Food, Food Additives and Dietary Supplements

The Wood Burditt Group provides counsel to producers, marketers, and distributors of foods, food additives, GRAS substances, dietary supplements. We assist in all legal regulatory matters administered by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the United States Department of Agriculture (USDA). We also assist with food law issues that are administered by other federal and state agencies, including the Centers for Disease Control and Prevention (CDC), the Environmental Protection Agency (EPA), the Bureau of Alcohol, Tobacco, Firearms and Explosives, the U.S. Customs Service, the U.S. Department of Justice, the Federal Trade Commission and the National Advertising Division (NAD).

The Wood Burditt Group provides counsel to the dietary supplement industry and advises clients on the regulations pursuant to the Dietary Supplement Health and Education Act (DSHEA).

We assist clients in their dealings with the Division of Dietary Supplement Programs, under the Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS). We provide counsel for dietary supplement companies on compliance and marketing matters, as well as on adulteration and mislabeling issues. Parts of our services include advising clients on Current Good Manufacturing Practices (CGMPs) and Dietary Ingredients. We also assist with import and export issues, as well as inspections, FDA enforcement actions and recalls.

We advise clients on legal/regulatory issues stemming from the numerous sources of FDA’s authority, including:

The Federal Food, Drug, and Cosmetic Act
The Public Health Service Act
The Fair Packaging and Labeling Act
The Infant Formula Act
The Nutrition Labeling and Education Act
The Dietary Supplement Health and Education Act

We assist clients in all stages of food and food additive testing, production, marketing, and post-marketing. Our services include providing counsel on:

– FDA inspection of establishments

– Food labels/labeling, claims and advertising

– FDA monitoring of imports

– premarket review

– notification programs (e.g., food contact substances, infant formula)

– regulations/agreements

– consumer studies, focus groups

– laboratory research pathogens and chemical contaminants in food

– food contaminants

– collection and analysis of information