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Litigation Practice
  
Regulatory and Compliance Litigation


A significant part of the firm’s practice is devoted to advising clients on federal and state regulatory matters. Amin Talati is most noted for its ability to handle a variety of regulatory matters concerning all types of federal and state agencies including the FDA, FTC, USDA, DEA, EPA and U.S. Customs, amongst others. Firm attorneys not only provide exemplary support in enforcement proceedings, but they also counsel on all aspects of regulatory compliance including good manufacturing practices, clinical testing, labeling, advertising and international trade implications.

Our Regulatory and Compliance Litigation Services Include:

  • Responding to 483s, Warning Letters, FDA/Customs Detentions and related FDA, FTC, State AG and Department of Health Regulatory Actions
  • Defending against product seizures, recalls, injunctions, and criminal proceedings
  • Filing 403(r)(6) Notifications to the FDA for Statements of Nutritional Support
  • Providing New Dietary Ingredient (NDI) and Old Dietary Ingredient (ODI) opinions
  • Developing and implementing key marketing strategies such as “Third Party Literature” (under section 5 of DSHEA), that may be used to substantiate disease/drug claims
  • Working with the FTC to arrive at settlements and representing clients in FTC enforcement proceedings
  • Pursuing Customs rulings, advisory opinions, duty drawback requests and liquidation protests
  • Representing clients in DEA enforcement proceedings involving product and asset seizures, prosecutions of DEA licenses and other DEA regulatory proceedings
  • Negotiating consent orders with the EPA and other related state agencies
     
  
 
 
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