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When you import foods, dietary supplements, cosmetics, drugs, devices, or tobacco into the U.S., you need a partner who understands your business, your products and the regulatory and legal environment that affects them. Do not try to import regulated products without knowing exactly your rights and responsibilities. At FDAImports.com, LLC, we handle all cases involving all types of highly-regulated commodities and help companies of all sizes find The Way Through the maze of U.S. regulatory requirements.
We routinely resolve FDA import detentions and FDA import refusals. We regularly help foreign companies on FDA import alerts obtain removal or exemption from those alerts. We help U.S. distributors and Internet marketers ensure that their advertising and marketing materials comply with FDA and FTC laws and regulations.
We will help you find The Way Through at FDAImports.com, LLC by providing services that promote your business success.
Click on the links below to learn more about the latest industry news and our recent blog posts:
- FDAImports.com Convinces an Obstinate FDA to Remove Client from Import Alert #72-03 Red List
- Earthquake Will Cause Importers of FDA-Regulated Products from Japan to Face New Hurdles
- U.S. Food and Drug Administration Publishes Import Refusal Data
- The Administrative State and Cost and Benefit Analysis: Who Really Benefits?
- The Food Safety Modernization Act Becomes Law: What Now?
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FDA issues a notice of detention or a refusal of admission if an imported product "appears" to violate the law. FDA detentions cost money but FDA refusals cost business and lose clients. FDAImports.com responds to FDA to improve your chance of successfully importing into the U.S.
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Import Alerts result in FDA automatic detention of affected products and processors. They substantially increase the cost of exporting to the USA. Removal from Import Alert requires submission of proof to FDA that products comply with U.S. law.
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The most comment reason for FDA to detain products is an incorrect label. Product labels are perhaps the most ubiquitous aspect of products. Yet, an assortment of laws strictly regulates what a label says and looks like. Without a proper label, a product becomes illegal.
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FDA requires the registration of facilities based upon the products they make or distribute. While this sounds simple, a company must verify whether it must register and then navigate through an unintuitive electronic submission process.
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The internet revolutionized marketing and advertising. Yet, many companies unknowingly make claims that turn their legal products into illegal ones. Each word must be carefully chosen to avoid this unfortunate occurrence while still successfully promoting the product.
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The time to worry about complying with the FDA or FTC law is at the beginning of product development. A proper regulatory evaluation allows a company to appreciate the challenges, but also helps protect the market gains of any new product. |
Regulatory compliance frequently requires legal advice. Therefore, your project is overseen and evaluated in the final stages by leading regulatory attorneys led by Benjamin England, former 17-year FDA veteran and attorney, to ensure your ability to legally sell your product in the U.S.
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State and local governments frequently add layers of regulation to your product, which can quickly become confusing. State or local licensing, permitting, registration and reporting requirements may apply to your product. Your company should know and meet these requirements prior to selling in the U.S.
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