• As previously reported on this blog, the Food and Drug Administration (FDA) received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” – which has not changed since 1994 – to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.  In September 2016, FDA issued a request for comments on the use of the term “healthy” on food labels, and by April 26, 2017, the Agency received over 1,000 comments.
  • On October 15, 2017, the Wall Street Journal (WSJ) interviewed FDA Commissioner Dr. Scott Gottlieb about the direction of the FDA under the current administration.  Commissioner Gottlieb acknowledged that claims should not be defined in the “absence of scientific framework” or by the courts without FDA review.   Commissioner Gottlieb went on to explain that FDA intends to “adjudicate some of the important claims that product developers want to make on labeling that could be important in informing consumers.”  Commissioner Gottlieb also stated “[w]e’re taking a more wholesale look right now inside the agency at the full range of claims that product developers want to make on labeling or are making on labeling where FDA hasn’t played a role, and making a decision from a public-health standpoint where it is important for us to step in.”  With regard to the “healthy” claim Commissioner Gottlieb stated that FDA “might make a decision that the claim is more of a commercial claim and doesn’t really convey something important from a public-health standpoint to a consumer.”  This could imply that FDA may not be taking action on “healthy” claims in the near future.
  • Commissioner Gottlieb’s interview suggests the Agency will continue to review and develop labeling claims to promote public health and prevent outside forces from defining those claims but will not address those claims that they view as simply commercial.   This presumes that companies will want to use defined claims that FDA has decided have an impact on public health as opposed to commercial claims that may in the company’s view better promote their products value to the consumer.
  • As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under the Food Safety Modernization Act (FSMA) became effective on November 16, 2015.  Covered large and small businesses are now required to be in compliance with the animal food CGMP requirements. Very small businesses must comply by September 17, 2018.  As of September 18, 2017, large animal food producers were also required to comply with the preventive controls provisions mandated by FSMA.
  • Today, the FDA released two guidance documents intended for facilities that may be subject to the Preventive Controls for Animal Food rule or the Preventive Controls for Human Food rule.
    • The first guidance document, entitled “Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals,” will assist animal food facilities that are subject to the Current Good Manufacturing Practice (CGMP) requirements for animal food at 21 CFR Part 507 Subpart B.  The guidance document further elaborates on the following:  (1) applicability of the animal food CGMPs especially with regard to facilities that handle human and animal food, (2) training and qualification requirements, (3) recordkeeping requirements; and (4) further discussion of the specific animal food CGMPs. Appendix B of the guidance document is a Self-Assessment Tool,  that facilities may use to evaluate their compliance with the animal food CGMP requirements.
    • The second guidance document, entitled “Application of the ‘Solely Engaged’ Exemptions in Parts 117 and 507,” addresses the applicability of the “solely engaged” exemptions for the Preventive Controls for Human Food and Preventive Controls for Animal Food rules. In particular, it explains when facilities are exempt from CGMP or preventive controls requirements because they are “solely engaged” in certain activities. The document also explains the circumstances under which the “solely engaged” exemptions do not apply (i.e., when a facility is also conducting certain other activities).  The “Solely engaged” draft guidance is open for a 180-day public comment period.
  • FDA has indicated that they intend to issue separate guidance to address hazard analysis and preventive controls for animal food in the future.
  • 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).  The ABA lost at trial court and on appeal before the state’s Commonwealth Court. Most recently, on 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.
  • In the meantime, the ABA has been endeavoring to have the Philadelphia City Council repeal the tax. And, just yesterday, a pair of Philadelphia politicians – Pennsylvania State Sen. Anthony Williams, D-Philadelphia and Philadelphia City Commissioner Alan Butkowitz – railed against the city’s controversial sweetened beverage tax in a Pennsylvania Senate hearing Tuesday.  While proponents of the bill argue that the tax will help expand pre-K and upgrade parks and recreation centers, Sen. Williams and City Commissioner Butkowitz contend that these goals should be funded instead by sustaining the current wage tax.
  • Coming on the heels of Illinois’ Cook County ending its tax on soda and sugar drinks earlier this month, it remains to be seen how the Philadelphia tax will fare and what, if any, impact the outcome in Philadelphia will have on the appetite of other U.S. jurisdictions to pursue similar legislation.
  • As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This 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. On June 28, 2017, USDA’s Agricultural Marketing Service (AMS) 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. One of those questions is:
    • “Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops?”
  • USDA has not yet posted the comments it has received, which were due by August 25, 2017; however, several organizations have posted the comments they submitted in response to the questions. Among the organizations supporting disclosure were the Grocery Manufacturers Assn. (GMA), the International Dairy Foods Assn. (IDFA)and the Consumers Union. Noting that excluding highly refined ingredients (HRI) from the scope of the mandatory disclosure standard would result in roughly 80% fewer products being subject to the disclosure requirements under the federal law, GMA wrote, “A clear, simple, and consistent mandatory disclosure standard that includes HRI will assist manufacturers in educating consumers about biotechnology as a safe and beneficial method of plant breeding.”
  • In contrast, the Information Technology & Innovation Foundation (ITIF) and The Biotechnology Innovation Organization (BIO) are opposed to mandatory disclosure of HRI. ITIF suggested that some refined products do not contain residual DNA sequences and that “[t]here are not analytical methods that would allow such products to be identified as coming from ‘GM’ plants or animals vs. others.”
  • While USDA develops mandatory disclosure requirements for bio-engineered foods, a number of class action laws suit have been filed suggesting that products containing GM ingredients are falsely labeled as natural. For example, last week, the U.S. Supreme Court refused to hear a bid by Conagra Brands Inc. to avoid a class-action lawsuit concerning cooking oil labeled 100% natural that contains GM ingredients (see S. News). And earlier this month, Frito-Lay North America agreed to not make any non-GMO claims on certain products “unless the claim is certified by an independent third-party certification organization”(see Food Navigator).
  • We will continue to monitor developments on the National Bioengineered Food Disclosure Standard and report them to you here.
  • USDA’s Food Safety and Inspection Service (FSIS) regulates the production of meat, poultry, and egg products. In 2014, FSIS published a final rule called the “Modernization of Poultry Slaughter Inspection” (79 FR 49566, Aug. 21, 2014) which amended the poultry regulations to establish an additional inspection system, called the New Poultry Inspection System (NPIS), for young chicken and turkey slaughter establishments. Under the final rule, the maximum line speed for young chicken slaughter establishments that operate under NPIS is 140 birds per minute.  See 9 C.F.R. 381.69(a).  On September 1, 2017, the National Chicken Council (NCC) petitioned  USDA-FSIS to implement a waiver system to permit young chicken slaughter establishments participating in the NPIS and the Salmonella Initiative Program (SIP) to operate without the line speed limitations imposed under the NPIS.  See previous blog coverage here.
  • On Friday, October 13, 2017, USDA-FSIS announced a 60-day period for the public to comment on the chicken industry’s petition to waive line speed restrictions under the New Poultry Inspection System (NPIS).
  • Because NPIS places organoleptic inspection duties in the processor’s hands and transfers FSIS inspectors to food safety verification procedures later in the production process, line speeds have become a particularly hot-button issue.  For example, earlier this year, Rep. Doug Collins (R-GA) sent a letter to USDA Secretary Sonny Perdue urging the Agency to bump maximum line speeds to 175 birds per minute from 140.  Rep. Collins contends that bumping the line speed would make U.S. poultry processing facilities more competitive in the global marketplace, noting that poultry producers in South America, Asia, Canada, and Europe are safely operating at line speeds that outpace the maximum speeds allowed in American facilities.  In response, a group of House Democrats, urged USDA to reject the renewed call to increase line speeds in poultry-processing plants, citing “detrimental effects” to food, worker and animal safety.
  • USDA will be accepting comments on NCC’s petition for the next 60 days (or until December 13, 2017).  Given the controversy surrounding this issue, it remains to be seen how USDA will ultimately respond to the petition.
  • 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 contributed to these efforts, 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.  Now, San Francisco is at the forefront of efforts to curb antibiotic use in food producing animals.
  • On October 3, 2017, the San Francisco Board of Supervisors unanimously approved an ordinance requiring major grocery chains to report information about antibiotic use in the raising of livestock, becoming the first U.S. city to do so.  The ordinance, which is scheduled to take effect in April 2018, requires grocers that own or operate 25 or more stores to submit annual reports that include the purposes for which the antibiotics were used, the number of animals raised, the total volume of antibiotics administered and whether the use was “medically important.” Grocers who violate the ordinance may be subject to fines (as much as $1,000 per day) or imprisonment.
  • Since no similar federal measures are expected in this arena in the near term, it is not inconceivable that other localities may seek to follow San Francisco’s lead.  We will monitor developments in this regard and report them to you here.
  • On April 18, 2017, as the House Committee on Appropriations marked up the FY 2017 agriculture spending bill, more than 65 agriculture and food industry groups sent a letter to Congress urging Congress to appropriate $3 million to FDA to fund a joint FDA/USDA consumer outreach program to educate consumers about foods produced with genetically modified organisms (GMOs).  In May 2017, as part of an overall federal budget agreement that prevented a government shutdown, the requested $3 million was appropriated to FDA to spearhead this initiative.
  • Today, FDA announced that the initial phase of its Agricultural Biotechnology Education and Outreach Initiative will involve two public meetings in November 2017 to be held in Charlotte, North Carolina, and San Francisco, California.  The Charlotte, NC meeting will be held on November 7, 2017 and the San Francisco, CA meeting will be held on November 14, 2017. FDA also announced that it will be opening a docket to receive public comments.
  • The FDA states that the goal of this initiative is to provide consumer outreach and education through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of agricultural biotechnology.  For additional information and to register for the upcoming meetings, click here.
  • On September 22, 2017, following an inspection of the company’s manufacturing facility, the U.S. Food and Drug Administration (FDA) issued a warning letter to Nashoba Brook Bakery regarding significant current Good Manufacturing Practice (cGMP) violations.  cGMPs describe the methods, equipment, facilities, and controls for producing food.  cGMPs prescribe the minimum sanitary and processing requirements for producing safe and wholesome food, and are an important part of regulatory control over the safety of the nation’s food supply.  In their warning letter, the FDA deemed Nashoba’s food adulterated for failure to manufacture foods in accordance with the cGMP requirements in 21 CFR Part 110 because the foods had been prepared, packed, or held in unsanitary conditions whereby they might have become contaminated with filth, or whereby they might have been rendered injurious to health.  Noted violations included failure to maintain sanitary buildings, fixtures, and facilities in order to prevent food from becoming adulterated, as required by 21 CFR 110.35(a), as well as a failure to provide an adequate screening or protection against pests, as required by 21 CFR 110.20(b)(7).  (As our readership is well aware, Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size.  Here, Nashoba Brook Bakery is subject to Part 110 due to its business size).
  • FDA also found several labeling violations, and one in particular caught media attention.  Based on FDA review, the granola products were found to be in violation of the food labeling regulations, 21 CFR Part 101, which causes the products to be misbranded within the meaning of Section 403 of the Food, Drug, and Cosmetic Act (FD&C Act).  As Law360 first reported, the Nashoba Brook Granola label listed the ingredient “Love.”  As our readers may know, ingredients required to be declared on the label or labeling of food must be listed by their common or usual name.  21 CFR 101.4(a)(1).  According to the FDA, “love” is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.  Nashoba CEO John Gates disagreed with FDA’s position on “love,” and stated, “[t]elling an artisan bakery that we can’t list love in our ingredients in our granola feels overreaching.”
  • FDA made clear, however, that the concerns about “love” were “not among the agency’s top concerns.”  The FDA stressed the significance of the sanitary issues found during the inspection, and the need for the company to follow the cGMPs and correct the violations noted in the warning letter.
  • As previously reported on this blog, a Cook County Ordinance that imposes a $0.01 per ounce tax on the retail sale of sweetened beverages became effective August 2. The unpopular tax applies to bottled sweetened beverages and makes soda sold in Chicago among the most expensive in the country.
  • Cook County Commissioner Sean Morrison announced on Friday that he had reached an agreement with of 11 of his fellow commissioners to support the Sweetened Beverage Tax Repeal Ordinance. That would be enough votes to override a veto by Cook County Board President Tony Preckwinkle. The ordinance would eliminate the beverage tax effective December 1, 2017, which is the beginning of Cook County’s Fiscal Year. The Repeal Ordinance will be called for a vote at today’s (Oct. 10) meeting of the Cook County Finance Committee.
  • The Cook County Sweetened Beverage Tax was originally passed to eliminate a $200 million budget shortfall. Addressing concerns about the budget shortfall once the tax is eliminated, Morrison stated, “I’m committed to working in a bipartisan and constructive manner with all of my board colleagues, President Preckwinkle and her administration to take the needed steps to find the fiscal solutions to create a balanced and responsible 2018 Budget for Cook County.”
  • Created in 2011, the Interagency Food Safety Analytics Collaboration (IFSAC) is a partnership of three federal agencies—the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the Food Safety and Inspection Service of the United States Department of Agriculture (FSIS). IFSAC aims to enhance the coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use.  In particular, IFSAC’s projects and studies seek to identify foods that are important sources of human illness and focuses its analytic efforts on four priority pathogens: Salmonella, Escherichia coli ( coli) O157:H7, Listeria monocytogenes (Lm), and Campylobacter.  IFSAC’s success is tied, in large measure, to its work with key partners, including federal and state public health and regulatory agencies and industry stakeholders.
  • Today, FDA announced that IFSAC will host a webinar on October 20, 2017 to discuss its latest report on updated foodborne illness source attribution estimates using outbreak data for 2013 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter. During the webinar, experts will share results from the report and discuss IFSAC’s approach to analyzing outbreak data to estimate which foods are responsible for foodborne illnesses related to specific pathogens.
  • For additional information on this webinar and to register, click here.