Category Archives Legislation, Regulations and Standards

The European Food Safety Authority (EFSA) has revised the rules governing “Declarations of Interest” as part of its ongoing effort to increase openness and transparency. Effective September 30, 2014, the updated rules clarify how the agency uses such declarations “to prevent the occurrence of conflicts of interest among the members of its governance bodies and its staff,” including those serving on EFSA’s Management Board, Advisory Forum, Scientific Committee, Scientific Panels, and Working Groups, as well as external experts, observers, tenderers, and grant beneficiary participants. Among other things, the new rules specify that a “food safety organization” “must receive more than 50% of its funding from public sources.” They also provide “a precise definition of what is meant by family members, namely spouses, registered partners and dependent descendants,” in addition to making annual Declarations of Interest “obligatory for all staff members.” “EFSA is committed to reviewing its policies and procedures to…

The European Food Safety Authority (EFSA) has rejected the evidence submitted by France “in support of its request to prohibit the cultivation of genetically modified [GM] maize MON 810 in the EU.” As requested by the European Commission, EFSA reviewed the French report but determined that none of the cited studies “would invalidate the previous risk assessment conclusions and risk management recommendations made by the EFSA GMO Panel.” Noting that many of the issues in question were previously addressed by the GMO Panel, EFSA also considered the concerns raised by French authorities “in light of the most recent and relevant scientific data.” Based on these findings, the agency ultimately found “no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the adoption of an emergency measure on the cultivation of maize MON 810 under Article 34 of Regulation (EC) 1829/2003.”  …

The U.S. Food and Drug Administration (FDA) seeks public comments on the estimated time burdens relating to the extension of an existing information collection pertaining to the recalls of all FDA-regulated products (including food, animal feed, drugs, animal drugs, medical devices, cosmetics, biological products intended for human use, and tobacco). The estimates are based on the total number of recalls from 2011 to 2013 (11,403) averaged to 3,801 per year and involve the time burdens of complying with the voluntary reporting requirements of the agency’s recall regulations. Comments must be submitted by October 3, 2014. See Federal Register, August 4, 2014.   Issue 533

The U.S. Food and Drug Administration (FDA) this week reminded consumers that “gluten-free” “now means what it says” after a final rule outlining the voluntary labeling standards took effect on August 5, 2014. According to FDA, the new standards stipulate that foods labeled “gluten-free,” “without gluten” or “no gluten” can contain gluten in amounts less than 20 parts per million (ppm) only, “the lowest level that can be consistently detected in foods using valid scientific methods.” “This level is consistent with those set by other countries and international bodies that set food safety standards,” explained the agency, which gave manufacturers one year to bring products into compliance. Additional details about the final rule appear in Issue 492 of this Update. See FDA Consumer Update, August 5, 2014.   Issue 533

In a letter signed by 110 members of Congress, U.S. Reps. Jim Costa (D-Calif.) and Rick Crawford (R-Ariz.) have urged Secretary of Agriculture Tom Vilsack and U.S. Trade Representative Ambassador Michael Froman to rescind the country-of-origin labeling (COOL) requirements imposed on imports from Canada and Mexico if the World Trade Organization (WTO) rules against the United States in its investigation of U.S. COOL regulations. The letter reportedly suggested that Congress is working on a permanent solution to the issue, and it warned that a WTO ruling against the United States could result in detriment to the U.S. economy. “Congress must be prepared to act and find a solution that maintains a healthy relationship with our trading partners and protects the American economy,” Costa said in a July 31, 2014, statement. The letter echoes a similar argument made by food industry groups in July 2014 correspondence. Additional information on the food…

A recent perspective article in the New England Journal of Medicine (NEJM) has questioned whether nutrient-content claims—such as “sugar-free,” “high in oat bran,” or “contains 100 calories”—are confusing to consumers. Authored by Allison Sylvetsky and William Dietz, the article claims that sugar- and calorie-related claims “may lead parents to underestimate the products’ energy content and allow their children to consume more than they otherwise would.” According to the authors, the use of nonnutritive sweeteners in sugar- and calorie-modified products “may still foster the development of a ‘sweet tooth’ because nonnutritive sweeteners are a hundred times sweeter than table sugar by weight.” In addition, U.S. consumers have no way to gauge whether their children have exceeded the acceptable daily intake for a particular nonnutritive sweetener because the amount added to any given product is considered proprietary information. “We believe that adopting a more straightforward and easily understandable ingredient-labeling system in the…

A recent Nature editorial warns that the U.S. Food and Drug Administration’s (FDA’s) reluctance to approve genetically-modified (GM) salmon for market could hinder future research into new gene-editing techniques. Titled “Fishy Business,” the article claims that even though a draft assessment found AquaBounty Technologies’ GM salmon “environmentally benign,” FDA conducted many of its deliberations “behind closed doors, fuelling confusion as to the cause of the setbacks, and rumors of political interference.” “As the delays have dragged on, the technology used to make AquaBounty’s salmon has become outdated,” explains the editorial. “In the current excitement over targeted gene editing that allows researchers to modify individual genes without leaving traces of foreign DNA, AquaBounty’s salmon—which contain a gene from another species—seem like a relic.” Meanwhile, FDA has yet to decide “how it will evaluate animals engineered with gene-editing techniques.” Raising questions about how these new products will fare under FDA’s oversight, the…

In a 9-2 en banc decision, the District of Columbia Circuit has affirmed an earlier panel decision that the U.S. Department of Agriculture (USDA) can require meat producers to include country-of-origin labeling (COOL) on their packaging. Am. Meat. Inst. v. USDA, No. 13-5281 (D.C. Cir., order entered July 29, 2014). The First Amendment allows for such required disclosures because the government’s interest is sufficient, the court found. Additional information on the American Meat Institute’s constitutional challenge and the D.C. panel’s decision appears in Issues 518 and 520 of this Update. In its discussion, the court interpreted the U.S. Supreme Court’s decision in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) to reach beyond mandated commercial labeling necessary to correct deception to include the “factual and uncontroversial disclosures required to serve other government interests” at issue in the COOL context. The language in Zauderer “sweeps far more broadly than…

The Federal Trade Commission (FTC) has approved a modified final order in proceedings against Phusion Projects, LLC, which markets the malt beverage Four Loko, to account for the Department of Treasury’s Alcohol and Tobacco Tax and Trade Bureau’s (TTB’s) denial of proposed changes to the company’s product labels. In re Phusion Projects, LLC, No. C-4382 (FTC, order entered July 24, 2014). Additional information about FTC’s January 2014 order and agreement with the company appears in Issue 471 of this Update. FTC alleged that Phusion and its principals “falsely claimed that a 23.5-ounce, 11 or 12 percent alcohol by volume can of Four Loko contains alcohol equivalent to one or two regular 12-ounce beers, and that a consumer could drink one can safely in its entirety on a single occasion.” The modified final order acknowledges the company’s attempt to comply with the January agreement by seeking TTB’s approval to display an…

National Labor Relations Board (NLRB) General Counsel Richard Griffin has reportedly determined that McDonald’s, USA, LLC will be named as a “joint employer respondent” if meritorious complaints alleging unfair labor practices against the company and its franchisees do not settle. According to the NLRB, 181 cases involving McDonald’s have been filed since November 2012. Press reports indicate that they involve claims that workers have been wrongfully fired, threatened or suspended because they have engaged in labor protests, campaigning for a $15 hourly wage and to unionize. Sixty-eight of the cases have apparently been found to have no merit, and 64 are currently under investigation. While Griffin’s advice memorandum to the NLRB’s regional offices authorizing 43 complaints brought by McDonald’s workers does not have the force of a full board ruling, it has sparked a firestorm of controversy among business interests. Noting that McDonald’s will contest the joint-employer allegation “in the…

Close