Dietary supplements and functional foods are the fastest growing segment of FDA-regulated products, largely due to their significant marketing flexibility based on less stringent regulation. Companies often seek to develop and position a product in these categories so they are not considered drugs or medical foods.
We 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 is 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.