Tag Archives allergen

The Center for Science in the Public Interest (CSPI) has asked Dannon to stop using carmine—a dye reportedly derived from the dried, crushed bodies of cochineal insects—to fruit-flavored yogurt to give it a pink color. According to the advocacy watchdog, Dannon’s practice not only cheats consumers, “who might expect that the named fruits—and not the unnamed creepy crawlies— are providing the color,” but also puts consumers at risk because it has been linked to allergic reactions ranging from hives to anaphylactic shock. See CSPI News Release, July 24, 2013.  

Research based on the International Study of Asthma and Allergies in Childhood (ISAAC) Phase Three has reportedly linked fast food consumption to asthma and eczema severity in kids. Philippa Ellwood, et al., “Do fast foods cause asthma, rhinoconjunctivitis and eczema? Global findings from the International Study of Asthma and Allergies in Childhood (ISAAC) Phase Three,” Thorax, January 2013. Analyzing data from more than 319,000 13- to 14-year-old adolescents in 51 countries and more than 181,000 6- to 7-year-old children in 31 countries, the study evidently relied on written questionnaires that asked participants about their asthma, rhinoconjunctivitis and eczema symptoms, as well as their dietary habits. In addition to “a potential protective effect on severe asthma… associated with consumption of fruit ≥3 times per week,” the results allegedly found that children and adolescents who consumed fast food three or more times per week had an increased risk of severe asthma, severe rhinoconjunctivitis…

The Food and Drug Administration (FDA) is seeking comments and other information, including data, to help determine whether the agency can establish regulatory thresholds for major food allergens such as milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. In a recent notice, FDA states that although “[We have] used several risk management strategies to reduce the risk from unlabeled major food allergens, such as targeted inspections or discussions with industry organizations, we have not established regulatory thresholds or action levels for major food allergens. The establishment of regulatory thresholds or action levels for major food allergens would help us determine whether, or what type of, enforcement action is appropriate when specific problems are identified and also help us establish a clear standard… Regulatory thresholds also would help industry to conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls.” In particular, FDA…

According to Nestlé Australia, some consumers feeding their babies NAN H.A. [hypoallergenic] 1 Gold® infant formula have complained about alleged adverse health effects. A news source indicates that purchasers have reported in online reviews that their children have experienced rashes, dark green stools, dehydration, and vomiting, among other symptoms. Calling product safety and quality a “non-negotiable priority for the company” Nestlé, which has been testing the product, further states on its website that results “to date confirm there is no food safety issue.” The company apparently reformulated the product in 2011, replacing calcium chloride with potassium chloride to produce “a better taste and a smoother texture to the powder,” and otherwise improving its “nutritional profile.” See Nestlé News Release, August 8, 2012; FoodProductionDaily.com, August 9, 2012.

A company that supplies specialty ingredients such as vitamins, chemicals and carotenoids to food producers has sued one of its suppliers, alleging that the company was forced to recall from customers more than 33,000 pounds of chromium amino acid chelate after learning that it contained a milk allergen. DSM Nutritional Prods., LLC v. Triarco Indus., Inc., No. C1928-12 (N.J. Super Ct., Morris Cty., filed July 26, 2012). The plaintiff also allegedly reported the matter to the Food and Drug Administration through the Reportable Food Registry. According to the complaint, in 2009, the defendant completed a questionnaire designed to inform the plaintiff “of the existence of any allergens or their derivatives contained in the product” sold to the plaintiff. “Not until July 27, 2010,” however, “did Defendant correctly label the product as containing a hydrolyzed milk protein, thus advising [the plaintiff] that Defendant’s product contained a milk allergen.” Alleging breach of contract…

FDA has issued a request for comments on a proposed information collection that will add the manufacturers of certain beers as respondents to its labeling regulations and seeks Office of Management and Budget approval of allergen labeling for these beers. The agency explains that after the Alcohol and Tobacco Tax and Trade Bureau determined that certain beers, which are made from substitutes for malted barley, such as sorghum, rice or wheat, do not meet the definition of “malt beverage” and are thus not subject to its regulations, the Food and Drug Administration (FDA) prepared draft guidance to assist these manufacturers in complying with its labeling regulations. On the basis of the labeling regulations discussed in the guidance, the agency provides estimates of the average burden per disclosure for each regulation— that is, “12 respondents will each label 2 products annually, for a total of 24 labels” and “the manufacturers will…

The Food and Drug Administration (FDA) recently published its second annual Reportable Food Registry (RFR) report summarizing information submitted by manufacturers, processors, packers and holders through the online Food Safety Portal from September 8, 2010, to September 7, 2011. Covering all human and animal food/feed regulated by FDA “except infant formula and dietary supplements,” RFR tracks “patterns of food and feed adulteration” to help FDA administer inspection resources more effectively. According to the report, FDA received 1,153 total entries in RFR’s second year compared with 2,600 in its first year, a difference which the agency ascribes to three major events in 2009-2010 that generated 1,284 subsequent records related to sulfites in prepared side dishes, Listeria monocytogenes in cheese spreads and Salmonella in hydrolyzed vegetable protein. Without these entries, FDA stated, the tallies for the first and second years would have differed by only 74 records. In particular, the second annual…

The U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued a final rule ordering “the disclosure of the presence of cochineal extract and carmine on the labels of any alcohol beverage containing one or both of these color additives.” According to TTB, the rule responds to a Food and Drug Administration (FDA) regulation that took effect on January 5, 2011, and requires manufacturers to label these two additives on all food and cosmetic products due to the potential for severe allergic reactions. Effective March 16, 2012, with a final compliance date of April 16, 2013, the TTB rule notes that FDA does not compel labels to disclose that cochineal extract and carmine are derived from insects native to subtropical South America and Mexico. In issuing its final decision, TTB rejected one comment that called for listing the additives’ source despite industry concerns that some consumers “would find the thought…

The Center for Science in the Public Interest (CSPI) recently issued a letter to the Food and Drug Administration (FDA) to update the agency on its findings about mycoprotein, a meat-substitute marketed under the brand name Quorn. Following up on a 2002 campaign, the latest initiative claims that the RNA-reduced mold Fusarium venenatum used to produce Quorn is not safe, with consumers reporting reactions such as vomiting and diarrhea, hives, and anaphylaxis. “CSPI has now received about 500 reports of adverse reactions from Americans, as well as about 1,200 from the United Kingdom, other European countries, Scandinavia, and Australia,” writes CSPI Executive Director Michael Jacobson. Believing that small-print allergen warnings are not enough in this case, the group has asked FDA to compel Quorn to display “a prominent and candid front-label disclosure” alerting consumers to the alleged side effects. CSPI has also requested a revocation of mycoprotein’s generally recognized as…

The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA) has issued a scientific opinion on the use of egg-derived lysozyme in wine manufacturing after the Oenological Products and Practices International Association (OENOPPIA) applied to permanently exempt the anti-microbial stabilizer from labeling requirements. According to NDA, which was tasked with assessing the likelihood of allergic reaction to lysozyme-treated wine, the additive is approved for use in some foods to control lactic acid bacteria but “must follow purity specifications set forth in European legislation.” Because it can evidently be used “at different stages of wine production and at different doses,” lysozyme was detected in some wines at residual amounts “considered sufficient to trigger allergic reactions in susceptible individuals.” OENOPPIA had apparently argued that lysozyme is not only “the weakest allergen among the four major egg white proteins,” but unlikely to cause a clinical reaction in egg-allergic individuals…

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