Formulators help ensure finished products meet regulatory standards and are efficacious by building regulatory review into the earliest stages of product development.

This starts with confirming that every ingredient is lawful and appropriate for the intended product category and market. This may include evaluating whether an ingredient is an old dietary ingredient, whether a New Dietary Ingredient Notification may be needed, whether the ingredient has an appropriate GRAS (generally recognized as safe) status where relevant, and whether the intended conditions of use are supported by safety data. Safety is the foundation of compliance.

Strong formulators also consider the global regulatory pathway early. A formula that works in the U.S. may not automatically work in the E.U., Canada, Australia or other markets. Maximum vitamin and mineral levels, permitted ingredient forms, novel food rules, botanical restrictions, required warnings and claim standards can vary significantly by country.

-Asa Waldstein