A recent Nature editorial warns that the U.S. Food and Drug Administration’s (FDA’s) reluctance to approve genetically-modified (GM) salmon for market could hinder future research into new gene-editing techniques. Titled “Fishy Business,” the article claims that even though a draft assessment found AquaBounty Technologies’ GM salmon “environmentally benign,” FDA conducted many of its deliberations “behind closed doors, fuelling confusion as to the cause of the setbacks, and rumors of political interference.” “As the delays have dragged on, the technology used to make AquaBounty’s salmon has become outdated,” explains the editorial. “In the current excitement over targeted gene editing that allows researchers to modify individual genes without leaving traces of foreign DNA, AquaBounty’s salmon—which contain a gene from another species—seem like a relic.” Meanwhile, FDA has yet to decide “how it will evaluate animals engineered with gene-editing techniques.” Raising questions about how these new products will fare under FDA’s oversight, the…
Category Archives Food and Drug Administration
The Center for Science and Democracy at the Union of Concerned Scientists has submitted a comment backed by more than 280 health experts asking the U.S. Food and Drug Administration (FDA) to include a percent daily value for the proposed “added sugars” declaration on food and beverage labeling. Responding to the agency’s request for comments on proposed changes to the nutrition and supplement facts labels, the letter signed by Robert Lustig, Marion Nestle and members of the Healthy Food Action network urges FDA to set a maximum daily value for added sugars at 50 grams—approximately 10 percent of recommended daily calorie intake—and to list a percent daily value on the Nutrition Facts label. “Many food and beverage manufacturers add excessive amounts of sugar to their products, including those that they market as healthy options. In our current food environment, many people are unknowingly and unavoidably consuming excess sugar,” opines the…
The Second Circuit has reversed a district court’s decision that ordered the U.S. Food and Drug Administration (FDA) to initiate hearings responding to a livestock antibiotics challenge from the Natural Resources Defense Council (NRDC) based on a 1977 agency finding that the use of growth antibiotics for healthy animals was unsafe. NRDC v. FDA, No. 12-2106 (2d Cir., order entered July 24, 2014). Two judges were “firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage,” that FDA has discretion on proceedings to withdraw approval of animal drugs, and that the law requires “withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety.” In 1977, FDA planned to…
Following the recent death of an Ohio teenager whose autopsy reportedly revealed blood levels of more than 70 micrograms of caffeine per milliliter, the Food and Drug Administration (FDA) this week issued “consumer advice” warning parents that powdered pure caffeine is a “powerful stimulant and very small amounts may cause accidental overdose.” Such products are unregulated and sold as dietary supplements. According to the agency, a teaspoon of pure caffeine is “roughly equivalent” to the amount contained in 25 cups of coffee. FDA is encouraging the public as well as health care providers to report any adverse events related to consumption of powdered pure caffeine to the agency. See Associated Press, July 19, 2014; FDA Consumer Advice on Powdered Pure Caffeine, July 21, 2014. Issue 531
Food and Drug Administration (FDA) representatives are slated to present findings of the agency’s analysis of more than 200 foods containing Class III and Class IV caramels for 4-methylimidazole (4-MEI), a chemical byproduct of manufacturing processes, during the American Chemical Society National Meeting & Exposition, August 10-14, 2014, in San Francisco, California. According to the session abstract, FDA’s analysis estimated dietary exposure to 4-MEI for six U.S. populations: infants younger than age 1; 1-year-olds; children ages 2 and older; children ages 2 to 5; children ages 6 to 12; and teenage boys ages 12 to 18. Consumer Reports has urged the agency to set standards for 4-MEI in foods and called on manufacturers to disclose the types of caramel color in their products so that consumers can avoid 4-MEI. The compound was added to California’s Proposition 65 list of substances known to the state to cause cancer in 2011 based…
The U.S. Food and Drug Administration (FDA) has released its final guidance on the use of nanotechnology in food as well as draft guidance on use of the technology in animal food. Rather than categorically judging nanotech as either safe or harmful, the agency indicated that it will consider specific characteristics of products with nanotech as they are produced. Among FDA’s nonbinding recommendations are encouragement for food manufacturers’ considerations of composition, safety and regulatory status as well as assurance that the guidance does not change the status of products already generally recognized as safe. The agency also recommends that manufacturers assess whether their implementation of nanotech will change their safety and regulatory status by determining what the physiochemical changes of the food product may be and invites consultations with the FDA about those determinations. “Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science,…
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…
In a putative class action alleging that a food company misled its customers by using the term “evaporated cane juice” (ECJ) instead of “sugar” on its labels, a California federal court has followed the lead of several other courts in recent decisions by dismissing the case without prejudice under the primary jurisdiction doctrine—this time, reversing its previous decision to allow the case to move forward. Swearingen v. Yucatan Foods LP, No. 13-3544 (N.D. Cal., order entered May 20, 2014). Guacamole producer Yucatan Foods had argued that the U.S. Food and Drug Administration (FDA) had primary jurisdiction over the matter, but Judge Richard Seeborg initially disagreed, finding that FDA had taken no action on ECJ since 2009 and thus that the agency considered the matter settled. On March 5, 2014, one month after the Yucatan decision was filed, FDA announced that it would reevaluate its previous draft ECJ guidance. Following the…
