Apparently motivated in part by an online petition started by a 15-year-old from Mississippi, PepsiCo has reportedly decided to remove brominated vegetable oil (BVO), a flame retardant, from Gatorade®. Sarah Kavanagh posted the petition on Change.org after she read about studies linking BVO to possible health effects, and it was signed by more than 200,000 who agreed with her call for its removal. Additional information about the petition appears in Issue 463 of this Update. The company will not remove BVO from Mountain Dew® products. A company spokesperson reportedly said that PepsiCo has been testing alternatives for about a year, but because it continues to believe that the ingredient is safe, was not going to change the formulation until the petition met with such a response. Kavanagh taped a segment for “The Dr. Oz Show” and visited The New York Times while she was in New York. When she learned about…
Tag Archives GRAS
The Food and Drug Administration (FDA) has rejected a Corn Refiners Association (CRA) petition urging the authorization of “corn sugar” as an alternate name for high-fructose corn syrup (HFCS). According to FDA’s May 30, 2012, response, CRA had asked the agency (i) “to amend the generally recognized as safe (GRAS) affirmation regulation for HFCS (21 CFR 168.11) to designate ‘corn sugar’ as an optional name for HFCS”; (ii) “to eliminate ‘corn sugar’ as an alternate name for dextrose”; and (iii) “to replace all references to ‘corn sugar’ with ‘dextrose’” in the GRAS regulations for corn sugar (21 CFR 184.1857). The trade association had apparently argued, among other things, that consumers confused by the name “high-fructose corn syrup” “incorrectly believe that HFCS is significantly higher in calories, fructose and sweetness than sugar.” In rejecting the petition, FDA countered that its regulations define sugar as “a solid, dried, and crystallized food; whereas…
The Food and Drug Administration (FDA) has reopened the comment period on revisions proposed in 1997 to its rule regarding substances generally recognized as safe (GRAS). Written or electronic comments are requested by March 28, 2011. The proposed revisions would “replace the voluntary GRAS affirmation petition process . . . with a voluntary notification procedure whereby any person may notify us of a determination that a particular use of a substance in human food . . . or in food for animals . . . is GRAS.” The proposal would also “clarify the criteria . . . whereby the use of a substance is not subject to the premarket approval requirements of the [Food, Drug, and Cosmetic Act] because it is GRAS.” The Federal Register notice refers to several developments since 1997, including the use of nanotechnology in foods, a Government Accountability Office (GAO) report on FDA oversight of GRAS…
The Food and Drug Administration (FDA) has called for comment on “the information collection provisions of FDA’s regulations for submission of petitions, including food and color additive petitions (including labeling) and generally recognized as safe (GRAS) affirmations.” As required by the Office of Management and Budget, the agency has invited comments on the following: (i) “Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility”; (ii) “the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used”; (iii) “ways to enhance the quality, utility, and clarity of the information to be collected”; and (iv) “ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.” FDA has also…
The U.S. Government Accountability Office (GAO) recently released a report criticizing the Food and Drug Administration’s (FDA’s) oversight of food ingredients determined to be generally recognized as safe (GRAS). Noting that companies are not required to submit their GRAS determinations to regulators, GAO examined whether FDA can vouch for these substances, which increasingly include nanomaterials. The report apparently concludes that not only does FDA’s oversight process fail to ensure the safety of both new and preexisting GRAS determinations, but it allows engineered nanomaterials to enter the food supply without the agency’s knowledge. According to the report, FDA “has not systematically reconsidered GRAS substances since the 1980s,” nor has it responded to “concerns about GRAS substances, such as salt and the trans fat in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008.” The findings also fault…
The Food and Drug Administration (FDA) has reportedly declined to send an objection letter to Arizona-based Wisdom Natural Brands™ concerning its request for generally recognized as safe (GRAS) status for its stevia sweetener, SweetLeaf®. Considered the gold standard in GRAS rulings, the lack of an FDA objection has confirmed earlier determinations by two independent scientific panels that reviewed SweetLeaf’s® GRAS status in March 2008. The company first lodged a notification of GRAS status with FDA for a “general purpose sweetener in various food categories” in March 2009. See FoodNavigator-USA.com, September 2, 2009. In a related matter, a Los Angeles Times article titled “Sweet stuffed: We eat lots (and lots of kinds) of sweeteners. What’s in them?” offers a primer of common and not-so-common sweeteners such as sucrose, glucose, fructose, corn syrup, high fructose corn syrup, lactose, honey, and agave syrup. “America’s sweet tooth is growing,” writes Wendy Hansen. “Like many other…
FDA has reportedly stated that it has no objection to granting GRAS (generally recognized as safe) status to stevia for use as a zero-calorie natural sweetener in foods and beverages. An extract form is currently marketed as a supplement, but FDA said it lacked the necessary scientific data to lift an import restriction on food-grade stevia, which is also known as rebaudioside A (Reb A). Several food companies recently requested approval for stevia-based sweeteners after supplying regulators with data that demonstrated the safety of the food additive at 95 percent purity or above. See BeverageDaily.com, December 18, 2008. The Center for Science in the Public Interest (CSPI), however, has called on the next Congress and President-Elect Barack Obama to reverse this “last minute” decision. The consumer watchdog cites research conducted by University of California, Los Angeles, scientists who purportedly concluded that stevia “is inadequately tested in terms of cancer and…
