• As previously reported on this blog, Senate Bill 764, which requires the labeling of genetically modified (GM) foods and food ingredients, was signed into law on July 29, 2016. The National Bioengineered Food Disclosure Law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018. Under the law, food companies have three options to disclose GMO ingredients: on-package text, a USDA-created symbol, or an Internet link.
  • A labeling mandate for GE salmon for human consumption is included in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Fiscal Year 2018 appropriations bill (S.1603), which was passed by the Senate Committee on Appropriations and introduced in the full Senate on July 20, 2017. Senator Lisa Murkowski (R-AK), who opposed S.764, announced in a press release that she “secured language [in the appropriations bill] that requires the Food and Drug Administration (FDA) to mandate labeling of GE salmon and that continues the current import ban until final labeling guidelines have been set by the FDA.”
  • Concerning the import ban of GE salmon, Sec. 757(c) of S.1603 states, “During fiscal year 2018, the Food and Drug Administration shall not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon until the Food and Drug Administration publishes final labeling guidelines for informing consumers of such content.”
  • USDA is currently conducting a study to determine the challenges of GMO disclosure through a smartphone-scannable digital code, and has posted a list of 30 questions to obtain stakeholder input to facilitate the drafting of mandatory disclosure requirements to implement the National Bioengineered Food Disclosure Law. If the provision requiring FDA to mandate labeling of GE Salmon remains in the final agricultural FY2018 appropriations bill, it remains to be seen how GE labeling requirements will be coordinated between FDA and USDA.​
  • A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14).  A health claim must contain the elements of a substance and a disease or health-related condition.  In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease.  Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims: (1) health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims.
  • A qualified health claim does not meet the “significant scientific agreement” standard.  Therefore, the FDA requires qualified health claims to be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim. Qualified health claims are currently evaluated under FDA’s interim guidance for such claims.  FDA issues letters of enforcement discretion when there is credible evidence to support a qualified health claim.  For a food to bear a qualified health claim, it is required to be low in fat and contain 10% or more of the Reference Daily Intake or the Daily Reference Value of the nutrients specified in 21 C.F.R. 101.14(e)(6) (i.e. vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC).
  • On July 24, 2017, the FDA announced that the Agency would permit the use of a qualified health claim regarding the relationship between consumption of macadamia nuts and a reduced risk of coronary heart disease (CHD) despite the nuts being above the typically permitted level of fat and below the typically required levels of nutrients.  FDA has typically required foods bearing CHD-related health claims to be low in saturated fat and low in cholesterol, and to meet the definition of a “low fat” food as defined under FDA’s labeling requirements.  In this case, however, citing to macadamia nuts’ favorable (5:1) unsaturated to saturated fat ratio, and the fact that these nuts contain potentially beneficial substances such as dietary fiber and phytosterols, FDA found that a qualified health claim about macadamia nuts and reduced risk of CHD might assist consumers in maintaining a healthy diet.  The claim permitted for use by the FDA is:
    • “Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”
  • FDA’s decision to permit a qualified health claim for macadamia nuts follows on the Agency’s interim final rule (81 FR 91716) published in December 2016 (previously discussed on this blog) to amend 21 C.F.R. 101.75 to expand the use of heath claims concerning the relationship between dietary saturated fat and cholesterol and risk of CHD to certain raw fruits and vegetables that were previously ineligible to make the claim.  The December 2016 interim final rule together with FDA’s response to the macadamia nut petition could signal the Agency’s willingness, going forward, to exercise its enforcement decision to permit qualified health claims for foods with similar nutrition profiles.
  • A Pew Charitable Trusts study released this month examines “preharvest” food safety control measures currently used on farms and feedlots and concludes that efforts to reduce contamination of meat and poultry products from harmful pathogens requires a comprehensive “farm to fork” approach.
  • The study specifically examined food safety control measures designed to limit exposure on farms and feedlots to pathogens such as Salmonella, Coli and Campylobacter that can affect cattle, swine and poultry.  According to the study, these pathogens accounted for a substantial portion of foodborne illnesses linked to meat and poultry consumption.  The study also reports that the annual cost of foodborne illnesses (i.e., medical costs, lost income and productivity) attributable to the consumption of such foods is estimated at $1.4 billion for beef, $2.5 billion for poultry and $1.9 billion for pork.
  • The study highlights the key characteristics shared by effective pre-harvest programs, including, but not limited to:
    • Reliance on feed safety, biosecurity, and pathogen surveillance, as well as specific pre-harvest interventions.
    • Combining multiple interventions, which improves the efficacy of the programs, makes use of potential synergisms between interventions, and reduces the ability of the pathogen to evolve mechanisms to circumvent an intervention.
    • Targeting interventions to the animal species and production system, allowing implementation when and where they work best and are successful, feasible, and cost-effective.
  • Importantly, the study notes that while identifying potential pre-harvest measures is a key first step in any food safety regiment, a comprehensive “farm to fork” approach is needed.  In other words, to successfully prevent against food safety hazards, it is necessary to control the spread of pathogens at the farm level, adopt consistent and effective measures throughout the animal management, slaughter and processing steps.  The complete study, including details on how several countries have successfully implemented comprehensive “farm to fork” food safety control programs is available here.

FDA announces FSMA funds to support states’ continued implementation of the produce safety rule.

  • The Food Safety Modernization Act (FSMA) was designed to update and strengthen FDA’s risk-based approach to the oversight of food safety.  The produce safety rule – which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption – is a critical part of FSMA.
  • On July 19, 2017, FDA announced that FDA is awarding $30.9 million in funding to support 43 states in their continued efforts to help implement the produce safety rule. This is the largest allocation of funds to date, made available by the FDA to help state agencies support FSMA produce safety rule implementation and develop state-based produce safety programs.  FDA notes that the funding will ensure that awardees have the resources to formulate a multi-year plan to implement a produce safety system and develop and provide education, outreach and technical assistance.
  • Due to the inherent complexity and breadth of the FSMA requirements, FDA must rely on strong partnerships with state agencies to ensure comprehensive and effective implementation.
  • Earlier this week, USDA’s Animal and Plant Health Inspection Service (APHIS) announced an atypical case of Bovine Spongiform Encephalopathy (BSE), a neurologic disease of cattle, in an eleven-year old cow in Alabama (AL).  APHIS reports that this animal never entered slaughter channels and at no time presented a risk to the food supply, or to human health in the United States.  Importantly, APHIS reports that this atypical BSE finding has no impact on America’s “negligible risk” status for BSE as designated by the World Organization for Animal Health (OIE).  Consistent with OIE guidelines for determining this status, atypical BSE cases do not impact official BSE risk status recognition as this form of the disease is believed to occur spontaneously in all cattle populations at a very low rate. As such, and consistent with APHIS’ announcement, this week’s finding of an atypical case will not change the negligible risk status of the United States, and should not lead to any trade issues.
  • Nevertheless, yesterday, South Korea announced that it had increased on-spot quarantine inspections of U.S. beef to 30 percent of imports from 3 percent in light of the BSE report from Alabama and has requested assurances that no beef from Alabama processing facilities enters the country.
  • South Korea’s response appears to be somewhat drastic given the fact that the atypical BSE detected in AL at no time presented a risk to the American food supply or exports to South Korea, and the U.S. continues to maintain a “negligible risk” BSE status. According to the Daily Livestock Report, the AL diagnosis of atypical BSE is expected to have “very little material impact” on domestic or export demand for U.S. beef.  Indeed, a Japanese agriculture official told Bloomberg News earlier this week that Japan currently sees no need to take additional action to prevent entry of BSE from the U.S. because the U.S. already has appropriate measures in place, and the new case is atypical.  It remains to be seen whether other countries will follow the thinking of Japan or South Korea.  We will be sure to report on any developments on this situation as they unfold.
  • As previously covered on this blog, on June 16, 2016, the Philadelphia city council voted 13-4 to approve a 1.5-cent-per-ounce tax on sugar-sweetened beverages.  The tax – which took effect on January 1, 2017 – is levied on distributors and covers a variety of beverages, including soda and diet soda, non-100% fruit drinks; sports drinks; flavored water; energy drinks; pre-sweetened coffee or tea; and non-alcoholic beverages intended to be mixed into alcoholic drinks.  Prior to the January 1, 2017 effective date, the American Beverage Association (ABA) together with retailers, distributors and consumers filed a complaint in September 2016 in the Philadelphia Court of Common Pleas challenging Philadelphia’s soda tax (see previous blog coverage here).  On December 19, 2016, the Philadelphia County Court of Common Pleas issued a decision upholding the Philadelphia Beverage Tax and dismissing the complaint challenging the tax in its entirety.  Last month, the Pennsylvania Commonwealth Court upheld Philadelphia’s beverage tax, dismissing arguments from the American Beverage Association and local retailers that the levy is unlawful.
  • On Thursday, July 13, 2017, the ABA filed a petition with the Pennsylvania Supreme Court asking it to hear the case and to ultimately overturn the 1.5-cent-per-ounce tax on sugary drinks and diet sodas.
  • Observers speculate that the PA Supreme court will likely take up the appeal. It remains to be seen what, if any, impact the outcome of this litigation will have on the appetite of other U.S. jurisdictions to pursue such legislation.
  • As background, on January 4, 2017, the Center for Science in the Public Interest (CSPI), a consumer-advocacy group, filed a complaint claiming that Coca-Cola and the American Beverage Association (ABA) misled consumers regarding the health risks of consuming sugary drinks such as soda.  The lawsuit specifically takes issue with Coca-Cola and the ABA’s emphasis on “calories in, calories out” and exercise as the best ways to manage health, which CSPI argues ignores scientific evidence linking sugar-sweetened drinks to obesity, diabetes, and cardiovascular disease. The suit also alleges that Coca-Cola purposefully misled consumers on the health risks of drinking soda by funding research that downplays the dangers of sugary beverages.
  • Coca-Cola immediately issued  a statement calling the lawsuit “legally and factually meritless,” and noting that the Company takes its “consumers and their health very seriously and [has] been on a journey to become a more credible and helpful partner in helping consumers manage their sugar consumption.” The company further stated that it has worked to improve products’ nutrition by adopting front-of-pack calorie labeling, expanding low- and no-calorie products, reformulating products to reduce added sugars, and being more transparent in regards to disclosing funding. Coca-Cola also said it does not advertise to children under 12.
  • The ABA, for its part, has long contended that obesity is a “complex condition,” noting, for example, that whereas obesity and diabetes rates have increased in recent years, soda consumption has dropped.  In response to the complaint, ABA stated that “unfounded accusations like these won’t do anything to address health concerns, but the actions we’re taking, particularly in areas where obesity rates are among the highest, can make a difference.”
  • The complaint was subsequently withdrawn and refiled on July 13, 2017 to include additional plaintiffs.  A copy of the refiled complaint is available here.
  • CSPI is demanding that Coca-Cola and the ABA disclose files on potential health implications of consuming sugar-sweetened drinks, fund a public health education campaign, and end advertising aimed at children as well as marketing that implies drinking sugary beverage is not linked to health problems.
  • Given the lack of scientific literature demonstrating a causal link between soda consumption and negative health outcomes, the plaintiffs likely face an uphill battle in advancing their key claims.  We will be sure to keep a close eye on developments in this case and report them to you here.
  • In 2008, New York City passed the first calorie disclosure rule for restaurants and in 2015, the city amended the rule to match federal requirements (for more information on the federal requirements, see the KHlaw.com article, FDA Issues Final Rules on Menu and Vending Machine Nutrition Labeling Requirements.) As we reported on this blog, FDA extended the menu labeling compliance date to May 8, 2018. In response to FDA’s delayed compliance date, New York City announced that its Health Department would begin enforcement of the city’s Health Code’s calorie labeling requirements on May 22, 2017, and would issue Notices of Violation subject to fines for any food service establishments that are not compliant beginning on August 21, 2017.
  • The National Restaurant Association (NRA), the Food Marketing Institute (FMI), the National Association of Convenience Stores (NACS), and the New York Association of Convenience Stores (NYACS) filed suit in the U.S. District Court for the Southern District of New York on July 14, 2017, to block the city’s enforcement of its’ menu-labeling standard prior to the May 2018 federal compliance date. The suit contends that New York City’s enforcement is pre-empted by federal law.
  • “New York City can’t jump the gun and start imposing fines when FDA hasn’t even figured out how disclosures should be made,” said Lyle Beckwith, Senior Vice President of Government Relations for NACS, in a NRA release about the lawsuit. Jennifer Hatcher, FMI Chief Public Policy Officer, further explained, “New York City’s actions threaten interstate commerce and would introduce unneeded elements of confusion into the food retail marketplace.”
  • We will continue to monitor developments with respect to both federal and local menu labeling requirements and report them to you here.
  • Meat, poultry, and egg products imported to the United States fall under the jurisdiction of the U.S. Department of Agriculture’s Food Safety & Inspection Service (FSIS). FSIS administers requirements that seek to ensure these products are produced under standards equivalent to the U.S. inspection system.  For nearly 2 decades, Dutch veal was banned from the U.S. due to bovine spongiform encephalopathy (BSE) concerns. But following a rigorous review by FSIS of the Dutch food safety system as it relates to veal production (in 2014 and 2015), the Netherlands won approval to renew exports of raw intact veal intended for intact use.
  • Yesterday, FSIS announced it will now also begin allowing imports of raw intact veal intended for raw non-intact use from the Netherlands from veal slaughtered on and after July 15, 2017.  This announcement follows the Agency’s review of the Netherlands’ raw veal Shiga toxin-producing Escherichia coli (STEC) verification activities.  FSIS Notice 36-17 explains procedures for FSIS inspection personnel to verify the accuracy of inspection certificates for imported raw non-intact veal and raw intact veal intended for raw non-intact use from the central competent authority of the Netherlands. The certificates serve to provide assurance that these products meet FSIS requirements.
  • Additional information concerning the expanded market access for Netherlands’ raw veal products is available here.
  • For years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production purposes.  Recently, states have also jumped into the fray, with California, for example, adopting strict limits in 2015 on the use of antibiotics in healthy livestock, effectively barring their routine use to prevent illness or promote growth.
  • Earlier this week, Pew Charitable Trusts released a new report that examines alternatives to antibiotics in animal agriculture.  In short, the report indicates that vaccines, probiotics, immune modulators and other innovative approaches to protect animals could minimize the use of antibiotics in food-producing animals.  The report focuses on nine possible alternatives that could help protect cattle, swine, chicken and turkey, including probiotics, in-feed enzymes, antimicrobial peptides, phytochemicals, heavy metals and hydrolases like bacteriophages and notes that some commercial food animal producers are already successfully using available alternatives for growth promotion and disease prevention, including probiotics and vaccines.
  • As industry and regulatory bodies around the world continue to tackle public health concerns associated with the use of medically important antibiotics, the use of antibiotic alternatives in food-producing animals is likely to pick up steam.  But practical challenges associated with bringing these products to market – including concerns about limited market size and a potential lack of incentives to use alternatives – could hinder commercial development of other alternative approaches.