Discussing the expedited approval process for food additives that took effect 17 years ago, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Michael Taylor recently told Washington Post reporter Kimberly Kindy that the agency does not have “the information to vouch for the safety of many of these chemicals.” According to the August 17, 2014, article, the number of additives in the food supply has increased to 9,000 from 800 over a 50-year span, in part because a voluntary certification system dependent on industry safety data has eclipsed FDA’s independent review process. Under the Generally Recognized as Safe (GRAS) scheme, companies need only submit a summary of their safety research to FDA, shortening time to approval even for new and novel food additives. In particular, the Post highlights how a mycoprotein marketed as “Quorn” achieved GRAS status despite one undisclosed study allegedly showing that 5 percent of test…
Tag Archives GRAS
The Natural Resources Defense Council (NRDC) has issued a report claiming that the U.S. Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) process for identifying food additives not required to undergo premarket approval is flawed and calling for legislation to change the process. According to NRDC, minimal FDA supervision and “a gaping loophole that allows companies to simply declare as safe hundreds of chemicals added to our foods—without any notification to the FDA or the public,” mar the U.S. food safety protection system. Under federal law, substances added to food are deemed food additives subject to FDA’s premarket approval unless they are considered GRAS by qualified experts or otherwise excluded from the food additive definition. While food companies can notify the agency that experts have made a GRAS determination, the law does not required them to do so. NRDC claims that it has identified “275 chemicals from 56…
The International Chewing Gum Association (ICGA) recently submitted comments to the U.S. Food and Drug Administration (FDA) about the agency’s proposal to revoke the generally recognized as safe (GRAS) status for partially hydrogenated oils (PHOs). Noting that PHOs are used in some chewing gum products “as softeners or texturizers at levels typically in the range of 0.2 to 2 percent of the finished gum,” ICGA has criticized FDA’s tentative determination as “misguided and overly broad.” In particular, the association has argued that FDA’s blanket revocation violates “the legal and scientific elements of the GRAS standard, which require a safety assessment for intended use by experts in ingredient safety.” According to ICGA, the tentative determination not only represents “a significant departure” from past efforts to reduce trans fat consumption through labeling initiatives, but discards a previous determination that PHOs in amounts less than 0.5 grams per serving “are effectively not present”…
The National Association of Margarine Manufacturers (NAMM) and American Bakers Association (ABA) have submitted comments to the U.S. Food and Drug Administration’s (FDA’s) rulemaking docket about the agency’s tentative determination to remove partially hydrogenated oils from the generally recognized as safe (GRAS) list. NAMM contends that “the great majority of margarine products no longer contain partially hydrogenated oils (PHOs), the source of trans fat, and that margarine is not a significant contributor of trans fats to the American diet.” In fact, NAMM suggested that margarine, with two-thirds less saturated fat than butter, 25 percent fewer calories than butter, no cholesterol (compared to 30 mg in butter), and no trans fat, is a healthier alternative. The ABA, meanwhile, commented that “bakers face unique challenges in removing remaining low levels of trans fat containing PHOs from certain bakery products.” It also found FDA’s tentative determination flawed, including its burdens of proof and…
The U.S. Food and Drug Administration (FDA) has entered a consent decree with the Center for Food Safety, which sued the agency over its alleged failure to comply with implementation rulemaking deadlines in the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decree filed February 20, 2014). Under the agreement, FDA will withdraw its Ninth Circuit appeal and will comply with the following timeline for the adoption of final rules: (i) Preventive Controls for Human Food and Preventive Controls for Animal Food—August 30, 2015; (ii) Foreign Supplier Verification Program, Produce Safety Standards, and Accreditation of Third Party Auditors—October 31, 2015; (iii) Sanitary Transport of Food and Feed—March 31, 2016; and (iv) Intentional Contamination— May 31, 2016. The deadlines may be extended by written agreement of the parties and court approval if “FDA believes good cause exists to seek an extension.” If agreement is…
The U.S. Food and Drug Administration (FDA) has issued two final guidance documents for industry on distinguishing liquid dietary supplements from beverages. Titled “Distinguishing Liquid Dietary Supplements From Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements,” the documents update 2009 draft guidance intended “to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product.” In “Distinguishing Liquid Dietary Supplements from Beverages,” FDA describes the factors characterizing liquid products deemed dietary supplements and those characterizing beverages deemed conventional foods. These include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling, advertising and other marketing practices, including promotional websites,…
Rep. Steve Israel (D-N.Y.) has reintroduced a bill (H.R. 3612) that would require clearer labeling of trans fat on food packaging. The move follows the U.S. Food and Drug Administration’s recent preliminary determination that partially hydrogenated oils, a major source of artificial trans fat in processed foods, are not deemed generally recognized as safe (GRAS) for use in food. Current regulations, which permit food companies to label products that contain partially hydrogenated oils as having 0 grams of trans fat if the value per serving is 0.4 grams or less, have been criticized by Israel and others, who point out that consumers can unknowingly exceed the recommended consumption of trans fat by eating multiple servings of a product containing 0.4 grams in a day. Israel’s legislation would amend this regulation to require manufacturers to indicate that a product contains less than 0.5 grams trans fat by using an asterisk in the “amount per serving”…
The public radio program Here and Now recently asked Corby Kummer, a food writer and senior editor for The Atlantic, whether the U.S. Food and Drug Administration’s (FDA’s) move to revoke the generally recognized as safe (GRAS) status for trans fat lays the groundwork for the agency to take a similar action against the use of added sugar in beverages and other products. During the November 18, 2013, interview, Kummer highlighted the history of the movement to prohibit trans fat, linking local restrictions such as those implemented by New York City to the growing public awareness that trans fats “were harmful at any level.” “I think it’s going to be a model for the way soda consumption can be limited in the public, which we certainly need to do,” explained Kummer. “It took a long time for scientific consensus to build. And at the beginning, the industry mercilessly exploited any trace…
The U.S. Food and Drug Administration (FDA) “has tentatively determined that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives.” If the agency finalizes this determination, “food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.” It would not, however, affect the trans fat that occurs naturally in small amounts in meat and dairy products. Announcing the initiative, FDA Commissioner Margaret Hamburg said, “The FDA’s action today is an important step toward protecting more Americans from the potential dangers of trans fat. Further reduction in the…
A recent study published in JAMA Internal Medicine has faulted the Food and Drug Administration’s (FDA’s) process for declaring food additives “generally recognized as safe” (GRAS), citing alleged financial conflicts of interest among those chosen by companies to verify the safety of new additives. Thomas Neltner, et al., “Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance,” JAMA Internal Medicine, August 2013. Led by Thomas Neltner, director of the Pew Health Group’s Food Additive Project, researchers used the Institute of Medicine’s conflict of interest criteria to analyze “451 GRAS notifications voluntarily submitted to FDA between 1997 and 2012.” In particular, they sought to determine (i) “the likelihood that a decision by an individual making a [GRAS] determination would be unduly influenced by the financial interests of a manufacturer of an additive,” and (ii) “the seriousness of possible harm if a GRAS…
