Category Archives Legislation, Regulations and Standards

The U.K. Advertising Standards Authority (ASA), has upheld four complaints challenging whether a TV ad for Bioglan “superfood” chia and flax seeds complied with the European Register of Nutrition and Health claims with its use of the word “superfood” and comparisons demonstrating the seeds’ protein, calcium and fiber content. At issue specifically was food manufacturer PharmaCare’s claim that adding its chia and flax seeds to breakfast provides “as much protein as a small egg; more calcium than 100 ml of milk; as much fiber as a cup of oats; and a high source of the Omega 3 fatty acid ALA.” Concluding that although PharmaCare was within its rights to present the seeds as sources of the specific nutrients, the multiple references to “superfood” to reference “a general, non-specific benefit of the food for overall health,” needed to be accompanied by a specific authorized health claim. “We noted that the Regulation…

The U.S. Department of Agriculture (USDA) has issued an order requiring pork producers, veterinarians and diagnostic laboratories to report new incidents of porcine epidemic diarrhea virus (PEDv) and porcine deltacoronavirus to state health officials or USDA’s Animal and Plant Health Inspection Service. The order formalizes measures announced in April to combat the spread of PEDv, which has killed some seven million piglets since it was identified in early 2013. USDA also announced $26.2 million to fund a variety of activities to combat the diseases and support affected producers, including vaccine development, state management and diagnostic testing. More information on the April announcement appears in Issue 521 of this Update.   Issue 526

The U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have joined to issue draft guidance on mercury levels and fish consumption, directed at pregnant women and guardians of young children. Recommendations include eating 8 to 12 ounces (two to three servings) of low-mercury fish like tilapia, catfish, cod, salmon, and shrimp as well as avoiding four fish high in mercury (shark, swordfish, king mackerel, and tilefish from the Gulf of Mexico) and limiting albacore tuna intake to less than 6 ounces per week. The conclusion of the comment period has not yet been announced. More information on FDA’s updated guidance appears in Issue 525 of this Update.   Issue 526

The U.S. Food and Drug Administration (FDA) has issued a clarification of its position on artisanal cheesemakers’ use of wood shelving, which can aid in aging cheese by controlling moisture to form rinds and hosting microbes that add character and flavor. FDA’s Constituent Update called reports that the agency established a new rule banning wood shelving “not accurate,” instead noting that its regulations merely require that “utensils and other surfaces that contact food must be ‘adequately cleanable’ and ‘properly maintained.’” The confusion comes from a letter sent by FDA’s Center for Food Safety and Applied Nutrition to the New York State Department of Agriculture and Markets indicating that wooden surfaces could not be adequately cleaned, thus violating the standards of the Food Safety Modernization Act. The Constituent Update noted that the letter was intended as a background of wood shelving use for aging cheeses and an analysis of relevant scientific…

The U.S. Food and Drug Administration (FDA) has announced a final rule setting standards for manufacturers of infant formula. With a compliance date of September 8, 2014, the final rule includes (i) “current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter”; (ii) “a requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth”; and (iii) “a requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.” Although many companies have already adopted these standards on a voluntary basis, the final rule creates federally enforceable requirements for powdered, liquid concentrate and ready-to-feed formulas. “FDA does not approve infant formulas before they can be marketed,” notes the agency in a June 9, 2014, press release. “However, all formulas marketed…

The Center for Science in the Public Interest (CSPI) has filed a complaint against the U.S. Department of Agriculture and Food Safety and Inspection Service, seeking a declaration that the agencies have unreasonably delayed taking action on its May 2011 petition requesting that certain strains of antibiotic-resistant (ABR) Salmonella in ground meat and poultry be declared adulterants. CSPI v. Vilsack, No. 14-895 (D.D.C., filed May 28, 2014). Details about CSPI’s petition appear in Issue 396 of this Update. According to the nutrition and health advocacy organization, if these pathogens are declared adulterants, affected meat and poultry products would be barred from entering commerce, and the action “would also confirm the agency’s authority to request without evidence of illness that a company recall products containing ABR Salmonella, or—in the absence of a company’s voluntary compliance—to detain and seize those products.” The complaint refers to a number of Salmonella outbreaks, some involving…

A California bill requiring labels to disclose genetically modified (GM) ingredients in food recently failed to pass after a close vote in the state senate. Opponents argued that it would cost the average consumer as much as $400 per year for labeling a category of food that presents no risk to the public. Vermont became the first state to enact a GM ingredient-labeling law in May 2014. Additional information about that statute appears in Issue 521 of this Update. See Reuters, May 29, 2014.

The California Senate has passed a bill (S.B. 1000) that would require all sugar-sweetened beverages (SSBs) containing more than 75 calories per 12-ounce serving to carry labels warning of obesity, diabetes and tooth decay. Milk-based beverages and 100 percent fruit and vegetable juices would be exempt. Introduced in February 2014 by state Sen. Bill Monning (D-Carmel) and co-sponsored by the California Center for Public Health Advocacy, the “Sugar-Sweetened Beverages Safety Warning Act,” is backed by the California Medical Association, Latino Coalition for a Healthy California and California Black Health Network. Noting “overwhelming evidence” linking obesity and the consumption of sweetened beverages,” and claiming that SSBs are the “single largest source of added sugars in the American diet,” the bill specifically seeks to “protect consumers and promote informed purchasing decisions . . . about the harmful health effects that result from the consumption of drinks with added sugars.” If passed by…

The U.K. Advertising Standards Authority has reversed an earlier decision upholding two complaints alleging that Heineken UK Ltd.’s print and TV advertisements gave the impression that its Kronenbourg 1664 beer was brewed in France and made primarily from French hops, despite text disclaimers stating that the product was “Brewed in the UK.” According to ASA, Heineken argued that Kronenbourg 1664 “could correctly and reasonably be described as a ‘French beer’ because of its heritage, the origin of its recipe and the use of the Strisselspalt hop, as well as its ownership and the yeast type used.” In particular, the company noted that the aromatic Strisselspalt hop— though not the sole hop used in the beer—was the key ingredient in creating the beer’s final character and taste, attributes that could not be captured “from a simple calculation of the proportion in which [the Strisselspalt hop] featured in the recipe.” In its…

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…

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