Category Archives Issue 526

Four food, beverage and business trade organizations have filed a constitutionally based challenge to Vermont’s recently enacted law that would require food and beverage manufacturers to disclose on product labels that their products are “produced with genetic engineering” (GE), or “may be” or are “partially” so produced and to prohibit the use of terms such as “natural” in the labeling, signage and advertising of GE products. Grocery Mfrs. Ass’n v. Sorrell, No. 14-0117 (D. Vt., filed June 12, 2014). According to the complaint, it will be difficult or impossible to comply with the law’s July 1, 2016, effective date, because members must “revise hundreds of thousands of product packages,” “establish Vermont-only distribution channels” or “revise the labels for all of their products, no matter where they might be sold in the United States.” The plaintiffs claim that the law’s proscriptions “are beyond Vermont’s power to enact” by “compelling manufacturers to…

A federal court in California has denied the motion to dismiss filed by The Hain Celestial Group in four consolidated putative class actions alleging that the company deceives consumers by labeling and promoting 10 of its Celestial Seasonings® teas as “100% Natural” when they contain chemical insecticides, fungicides and herbicides. Von Slomski v. The Hain Celestial Group, Inc., No. 13-1757 (C.D. Cal., order entered June 10, 2014). So ruling, the court disagreed that the plaintiffs failed to state a claim or lacked standing, or that the litigation should be dismissed under the primary jurisdiction doctrine. The company challenged the Eurofins test on which the plaintiffs rely to support their claim that the teas contain “significant levels” of man-made, chemical pesticides. According to the defendant, the plaintiffs failed to provide details about the testing, and the study “was published by ‘an admittedly biased short-seller that admits that it issued the report…

The New York State Senate has passed legislation (S7217A) that would ban the sale of powdered alcohol, a concentrated alcoholic beverage deemed “unnecessary” and “dangerous” by the bill’s sponsor, Sen. Joseph Griffo (R-Rome). One such product, Lipsmark, LLC’s Palcohol®, was approved in April by the Alcohol and Tobacco Tax and Trade Bureau (TTB), but the agency later reversed its approval, stating that it had been made in “error.” Lipsmark has reportedly resubmitted its application for approval. If the bill is passed by the New York State Assembly, powdered alcohol would be banned in the state even if TTB approves it to be marketed in the United States. “Should the [Food and Drug Administration] reverse its decision again and approve it, we should have a law in place to prohibit the sale of this product in New York. I hope the Assembly will join us in passing this legislation,” said Griffo.…

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…

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