• As many of our readers may know, marijuana is listed as a Schedule I substance under federal law.  However, individual state laws do not always conform to the federal standard.  In eight states, the sale and possession of marijuana is legal for both medical and recreational use, and twenty-three states and the District of Columbia allow some degree of medical marijuana use.  To date, the Food and Drug Administration (FDA) has not approved a marketing application for marijuana for any indication.  However, the FDA is aware of some marijuana products marketing claims of health benefits.
  • At an October 3rd hearing before Congress on a separate matter, FDA Commissioner Scott Gottlieb hinted that the Agency may start cracking down on claims that marijuana has health benefits that have not been proven.  “I see people who are developing products who are making claims that marijuana has antitumor effects in the setting of cancer,” Commissioner Gottlieb said.  “It’s a much broader question about where our responsibility is to step into this.”  Conducting clinical research using marijuana involves interactions with several federal agencies, including the Drug Enforcement Administration (DEA) and the National Institute on Drug Abuse (NIDA), which means a decision regarding marijuana does not fall solely to the FDA.  And while the FDA supports adequate and well-controlled clinical trials which may lead to the development of safe and effective marijuana products to treat medical conditions, the FDA has yet to find any product that contains or is derived from botanical marijuana to be safe or effective for the treatment of any disease or condition.
  • FDA appears to be considering rules around the plant, with Commissioner Gottlieb admitting, “We’ll have some answers to this question very soon because I think we do bear some responsibility to start to address these questions.”
  • Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts.  Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness. In 2012, FDA launched GenomeTrakr.  GenomeTrakr is an international network of laboratories that sequences microbial foodborne pathogens and uploads the data to a common public database in real time.
  • At a recent Codex Alimentarius Commission meeting in Geneva, FDA scientists explained that WGS has fundamentally changed the way microbiological food hazards in the U.S. are detected and noted that the most effective use of WGS in foodborne disease surveillance requires coordination and collaboration.
  • The FDA hopes that other countries currently using WGS will share their data with GenomeTrakr. FDA is aiming to include developing countries as they are able to join. As it stands, GenomeTrakr consists of 13 federal labs, 25 state health and university labs, one U.S. hospital lab, two other labs located in the U.S., 20 labs located outside of the U.S., and collaborations with independent academic researchers.
  • To date, GenomeTrakr has collected more than 142,000 sequenced strains.  Proponents of WGS proffer that greater availability and coordination of WGS data could go a long way towards helping to identify the source and extent of outbreaks more quickly so fewer people get sick from preventable foodborne illnesses.
  • In a recent letter to Japan’s Minister of Agriculture, Forestry and Fisheries, several dairy industry associations urged Japan to respect current trade relationships with respect to geographical indicators (GIs). Noting that Japan and the European Union (EU) are in the final stages of negotiating a free trade agreement, the National Milk Producers Federation (NMPF), the U.S. Dairy Export Council (USDEC), and the International Dairy Foods Association (IDFA) stated in the letter, “…it is imperative that Japan’s efficient and transparent GI review process ensures that generic names and terms remain accessible to all.”  The associations suggested the term “Parmigiano Reggiano” is an acceptable GI but that “parmesan” should be a generic term.
  • In the recently completed European Union-Canada Comprehensive Economic and Trade Agreement (CETA), IDFA suggested that some of the GI protections amount to trade barriers. Of particular concern, according to IDFA, is the protection that the EU gained for five generic cheese names: “asiago,” “feta,” “fontina,” “gorgonzola” and “muenster.” “The outcome in CETA on GIs goes against the very core of a trade agreement, which is to remove trade barriers – not erect new ones – and allow for greater competition,” Michael Dykes, D.V.M., president and CEO of IDFA, stated in a press release.
  • The Consortium for Common Food Names (CCFN) told U.S. trade representatives that common food and beverage names should be safeguarded as the North American Free Trade Agreement (NAFTA) is re-negotiated. “The [EU] has been waging a predatory strategy on GIs that is designed to monopolize commonly used names for many cheeses, wines, meats and other foods,” CCFS Senior Director Shawna Morris, stated in an August 31 press release.
  • As we reported previously on this blog, a study commissioned by CCFN on extending GI protections recommended by the EU could cost the U.S. dairy industry billions of dollars.
  • A recently released Office of the Inspector General (OIG) report has found that the U.S. Food and Drug Administration (FDA) is making steady progress on its implementation of the Food Safety Modernization Act (FSMA) with specific regard to inspections of domestic food facilities, but challenges remain.
  • In particular, the OIG found, in part, that:
    • Although FDA is on track to meet the FSMA inspection mandates, this did not result in a greater number of facilities being inspected;
    • FDA did not always take action to ensure that facilities corrected significant inspection violations;
    • When FDA did take action, it most commonly relied on facilities to voluntarily correct significant inspection violations; these actions were not always timely nor did they always result in the correction of these violations; and
    • FDA did not consistently conduct timely follow-up inspections to ensure that facilities had corrected significant inspection violations.
  • OIG recommends that FDA:
    • Improve how it handles attempted inspections to ensure better use of resources;
    • Take appropriate action against all facilities with significant inspection violations;
    • Improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions; and
    • Conduct timely follow-up inspections to ensure that significant inspection violations are corrected. FDA concurred with all four recommendations.
  • FDA concurs with all four recommendations.
  • In May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially set for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As previously covered on this blog, however, FDA announced earlier this year that the compliance dates for the new nutrition labeling requirements will be extended.  And, earlier this month, FDA Commissioner Gottlieb tweeted that the Agency intends to propose an extended compliance date for the new nutrition labeling requirements somewhere in the range of “closer to 18 months.”
  • Today, FDA released a proposed rule on the new Nutrition Facts panel compliance date, proposing to extend the deadline by 1.5 years. Under the proposed extension, all FDA-packaged food product labels would need to comply with the new Nutrition Facts requirements by January 1, 2020. Manufacturers with annual food sales of less that $10 million would have an additional year to comply.
  • The proposed rule is scheduled to be published in the Federal Register on October 2, 2017.  FDA will be accepting comments for 30 days following the publication of the proposed rule.
  • Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts.  Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness. For example, FDA reports that WGS was recently used to help match samples of soft cheese to the genetic fingerprint of Listeria monocytogenes involved in a deadly foodborne illness outbreak in early March 2017.
  • On September 22, 2017, the Food Safety and Inspection Service (FSIS) announced that it will host a public meeting on October 26 and 27, 2017, to discuss overall federal food safety agency practices and, more specifically, plans for collecting and analyzing whole genome sequence (WGS) data of bacteria isolated from official samples, including the state of the science and other issues surrounding use of this technology. During the meeting, FSIS also intends to discuss the Agency’s recent experience in using WGS as well as its intention to expand its use in the future.
  • It remains to be seen the extent to which WGS may potentially revolutionize the way in which food regulatory bodies – in the U.S. and abroad – achieve their enumerated food safety and public health goals.
  • For further information concerning the upcoming October 26–27, 2017, please visit the FSIS Meetings and Events page.
  • For years, undeclared food allergens have been the leading cause of food recalls in the U.S. According to the Centers for Disease Control (CDC), more than 50 million Americans suffer from allergies each year.  Earlier this year, the Food Marketing Institute (FMI) reported that the prevalence of reported food allergies has significantly increased, with an estimated four to six percent of children and four percent of adults affected by food allergies.
  • On September 25, 2017, the Food Marketing Institute Foundation awarded the Food Allergy Research and Resource Program at the University of Nebraska – Lincoln’s Food Science and Technology Department – a $20,000 grant to identify root-cause labeling errors and to recommend best-practice procedures for manufacturers, suppliers and retailers in order to reduce undeclared allergen recalls.  The research will evaluate and classify the latest two years of U.S. Food and Drug Administration and USDA allergen recalls, in accordance with explanations supplied by the manufacturer and reported by these regulatory agencies.
  • FMI indicates that at the conclusion of this project, preliminary outcomes are slated to be presented at the annual Safe Quality Food International Conference in Dallas in November. A whitepaper publication will be prepared and submitted to the Food Marketing Institute Foundation, and the researchers intend to submit a paper for peer-reviewed publication.
  • Legislation that would increase funding for two U.S. Department of Agriculture export promotion programs was introduced in the U.S. Senate last week. Sponsored by Senators Angus King (I-ME), Joni Ernst (R-IA), Joe Donnelly (D-IN), and Susan Collins (R-ME), the “Cultivating Revitalization by Expanding American Trade and Exports (CREAATE) Act” (S. 1839) would increase funding for USDA’s Foreign Market Development Program (FMD)) from $34.5 million to $69 million annually and the Market Access Program (MAP) from $200 million to $400 million. A companion bill, H.R. 2321, was introduced in the House on May 03, 2017, by Congressmen Dan Newhouse (R-WA) and Chellie Pingree (D-ME).
  • “Export promotion programs like MAP and FDMP have a proven track record of helping American farm products reach foreign markets, opening up new opportunities and adding billions of dollars to our nation’s agricultural industry. However, recent funding levels for these programs do not reflect their importance to American exports,” stated Senator King in a release about the legislation.
  • National and state associations representing growers were quick to announce support for the Senate bill, including the National Corn Growers Association, the American Soybean Association, the National Sorghum Producers, and the Iowa Corn Growers (ICGA).  The Coalition to Promote U.S. Agricultural Exports and the Agribusiness Coalition for Foreign Market Development pointed out in a release that the European Union spends more than $255 million per year just to promote wine exports, more than the U.S. currently spends for the promotion of all commodities through MAP and FMD. The group added, “If this trend continues, the disadvantage in the global marketplace for American producers will only worsen.”
  • H.R. 2321 was referred to the House Committee on Agriculture on May 3, 2017, and no further action has been taken.
  • Foie gras is a culinary delicacy made from the fattened liver of a duck or goose.  It can be produced through a process called gavage in which the birds are force-fed through tubes inserted into their esophagus.  Foie gras sales derived from this method were prohibited in California following the passage of a bill in the state legislature in 2004 which took effect in 2012. Foie gras produced in other ways is not banned under the CA law.  Soon after the law took effect, Hot’s Restaurant Group in California, Hudson Valley Foie Gras in New York and the Association des Eleveurs de Canards et d’Oies du Quebec in Canada immediately filed a lawsuit to overturn the ban arguing that it was unconstitutional and vague because it does not provide adequate guidance to farmers on how much food they may feed their birds and because sellers cannot determine how much the birds they obtain have been fed in their lives.
  • The farmers and restaurant owners’ constitutional challenge failed, and the ban was upheld in 2013.  But in January 2015, Ninth Circuit, U.S. District Judge Stephen V. Wilson ruled that the state prohibition was preempted by federal poultry standards and enjoined the state from enforcing the ban.  The next month (February 2015) the California Attorney General appealed the court’s order lifting the ban.
  • On September 15, 2017, the Ninth Circuit upheld California’s ban on force-feeding birds to produce foie gras reasoning that the state law was not preempted by USDA’s Poultry Products Inspection Act (PPIA).
  • More specifically, a three-member panel for the circuit unanimously vacated the lower court’s decision to lift the ban on the sale of force-fed foie gras, lifting an injunction against enforcing the law and remanding the case to a California federal court. The panel found that the California ban did not clash with the PPIA as Congress intended for states to have extensive involvement in regulating poultry products. The panel further found that the California ban did not force foie gras to be made a certain way — rather, it bans “cruelty” to animals.  The panel did not accept the farmers’ and restaurant owners’ contentions that the law effectively amounts to an ingredient ban because it requires the production of non force-fed livers.
  • Notwithstanding the recent decision upholding California’s ban on foie gras, for now, foie gras derived from gavage remains legal to buy, sell and consume in California. The September 15th ruling will not take effect until the appeals process is concluded and a mandate is issued.
  • On September 19, 2017, USDA’s Food Safety and Inspection Service (FSIS) issued a notice requiring inspection personnel to notify establishments in hurricane-affected areas to reassess their hazard plans to ensure products are unadulterated.
  • Under FSIS requirements, every establishment must reassess the adequacy of its HACCP plan whenever any changes occur that could affect the hazard analysis or alter the plan. A hurricane is considered such a change.
  • FSIS inspection personnel will be:
    • Verifying whether sanitation procedures and any cleaning and related monitoring are adequate to address any additional sanitation problems related to the hurricanes; and
    • Reviewing the establishment’s testing data to identify any adverse trends that may indicate problems with microbial contamination.
  • In establishments producing ready-to-eat products that were affected by service failures including flooding, prolonged electric service failure and boil water orders, FSIS may schedule risk-based Listeria monocytogenes sampling to verify restoration of sanitary conditions upon re-starting operations.  For additional information click here.