Generally Recognized as Safe

Generally Recognized as Safe
Name	Generally Recognized as Safe
Country	United States
Agency	Food and Drug Administration
Type	Regulatory designation
Established	1958
Status	Active

Generally Recognized as Safe. It is a Food and Drug Administration designation for a chemical or substance added to food that experts consider safe under the conditions of its intended use, exempting it from the usual Federal Food, Drug, and Cosmetic Act premarket approval process. The concept was formally established by the Food Additives Amendment of 1958 and is a cornerstone of the United States food safety regulatory system. This status applies to a wide range of ingredients, from common substances like vinegar and salt to specific chemical additives used in modern food processing.

Definition and legal basis

The legal definition is codified in the Federal Food, Drug, and Cosmetic Act, specifically under sections pertaining to food additives. A substance achieves this status through either a long history of common use in food before 1958 or through scientific procedures requiring the same quantity and quality of evidence as would be required for a formal food additive petition. The Food and Drug Administration plays a central role in reviewing and affirming such determinations, which can be made either by the agency itself or by qualified experts outside the Food and Drug Administration. The framework was a direct legislative response to growing public concern over chemical additives, exemplified by events like the cranberry scare of 1959, and was championed by figures such as James Delaney.

History and development

The historical foundation stems from centuries of using common ingredients like spices, vinegar, and baking soda without documented harm. The modern regulatory history began with the passage of the Pure Food and Drug Act of 1906 and evolved significantly with the Food, Drug, and Cosmetic Act of 1938. The pivotal moment was the 1958 amendment, which created the formal legal category and established the Delaney Clause addressing carcinogens. Subsequent decades saw the Food and Drug Administration develop more detailed guidelines, particularly after the Procter & Gamble petition for olestra in the 1970s, which highlighted the need for clearer evaluation protocols. Key administrative actions and reviews have continued to shape its implementation under various FDA Commissioners.

Criteria and evaluation process

The criteria for recognition are stringent and based on two primary pathways. The first is based on experience through common use in food prior to 1958, requiring a substantial history of consumption by a significant number of consumers. The second, and more common for new substances, is through scientific procedures requiring published studies, often reviewed by panels from organizations like the Federation of American Societies for Experimental Biology or the Life Sciences Research Office. The evaluation process examines comprehensive toxicological data, including studies on metabolism, chronic toxicity, and reproductive toxicity, and considers the intended technical effect in food. Notifications for new determinations are published in the Federal Register, allowing for public comment and potential review by bodies like the Center for Food Safety and Applied Nutrition.

Examples of GRAS substances

A vast array of substances hold this status, ranging from traditional ingredients to modern compounds. Common examples include many macronutrients like sucrose, fructose, and certain amino acids, as well as minerals like calcium carbonate and ferrous sulfate. Widely used chemical preservatives and additives such as ascorbic acid, benzoic acid, and sodium nitrite are included. The list also encompasses substances like caffeine, used in cola beverages, and various gums like guar gum and xanthan gum used as stabilizers. More recent notifications have included ingredients derived from new processes or sources, such as certain steviol glycosides from the Stevia rebaudiana plant.

Controversies and criticisms

The system has faced significant criticism from consumer advocacy groups like the Center for Science in the Public Interest and the Environmental Working Group. A major controversy involves the self-determination process, where a manufacturer's expert panel can conclude a substance is safe without prior Food and Drug Administration approval, though the agency can later challenge this. Notable contested substances have included partially hydrogenated oils, which were later deemed not safe, and certain uses of nanotechnology in food. Critics argue the process lacks transparency and can be influenced by industry-funded science, pointing to episodes like the regulatory debate over brominated vegetable oil and some artificial food coloring.

Comparison with other regulatory frameworks

Other major regulatory bodies have analogous but distinct systems for approving food additives. The European Food Safety Authority in the European Union operates under a centralized pre-market authorization model for all food additives, outlined in regulation EC 1333/2008, which is generally considered more restrictive. Health Canada utilizes a similar "food additive" categorization that requires pre-market assessment for all new substances. In Japan, the Ministry of Health, Labour and Welfare oversees a positive list system for food additives under the Food Sanitation Act. The Joint FAO/WHO Expert Committee on Food Additives provides international risk assessment recommendations that influence standards for the Codex Alimentarius, serving as a global benchmark that differs in process from the United States approach.

Category:Food law Category:United States food and drug law Category:Food safety