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, 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.

FDA Detention And Refusals FDA Import Alerts Export Services
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. responds to FDA to improve your chance of successfully importing into the U.S.
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.
Companies that export products from the United States frequently need compliance services before and during border transactions.
FDA Label Review Internet Marketing Product Claims FDA FTC New Product Evaluation
The most common 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.
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.
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.
FDA Registration And Listing FDA Attorney Benjamin England California Regulation
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.
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.
Operating in the State of California presents uncommon opportunities, but also creates unique legal and regulatory risks for FDA-regulated businesses, including unique registration and licensing requirements, product labeling obligations, and potential litigation related to California-specific risks.