Dietary Supplements
Dietary supplements imported into the United States are governed by a complex body of federal laws and regulations. These laws and regulations establish requirements that pertain to product manufacturing practices, product and ingredient safety, labeling, marketing claims and product importation procedures, among other matters. US Imports can help you comply with this complex array of laws and regulations.
FDA Registration and U.S. Agent
US Imports makes registering your facility with FDA quick and easy. We can serve as the U.S. Agent for food facilities located outside the United States. Upon registration you will receive a certificate confirming your FDA facility registration number.
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FDA Label Review
All imported foods and dietary supplement labels must be in English and comply with FDA labeling requirements. Our food labeling specialists review your label for FDA compliance and provide you a detailed list of suggested changes along with a complete markup of your label. We also include one additional review of your label as part of our labeling review service.
Learn MoreFDA Claims Review
Labeling claims must comply with FDA regulations or a label will be considered misbranded and your product will be denied entry into the United States. A claim is any representation made about a product on the label, website, flyer or even social media. US Imports’ specialists can review your claims and, if appropriate, offer alternative suggestions to maintain FDA compliance.
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Trademarks
US Imports experts can help protect your name, logo or slogan from the competition. Don't let others profit from your customer goodwill. Protect your brand today!
Learn MoreForeign Supplier Verification Program
Importers of food, beverages and dietary supplements to the United States are required to have a FSVP to verify the products are being manufactured in accordance with U.S. safety standards. Our specialists can help develop or review FSVP plans to ensure compliance with FDA regulations.
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FSVP Agent
Importers must designate an FSVP Agent upon entry of a food product to the United States. An FSVP Agent must be a “qualified individual” physically located in the U.S. to serve as the importer's representative with the FDA. US Imports can serve as your U.S. FSVP Agent.
Learn MoreDUNS Number
A DUNS number is a unique nine-digit identifier for businesses issued by Dun & Bradstreet. Businesses are required to provide a DUNS number when registering with FDA. US Imports can help you get a DUNS Number.
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EIN Number
Nearly all businesses must obtain an employer identification number (EIN) from the U.S. Internal Revenue Service (IRS). Foreign businesses need an EIN when filing U.S. Customs paperwork and registering with the FDA. Obtaining an EIN for a non-U.S. business can be complicated, so let US Imports handle it for you.
PurchaseAdverse Event Agent
All dietary supplement labels must list a United States address or phone number to receive reports of serious adverse events from consumers. FDA considers labels failing to list U.S. contact information misbranded and will deny imports entry. US Imports can serve as your U.S. Agent to collect and forward consumer reports directly to you.
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Prior Notice
Importers must file Prior Notice with FDA before any shipment reaches the United States. Shipments arriving at a U.S. port without a bar coded FDA Prior Notice may be refused entry. US Imports’ specialists can assist in drafting and filing Prior Notices.
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DISCLAIMER: US Imports is an information service provider. We are not a law firm and cannot provide any type of legal or financial advice, explanation, opinion or recommendation. US Imports is not a substitute for legal advice from an attorney or law firm. Use of US Imports is subject to our Terms of Use and Privacy Policy.
