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…
Category Archives Food and Drug Administration
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
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 U.S. Food and Drug Administration (FDA) has published modifications to the 2013 Food Code based on recommendations made by industry, regulators and other stakeholders during the 2014 Biennial Meeting of the Conference for Food Protection. The Food Code and its Supplement offer the federal agency’s best advice for minimizing the risk of foodborne illness in retail and foodservice venues. Changes to the 2013 iteration of the Code include: (i) clarification of what information should be included in a Hazard Analysis and Critical Control Point Plan required by a regulatory authority; (ii) clarification of the difference between Typhoid Fever and non-typhoidal Salmonellosis when reporting illness and the exclusion and restriction of sick food employees; and (iii) expansion of the duties of the “Person in Charge” to include oversight of the routine monitoring of food temperatures during hot and cold holding. FDA plans to issue its next complete revision of the…
Citing stakeholder concerns over insufficient time to achieve appropriate implementation, the U.S. Food and Drug Administration (FDA) has extended by one year the compliance date for its controversial menu-labeling rule from December 1, 2015, until December 1, 2016. The new requirements apply to restaurants and similar retail food establishments with more than 20 locations, as well as food facilities in movie theaters, amusement parks and other entertainment venues. According to a statement from FDA Deputy Commissioner Michael Taylor, the agency will continue its ongoing discussions with covered establishments and plans to release draft guidance in August 2015 that answers frequently asked questions about complying with the rule. See FDA Statement, July 9, 2015. Issue 571
The U.S. Food and Drug Administration (FDA) has issued a determination revoking the generally recognized as safe (GRAS) status of partially hydrogenated oils (PHOs), “the primary dietary source of industrially-produced trans fatty acids.” To comply with the declaratory order, food and beverage companies must remove PHOs from products by June 18, 2018, or request food additive approval for specific uses of PHOs. Concluding that there is no longer expert consensus as to the safe use of artificial trans fat in human food, FDA argues that the action is “expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.” In the wake of its November 2013 tentative decision, the agency apparently received more than 6,000 comments from individuals, industry and trade associations, consumer groups, and government officials, the majority of which purportedly supported the reduction of trans fat in the food supply. “Studies show that diet…
The U.S. Food and Drug Administration (FDA) has announced the availability of industry guidance on food allergen labeling exemptions. Titled “Food Allergen Labeling Exemption Petitions and Notifications,” the guidance reportedly explains the agency’s “current thinking on the preparation of regulatory submissions for obtaining exemptions for ingredients from the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (FD&C Act) through submission of either a petition or a notification.” The guidance aims to clarify the criteria for labeling exemption petitions submitted under the Food Allergen Labeling and Consumer Protection Act of 2004, which requires all food and beverage labeling to declare the presence of major food allergens using their common names. Under these rules, companies can obtain labeling exemptions by demonstrating that an ingredient derived from a major allergen ‘‘does not cause an allergic response” or “‘does not contain allergenic protein.” See Federal Register, June 19,…
A June 10, 2015, petition filed by consumer and environmental groups asks the Food and Drug Administration (FDA) to ban the following synthetic substances widely used in baked goods, ice cream and beverages: (i) benzophenone (also known as diphenylketone); (ii) ethyl acrylate; (iii) eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol); (iv) myrcene (also known as 7-methyl-3-methylene- 1,6-octadiene); (v) pulegone (also known as p-menth-4(8)-en-3-one); (vi) pyridine; (vii) styrene; and (viii) trans,trans-2,4-hexadienal. Signed by the Center for Science in the Public Interest, National Resources Defense Council, Center for Environmental Health, Environmental Working Group, Center for Food Safety, Consumers Union, and Improving Kids’. Environment, the petition claims that the flavorings are not safe for use in human food under the Delaney Clause of the Food Additives Amendment Act (21 U.S.C. § 348 (c)(3)(A)) because the National Toxicology Program and other agencies have linked them to animal or human cancers. The…
In a recent journal article, a Babson College marketing law professor discusses legal disputes over the labeling of food as “natural,” noting drawbacks of using courts as public policy developers on the issue. Ross D. Petty, “‘Natural’ Claims in Food Advertising: Policy Implications of Filling the Regulatory Void with Consumer Class Action Lawsuits,” Journal of Public Policy & Marketing, Spring 2015. Petty provides a history of the debate and litigation over use of the terms “natural” and “unprocessed” on food labels, beginning with U.S. Federal Trade Commission (FTC) actions against Sugar in The Raw® and Hawaiian Punch® in the 1970s. The article also details efforts by the U.S. Food and Drug Administration (FDA) and Department of Agriculture (USDA) to define “natural,” “synthetic,” “healthy” and “good source.” Petty highlights industry self-regulation, such as the processes established by the National Advertising Division of the Council of Better Business Bureaus, as a venue for…
