Tag Archives allergen

The U.S. Food and Drug Administration (FDA) has announced the availability of industry guidance on food allergen labeling exemptions. Titled “Food Allergen Labeling Exemption Petitions and Notifications,” the guidance reportedly explains the agency’s “current thinking on the preparation of regulatory submissions for obtaining exemptions for ingredients from the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (FD&C Act) through submission of either a petition or a notification.” The guidance aims to clarify the criteria for labeling exemption petitions submitted under the Food Allergen Labeling and Consumer Protection Act of 2004, which requires all food and beverage labeling to declare the presence of major food allergens using their common names. Under these rules, companies can obtain labeling exemptions by demonstrating that an ingredient derived from a major allergen ‘‘does not cause an allergic response” or “‘does not contain allergenic protein.” See Federal Register, June 19,…

Two plaintiffs have filed a lawsuit against Gerber Products Co. alleging that the company misrepresented its Gerber® Good Start® infant formula by advertising it as the “first and only formula whose consumption reduces the risk of infants developing allergies.” Hasemann v. Gerber Prods. Co., No. 15-2995 (E.D.N.Y., filed May 21, 2015). The complaint echoes a similar lawsuit against Gerber pending in New Jersey federal court. The plaintiffs assert that Gerber advertises its product as providing health benefits through partially hydrolyzed whey protein despite an alleged U.S. Food and Drug Administration denial in 2005 that Gerber’s formula aids against allergy development. The plaintiffs seek class certification and damages of more than $5 million. Additional details about Gerber’s successful motion to receive medical records in the analogous case appear in Issue 562 of this Update. See Legal Newsline, June 2, 2015.   Issue 567

The European Food Safety Authority (EFSA) has announced a June 17, 2015, workshop in Brussels, Belgium, to discuss supplementary guidance for the allergenicity assessment of genetically modified organisms (GMOs). According to the agency, the supplementary guidance aims to reflect technological and scientific advances as well as assessment methodologies developed since EFSA finalized the current guidance in 2011. The Working Group of EFSA’s GMO Panel requests feedback from member states, international partners, academia, non-governmental organizations and industry on the following topics: (i) non-IgEmediated immune adverse reactions to foods; (ii) in vitro digestibility tests for allergenicity assessment; and (iii) endogenous allergenicity. The June workshop will feature the work of 90 experts with a focus on molecular allergology, protein chemistry, plant science, clinical allergy, gastroenterology, food chemistry, and risk assessment. See EFSA News Release, April 14, 2015.   Issue 562

The parents of an 11-year-old boy who died in 2013 have filed a wrongful death lawsuit against Quorn Foods, Inc. and several distributors alleging that the mycoprotein in a Quorn® Turk’y Burger caused their son to go into anaphylactic shock, which resulted in his death. Bengco v. Quorn Foods, Inc., No. BC576522 (Cal. Super. Ct., C.D. Los Angeles Cty., filed March 24, 2015). The complaint calls Quorn’s product “highly processed mold,” to which the boy had a severe allergy. According to the complaint, the product label of Quorn’s Turk’y Burger lists “Mycoprotein (47%)” as the first ingredient, and the description explains that “’myco’ is Greek for ‘fungi.’” The description also explains that “[t]here are believed to be over 600,000 varieties of fungi in the world, many of which are among the most sought after foods like varieties of mushrooms, truffles, and morels” but the product is not, the complaint notes, a…

The U.S. Food and Drug Administration (FDA) has issued the results of a study finding that dark chocolate products may contain milk that is not declared on other labels. According to a February 11, 2015, consumer update, the agency tested dark chocolate bars for the presence of milk after dividing them into categories based on their labeling: (i) those that included precautionary statements such as “may contain milk” or “may contain traces of milk”; (ii) those labeled “dairy-free” or “allergen-free”; (iii) those that made no mention of milk on the label; and (iv) those with inconsistent labels—for example, a “vegan” product with a label indicating the possible presence of milk traces. The results evidently identified milk in (i) two of the 17 dark chocolates labeled “dairy-free” or “allergen-free”; (ii) 55 of the 93 products that gave no clear indication of the presence of milk in the products; and (iii) all…

The Center for Science in the Public Interest (CSPI) has filed a citizen petition with the U.S. Food and Drug Administration (FDA) seeking a rule that would require sesame seeds and sesame products to be disclosed on food labels in the same way that allergens, such as milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy, are disclosed. CSPI asks that sesame be added to FDA’s list of allergens in its “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens” “to address both labeling and cross contact issues related to food manufacturing practices.” The petition includes letters from parents of purported sesame-allergic children “explaining why better labeling is so important for their families.” They claim that reactions to sesame have been severe and life-threatening. See CSPI News Release, November 18, 2014.

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…

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 

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