Nutrition News, Views and Politics

A ‘GRAS’ designation is a classification used by the Food and Drug Administration (FDA) to indicate that a substance is considered safe as for human consumption within certain restrictions. To qualify, the ingredient is evaluated by an independent panel of experts qualified to read and interpret all available scientific information both public and private about the material, and it’s safety is evaluated under the conditions of its intended use. Alternatively, the ingredient may have achieved that status by virtue of having been widely consumed and in the human food supply prior to 1958. The criteria for GRAS were set out in the Federal Food, Drug and Cosmetic Act (sections 201 and 409, in case you care). Remarkably, a number of things present in our food are Not GRAS, nor do they need to be! Among these are food additives - which are evaluated solely by the FDA using data provided by the company or group seeking food additive status.  The regulations governing implementation of this Act are published in the Code of the Federal Register (CFR) chapter 21, section 170. Determining that a substance is “safe” is a challenging task, even for a scientist specifically qualified and experienced in these evaluations. Information from a wide array of fields such as ethnobotany, epidemiology, toxicology, nutrition, food science, genetics and agricultural science may need to be reviewed, evaluated and synthesized. The scientists performing these evaluations are recruited by companies who are hired by the companies providing the material to be assessed. The scientists performing the analysis are ‘blind’ to the sponsor, and get paid regardless of their determination, which reduces the chance of bias. This is called ‘self-affirmed GRAS’. These opinions may if the company chooses, be submitted to the FDA for a ‘no dispute’ letter - the FDA does not ‘certify’ the product as GRAS - they only indicate that they have no disagreement with the application. Products can be sold as dietary supplements that are NOT GRAS-affirmed, and have not been evaluated even for safety by any independent authority!  While having GRAS affirmation says nothing about efficacy, it does at least indicate that someone with appropriate expertise has reviewed the literature regarding safety. So for my money, I try to stick with supplements that are also GRAS affirmed, which is likely to be clearly stated in the product advertising or associated material, since it is something they will have spent significant amounts of time and money to achieve, and reflects a higher level of concern for scientific rigor throughout their operation. This isn’t always possible, and non-GRAS does not = unsafe. It is just one added level of confidence that the producer cares about doing things the right way.