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    Food

 

  • Representation for various food-related entities, such as agribusiness, bottlers, brewers, brokers, dairies, distilleries, distributors, farmers, food brokers, food lobbyists, grain ethanol facilities, groceries, manufacturers, micro-brewers, packers, processors, restaurants, transporters, suppliers, retailers, vintners, warehousers, wholesalers.

 

  • Legal support for typical tasks related to various aspects of various food-related businesses, such as: air and water rights; assistance with FDA inspections; business process outsourcing; co-packing arrangements; commercial agreements; corporate formation and structuring; defending consumer class actions; direct-from-farm sourcing relationships; employee benefits, Employee Retirement Income Security Act (ERISA) issues; handling product recalls; managing ingredient suppliers; interfacing with governmental agencies regarding labeling issues; investigations of employee issues; litigating food safety cases; negotiations to obtain real property on which to build facilities; regulatory compliance counseling; responses to Food and Drug Administration (FDA) Form 483 issues; handling labor relations; processing Occupational Safety and Health Administration (OSHA) and Workers' Compensation claims; permitting; procuring all necessary insurance; sponsorships; state and federal environmental issues; supply chain; and, technology purchases.

 

  • Consultation for ancillary issues related to the food production business, such as advertising, antitrust, bankruptcy, brand protection breach of contract, copyright, business reorganizations, consumer fraud, consumer products, corporate governance, creditors’ rights, data security, defamation, disparagement, distribution, divestitures, employment, false advertising, financing, franchising, immigration, intellectual property (IP), joint ventures, licensing, litigation, logistics, mergers and acquisitions (M&A), patent, privacy, product liability, promotions, real estate, regulatory, securities, slack-fill complaints, trade secrets, trademarks, and the like.

 

  • Representation for restaurant companies, restaurateurs such as franchisees, franchisors, investors, landlords, lenders, managers, operators, owners and tenants.

 

  • Legal support for consumer issues, such as: "bait-and-switch" allegations; data security breaches; false advertising; failure to warn of hazards due to consumption (generally relating to the common food allergens recognized by the FALCPA:crustaceans; eggs; fish; peanuts; nuts grown on trees – such as almonds, brazil nuts, cashews, chestnuts, filberts, hazelnuts, hickory nuts, macadamia nuts and the like – milk; shellfish; soy; soy beans; and, wheat); hidden charges, overcharges, price-fixing; mislabeling; incorrect credit reporting; incorrect specifications of ingredients; and, product defects.

 

  • Legal support for financing arrangements, including: angel, private equity and venture financing; asset-based lending; brand licensing transactions; capital raising; corporate organization and structuring; distribution, supply and master supply agreements;equity structuring; insurance recovery, review and planning; private equity investments; venture lending; startup formation, funding and organization; strategic partnerships; tax planning; estates, trusts and succession planning.

 

  • Authored, revised and reviewed food safety plans.

 

  • Developed supply chain self-assessment protocols and checklists.

 

  • Authored and updated inspection and recall manuals.

 

  • Compliance with Federal agencies, directives, guidelines, orders, regulations, rules and statutes, such as from the Agricultural Marketing Act (AMA), Agricultural Marketing Service (AMS), Animal and Plant Health Inspection Service (APHIS), Animal Drug User Fee Act (ADUFA), Center for Food Safety and Applied Nutrition (CFSAN), Consumer Product Safety Commission (CPSC), Department of Agriculture (USDA), Department of Health and Human Services (DHHS), Dietary Supplement Health and Education Act (DSHEA), Drug Enforcement Agency (DEA), Environmental Protection Agency (EPA), Farm Security and Rural Investment Act (FSRA, also known as the "Farm Bill"), Federal Food, Drug, and Cosmetic Act (FFD&CA), Federal Trade Commission (FTC), Food Allergen Labeling and Consumer Protection Act(FALCPA), Food and Drug Administration (FDA), FDA Office of Criminal Investigation (OCI), Food Safety Modernization Act (FSMA), Grain Inspection, Packers, and Stockyards Administration (GIPSA), Lanham Act, National Marine Fisheries Service (NMFS), Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPRA), Sanitary Food Transportation Act (SFTA).

 

  • Consultation regarding compliance within the European Union (EU) with EU regulations governing food products, particularly food products that might be imported from the EU for possible resale in the US, such as the EU Commission "Regulation (EU) No 1333/2011 of 19 December 2011", specifying marketing standards for bananas throughout the EU, which replaced the earlier EU Commission "Regulation (EC) No. 2257/94 of 16 September 1994", specifying quality standards (regarding, color, curvature, shape and size) for bananas to be sold originally in the EU (also known as the "bendy banana law").

 

  • Consultation regarding EU regulations applicable to commercial practices in the EU, such as the commercial agents directive, EU Directive 86/653/EEC on the laws of the relating to self-employed commercial agents.

 

  • Familiarity with the laws governing commercial practices relating to food production in Brazil, Canada, Japan, Mexico, the People's Republic of China (mainland), the Republic of China (Taiwan), the Russian Federation, and several Central and South American jurisdictions.

 

  • Consultation for the guidelines regarding the regulation of packaging materials for cosmetics, drugs, foods and food-contacting materials.

 

  • Due diligence audits of advertising, labeling, manufacturing operations, marketed products, for both internal control purposes and as part of M&A transactions.

 

  • Ensuring compliance of additives, food ingredients, functional foods, processing equipment and substances used in food packaging.

 

  • Preparation and submittal of required filings, such as food additive petitions, food-contact notifications, technical dossiers.

 

  • Legal support for obtaining regulatory clearance for the use of new food additives, novel foods, novel food ingredients and substances used in packaging materials.

 

  • Extensive reference to the Food Chemicals Codex (FCC) and Association of American Feed Control Officials (AAFCO) monographs.

 

  • Consultation regarding the criteria for claiming that a product is "organic".

 

  • Legal support for issues related to contained use, experimental release, labeling and marketing of genetically modified organisms (GMOs) and products derived from GMOs.

 

  • Legal support for dietary supplements, functional foods, and nutraceuticals, such as: assistance for safety testing of dietary ingredients, including carcinogenicity, toxicology and sensitivity testing for volunteers; compliance with the DSHEA adulteration, current good manufacturing practices (cGMPs), misbranding and new dietary ingredient requirements; consultation on the classification of a product as a conventional food or as a drug, based on written product representations; defense concerning FTC advertising complaints, enforcement actions and prosecutions; litigation against competitor court challenges; product liability issues; review of advertising copy, labels, labeling and promotional materialsfor compliance regarding the types of health-related representations (and the required substantiation therefore) that may appear in such advertising, labels, labeling and promotional materials; review of all materials to be posted on websites, including in particular the representations used to market dietary supplements.

 

  • Representation for companies that develop, distribute and market color and food additives, animal and human food additives derived from biotechnology, animal feed products, bioengineered foods derived from plants, dietary supplements, food components, generally-recognized-as-safe (GRAS) substances, infant formulas, medical foods, packaging materials.

 

  • Auditing for compliance with the Hazard Analysis and Critical Control Points (HACCP), Hazard Analysis and Risk-Based Preventive Controls (HARP).

 

  • Compliance with the regulation of eggs, meat and poultry products by the Food Safety and Inspection Service (FSIS) of the FDA.

 

  • Legal support for import detention issues, recalls and reportable food events.

 

  • Compliance with the FSIS continuous inspection, preventive food safety and prior label approval requirements.

 

  • Created standardized template commercial agreements for repetitive transactions.

 

  • Authoring and drafting corporate policies intended to promote compliance with applicable laws and to discourage food fraud (such as:counterfeiting; incorrectly labelling the weight; labelling aquaculture-bred fish as wild-caught; marketing food past its use-by date; replacing key ingredients with cheaper alternatives; selling ordinary foods as "organic"; unfairly using animal welfare quality or origin logos; and, wrongly labelling the animal species used in a meat product).

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    Last edited 201110_2205

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