GRAS stands for “Generally Recognized as Safe,” a designation given by the U.S. Food and Drug Administration (FDA) to substances that are considered safe to use in food products based on a long history of common use or scientific evidence. The GRAS designation has raised several concerns due to the lack of independent oversight. Companies can determine whether a substance is GRAS themselves without needing approval from the FDA. This process, known as “self-affirmation,” relies on the company’s own evidence that a substance is safe. Some substances classified as GRAS may have been approved based on outdated safety data or research that no longer reflects modern scientific understanding. GRAS substances are often not subjected to long-term human studies. The safety of a food additive may be assumed based on short-term animal studies or limited human data. Our understanding of food additives, chemicals, and their impact on human health changes over time. However, once a substance is GRAS, it may continue to be used without reassessment, even if new scientific evidence emerges indicating potential harm.
Some artificial food dyes, preservatives, and chemicals used in food products are GRAS but have been linked to health issues in recent years. For example, the food coloring Red 40 or preservatives like BHA and BHT have been questioned for their potential links to cancer, allergic reactions, or hyperactivity in children. While GRAS status generally indicates that a substance is considered safe, it is not an absolute guarantee of safety, especially given potential long-term risks, the self-affirmation process, and the evolving nature of scientific research. This is why consumers, health advocates, and researchers remain cautious and call for more rigorous, transparent testing and ongoing safety reviews of food additives.