Foods and Dietary Supplements
Foods and Food Additives
For many years, we have represented companies involved in the development, marketing, and distribution of food and color additives, food components, generally-recognized-as-safe (GRAS) substances, medical foods and infant formulas, packaging materials, and animal feed products. We have experience dealing with traditional and biotechnology-derived human and animal food additives, bioengineered plant-derived foods, and health claims for foods.
We regularly assist with the appropriate safety assessment and submissions for food ingredients, including food additive petitions, food contact notices, and expert GRAS panels. Supported by chemists and toxicologists, we provide the full array of services needed to bring new food additives to market. At the postmarket stage, we handle product labeling issues, as well as FDA and state enforcement matters, including reportable food events, recalls, and import detention issues. We advise on current good manufacturing practice (cGMP) issues and enforcement actions (483s).
Dietary SupplementsWe assist manufacturers in filing new dietary ingredient and 30-day market claim notices with the FDA. We also help determine the appropriateness of new or novel dietary supplement ingredients, and whether a product's delivery mechanism affects the product's regulatory status. So that companies may avoid more rigorous regulation, we advise on the types of health and structure and function claims that can be made without converting the product into a drug or medical food.
Once it has been established that a product is a dietary supplement or functional food, we provide strategic assistance and creative solutions in connection with broadcast, print, and Internet advertising, and assist in preparing aggressive, defensible labeling to support claims that the supplement or food provides an enhanced function, while reducing the risk of additional FDA regulation.