Food Regulation & Food Contact Materials

Steptoe provides a broad range of international legal and regulatory services to support our clients in their production and marketing of finished food, food ingredients, food contact materials (including packaging materials), dietary supplements, drugs, and medical devices.  Our multi-disciplinary team consists of highly specialized and experienced lawyers, former decision makers in the leading regulatory authorities, non-attorney regulatory specialists, and scientists who work with clients to develop innovative compliance strategies for individual products and product lines.  Steptoe has well established relationships with the relevant industry bodies and regulators, such as the US Food and Drug Administration (FDA), US Department of Agriculture (USDA), Environmental Protection Agency (EPA), US Federal Trade Commission (FTC), European Commission (EC), EU Member State authorities, European Food Safety Authority (EFSA), and equivalent authorities in other jurisdictions. 

We work with clients on a broad range of food regulation, food related product development and marketing issues, including:

• Providing legal and scientific advice and assistance regarding compliance with the FDA Food Safety Modernization Act
• Establishing regulatory compliance of food ingredients, including self-determinations of FDA compliance based on “generally recognized as safe” (GRAS) status
• Establishing regulatory compliance of dietary supplement products including new dietary ingredients
• Establishing regulatory compliance of food contact substances, including self-determinations of FDA compliance based on the absence of significant migration to food or on GRAS status and requirements in the EU and its Member States
• Preparing direct food additive petitions, food contact notifications (FCNs) and food contact material authorization dossiers to the European Food Safety Authority (EFSA)
• Assisting to ensure compliance of food contact substances in other jurisdictions, including China 
• Providing guidance on the toxicology testing of food and dietary ingredients and determinations of dietary exposure; guidance on migration testing and toxicology testing of food contact substances
• Advising on the use of nanomaterials in food and food contact applications
• Advising on food labeling (including allergen labeling), point-of-purchase materials, advertising claims and promotional materials
• Advising on permissible health and nutrition claims and related authorization procedures
• Assisting with post-market compliance issues concerning food, direct food additives and food contact substances
• Advising on traceability issues, and managing product recalls
• Providing risk management advice to companies in the food supply chain (retailers, food producers, food additive and color additive suppliers, food contact substance suppliers)
• Assisting with pre-market approval and compliance issues related to drug products, drug ingredients, and drug packaging (including drug master files)
• Responding to regulatory inspections and enforcement actions, including mandatory and voluntary recalls
• Advising on good manufacturing practice compliance
• Assisting with food import and export issues, including pesticide residues
• Advising on food related legislative and policy developments 

Click here to e-mail the Steptoe & Johnson LLP team on Food Contact Materials & Food Regulation with questions or comments. 

Noteworthy

• Ranked, Legal 500 Europe, Middle East & Africa for EU Regulatory - Food (2011 and 2012)

Select News & Events

• Chambers Europe 2013 Recognizes Steptoe Practices and Lawyers
• Steptoe Recommended in Legal 500 EMEA
• Steptoe Bolsters Environment & Life Sciences Practice with Ruxandra Cana and Her Team
• Law360 Quotes Ralph Simmons on FDA Proposal, New Tracking Requirements
• "Terminology and the Evolution of Definitions," IFT International Food Nanoscience Conference
• 5th International Fresenius Conference on Health and Nutrition Claims
• "Consumer Perceptions, Education, Risk Communication," IFT International Food Nanoscience Conference
• Food Labeling: What You Can Say, What You Must Say, and How to Defend It

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Publications

• Is My Health Claim on the Permitted List?
  June 4, 2013, AmCham Connect
• Test Methods for Food Ingredients
  NanoWatch
  May 2013, Chemical Watch
• Chinese Authorities Announce Reconfigured Food Safety Responsibilities
  April 10, 2013
• Will Your Health Claims Still be Legal?
  Majority of Health Claims on EU Food and Dietary Supplements to Become Illegal
  October 22, 2012

More Publications »