Citing stakeholder concerns over insufficient time to develop meaningful submissions, the U.S. Food and Drug Administration (FDA) has extended by 90 days the period in which to submit comments about the agency’s risk assessment titled, “Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.” FDA seeks suggestions for improving the specific criteria, scoring and weighting scheme; selection of animal drugs evaluated; and transparency of the risk assessment. Electronic or written submissions are now due by October 27, 2015. See Federal Register, July 30, 2015. Issue 573
Category Archives Legislation, Regulations and Standards
The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry about the agency’s current thinking regarding the disclosure of small amounts of nutrients and dietary ingredients on nutrition labeling. The document focuses on how the agency intends to use its enforcement discretion when a conflict occurs between compliance with § 101.9(c) and § 101.9(g) of Title 21 of the Code of Federal Regulations such that compliance with both sections is not possible. FDA is also considering whether to revise both sections and, if so, may reportedly amend or withdraw the draft guidance. Those wishing to submit comments on the draft guidance must do so by September 28, 2015. See Federal Register, July 30, 2015. Issue 573
The U.S. Food and Drug Administration (FDA) has told a California federal court that the agency will not issue guidance until 2016 about the use of “evaporated cane juice” (ECJ)—which plaintiffs nationwide assert is merely sugar—on food and beverage labeling. Swearingen v. Late July Snacks LLC, No. 13-4324 (N.D. Cal., agency letter filed July 13, 2015); Swearingen v. Healthy Beverage LLC, No. 13-4385 (N.D. Cal., agency letter filed July 13, 2015). The court issued an order in May 2015 requesting FDA to indicate whether the agency would issue guidance within 180 days. “FDA is actively working on a final guidance to address this issue,” Associate Commissioner for Policy Leslie Kux writes. “However, because of competing priorities, FDA cannot commit to issuing a decision within 180 days. . . . We have received a substantial number of comments and extensive amounts of supporting materials. FDA is obligated to review and consider…
The U.S. Food and Drug Administration (FDA) has issued proposed revisions to the required information appearing in food and beverage products’ Nutrition Facts labels. The changes include a required declaration of the percent daily value for added sugars based on the recommendation that daily intake from added sugars not exceed 10 percent of total calories. The proposal would also revise the footnote appearing on the Nutrition Facts label “to help consumers understand the percent daily value concept.” FDA has reopened a 60-day comment period addressing its proposed revisions. “The FDA has a responsibility to give consumers the information they need to make informed dietary decisions for themselves and their families,” Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, was quoted as saying in a July 24, 2015, press release. “For the past decade, consumers have been advised to reduce their intake of added sugars, and…
By failing to adequately fund and implement the Food Safety Modernization Act (FSMA), the “Obama administration and Congress have all but squandered an opportunity to give the anemic Food and Drug Administration, which is responsible for the safety of 80 percent of the nation’s food supply, a level of oversight the public long assumed it had,” according to a July 14, 2015, Politico investigation. The lengthy article details various delays in implementing the law and serious outbreaks of foodborne illnesses that might have been prevented had FDA been given the financial resources for inspections and other food-safety initiatives. Issue 572
In a recent Associated Press (AP) interview, U.S. Associate Attorney General Stuart Delery warns that the Department of Justice (DOJ) will pursue criminal penalties against companies that sell poisoned food. AP cites the recent prosecution of Peanut Corp. of America executives along with actions against the producers of tainted cantaloupe and eggs as evidence of the federal government’s increased focus on criminal enforcement of food safety laws. Plaintiffs’ attorney Bill Marler reportedly told the news organization that the DOJ’s actions were especially notable because the company executives charged in the prosecutions often did not know that their food products were tainted. “We have made a priority holding individuals and companies responsible when they fail to live up to their obligations that they have to protect the safety of the food that all of us eat,” Delery said. “The criminal prosecutions we bring should stand as a stark reminder of the…
The U.K. Scientific Advisory Committee on Nutrition (SACN) has released its final Carbohydrate and Health report recommending that “free sugars account for no more than 5% of daily energy intake.” Asked by the U.K. Department of Health and the Food Standards Agency to “examine the latest evidence on the links between consumption of carbohydrates, sugars, starch and fiber and a range of health outcomes,” the expert panel commissioned systematic reviews of evidence from prospective cohort studies and randomized controlled trials, in addition to considering comments submitted in response to its first draft report. Based on these findings, the report concludes, among other things, that (i) “high levels of sugar consumption are associated with a greater risk of tooth decay”; (ii) “drinking high-sugar beverages results in weight gain and increases in BMI in teenagers and children”; and (iii) “consuming too many high-sugar beverages increases the risk of developing type 2 diabetes.”…
The U.S. Food and Drug Administration (FDA) has announced a public meeting of its Science Board for July 29, 2015, at the agency’s campus in Silver Spring, Maryland. Among other things, the 21-member group will hear updates by Center for Veterinary Medicine representatives about two scientific initiatives and provide feedback about implementation of certain directives in the National Strategy for Combating Antibiotic-Resistant Bacteria. The board will also discuss the 21st Century Cures Act and be provided a status update about the Office of Medical Products and Tobacco. See Federal Register, July 13, 2015. Issue 572
The Centers for Disease Control and Prevention (CDC) has issued a notice of proposed rulemaking that would add certain highly pathogenic avian influenza strains (HPAIs) to the Department of Health and Human Services’ (HHS) list of select agents and toxins. In addition to listing any influenza virus that contains hemagglutinin (HA) from the Goose Guangdong/1/96 lineage, including wild-type viruses, CDC seeks to categorize as a Tier 1 select agent any virus containing HA from the HPAI H5N1 lineage “that were made transmissible among mammals by respiratory droplets in a laboratory.” As directed by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, HHS maintains “a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety.” Tier 1 designates those agents and toxins that “present the greatest risk of deliberate misuse with significant potential for mass casualties or…
Diageo Great Britain Ltd. reportedly plans to appeal the U.K. Advertising Standards Authority’s (ASA’s) decision to ban a Smirnoff ® advertisement for allegedly violating the marketing rules for social responsibility in alcohol marketing. Upholding its own complaint, which claimed that the ad in question linked social success to alcohol consumption, ASA found that “the ad’s presentation implied that before the visitor asked for an alcoholic drink, the bar was cold and uninviting and that once his drink had been ordered, the bar changed and became livelier and more fun.” Diageo disputed this interpretation, arguing that the TV spot showed the bar “tilting” to filter out the elements that gave it an unwelcoming atmosphere. According to the ruling’s summary of Diageo’s response, “The tilt acted as a physical division within the ad and where the pretentious items in the first scene were filtered out and the bar now had a warm…
