The U.S. Food and Drug Administration (FDA) plays a crucial role in regulating a significant portion of imports, overseeing about 40% of the U.S. GDP. FDA regulations impact various product categories, including: Food Products: FDA regulates most food products,...
Understanding the nuances of FDA regulations, especially when selling products online or conducting international research, is important to successfully bring products into the U.S. market. There are some critical but often overlooked issues regarding the importation...
Benjamin England has a unique and extensive background at the intersection of FDA regulations and customs law. With over 20 years of experience, he has worked across various sectors, providing both legal counsel and consulting services to businesses engaged in...
On March 26, 2021, the Food and Drug Administration (FDA) republished the Over the Counter (OTC) Monograph Drug user fee rates for the fiscal year 2021 under the OTC Monograph Drug User Fee Program (OMUFA). While most OTC facilities will now be required to pay a...
The Food and Drug Administration (FDA) started 2020 off strong; on January 1, 2020, FDA required compliance with new food and dietary supplement labeling regulations for manufacturers with ten million dollars in annual sales. Manufacturers with less than ten million...
Update 01/13/2019:Commissioner Scott Gottlieb announced that they have increased surveillance sampling of imported high-risk products. Additionally, the FDA has expanded other activities that they have deemed "excepted, unpaid work because they're necessary to...
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