Days after the U.S. Federal Trade Commission (FTC) filed a lawsuit to enjoin Gerber Products Co. from claiming that its Good Start® Gentle infant formula helps reduce allergies in children, a consumer filed a putative class action in Arizona federal court alleging the same facts. Werthe v. Gerber Prods. Co., No. 14-8216 (D. Ariz., filed November 3, 2014). Additional information about FTC’s lawsuit against Gerber appears in Issue 543 of this Update. Like the FTC complaint, the consumer action alleges that Gerber advertises the partially hydrolyzed whey protein (PHWP) in its Good Start® Gentle formula as reducing the risk of atopic dermatitis in infants. As a result, Gerbercharges “a significant premium” over other infant formulas, the plaintiff asserts. The complaint cites Gerber’s labeling, which allegedly promises thatits product is the “1st & Only Routine Formula to Reduce the Risk of Developing Allergies” and that it “Meets FDA [U.S. Food and Drug…
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The U.S. Federal Trade Commission (FTC) has filed a complaint in a New Jersey federal court against Gerber Products Co., alleging that since 2011 the company has falsely promoted its Good Start Gentle infant formula as a product that can prevent or reduce the risk of a child developing allergies. FTC v. Gerber Prods. Co., No. 14-6771 (U.S. Dist. Ct., D.N.J., filed October 29, 2014). The formula is apparently made with partially hydrolyzed whey proteins (PHWPs) that Gerber purportedly claims make the product easier to digest than formula made with intact cow’s milk protein. Product stickers and ads compare the product to breastfeeding as a way to naturally protect a baby from allergies and claim that the formula is the “1st and ONLY” “TO REDUCE THE RISK OF DEVELOPING ALLERGIES.” The company also allegedly claims that the formula “is the first and only infant formula that meets the criteria for…
A recent study in the Annals of Allergy, Asthma and Immunology reportedly attributes an anaphylactic reaction in a 10-year-old girl to the antibiotic pesticide applied to the blueberries in the pie she was eating. François Graham et al., “Risk of allergic reaction and sensitization to antibiotics in foods,” Annals of Allergy, Asthma and Immunology, September 2014. The girl was known to be allergic to penicillin and cow’s milk but not to any ingredients in the blueberry pie. Following weeks of testing on the girl and on the sample of pie, researchers concluded that the streptomycin, an antibiotic often used as a pesticide to combat the growth of bacteria, fungi and algae in fruit, caused her reaction. “As far as we know, this is the first report that links an allergic reaction to fruits treated with antibiotic pesticides,” lead author Anne Des Roches was quoted as saying in a September 3, 2014,…
The U.S. Food and Drug Administration (FDA) recently issued a consumer update warning that the lupin (or lupine) legume could cause allergic reactions in susceptible individuals, especially those with existing peanut allergies. According to FDA, the use of lupin-derived ingredients has increased in recent years because they are used in gluten-free products as a substitute for other flours. “Although lupin is a food staple for many Europeans—who may be more aware of its allergenic properties and are accustomed to seeing it listed as a food ingredient—it is relatively new to the U.S. market,” notes FDA, which “is actively monitoring complaints of lupin allergies.” To this end, the agency has asked consumers and healthcare professionals to report lupin-related adverse events through the FDA reporting system. See FDA Consumer Update, August 15, 2014. Issue 535
The European Food Safety Authority (EFSA) has launched a public consultation on a draft scientific opinion evaluating “allergenic foods and food ingredients for labeling purposes.” Prepared by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), the new draft updates previous scientific opinions “relative to food ingredients or substances with known allergenic potential listed in Annex IIIa of 2003/89/EC,” including cereals containing gluten, milk and dairy products, eggs, nuts, peanuts, soy, fish, crustaceans, mollusks, celery, lupin, sesame, mustard, and sulfites. To this end, NDA addresses the following topics: (i) “the prevalence of food allergies in unselected populations”; (ii) “proteins identified as food allergens”; (iii) “cross-reactivities”; (iv) “the effects of food processing on allergenicity of foods and ingredients”; (v) “methods for the detection of allergens and allergenic foods”; (vi) “doses observed to trigger adverse reactions in sensitive individuals”; and (vii) “approaches used to derive individual and population thresholds for selected allergenic…
The U.S. Food and Drug Administration (FDA) has issued draft guidance intended to help the food industry prepare submissions for obtaining exemptions from the labeling requirements for major food allergens. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that food labels identify products containing major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans). Because an ingredient derived from a major food allergen may be modified to such an extent that it does not contain allergenic protein or does not cause an allergic response that poses a risk to human health, FALCPA apparently provides two processes through which manufacturers can obtain an exemption from this labeling requirement for a specific ingredient. An ingredient may be exempted through submission and approval of either (i) a petition containing scientific evidence which demonstrates that the ingredient “does not cause an allergic response that poses a…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued guidance for identifying, controlling and labeling allergens and other ingredients of public health concern through hazard analysis and critical control point (HACCP) plans, standard operating procedures (SOPs) or other prerequisite programs. Geared toward meat and poultry products, the guidance seeks to ensure “that product labels declare all ingredients, as required in the regulations, and that the product does not contain undeclared allergens or other undeclared ingredients.” In particular, the agency points to “a sustained increase in the number of recalls of FSIS-regulated products that contained undeclared allergens,” noting that such recalls are “preventable, as many have been due to ingredient changes, product changes, products in the wrong package, or products with misprinted labels.” In addition to establishing best practices for SOPs and HACCP plans, the recommendations clarify how to properly process, handle, store, and label a product…
The U.K. Advertising Standards Authority (ASA) has ruled that an advertisement for a range of lactose-free products made “sufficiently clear that the Lactofree products were not suitable for dairy allergy sufferers but were suitable for those intolerant to lactose.” Responding to a complaint alleging that the ad failed to adequately differentiate between lactose intolerance and dairy allergy, Arla Foods Ltd. reportedly noted that its TV commercial included an on-screen footnote stipulating that the products displayed were “Not suitable for milk allergy sufferers,” and that consumers in doubt should consult their physician. Warning that the ad’s voice-over—“Listen up hedgehogs, you’re not intolerant to dairy, you’re just intolerant to lactose, the sugars in dairy”—could be misunderstood as a stand-alone statement, ASA nevertheless agreed with Arla’s position, dismissing the complaint on the ground that the on-screen text not only provided a clear reference to milk allergy, but also instructed consumers to “Search Lactofree”…
According to data recently issued by Stericycle Expert Solutions, the number of food recalls documented by the U.S. Food and Drug Administration (FDA) during the third quarter (Q3) of 2013 declined 14 percent compared to the previous quarter. Of the foods recalled, 44 percent, an increase of 8 percent from the previous quarter, were classified as Class I recalls, which means they can potentially cause illness or death. The volume of Q3 recalls—seven million units—however, doubled the number of units recalled in Q2, with a 17-percent increase in the number of companies involved. According to FDA, one recall affected 2.5 million units, three recalls affected between 500,000 and one million units, and eight recalls affected between 100,000 and 500,000 units. As in previous years, allergens were the single largest cause of food recalls, representing more than 40 percent of recalls reported during Q3. One company was involved in 24, or more…
An August 7, 2013, Slate article by Genetic Literacy Project Executive Director Jon Entine has criticized a recent magazine story allegedly linking eosinophilic disorder—“a multisystemic condition in which white blood cells overproduce in response to allergens”—to genetically modified (GM) corn, calling out Elle writer Caitlin Shetterly for stoking “conspiratorial fears that the government is covering up evidence that GMO foods can damage the public health.” According to Entine, the article in question “was particularly appalling” insofar as it failed to produce any evidence or tests to confirm the “unusual diagnosis” that GMO foods caused Shetterly’s autoimmune disorder. Instead, Entine argues, Shetterly relied on a “journalistic trick… to frame a settled issue in the scientific community as a mystery or a controversy.” “There has not been one study that links the genetically engineered corn or any approved genetically modified food on the market to allergies,” University of California, Davis, plant geneticist…
