The U.S. Food and Drug Administration (FDA) has extended the public comment periods for draft guidance “that provides practical, voluntary sodium reduction targets for the food industry.” Titled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods,” the guidance sets short- and long-term sodium targets for the following food categories: (i) cheese; (ii) fats, oils and dressings; (iii) fruits, vegetables and legumes; (iv) nuts and seeds; (v) soups; (vi) sauces, gravies, dips, condiments and seasonings; (vii) cereals; (viii) bakery products; (ix) meat and poultry; (x) fish and other seafood; (xi) snacks; (xii) sandwiches; (xiii) mixed ingredient dishes; (xiv) salads; (xv) other combination foods; and (xvi) baby/toddler foods. The agency will now accept comments pertaining to the food categories and two-year salt reduction goals until October 17, 2016. The comment period for the 10-year targets as well as feedback on technical…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Food and Drug Administration (FDA) has extended until July 26, 2018, the deadline for posting the calorie counts of “certain gums, mints, and roll candy products” sold in glass-front vending machines, as well as for complying with type-size front-of-pack (FOP) labeling requirements. Published December 1, 2014, and effective December 1, 2016, the final rule requires businesses operating 20 or more vending machines to clearly disclose calorie counts “in a direct and accessible manner” if calories are not easily visible to prospective purchasers via FOP labeling. According to FDA, “several trade associations requested the extension for glass-front vending machines because of concerns regarding the requirements for the size of front-of-pack (FOP) calorie disclosures.” The trade associations apparently noted that “current voluntary FOP labeling programs require calorie information to be presented in a type size that ranges from 100 to 150 percent of the size of the net weight contents…
Following an investigation into potential criminal violations of federal immigration laws, Mary’s Gone Crackers Inc. will pay $1.5 million and establish a corporate compliance program but will not be prosecuted, the U.S. Department of Justice has announced. The investigation determined that 48 of the company’s employees were ineligible to work in the United States; Mary’s informed Immigration and Customs Enforcement that the employees had left the company, but further investigation found that Mary’s hired at least 13 of those employees back under different names. In addition to the $1.5-million payment, Mary’s must establish an anonymous tip line for employees to report noncompliance issues, provide I-9 training to employees and report compliance measures to the U.S. Attorney’s Office for two years. Issue 613
The U.S. Department of Agriculture’s National Organic Standards Board (NOSB) has removed five non-organic nonagricultural substances—egg white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate—from the National List of Allowed and Prohibited Substances governing the use of synthetic and non-synthetic substances in organic food production and handling. After determining that these substances “are no longer necessary or essential for organic handling” based on public comments and supporting documents, NOSB decided to let their use exemptions expire on September 12, 2016. According to NOSB, suitable alternatives or new processing and handling practices have eliminated the need for (i) egg white lysozyme as a “processing aid/preservative for controlling bacteria that survived the pasteurization process of milk that is used for cheese manufacture”; (ii) cyclohexylamine, diethylaminoethanol and octadecylamine “for use only as a boiler water additive for packaging sterilization”; and (iii) tetrasodium pyrophosphate “for use only in meat analog products.” See Federal Register, August…
The Federal Trade Commission (FTC) and U.S. Department of Agriculture (USDA) have released an August 10, 2016, joint report examining consumers’ perceptions of “recycled content” and “organic” claims, especially for non-agricultural products and services. Using data from Internet-based questionnaires completed by 8,016 respondents, the study sought to determine whether consumers view products marketed with such claims as having “particular environmental benefits or attributes.” Among other things, FTC and USDA asked consumers to assess the accuracy of recycled content and organic claims when applied to products made with varying types of recycled materials and varying proportions of “man-made” substances. While the agencies reported no significant difference among consumer perceptions of products that used either pre- or post-consumer recycled materials, “a significant minority of respondents disagreed that the organic claims accurately describe the product” when a small percentage of materials (i.e., “less than 1%; 1% to 5%; and 5% to 10%”) was…
The U.S. Federal Trade Commission (FTC) has issued warning letters to 28 unnamed companies that allegedly represent themselves as participants in the Asia-Pacific Economic Cooperative (APEC) Cross Border Privacy Rules system despite failing to meet the requirements underlying that claim. According to FTC, certification is granted based on the following data privacy principles: (i) preventing harm, (ii) notice, (iii) collection limitation, (iv) use choice, (v) integrity, (vi) security safeguards, (vii) access and correction, and (viii) accountability. The FTC warning letters instructed the companies to remove the APEC certification claims from their websites and notify the agency of completion or provide documentation supporting the claims. See FTC Press Release, July 14, 2016. Issue 611
The U.S. Food and Drug Administration (FDA) has filed an opposition to a petition for a writ of mandamus seeking a response to several consumer groups’ petition to prohibit perchlorate, an additive currently approved for limited use in food packaging. Breast Cancer Fund v. FDA, No. 16-70878 (9th Cir., petition filed July 8, 2016). The groups’ petition urged the Ninth Circuit Court of Appeals to compel FDA to respond to their December 2014 food additive petition, arguing the agency was required to respond by June 2015. Details about the petition for a writ of mandamus filed by the groups—which include the Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Working Group and the Natural Resources Defense Council—appear in Issue 599 of this Update. FDA’s response first challenges the group’s standing to sue. “Even if petitioners could demonstrate that perchlorate poses some risk…
The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and Agricultural Marketing Service are convening an August 1, 2016, public meeting in Washington, D.C., to evaluate draft positions and receive public comments in advance of the 28th Session of the Codex Committee on Processed Fruits and Vegetables (CCPFV) slated for September 12-16 in Washington, D.C. The CCPFV sets global standards for canned, dried and frozen products as well as fruit and vegetable juices and nectars. Agenda items for the August 1 meeting include (i) food additive provisions in Codex standards for processed fruits and vegetables, (ii) a discussion paper about the standardization of dry and dried produce, and (iii) proposed draft annexes on quick frozen vegetables. See Federal Register, June 30, 2016. Issue 610
Former U.S. Food and Drug Administration (FDA) Commissioner for Foods David Acheson has authored an article warning food company officials to prioritize food safety in light of the U.S. Department of Justice’s (DOJ’s) increasing prosecutions against executives of food companies responsible for pathogen outbreaks. Acheson describes the Park Doctrine, which allows the government to seek misdemeanor convictions against company officials without requiring proof that the officials knew of or participated in the federal Food, Drug and Cosmetic Act violations. Further, after a misdemeanor conviction, subsequent violations are automatic felonies. “It is for all these reasons that it is critical that everyone in a food facility understand and follow all food safety practices, and that executives stay tuned in to everything going on in their operations—as they are ultimately responsible for every act that takes place,” Acheson writes. “Additionally, while I caution against simply writing up a food safety plan in order…
Following the release of U.S. Food and Drug Administration (FDA) final guidance finding that “evaporated cane juice” (ECJ) should be labeled as “sugar” on food products, Lifeway Foods has filed a motion arguing that the May 2016 rule should not affect the outcome of a consumer’s lawsuit against the company arguing it mislabeled its kefir smoothies. Figy v. Lifeway Foods Inc., No. 13-4828 (N.D. Cal., San Francisco Div., motion filed June 13, 2016). The case is one of many stayed or dismissed without prejudice awaiting FDA guidance after the agency announced it would reconsider the issue in March 2014. In its motion, Lifeway argues that the guidance is “intended to advise” and “does not establish any rights for any person and is not binding on the FDA or the public.” “The Guidance has no more bearing on Plaintiff’s claims under California’s consumer protection statutes than it has on his common…
