The U.S. Food and Drug Administration (FDA) has issued final guidance to help chain establishments with 20 or more locations (e.g., grocery and convenience stores, quick-service and fast-food restaurants, pizza delivery outlets, and movie theaters) comply with menu labeling requirements for standard menu items and self-service offerings under the Federal Food, Drug, and Cosmetic Act. According to FDA, the final guidance provides “additional examples and new or revised questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and recordkeeping requirements.” Enforcement of the menu labeling final rule will begin on May 5, 2017. See Federal Register, May 5, 2016. Issue 603
Category Archives U.S. Government and Regulatory Agencies
The Organic Consumers Association (OCA) has filed lawsuits against The Hain Celestial Group, Inc. and The Honest Co., Inc. alleging the companies’ “organic” infant formula products contain multiple substances prohibited for use in organic food by the U.S. Department of Agriculture (USDA). Organic Consumers Assoc. v. Hain Celestial Grp., Inc., No. 16-2533 (D.C. Super. Ct., filed April 5, 2016); Organic Consumers Assoc. v. Honest Co., Inc., No. SC125655 (Cal. Super. Ct., Los Angeles Cty., filed April 6, 2016). The lawsuit against Hain Celestial challenges the label claims of its Earth’s Best products, which the complaint argues are all labeled organic despite none meeting federal organic regulations. “Behind the picturesque red barn of the Earth’s Best logo displayed on each of the Falsely Labeled Products lies a chemical soup of synthetic, toxic, and hazardous ingredients,” the complaint argues. “For example, of the 48 ingredients in Earth’s Best Organic Infant Formula, more than…
Public-interest group Cornucopia Institute has filed a lawsuit against Tom Vilsack in his capacity as Secretary of Agriculture alleging that he and the U.S. Department of Agriculture (USDA) violated the Organic Foods Production Act of 1990 by appointing “unqualified individuals” to the National Organic Standards Board (NOSB), which develops a list of synthetic substances allowed in the production of organic food, the National List of Allowed and Prohibited Substances. Cornucopia Inst. v. Vilsack, No. 16-0246 (W.D. Wis., filed April 18, 2016). Federal law requires the composition of the NOSB to be “balanced and independent,” Cornucopia argues, but USDA “inappropriately influenced” the board in a number of ways, including (i) disbanding its Policy Development Subcommittee, (ii) allowing the self-appointment of the board’s co-chairperson, and (iii) removing the board’s ability to set its own work plan. “USDA’s unlawful meddling with the composition and rules governing the NOSB has created a NOSB hostile…
The Salt Institute has penned an April 11, 2016, letter asking the U.S. Department of Agriculture (USDA) and Department of Health and Human Services (HHS) to withdraw the sodium provisions included in the 2015-2020 Dietary Guidelines for Americans, which advise individuals to consume less than 2,300 milligrams (mg) per day of sodium. According to the Salt Institute, these provisions—in addition to those that appear in the 2010 Dietary Guidelines for Americans—violate the statutory mandate that requires them to reflect “the preponderance of the scientific and medical knowledge which is current at the time the report is prepared.” In particular, the letter argues that both the 2010 and 2015 Dietary Guidelines Advisory Committees (DGACs) based their sodium recommendations on a 2004 Institute of Medicine (IOM) report that failed to contain enough evidence to set a recommended dietary allowance. “Rather than thoroughly assessing the current scientific and medical knowledge, the Agencies reached…
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.
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has proposed amendments to organic livestock and poultry production requirements to clarify “how producers and handlers must treat their livestock and poultry to ensure their health and well-being throughout life.” Based on recommendations from the National Organic Standards Board, the draft rules also specify “which physical alterations are allowed and prohibited” and establish “minimum indoor and outdoor space requirements for poultry.” In particular, the proposed amendments provide for “a feed ration sufficient to meet nutritional requirements, including vitamins, minerals, protein and/or amino acids, fatty acids, energy sources, and fiber (ruminants), resulting in appropriate body condition.” They also limit physical alterations to those performed only at “a reasonably young age, with minimal stress and pain and by a competent person,” and only in cases determined to “benefit the welfare or hygiene of the animals, or for identification purposes or safety.” In…
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…
