The U.S. Food and Drug Administration (FDA) has approved folic acid fortification of corn masa flour in response to a 2012 petition from the March of Dimes Foundation, National Council of La Raza and other groups. FDA’s action allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour. Used in tortillas, tamales and other foods, corn masa flour is a dietary staple for many people of Mexican and Central American descent, and the petitioners sought the voluntary fortification to increase the folic acid intake for U.S. women of childbearing age who regularly consume such products. Folic acid is a synthetic form of folate, a B vitamin linked to the decreased incidence of neural tube defects. See Federal Register, April 15, 2016.
Category Archives Food and Drug Administration
Food and Water Watch, the Center for Food Safety, Friends of the Earth and other consumer and environmental groups have filed a lawsuit against the U.S. Food and Drug Administration (FDA) arguing the agency approved the use of genetically engineered (GE) salmon AquaBounty for human consumption without properly investigating related environmental risks. Inst. for Fisheries Res. v. Burwell, No. 13-1574 (N.D. Cal., filed March 30, 2016). The complaint alleges that AquaBounty received approval for two facilities only but has told its investors that it will expand in 2016; the organizations assert that FDA should have investigated the environmental effects of AquaBounty’s “necessary outgrowth” rather than limiting its analysis to the effects of two facilities. The complaint further alleges that FDA “failed to consult with the federal fish and wildlife agencies to insure that its approval for AquaBounty’s application was not likely to jeopardize endangered and threatened species or adversely modify…
Several consumer organizations, including the Center for Food Safety, Environmental Working Group and Natural Resources Defense Council, have filed a petition for a writ of mandamus in the U.S. Court of Appeals for the Ninth Circuit seeking a writ compelling the U.S. Food and Drug Administration (FDA) to address the groups’ administrative petition filed in December 2014. Breast Cancer Fund v. FDA, No. 16-70878 (9th Cir., petition filed March 31, 2016). FDA missed a June 2015 deadline to respond to the groups’ petition, which implored FDA to rescind foodcontact approval for perchlorate, “an endocrine-disrupting chemical that interferes with the thyroid gland” used in food packaging. “Perchlorate is primarily used in rocket fuel. There is no reason FDA should allow a chemical like this in or on food products,” Andrew Kimbrell, executive director of Center for Food Safety, said in a March 31, 2016, press release. “It is irresponsible, illegal, and…
The U.S. Food and Drug Administration (FDA) has issued a finalized rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent the contamination of human and animal food during transportation. Among other things, the sanitary transportation rule requires those transporting food by motor or rail vehicle to follow recognized best practices for hygiene, including the provision of appropriate temperature control, cleaning between loads and security measures. The rule was initially proposed in February 2014 and its final iteration took into consideration the comments of some 200 stakeholders. See Federal Register, April 6, 2016. Issue 599
The U.S. Food and Drug Administration (FDA) has issued draft guidance proposing an action level of 100 µg/kg for inorganic arsenic in rice cereals for infants. The agency has also released supporting documentation for its proposal as well as a risk assessment that includes (i) “a quantitative estimate of lung and bladder cancer risk from long-term exposure to these products and the predicted impact of various scenarios to reduce the risk,” and (ii) “a qualitative assessment of certain potential non-cancer risks, in certain susceptible life stages.” “We conclude that the 100 µg/kg action level will help protect the public health and is achievable with the use of current good manufacturing practice, but we especially welcome comments and information bearing on the achievability and public health benefits and risks of 100 µg/kg, as compared with other potential action levels (including no action level),” states FDA, which will consider comments submitted by…
The Center for Science in the Public Interest (CSPI) has called on the U.S. Food and Drug Administration (FDA) to require labeling on foods containing synthetic food dyes such as FD&C Green 3 and FD&C Blue 2. CSPI’s latest move follows its January 2016 publication of a report critical of FDA’s inattention to food dyes and pointing to studies allegedly linking food-dye consumption to behavioral issues in children, particularly those with Attention Deficit/Hyperactivity Disorder (ADHD). The health advocacy group’s proposed labeling would state: “WARNING: This food contains synthetic food colorings that may impair the behavior of some children.” “As long as dyes are permitted, only a warning label will provide consumers with the appropriate information to enable them to make the association between foods containing those dyes and their children’s behavioral symptoms,” CSPI said in its March 15, 2016, letter to FDA. “The FDA has mandated such labeling in the…
The U.S. Food and Drug Administration (FDA) has announced that two rules requiring calorie information to be listed on menus and menu boards in chain restaurants will not be enforced December 1, 2016, as initially planned, but will instead be delayed until one year after final guidance is issued. The announcement credits the omnibus appropriations bill enacted December 18, 2015, as cause for the delay. The agency is currently reviewing comments about related draft guidance issued in September 2015. See FDA Statement, March 9, 2016. Issue 597
The U.S. Food and Drug Administration has issued guidance titled “Acrylamide in Foods” that finalizes a November 2013 draft on the topic. The document provides information about reducing acrylamide in potato-based, cereal-based and other foods as well as information to provide consumers on cooking packaged frozen french fries. See Federal Register, March 11, 2016. Issue 597
A Delaware cheese company and two individual defendants have pled guilty to a misdemeanor violation of the federal Food, Drug, and Cosmetic Act for distributing adulterated ricotta, queso fresco and fresh cheese curds in several neighboring states. U.S. v. Roos Foods, Inc., No. 16-0013 (D. Del., information filed January 22, 2016). Roos’ cheese was connected to a 2014 outbreak of Listeria that caused five adults and three newborns to contract listeriosis. The criminal information alleged the company produced the cheese in unsanitary conditions, including the “[f]ailure to clean food-contact surfaces as frequently as necessary to protect against contamination of food” and “failure to store raw materials or ingredients in a manner that protects against contamination.” In their agreement with the U.S. Food and Drug Administration (FDA), the defendants agreed to an injunction preventing them from processing or distributing food products until they undergo an FDA inspection and facility testing by…
Led by the Vermont Maple Sugar Makers’ Association (VMSMA), the maple syrup industry has penned a February 15, 2016, letter asking the U.S. Food and Drug Administration (FDA) to take enforcement action “concerning misrepresentative labeling of food products whose labels incorrectly indicate the presence of maple syrup.” The signatories—which include the International Maple Syrup Institute and North American Maple Syrup Council, as well as several state organizations—identify several instant oatmeal, natural sweetener and other products that allegedly violate Food, Drug and Cosmetic Act regulations by using the word “maple” in their product descriptions without containing maple syrup. Drawing parallels to the agency’s conclusion that Hampton Creek’s Just Mayo® eggless sandwich spread was mislabeled because “mayo” has “long been used and understood as shorthand or slang for mayonnaise,” the letter argues that the term “maple” “has long been used and understood to refer to ‘maple syrup.’” As VMSMA opines, “This unchecked…
