Do you ever wonder how controversial ingredients end up in your food in the first place? For instance, why are energy drink companies allowed to add novel ingredients such as botanical extracts to their products? And why were companies ever allowed to use partially hydrogenated oils (PHOs), a major source of artificial trans fat, in processed foods? In other words, can companies add whatever ingredients they want? Or does the federal government have a say in the matter? If you presumed that the federal government approves and monitors food and beverage ingredients, then you are somewhat right. But you are also somewhat wrong. On one hand, food ingredients are subject to federal regulation. On the other hand, federal regulations give companies significant independence to determine which ingredients are safe. The U.S. Food and Drug Administration (FDA), the agency most responsible for food ingredients, has made several recent announcements about what companies can and cannot put into their products. Specifically, FDA is concerned about the safety of energy drink ingredients and PHOs. But to understand FDA’s announcements on these issues, it is helpful to understand the legal process surrounding food ingredients. So here is a basic breakdown of how companies legally add new substances to food and beverages. Three Paths to Food To most consumers, food is made with ingredients. But for the purposes of the law, food is made with substances. If a company wants to add a substance to a food or beverage for distribution in interstate commerce, e.g. across state lines, then it must comply with the Federal Food, Drug, and Cosmetics Act (FD&C). Under the FD&C, a substance legally enters the U.S. food system via one of three paths: 1) as a food additive, 2) as a listed exception, or 3) as generally recognized as safe (GRAS). 1) Food Additives A company adds a substance as a food additive when the substance is within the definition of food additive. The definition is inclusive: a food additive is any substance intentionally added to food except for specifically listed exceptions and GRAS substances. Thus, the other two paths for substances to enter the food system, e.g. via the listed exception or GRAS path, are actually exceptions to the food additive path. Of the three paths, the food additive path is the most burdensome because it requires pre-market approval. Pre-market approval means that FDA must review and approve the food additive as well as set restrictions before a company can use it. And companies bear the burden of proving the food additive’s safety. 2) Listed Exceptions A company adds a substance as a listed exception when it falls within a specific list of exceptions to the definition of food additive. Examples include pesticide chemicals, color additives, new animal drugs and dietary substances. A company must meet certain requirements before it can add these listed substances to its products. But, generally, those requirements are less onerous than the requirements for food additives. 3) GRAS Most commonly, companies add substances as GRAS. GRAS substances are substances that are “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.” Of the three paths, GRAS is the quickest way to add a new substance because it does not require pre-market review or approval. The GRAS process was created to give companies a quicker, more efficient method of adding substances to their products. The underlying rationale is that not all foods, especially those with a history of safety, require the level of FDA involvement required for food additives. The GRAS process permits companies rather than FDA to determine whether a substance meets the definition of GRAS or not. But the definition of GRAS begs key questions such as: Who are qualified experts? What is “adequately shown”? What is “safe”? And what are the “intended uses?” FDA has not clarified most of these questions. Thus, companies have a significant degree of discretion over which ingredients they add without pre-market approval because companies make their own GRAS determinations. And they make the determinations based upon a mostly unclarified standard. Two Routes to GRAS Companies determine whether a substance is GRAS via one of two available routes. The first route is available for substances that have been used in food before 1958. Substances used in food before 1958 are GRAS if there is a substantial history of consumption of the substance in food by a significant number of consumers. The second route is available if the substance was not used in food before 1958. If so, then the company makes the GRAS determination through scientific procedures. According to FDA, this route “requires the same quantity and quality of scientific evidence as required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.” FDA has not fully clarified either of these standards, so companies can, and do, use their discretion to determine whether a substance is GRAS. One Step to Approval After a company makes a GRAS determination, it has basically has one step left before putting the substance on the market: it may voluntarily submit its GRAS determination for review. Although companies make their own GRAS determinations, FDA does have authority to review these determinations. FDA has never issued a final rule on this authority, but it did propose a voluntary review process. And, for the most part, the voluntary review process controls how GRAS determinations are made today. Here is the process: First the company makes a GRAS determination. Then it voluntarily sends FDA notification of that determination. The notification includes a description of the substance, its conditions of use, and the basis of the determination. It also includes information about the physical properties, including toxicology. Next, FDA evaluates the GRAS determination based on the information submitted. FDA may use published or unpublished studies if they are available, but it will not likely conduct its own independent research. Finally, FDA issues a letter, which will include one of three responses: 1) FDA does not question the determination, 2) FDA concludes the determination does not have a sufficient basis, or 3) FDA has ceased to evaluate the determination based upon your request. The response is not an official approval or disapproval. It is more like a suggestion: either FDA thinks the GRAS determination is OK or the agency thinks the company needs more information. While the review process is completely voluntary, FDA does have authority to de-GRAS a substance. If FDA exercises this authority, then the company must add the substance via the food additive path and obtain pre-market approval. Summary For the most part, substances are added to food either as food additives or as GRAS. The difference between the two paths is significant: FDA must sign off on food additives, but companies can use GRAS substances without FDA approval. Notably, companies make their own GRAS determinations, which they may or may not voluntarily submit to FDA for review. FDA can de-GRAS a substance and therefore require pre-market approval if it chooses to exercise that power.