Food and Beverage

Regulatory and Compliance

• Counseled a large food ingredient supplier with operations in Europe and the United States on compliance with FSMA, including a gap analysis of existing FSMA compliance efforts and determination of facilities covered by the definition of processor.
• Advised a trade association on comments to the proposed FSMA regulations, unfair trade proceedings against U.S. imports of sugar from Mexico, free trade agreement negotiations with Asia and the EU, and market access disputes in Latin and South America.
• Helped a client demonstrate to FDA the safety of its produce and secured removal of an import alert the agency imposed after preliminary data suggested possible microbial contamination.
• Performed legal review of advertising campaigns for a variety of major advertisers across a wide swath of industries, including manufacturers of food and both alcoholic and non-alcoholic beverages.
• Counseled a client on its response to a finding that an ingredient it distributed to food manufacturers may have been contaminated with prescription drug residues.
• Advised food and beverage clients to help them obtain duty savings on imports into the U.S., EU and other countries through favorable tariff classification decisions, customs valuation first sale rule and royalty decisions, free trade agreement programs, tariff remission proceedings, duty drawback and establishment of foreign trade zones.  
• Advised food and beverage clients in customs enforcement proceedings, investigations, seizures, audits and litigation to successfully mitigate penalties and increase compliance.                 
• Helped client prepare comments to proposed regulations implementing the Foreign Supplier Verification Program and counseled on compliance strategies.
• Reviewed new preventive controls used in food manufacturing and other efforts to comply with rules imposed by the latest food safety legislation, such as new menu and other nutrition labeling requirements.
• Provided advice on safety and labeling requirements and other compliance issues for pet food and other pet care products.
• Assisted a producer of feed in seizing and destroying a competitor's EU stock of feed produced with a prohibited bacterial strain.
• Trained sales personnel of a global food company on antitrust compliance issues.
• Provided advice on the scope and substance of FDA regulations covering food contact surfaces and guidance on complying with such requirements including:
• FDA requirements for food packaging;
• submission of food contact notifications;
• the sufficiency of testing products intended as food contact surfaces.
• Provided advice on whether new products containing specific antimicrobial and antifungal constituents are regulated by FDA as food contact substances, and if so, whether they complied with applicable FDA regulations.
• Provided advice regarding California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) relative to acrylamide in coffee, lead in toothpaste, and other Prop 65-listed chemicals in food products.

Litigation and Investigations

• Defended a national fast food retailer in nationwide class action alleging consumer fraud in the marketing of foods as trans-fat free.
• Defended a bread wholesaler in a putative class action alleging that the company’s breads were misleadingly labeled and marketed as all natural and that the labeling and marketing misled consumers about the grain content of the breads.
• Prepared and defended against NAD challenges in numerous industries, including food and beverages and consumer products.
• Handled unfair competition claim alleging failure to comply with NY state ban on trans fats in restaurant menu items.
• Prepared successful responses to inspectional observations (FDA Form 483) following establishment inspections by FDA.
• Defended a bread wholesaler in a consumer group's lawsuit alleging that labeling and marketing of the company’s wheat breads violated the D.C. Consumer Protection Procedures Act by falsely representing the whole grain content.
  
• Represented a Canadian multinational food manufacturer in an EU Member State court litigation relating to a competitor’s misleading advertising claims on the percentage of fat in its French fries.

Recalls

• Advised client on appropriate regulatory response and recall strategy after discovery that a manufacturing machine failure left plastic shards in raw food product shipped to franchise stores.
• Helped client develop strategy in response to FDA recall demands following discovery of salmonella in the client’s manufacturing facility. Crowell guided the company through meetings with FDA officials, including with the Director of FDA's Center for Food Safety and Applied Nutrition, to arrive at a reasonable recall plan to ensure consumer safety.
• Guided a client's market withdrawal of food items distributed to franchise stores after discovery that a mechanical failure during manufacturing may have dispersed foreign objects into the articles of food.
• Advised client on appropriate regulatory response and recall strategy after discovery of toxins in enzymes made by the client and used in food manufacturing.
• Advised ingredient manufacturer on how to handle accusations by customer that an ingredient the client made was the source of listeria monocytogenes found in finished product sold to consumers.