Food & Beverage Regulatory Compliance

We regularly represents clients in FDA compliance and enforcement matters. We are equipped to deal with FDA headquarters' compliance offices and the regional, district, and resident field offices. If you face inspection observations and/or warning letters, we craft responses and corrective action programs, and guide you through determining the scope of recall actions, implementing requisite recalls, and advise you on field corrections, retrofits, and supplemental labeling.

If you have more substantive FDA issues, we represent you in injunction actions and seizures, and litigate or negotiate consent degrees so you can continue or resume product distribution. Our attorneys believe in taking a proactive stance on your behalf. We also will help you avoid future enforcement problems by conducting regulatory and compliance audits for situations, general or discreet, about which you may have exposure concerns.

In addition, we also monitor compliance with FDA regulations relating to the Bioterrorism Act, including facility registration, prior notice of imported food and beverage shipments, and records maintenance and inspection; with FDA Hazard Analysis and Critical Control Points programs; and with import/export procedures.

Our Food & Beverage attorneys represent clients before the FDA, USDA, FTC, or other related agencies. Whether you need assistance with human and animal foods, functional foods, beverages, nutraceuticals, or dietary supplements, we are prepared to:

• Review health claims, nutrient content claims, structure-function claims, and dietary guidance statements
• Review nutrition and organic labeling
• Monitor compliance with USDA and Customs and Border Protection country of origin labeling requirements
• Represent you in FTC proceedings (e.g., advertising claims under the Lanham Act as well as in proceedings before the National Advertising Division of the Council of Better Business Bureaus)
• Handle food and beverage safety compliance issues, including product recalls, Good Manufacturing Practices (GMPs), FDA inspection procedures and warning letters, and conducting safety assessments of food and beverage additives and ingredients
• Monitor compliance with FDA’s Hazard Analysis and Critical Control Points programs
• Monitor compliance with the 1994 Dietary Supplement Health and Education Act (DSHEA), including advising on general labeling and advertising issues, nutrition labeling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
• Monitor compliance with GMP guidelines
• Prepare and submit notifications of new dietary ingredients

We also assist with pathway issues relating to the approval and marketing of direct and indirect food and beverage additives and dietary ingredients for dietary supplements in the United States, the European Union (EU), Latin American, and the Asian/Pacific regions. We work with you to define your objectives and goals and determine an optimal outcome. With that outcome in mind, we join forces with scientific staff on projects from inception, assisting your company from concept to commercialization. In addition, we advise on the content and business implications of the EU’s Registration, Evaluation and Authorization of Chemicals (REACH) control policy.

We provide counseling on approval pathways for food and beverage additives and help you obtain FDA approval for the use of new food and beverage additives. We also prepare and submit food and beverage additive petitions and notifications establishing that an additive is Generally Recognized as Safe (GRAS), and analyze for GRAS status for food and beverage additives, food and beverage packaging materials, and components of packaging materials. We offer counseling on the regulatory compliance of substances used in food and beverage packaging and processing equipment and can help you prepare and submit food and beverage contact notifications.

If you require DSHEA assistance, we evaluate proposed ingredients for compliance and determine whether a proposed dietary ingredient is subject to DSHEA’s new dietary ingredient notification requirements. We also prepare pre-market notifications for new dietary ingredients and counsel on dual-pathway strategies for dietary ingredient/supplement approval in combination with food and beverage additive or drug approval.

Doing business in Europe requires additional consideration, as the EU has established one of the largest consumer product regulation efforts in history relating to chemical and waste control. These initiatives are being emulated by state regulators, as well as by other international markets like Japan and China. We work with you to identify and address any issues you have relating to the EU REACH control policy, including explaining the impact of REACH on your product lines, and advising you on REACH's broader impact.

In addition, we can help you comply with the EU's comprehensive hazardous waste disposal regulations.

Our FDA Regulatory Practice works closely with our legislative attorneys to help represent your interests on Capitol Hill whenever Congress considers amending the Federal Food, Drug, and Cosmetic Act.

We promote your interests by:

• Preparing written testimony
• Arranging and preparing for appearances before the relevant committees
• Drafting proposed legislative language
• Developing grass roots and scientific support by collaborating with existing and ad hoc associations
• Preparing you for and representing you at congressional investigatory hearings

Customs, tariff and non-tariff barriers, and sanitary and phytosanitary standards are some of the issues that may directly impact your business. We interpret the legal impact of these laws and work with you to secure exemptions, and with policymakers to address regulatory trends that impact supply chains and sales.

We work closely with the U.S. Congress, CBP, the Office of the U.S. Trade Representative, the Departments of Commerce and State, the World Trade Organization (WTO), and the World Customs Council to develop strategies for reducing duties, and to identify and address trade barriers — whether involving the entry of a single product or a broad-based trade barrier policy issue. In addition, we identify and follow trends for you, proactively anticipating any changes that may affect your business in the long term.

We have extensive experience in the area of U.S. and international policy relating to the regulation and trade of agricultural commodities, food and beverage, textiles, and plant-based pharmaceutical products derived from biotechnology, as well as other emerging technologies, most notably nanotechnology.

Tracking the evolution of these controversial issues from their inception, our attorneys and professionals from our Public Policy Practice have developed a thorough understanding of the regulatory regimes of many major U.S. trading partners worldwide. We also have amassed a vast network of U.S. and international contacts, and have compiled an extensive database of international regulations governing agricultural commodities, food and beverage, and plant-based pharmaceutical products derived from biotechnology, cosmetics, food and beverage packaging, and other products derived from nanotechnology. We address issues ranging from advising whether a product containing transgenic materials must be labeled in Peru to recommending how to arrange a transfer of sophisticated transgenic materials to China.

New policy initiatives continue to be proposed regulating food and beverage, agricultural commodities, and pharmaceutical products derived from biotechnology, as well as the fast-growing range of products derived from nanotechnology processes. We will continue to use our knowledge and experience and determine how it directly affects you.

We help market your products in ways that minimize any potential disruptions by regulators. For example, we assist with developing the elements of a quality system, including procedures for compliance with GMP regulations and providing standard operating procedures and developing effective complaint handling systems, including provisions for failure investigations. We also implement procedures to comply with food and beverage reporting regulations, as well as with handling labeling and promotional issues, including nutritional, organic, and other label concerns. We can help you in developing advertising and promotion materials, and managing their associated costs. We also work with you to gain the support of professional societies.

Whether you are an inventor, company, or investor, you need to be aware of the probable FDA regulatory status and approval pathway of proposed new products and product concepts. We can guide you through the process, particularly in:

• Determining the application or notification type and assisting with supporting data required for FDA concurrence or approval
• Drafting meeting requests and preparing for meetings with FDA and expert committees
• Assisting with the preparation of requests for determinations for combination products
• Resolving complications that may arise during FDA application review
• Providing guidance throughout the approval and notification process
• Reviewing promotional statements and claims to promote products in the market