Five public advocacy groups have filed suit against the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) seeking to vacate FDA’s “Substances Generally Recognized as Safe” (GRAS) rule, which allegedly allows “potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the Federal Food, Drug and Cosmetic Act (FDCA).” Ctr. for Food Safety v. Price, No. 173833 (S.D.N.Y., filed May 22, 2017). The plaintiffs argue that the GRAS rule allows manufacturers to certify that a substance is GRAS without notice to FDA or the public, although the rule gives them the option to notify the agency about certification. However, they allege, the Food Additives Amendment to the FDCA requires food additives to go through an FDA approval process. FDA allowed manufacturers to begin using the proposed rule’s optional notification…
Tag Archives allergen
A Georgia court has dismissed with prejudice a complaint against television personality Mehmet Oz accusing the physician of making false claims about the quality of olive oil in the United States, finding that Oz’s statements were protected under a state anti-SLAPP (strategic lawsuit against public participation) law protecting speech made in connection with an issue of public concern. N. Am. Olive Oil Assoc. v. Oz, No. 2016-283156, (Sup. Ct. Ga., Fulton Cty., order entered March 3, 2017.) The North American Olive Oil Association alleged that Oz and his guests made “false statements regarding the quality and purity” of olive oil sold in U.S. supermarkets. One of the guests was employed by olive oil producer California Olive Ranch, but the guest’s ties to the company were allegedly not disclosed on the show. The court said it had “grave concerns that the motivation for the present action falls directly within the purpose…
A California federal court has granted voluntary dismissal to the plaintiff in a putative class action alleging P.F. Chang’s China Bistro Inc. discriminates against customers with a gluten allergy by adding a surcharge to gluten-free dishes. Phillips v. P.F. Chang’s China Bistro Inc., No. 15-0344 (N.D. Cal., San Jose Div., order entered June 6, 2016). The order granted dismissal to the plaintiff with prejudice but without prejudice as to the putative class, leaving the possibility that another plaintiff may step into the lead plaintiff role. The court also imposed the defendant’s costs on the plaintiff. Details on the complaint appear in Issue 555 of this Update. Issue 607
Responding to public comments solicited in April 2014, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued revised guidance for identifying, controlling and labeling allergens and other ingredients of public health concern through hazard analysis and critical control point (HACCP) plans, sanitation 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.” See Federal Register, November 16, 2015. Issue 585
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.
