Tag Archives: GRAS

Court Rules on Preliminary Motions in NGO Suit on GRAS Rule

On August 17, 2016, FDA finalized the rule – codified at 21 CFR Parts 170 and 570 for human food and animal feed respectively – that was originally proposed on April 17, 1997 permitting manufacturers to reach a Generally Recognized as Safe (GRAS) determination with the option of notifying FDA.  Prior to 1997, companies were … Continue Reading

CFS and Others Sue FDA Over GRAS Rule

FDA has premarket review authority over food additives; however, substances that are generally recognized as safe (GRAS) are not legally considered “food additives” as that term is defined under the Federal Food, Drug and Cosmetic Act, and therefore are not subject to the premarket clearance requirements that apply to other substances used in or in … Continue Reading

GRAS AT LAST

FDA Issues Final Rule on Food Ingredients that May Be “Generally Recognized as Safe” (GRAS) Although FDA has premarket review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without the Agency’s premarket review or approval if the substance is generally recognized, among qualified experts, to … Continue Reading

GRAS Under Fire

Senator Markey sends letter to FDA criticizing GRAS review system. As the food industry is well aware, consumer groups and others have been criticizing the “Generally Recognized as Safe” or “GRAS” exemption in the U.S. for the past several years.  GRAS opponents criticize FDA’s alleged lack of oversight and direct involvement in the marketing of … Continue Reading

Assault on Salt

Consumer advocacy group sues FDA to compel Agency action on sodium. Sodium reduction has been a hot topic for many years, with average dietary intakes remaining higher than the recommended value of 2,300 mg/day (or 1,500 mg/day for certain at-risk groups).  The food industry has embarked on voluntary efforts to reduce sodium levels in processed … Continue Reading

PHO Protections

House Appropriations Committee approves bill amendment aimed at protecting food industry from PHO-related litigation until 2018. As recently covered on this blog, FDA issued a final determination stating that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food. … Continue Reading

PHOs Not GRAS

FDA announces final determination that Partially Hydrogenated Oils are not GRAS. In November 2013, FDA announced its tentative determination that partially hydrogenated oils (PHOs) were not generally recognized as safe (GRAS) based on the link between trans fats and health risks, such as coronary heart disease (CHD), as identified by scientific evidence and expert scientific panels, such as … Continue Reading

Will the GRAS be Greener?

FDA may take recent consumer group comments into account before finalizing GRAS proposal next year. In recent years, the “Generally Recognized as Safe” or “GRAS” exemption has come under attack from consumer groups and consumers, who argue that it permits the marketing of new food substances in the United States without sufficient agency oversight.  In … Continue Reading

Oh, PHOoey

Two major food manufacturers face class action lawsuits for using artificial trans fats in processed foods. (subscription to Law360 required) Artificial trans fats are substances created by the addition of hydrogen to liquid vegetable oils to make them more solid.  The primary source of dietary trans fats in processed food is “partially hydrogenated oils” or … Continue Reading

GRAS Under Attack

Consumer safety groups file extensive comments criticizing GRAS process. In recent years, consumer groups have been attacking the “Generally Recognized as Safe” or “GRAS” exemption that permits the marketing of food substances in the United States without the need for FDA premarket approval.  GRAS opponents criticize FDA’s alleged lack of oversight and direct involvement in … Continue Reading

Propylene Paraben Petition

Food safety advocates petition for removal of propyl paraben from food. The fact that foods may be marketed in the U.S. on the basis of general recognition of safety, or “GRAS” status, has come under heavy attack by food safety advocates and consumer groups in recent years.  In particular, some groups object to the fact … Continue Reading
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