Business clients


Compliance with U.S. FDA

The U.S. market remains the world’s leading economy with food, cosmetics and personal care products, medical devices, Over-the-Counter (OTC) drugs, and housewares and related products at the top of the list for products that are distributed in the U.S. With our legal expertise and regulatory compliance services, U.S. distributors have support in ensuring regulatory compliance, responding to enforcement issues, and finding new suppliers, importers and partners.

Distributing in the United States may require compliance with various federal, state and local regulations. For distributors of foods, dietary supplements, cosmetics and personal care products, medical devices, Over-the-Counter (OTC) drugs, animal and veterinary products, beverage alcohol, and more, this may include, depending on roles and responsibilities, compliance with U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Consumer Product Safety Commission (CPSC), Alcohol and Tobacco Tax and Trade Bureau (TTB), U.S. Environmental Protection Agency (EPA), California Proposition 65, U.S. Customs and Border Protection (CBP), and other agency and/or state regulation, as applicable. Distributors are also advised to have distribution agreements in place with supply chain parties to properly identify and allocate regulatory liability.

Compliance with U.S. distribution requirements may help reduce costs associated with import delays, testing, storage, frustration to ultimate purchasers caused by unpredictable trade flow, and reputational damage. By complying with requirements, distributors have a greater likelihood of fostering positive trade flow, a healthy relationship with regulatory agencies such as CBP and FDA, boosting consumer confidence and adding to their bottom line.

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