Practice Groups

Compliance, Investigations & White Collar


FDA Compliance Advisory

We possess the expertise necessary to help businesses comply with federal regulations governing the food, dietary supplement/nutraceutical, cosmetics and natural products industries.  With a deep knowledge and understanding of the regulatory scheme, we navigate our clients through the myriad of regulations their businesses must deal with daily.  Our attorneys are intimately familiar with key players at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Division of Dietary Supplement Programs.  Our vast experience – from the safety and efficacy of new ingredients for use in dietary supplements (New Dietary Ingredients/NDI) and conventional foods (Generally Recognized as Safe/GRAS), to basic operational considerations under current Good Manufacturing Practices (cGMP), to the creation of compliant, accurate, product labels and labeling – has proven rewarding for clients dealing with compliance issues.

For manufacturers, importers, or distributors of OTC Drugs, cosmetics and natural products (foods and dietary supplements) located throughout the United States and internationally, an FDA inspection can be a difficult, sometimes traumatic experience that often triggers a series of events that could have serious consequences for their businesses.  Our attorneys possess the knowledge and experience to assist in the defense of FDA inspections and respond to an FDA Form 483 (Report of Inspectional Observations), Warning Letter, Notice of Detention, Import Alert or even a threatened seizure or injunction that could force a company to shut its doors absent a well-thought-out response and defense.  With our hands-on experience, preparation, and access to all of the resources needed to protect a company facing regulatory challenges, we can help ensure that you are doing everything possible to protect your business.

 


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