Raw Material Suppliers

Related Practices

HPM’s attorneys advise chemical and other raw material suppliers on the FDA and USDA regulation of their products when used in human and animal foods, food contact articles, dietary supplements, drugs, medical devices, cosmetics, and tobacco products.  Our attorneys assist raw material suppliers by providing services that include the following:

Human Foods and Dietary Supplements

• Provide counsel on compliance with good manufacturing practice (GMP) and preventive controls requirements
• Evaluate the regulatory status of ingredients and help prepare petitions and notifications, such as food additive petitions, generally recognized as safe (GRAS) self-determinations and notifications, threshold of regulation exemption petitions for indirect food additives (including food packaging materials), food contact notifications, color additive petitions, and new dietary ingredient notifications
• Provide guidance on U.S. aspects of global regulatory strategies for novel food ingredients, including sweeteners, functional ingredients, processing aids, color additives, fermenting agents, and flavor modifiers
• Provide counsel on organic regulations and help clients with petitions to place ingredients on the National List of Allowed and Prohibited Substances
• Help clients develop USDA-regulated products, including ingredients for use in meats, poultry, and egg products
• Develop strategies for addressing manufacturing problems, including issues related to microbial, chemical, and physical contamination
• Help resolve import detentions

Animal Drugs and Feed

• Counsel clients regarding Association of American Feed Control Officials (AAFCO) Official Definitions for use of new ingredients in animal feed and pet foods
• Assist with GRAS determinations for animal feed ingredients
• Provide counsel regarding import of animal products and assist with client responses to FDA import detentions

Over-the-Counter Drugs and Cosmetics

• Advise clients on the use of color additives in cosmetics and on safe and suitable excipients in OTC drugs