Weight: Display in ounces (oz.) before grams (g.), centered on the label.
- Country of Origin: “Product of Thailand” or “Made in Thailand”.
- Other Details: Ingredients, manufacturer information, warnings, production/expiration dates, usage instructions, and barcodes (if applicable).
Label Checking Fees: Starting at 30 USD per item.
Why Choose Pankesum?
Pankesum, a U.S.-based company specializing in sourcing and shipping Thai products, offers end-to-end support for regulatory compliance. Our expertise ensures that your products meet all necessary standards for the U.S. market.
Our Services Include:
- Registering manufacturing facilities for FDA compliance.
- Reviewing and adjusting product labels to meet U.S. regulations.
- Acting as your representative in communication with U.S. authorities.
How to Get Started: Email us your product details, and our team will provide tailored assistance. Whether you need FDA registration, label adjustments, or both, Pankesum is here to help.
Simplify Your Export Process
Exporting products to the U.S. can be challenging, but with the right guidance, it becomes seamless. Trust Pankesum to guide you through every step, from FDA registration to label compliance, so your business can thrive in the global market.
Photo by Andrea Piacquadio on Pexels.com
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