An overwhelming number of worldwide experts, including World Health Organization (WHO), American Dietetic Association and European Commission, agree that GMOs are safe for human consumption. In advance of a GMO product being commercialized, the innovation provider voluntarily submits to the U.S Food and Drug Administration (FDA) a dossier of compiled studies to be evaluated to determine the safety of the product as a food or food ingredient for consumers in the U.S. marketplace.
The FDA has well-established scientific procedures to evaluate the safety of GMOs with an expectation on developers of genetically engineered (GE) food to analyze the composition of new crop varieties. This is to ensure that any changes compared to the food’s conventionally derived counterpart are appropriately considered and addressed before marketing such foods. The FDA’s review and analysis includes consideration as to whether any newly introduced GMO may be allergenic or toxic and whether levels of important nutrients or anti-nutrients have been changed in a way that is important to food safety or nutritional value of that product.
Food growers, manufacturers and distributors all have a role in ensuring that food products marketed in the United States are safe. To help developers of GE food comply with their obligations under the Federal Food, Drug & Cosmetic (FD&C) Act and FDA regulations, the agency encourages them to participate in a voluntary consultation process with the FDA prior to commercial distribution. The goal of the voluntary premarket consultation process is to ensure that any safety or other regulatory issues associated with food from the new plant variety are resolved prior to commercial distribution.
It is important to note that the FD&C Act places a legal duty on developers, manufacturers, and distributors to ensure that the foods they market to consumers are safe and comply with all legal requirements.
The fact that participation in the process is voluntary should not mislead individuals to believe that the process does not provide for a rigorous food safety evaluation. It is not uncommon for the FDA to request additional data and information or clarification about the data and information submitted by the developer. This iterative process makes for a rigorous safety evaluation. The FDA considers a consultation to be complete only after all safety and other legal issues have been resolved.