FDA Delays Menu Labeling Rule

  • As previously covered on this blog, over the past few years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items.  Although the menu labeling requirements were originally scheduled to take effect on December 1, 2015, enforcement was later delayed to December 1, 2016.  Enforcement was subsequently delayed to May 5, 2017.
  • On April 26, 2017, the FDA submitted an interim final rule (IFR) to the Office of Management and Budget (OMB) seeking an “Extension of Compliance Date”. The IFR is entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date; Request for Comments.”  It appears that FDA is extending the compliance date for menu labeling to allow interested parties to submit additional comments – potentially on specific issues raised by the National Association of Convenience Stores (NACS) and the National Grocers Association (NGA) in their citizen petition filed on April 5, 2017 (available here).  The NACS/NGA citizen petition did not request a specific amount of time industry needs to comply, but rather contested the validity of the scope of the regulation and requested a stay until outstanding issues have been resolved).
  • It is unclear when the IFR will be published, but given that the menu labeling compliance date, May 5, is a week from today, and the fact that a delayed compliance date, potentially leading to less burdensome requirements for industry, are in keeping with the stated goals of the Trump administration, we expect OMB will do its best to fast-track publication.

Maine Seeks Modification to USDA SNAP (Food Stamp) Benefits

  • USDA’s Food and Nutrition Service (FNS) administers the Supplemental Nutrition Assistance Program (SNAP), also colloquially known as the “Food Stamps” Program.  SNAP, through State Agency partners, offers nutrition assistance to more than 47 million eligible, low-income individuals and families. Under the Food and Nutrition Act of 2008 (the Act) and corresponding SNAP regulations, states have little room to modify eligibility standards or otherwise dictate what foods may be purchased with SNAP benefits.
  • The State of Maine is requesting a waiver from the USDA that would allow the state to ban its SNAP recipients from purchasing candy and soda using the federal benefits.  Under the previous administration, the USDA denied a similar waiver from Maine last year.  USDA is currently considering the state’s new request.
  • With a new administration at the helm, changes to SNAP could be forthcoming, including perhaps endowing states with more freedom to modify the rules of the program as they see fit.  The food industry, of course, has a vested interest in how this all transpires and would likely coalesce to oppose any legislative or policy initiatives – at the federal, state or local level – that would have the effect of curtailing eligible products and hence restricting consumer choice.

USDA to Undertake Study on Antimicrobial Use in Pork Operations

  • The USDA Antimicrobial Resistance Action Plan, released in 2015, recommended that USDA agencies perform enhanced monitoring of antimicrobial use in food-producing animals. In addition, as our readership is well aware, beginning on January 1, 2017, the Food and Drug Administration (FDA) initiated policy changes regarding the use of antimicrobials in food-producing animals. These changes include: (1) Eliminating the use of medically important antimicrobials for growth promotion purposes in food-producing animals, and (2) Requiring veterinary oversight for use of medically important antimicrobials in animal feed or water.
  • Next month, USDA’s National Animal Health Monitoring System (NAHMS), along with the National Agricultural Statistics Service (NASS) will begin a four-month study concerning how antimicrobials are used in U.S. swine operations.  The study will focus on antimicrobial use and stewardship practices on swine nursery and grower-finisher facilities with a capacity of at least 1,000 head. Goals of the study include:
    • Describe antimicrobial-use practices in feed and water on production sites with a capacity of at least 1,000 weaned market pigs.
    • Estimate the percentage of production sites using and the percentage of weaned market pigs receiving specific antimicrobials in feed and/or water by reasons for use.
    • Provide baseline data on antimicrobial-use practices in place before implementation of FDA policy changes. This baseline can be used for evaluating trends over time.
    • Describe antimicrobial stewardship practices on production sites with weaned market pigs.
  • It remains to be seen what impact the results of this study may have on how, and to what extent, antimicrobials are used in U.S. swine operations.  We will be sure to keep a close eye on any developments in this regard and report them to you here.

Sonny Perdue Becomes 31st U.S. Agriculture Secretary

  • On April 24, the U.S. Senate confirmed former Georgia Governor Sonny Perdue as Secretary of Agriculture by a vote of 87 to 11 and on April 25, 2017 he became the 31st United States Secretary of Agriculture. Perdue, 70, grew up on a dairy farm and holds a doctorate in veterinary medicine.
  • In announcing the Senate confirmation of Perdue, Sen. Pat Roberts (R-Kan.), Chairman of the Senate Committee on Agriculture, Nutrition, and Forestry, praised him by stating that during his confirmation hearing, “Governor Perdue demonstrated a real understanding of the challenges facing the agriculture industry and a willingness to work together to find solutions.” Sen. Roberts also noted that, “The Agriculture Committee received many letters in support of his nomination, including support from 6 former U.S. Secretaries of Agriculture representing both Republican and Democratic presidents and another from nearly 700 organizations across the agriculture and food value chain.”
  • President Donald Trump nominated Perdue in January but progress on his confirmation was slow due to media reports suggesting that undoing his various business entanglements caused delays in the ethics filings, according to U.S. News. Perdue filed his disclosure forms in mid-March. The Senate Agriculture Committee held a hearing on Perdue on March 23, and favorably voted him out of the Committee on March 30.
  • When Perdue was nominated as Agriculture Secretary in January, the Grocery Manufacturers Association (GMA) issued the following statement by Pamela G. Bailey, President and CEO of GMA, “As Secretary of Agriculture, Sonny Perdue’s agricultural business background and experience as governor will serve the U.S. well. GMA looks forward to working with him on issues key to keeping America’s food the safest and most affordable food supply in the history of the world.”
  • A statement on USDA’s website provides more information on Secretary Sonny Perdue.

Campylobacter and Salmonella Top CDC’s 2016 List of Causes of Foodborne Illnesses

  • The Foodborne Diseases Active Surveillance Network (FoodNet) has been tracking trends for infections transmitted commonly through food since 1996, collecting data on approximately 15 percent of the U.S. population.  FoodNet is a collaboration of the Centers for Disease Control and Prevention (CDC), 10 state health departments, USDA’s Food Safety and Inspection Service (FSIS) and the Food and Drug Administration.  FoodNet’s research helps industry and public health agencies alike determine where efforts are needed to reduce the burden of foodborne illness.
  • Preliminary data from the CDC’s annual FoodNet surveillance report, released on Friday, April 21, 2017, shows that campylobacter caused the most reported bacterial foodborne illnesses in 2016, followed by salmonella and shigella.  Other key findings of the annual FoodNet surveillance report are summarized here.  Recent regulatory measures developed and implemented by both American federal public health agencies and industry are expected to help stem the prevalence of foodborne illnesses in the U.S.  Some of these measures include:
    • USDA-FSIS: Tighter standards for preventing Salmonella and Campylobacter contamination of ground chicken and turkey products, as well as raw chicken parts such as legs, wings, and breasts
    • FDA: Implementing the FDA Food Safety Modernization Act (FSMA) rules. The first major compliance date was on Sept. 19, 2016, for the preventive controls rules for human and animal food. Larger facilities producing human food must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs). Larger animal food facilities also must also meet CGMPs
    • Chicken industry: Steps to decrease chicken contamination, including vaccinating chicken flocks against Salmonella.
  • It remains to be seen whether this latest report will result in the development of any additional rules or policies seeking to control and prevent foodborne disease.

Beverage Industry Critiques Study Tying Diet Soda Consumption to Stroke and Dementia

  • As our readership is well aware, low-calorie sweeteners have been extensively reviewed by government safety authorities around the world, including the U.S. Food and Drug Administration (FDA), and proven to be safe for consumption.  Over the years, artificially sweetened drinks, like diet sodas, have come under scrutiny in studies attempting to associate the consumption of such drinks with negative health outcomes.  Importantly, no studies have shown an actual cause-and-effect relationship between consumption of artificially-sweetened drinks and increased risk for a negative health outcome.
  • Yesterday, a new study published in the American Heart Association’s journal Stroke reported that artificially sweetened drinks, such as diet sodas, were tied to a higher risk of stroke and dementia.  The study sheds light only on an association and not an actual cause-and-effect relationship between consuming artificially sweetened drinks and an increased risk for stroke and dementia. The study has been covered widely in the press (see e.g., here and here).  The American Beverage Association (ABA) immediately pushed back, highlighting the fact that the authors of the study “acknowledge that their conclusions do not – and cannot – prove cause and effect.”  ABA further notes that, “According to the National Institutes of Health (NIH), many risk factors can increase an individual’s likelihood of developing stroke and dementia including age, hypertension, diabetes and genetics. NIH does not mention zero calorie sweeteners as a risk factor.”
  • Given the substantial scientific literature favoring the safety of low-calorie sweeteners, this latest study – which does not prove cause and effect – will have little impact on the ongoing discourse concerning the safety of low-calorie sweeteners and, in particular, diet sodas, in the long term.

USDA Seeks to Advance “Modernization of Pork Slaughter” Rule

  • As our readership is well aware, USDA’s Food Safety and Inspection Service (FSIS) regulates the production of meat, poultry, and egg products. To help achieve its enumerated food safety goals, FSIS is continuously seeking to develop and promote best practices at slaughter that may be used to prevent, eliminate, or reduce levels of potential microbiological contamination of the food products subject to its jurisdiction.  To this end, in 2014, FSIS published a final rule called the “Modernization of Poultry Slaughter Inspection” (79 FR 49566, Aug. 21, 2014) which requires all poultry slaughter establishments, except for establishments that slaughter ratites, to develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal material throughout the entire slaughter and dressing operation (9 CFR 381.65(g)).  In particular, under the rule, the Agency requires poultry companies to implement prophylactic measures to prevent against Salmonella and Campylobacter contamination, as opposed to simply addressing contamination after it occurs.  A cornerstone of the rule is the Hazard Analysis and Critical Control Points (HACCP) Inspection Model Project (HIMP).
  • Last week, the National Pork Producers Council (NPPC) reported that FSIS is seeking to move forward with a similar rule for pork – a “Modernization of Pork Slaughter” rule. NPPC reports that the regulation would increase efficiency and effectiveness of the federal inspection process and allow for the rapid adoption of new food safety technologies in pork slaughter.  Such a rule could also potentially lead to an increase in U.S. hog slaughter capacity.  Similar to the modernization of poultry inspection rule, the pork version of the rule would involve the implementation of HIMP as an option for hog companies which would effectively facilitate the streamlining of the Agency’s inspection resources, allowing FSIS to partner with the pork industry in a more efficient and effective manner to ensure that safe products are entering the food supply.  Certain food safety responsibilities would be shifted from federal inspectors to packing plant workers and could thus lead to faster pork production lines. Currently, five U.S. pork packing plants are participating in HIMP pilot projects; enactment of a modernization rule would make the system available to all pork packers.
  • Given that industry supports a Modernization of Pork Slaughter rule, we expect that FSIS will be taking steps to roll out a proposed rule in the near future.

U.S. FDA Recognizes Australia as Having a Comparable Food Safety System

  • Today, the U.S. Food and Drug Administration (FDA) announced that the Agency has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to one another. This follows FDA’s decision to recognize New Zealand and Canada as comparable foreign food safety systems in 2012 and 2016, respectively.  In recognizing each other’s systems as comparable, the FDA and Australian Department of Agriculture and Water Resources have expressed confidence that they can leverage each other’s science-based regulatory systems to help ensure food safety.
  • Imports from Australia must continue to comply with U.S. statutory and regulatory requirements to ensure safety and proper labeling, including the new standards adopted under the FDA Food Safety Modernization Act.  As a practical matter, however, FDA’s recognition of Australia’s food system as comparable means that importers of certain foods originating in Australia will face less of a compliance burden with respect to FDA’s Foreign Supplier Verification Program (FSVP) Rule.  Under FSVP, certain types of foods originating from “comparable” countries are excluded from most of the standard FSVP requirements (including hazard analysis and verification requirements) provided that:
    • The food is within the scope of the relevant official recognition or equivalency determination;
    • The importer determines that the foreign supplier of the food is in good compliance standing with the relevant food safety authority; and
    • The food is not intended for further processing in the United States, e.g., packaged food products and raw agricultural commodities (RACs) that will not be processed further before consumption.
  • Keller and Heckman attorneys are well-versed in FSVP requirements (and exemptions), particularly as they relate to foods originating from “comparable” countries.  Please feel free to contact us with any questions at: fooddrug@khlaw.com

Connecticut Debates Sweetened Beverage Tax

  • As previously covered on this blog, a number of local jurisdictions throughout the U.S. have sought to implement a “soda tax”. (See our February 27, 2017 blog and November 15, 2016 blog.) Now Connecticut is considering taxing certain sweetened beverages. Connecticut H.B. 7314 was referred to the Joint Committee on Finance Revenue and Bonding on March 29, 2017 and the committee held a hearing on the legislation earlier this month.
  • The bill would impose a one cent per ounce tax at retail on sweetened beverages. A sweetened beverage is defined as prepackaged, carbonated or noncarbonated nonalcoholic beverage that contains an added caloric sweetener. Milk, nondairy creamers, 100% juices, infant formula and medical food would be exempted. The funds collected from the tax would be placed in a separate account and be used to fund early childhood education and outreach efforts aimed at reducing obesity, heart disease and diabetes.
  • The Hartford Business Journal reported that during the public hearing on the legislation, Republican committee members expressed concern that the money raised from the tax—estimated to be about $145 million annually—would not be spent on the intended programs. Others pointed out that about a third of the tax would be paid for by households that make less than $40,000 per year and that many people would purchase sugary beverages, along with other groceries, in neighboring states if the tax was implemented. Connecticut Voices for Children, Dr. David Katz (Director of Yale University’s Prevention Research Center and former Editor-in-Chief of the journal Childhood Obesity) and others who testified in favor of the legislation suggested that that tax would reduce soda consumption and, therefore, have health benefits. We will continue to monitor efforts by states and local jurisdiction to tax soda and other beverages.

FDA Considering Requests to Maintain or Extend Scheduled Implementation of Nutrition Facts Label Changes

  • As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As the compliance deadline steadily approaches, some in the industry have sought to delay the rule’s implementation.  And, as reported on this blog last week, Scott Gottlieb, President Trump’s nominee to head the FDA has expressed a willingness to consider postponing the deadline for implementing the Nutrition Facts Panel label changes.
  • Against this backdrop, Susan Mayne of FDA’s Center for Food Safety and Applied Nutrition recently announced that FDA is considering requests to maintain the schedule for revamping the Nutrition Facts Label and requests to delay its implementation and coordinate it with USDA’s forthcoming mandatory disclosure requirements for bioengineered foods.
  • With much of the industry and President Trump’s nominee to head the FDA aligned on this issue, a delay to the scheduled implementation of the Nutrition Facts label changes seems increasingly possible if not likely.  We will continue to keep a close eye on any developments in this regard and report them to you here.