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…
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A federal court in California has preliminarily approved the settlement of class claims that Quaker Oats violated consumer protection laws by labeling its snack bars and instant cereal products as “wholesome” with “0g Trans Fat” when they actually contain “unhealthy” ingredients, such as partially hydrogenated vegetable oils (PHOs). In re Quaker Oats Labeling Litig., No. 10-0502 (N.D. Cal., San Francisco Div., order entered February 12, 2014). Under the proposed settlement, Quaker Oats, which admits no wrongdoing, has agreed to remove PHOs from products that contain them by December 31, 2015, and will not reintroduce PHOs into these products for 10 years. The company has also agreed to not introduce PHOs into products such as Quaker Chewy bars or Instant Quaker Oatmeal products that do not contain them for 10 years, and, by December 31, 2014, will cease stating on product labels “contains a dietarily insignificant amount of trans fat” for…
The U.S. Food and Drug Administration (FDA) has extended until March 8, 2014, the period for submission of comments and scientific data pertaining to its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food. FDA published a notice in the November 8 Federal Register announcing this determination and requesting comments on (i) possible alternative approaches; (ii) the time needed for reformulation; (iii) the burden on small businesses; and (iv) other technical challenges to removing PHOs from the food supply. Additional details about FDA’s opinion on trans fat appear in Issue 503 of this Update. See CFSAN Constituent Update, December 17, 2013. Issue 508
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 issued a request for comments regarding a proposed information collection about food labeling regulations. According to FDA, current approval periods for information collection requests regarding (i) third-party disclosure burdens about the amount of trans fatty acids present in a food, and (ii) voluntary declarations of the quantitative amount and the percent of Daily Value of a dietary ingredient on a “per day” basis in addition to the required “per serving” basis, have expired. To remedy the oversight, to most appropriately streamline these information collections, and to eliminate redundancy in its information collection requests, FDA seeks to revise the collection to “include these third party disclosure elements and have included them in the burden estimates and discussion.” Comments will be accepted until December 31, 2013. See Federal Register, November 1, 2013.
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 federal court in California has significantly narrowed the consumer-fraud claims that may be asserted against Frito-Lay involving a number of its snack products labeled as “All Natural,” “0 Grams Trans Fat” and “No MSG.” Wilson v. Frito-Lay N. Am., Inc., No. 12-1586 (N.D. Cal., order entered October 24, 2013). All claims dismissed were with prejudice. The court dismissed claims based on products the plaintiffs did not purchase, because they failed to specify how or whether the 85 products added in their second amended complaint were substantially similar to the purchased products. The court also dismissed any claims based on statements the company made on its website. According to the court, the Food and Drug Administration (FDA) may have warned other companies about whether their Websites constituted labeling, but it had not done so as to the defendant’s products. The court also said, “The website address appears below Defendant’s physical address,…
A second amended complaint has been filed in a putative nationwide class action alleging that The Hain Celestial Group’s food and beverage product labels render their products misbranded and further mislead consumers because they use the terms “No Trans Fat,” “Evaporated Cane Juice” or “All Natural” in violation of state law. Smedt v. The Hain Celestial Group, Inc., No. 12-3029 (N.D. Cal., filed August 30, 2013). Details about the court ruling dismissing the claims with leave to amend appear in Issue 495 of this Update. The plaintiff has omitted any claims that the company’s website misled consumers and has otherwise attempted to address the court’s concerns about ambiguous fraud allegations in her initial pleadings.
A federal court in California has dismissed putative nationwide class claims against The Hain Celestial Group alleging that the company’s food and beverage product labels and website mislead consumers because they (i) list the ingredient “Evaporated Cane Juice” or “Organic Evaporated Cane Sugar Juice,” (ii) are falsely labeled “All Natural” or “Only Natural,” and (iii) falsely claim to have “No Trans Fat” or other nutrient content claims. Smedt v. The Hain Celestial Group, Inc., No. 12-3029 (N.D. Cal., San Jose Div., order entered August 16, 2013). The court dismissed the statutory warranty claims with prejudice on the grounds that the food products are consumables and not covered under the state and federal laws and because food and beverage labels “do not constitute express warranties against a product defect.” The court dismissed the fraud-related claims with leave to amend within 15 days, finding that the amended complaint failed to “unambiguously specify the…
