Generally Recognized as Safe (GRAS)

What does “generally recognized as safe” mean?

"Generally recognized as safe" (GRAS) is a designation used by the U.S. Food and Drug Administration (FDA) to classify substances (such as food additives or ingredients) that are considered safe for their intended use in food based on a history of common usage in food or through scientific procedures.

Under the Federal Food, Drug, and Cosmetic Act, the FDA requires premarket review and approval for all food additives, except those determined to be GRAS. This means that experts generally agree, based on available data and information, that the substance is safe under the conditions of its intended use.

The GRAS designation can be established through two primary pathways:

  • Common use in food: If a substance has been widely consumed in food prior to 1958, it may be considered GRAS if its safety can be adequately demonstrated based on a history of common use.
  • Scientific procedures: Substances that have not been historically used in food or do not have a history of common use before 1958 may also achieve GRAS status through scientific procedures. This involves conducting scientific studies and evaluations to demonstrate safety, often involving experts in relevant scientific fields.

It's important to note that the determination of GRAS status is made by qualified experts, such as toxicologists or other scientific professionals, and may involve a review of scientific literature, data, and other relevant information. Additionally, the FDA can review the evidence supporting a GRAS determination and may challenge or question it if there are concerns about safety.

How does GRAS promote health?

The "generally recognized as safe" (GRAS) designation promotes health in several ways:

  • Safety assurance: GRAS substances have been determined by qualified experts to be safe for their intended use in food based on available scientific data and/or history of common use. This assurance of safety helps protect consumers from potential health risks associated with consuming harmful substances in food.
  • Encourages innovation: By providing a pathway for substances to attain GRAS status through scientific evaluation, the designation encourages innovation in the food industry. This promotes the development and use of new ingredients, additives, and technologies that can enhance the nutritional quality, taste, and overall appeal of foods while ensuring their safety.
  • Facilitates food production: GRAS substances play essential roles in food production, processing, and preservation. They help maintain food quality, extend shelf life, and enhance flavor, texture, and appearance, which can contribute to a diverse and accessible food supply.
  • Supports regulatory compliance: Food manufacturers and producers can use GRAS substances in their products with confidence, knowing that they comply with FDA regulations regarding food safety. This streamlines the regulatory process and ensures that foods containing GRAS substances meet established safety standards.
  • Contributes to balanced diets: Many GRAS substances are essential nutrients or are derived from natural sources, such as vitamins, minerals, amino acids, and plant extracts. Including these substances in foods can help fortify diets and promote overall health and well-being.

Overall, the GRAS designation plays a role in promoting public health by ensuring the safety of substances used in food and supporting the development of nutritious food products.