• As reported on this blog in October 2017, the U.S. Food and Drug Administration (FDA) proposed a rule to revoke a regulation authorizing the use of a health claim on the relationship between soy protein and coronary heart disease (CHD) (21 CFR 101.82) on the label or in the labeling of foods. FDA estimates that 200 to 300 products currently use that health claim.
  • By way of background, FDA authorized the health claim about the relationship between soy protein and reduced risk of CHD in 1999 in response to a petition from Protein Technologies International, Inc. (now DuPont Nutrition & Health). In 2007, FDA announced its intent to re-evaluate the scientific evidence for certain health claims, including the authorized health claim for soy protein and risk of CHD. After considering new research conducted over the last 18 years, FDA tentatively determined that “the strength of the totality of the publicly available data does not meet the SSA [significant scientific agreement] standard for a relationship between soy protein intake and CHD risk.
  • FDA received 994 comments on that proposal (click here to access the comments). Most of the comments were from individuals supporting revocation of the heart health claim for soy protein. However, DuPont Nutrition & Health suggested in comments that, “by modifying the existing status of the soy heart health claim, FDA is not meeting [its] mandate for providing clear, evidence-based guidance that is practical and actionable.” Dupont agreed with FDA’s approach to limit or omit many of the 709 publication on the relationship between soy and heart health but questioned the criteria used. For example, noted Dupont, over half of the studies considered by FDA were conducted outside North America and, therefore, are not relevant to the U.S. population. Dupont also stated that FDA didn’t include studies that potentially better reflected the dietary patterns and health status of the current population.
  • “Soy protein can be included in the diet along with other recognized components that have a beneficial effect on heart health, in alignment with current Dietary Guideline, suggesting a greater shift toward plant-based eating,” Dupont concluded.
  • Last week, we reported that the White House Office of Management and Budget (OMB) cleared USDA’s “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process for pork and to allow for the rapid adoption of new food safety technologies in pork slaughter.  The rule could potentially lead to an increase in U.S. hog slaughter capacity.
  • On January 19, 2018, USDA released the proposed rule. Under the proposed rule, hog slaughter plants could voluntarily join a new inspection system whereby establishment personnel would be responsible for sorting and removing unfit animals and identifying defects before FSIS inspection. FSIS inspectors who currently perform this function would be moved to other areas of the plant focused more on food safety. FSIS online inspectors would be reduced to a maximum of three per line per shift.  The rule also specifically proposes to lift caps on line speeds in processing plants.
  • FSIS will be accepting stakeholder comments on the proposed rule for 60 days following its imminent publication in the Federal Register. If you have any questions concerning the proposed rule or any other USDA-related questions, please contact us at fooddrug@khlaw.com
  • As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current recall process can be too slow and puts consumers at risk.  Yesterday, FDA Commissioner Dr. Scott Gottlieb announced plans to strengthen the recall process for food, drugs, medical devices and cosmetics.
  • Today, FDA published a draft guidance (83 FR 2758) aimed at clarifying its approach to notices and warnings about recalled products to ensure consumers learn about such issues in a more timely way.  The Federal Register Notice announcing the draft guidance states that the intent of the draft guidance is to “increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled.” FDA also states that the draft guidance “clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.”
  • The draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The draft guidance also sets out the Agency’s policy for posting recalls to FDA’s Enforcement Report before a final health risk determination is made.
  • In a press release, Dr. Gottlieb stated that new policies regarding the type of information the FDA shares with the public to identify “hazardous recalled food,” as well as a new approach to publicizing food recalls are being developed.
  • FDA will be accepting comments on the draft guidance until March 20, 2018. Keller and Heckman attorneys regularly advise clients on product recall and related crisis management matters and stand ready to assist interested parties with preparing stakeholder comments on the draft guidance.  We may be reached at fooddrug@khlaw.com
  • On January 11, 2018, the U.S. Food and Drug Administration released its Strategic Policy Roadmap for 2018.
  • As part of its Strategic Policy Roadmap, FDA has signaled its intent to modernize certain standards of identity to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat. To accomplish this goal, FDA intends to issue a request for information to identify and help prioritize which potential standards of identity should be modernized based on their public health value.
  • The modernization of certain standards of identity could conceivably lead the FDA to wade into the controversial plant-based milk and cheese debate this year.  It remains to be seen which standards the Agency ultimately decides to tackle. Finally, we estimate that the process will take many years to complete as it involves formal notice and comment rulemaking possibly including revisions to existing regulations and promulgation of new regulations.
  • Last year, we reported that USDA’s Food Safety & Inspection Service intends to move forward with plans to modernize swine slaughter inspections by way of a “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process for pork and to allow for the rapid adoption of new food safety technologies in pork slaughter.  The rule could potentially lead to an increase in U.S. hog slaughter capacity.  The rule also calls for certain food safety responsibilities to be shifted from federal inspectors to packing plant workers and could thus lead to faster pork production lines.
  • This week, the White House Office of Management of Budget (OMB) cleared the rule.  OMB’s approval is the last step in the rule-making process before the Modernization of Swine Slaughter Inspection Rule is finalized for publication in the Federal Register.
  • Although some pushback is expected from food and worker safety advocates, the “Modernization of Pork Slaughter” rule – which bears many similarities to the “Modernization of Poultry Slaughter Inspection” rule – is anticipated to ultimately become law.  (As our readership will recall, food and worker safety advocates met with OMB officials in 2012 seeking to upend USDA’s efforts to implement the poultry rule which has since become law).  We will, of course, continue to keep an eye on any developments related to the “Modernization of Pork Slaughter”  rule as they unfold and report them to you here.
  • Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. 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” must be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim.
  • FDA denied a request for the use of a qualified health claim suggesting that the consumption of vitamin D may reduce the risk of developing multiple sclerosis (MS) in healthy individuals. The petition, submitted on June 3, 2016, requested that FDA authorize the claim for use on the labels of conventional food and dietary supplements containing vitamin D. In a letter to the petition submitter, FDA stated that after reviewing 85 publications submitted with the petition and all of the publications cited in the petition’s appendix, and conducting an independent literature review, it concluded that “there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of MS.”
  • FDA also stated that it considered the use of a disclaimer or qualifying language to accompany the proposed claim for Vitamin D intake and a reduction in the risk of multiple sclerosis, but concluded that neither would suffice to prevent consumer deception. FDA concluded the letter by stating that it would evaluate any new scientific information that becomes available that supports the use of a qualified health claim or significant scientific agreement if it is submitted to the Agency.

 

  • 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.
  • This week, the Centers for Disease Control and Prevention (CDC) announced that the use of whole genome sequencing to monitor for outbreaks of Listeria, Salmonella, Campylobacter and coli that are commonly transmitted through food and animal contact has expanded to 38 states and two cities. This data is reported in the CDC’s Antibiotic Resistance (AR) Investment Map, which shows early progress by states to combat antibiotic resistance. This year’s Antibiotic Resistance Investment Map features more than 170 state-reported successes, including rapidly identifying and containing rare and concerning resistant germs to protect communities. Each state reported multiple successes.
  • You can learn more about CDC’s AR Solutions Initiative and ongoing work to combat antibiotic resistance at cdc.gov/DrugResistance.
  • As previously covered on this blog, mandatory country of origin labeling (COOL) rules for beef products have long been the subject of controversy and challenge, culminating in: (1) a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and (2) Congress repealing COOL as of December 21, 2015.
  • Since then, some states have sought to require COOL labeling for beef within their states.  For example, as previously reported on this blog, in 2017, Wyoming, South Dakota and Colorado considered state-level COOL legislation, but in each case, the measures were defeated.
  • Against this backdrop, on January 5, 2018, Colorado state legislators introduced a bill titled “Beef Country of Origin Recognition System” also referred to as the “Beef COORS bill.”  If passed, the bill would require Colorado retailers to post signage informing consumers whether beef was derived exclusively from animals that were born, raised, and slaughtered in the United States, or whether the beef was imported or derived from imported animals.
  • As states like Colorado continue their attempts to implement stronger versions of COOL at the behest of livestock producers, efforts to reinstate COOL at the federal level continues.  For example, in November 2017, Public Justice, The Ranchers-Cattlemen Action Fund (R-CALF), Food & Water Watch, and Farm Aid delivered the signatures of 37,299 Americans demanding that the Trump Administration follow through on its campaign promise to create a level playing field for independent domestic meat producers through increasing transparency for consumers, i.e., that COOL comprise a key element of the Administration’s North American Free Trade Agreement (NAFTA) renegotiations.
  • Given the controversial nature of COOL requirements, it remains to seen whether we will see COOL implemented at the state or federal level.
  • The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is proposing to amend the egg products inspection regulations by requiring official plants that process egg products to develop Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with the meat and poultry regulations. Under the HACCP system, plants that process egg products will be afforded the flexibility to tailor a food safety system that best fits their particular facility and equipment.
  • Highlights of the proposed rule include:
    • Those regulatory provisions not consistent with that of USDA’s meat and poultry regulations would be eliminated
    • Generic approval would be permitted as part of the prior label approval system for egg products
    • Labeling requirements for shell eggs would be updated to be consistent with those in the U.S. Food and Drug Administration’s (FDA’s) regulations
    • Special handling instructions would be required on egg products
    • Requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment would be eliminated
    • Egg products plants would be incorporated into the coverage of the “Rules of Practice” that the Agency follows when initiating administrative enforcement actions and
    • The Agency’s interpretation of the requirement for “continuous inspection” set out at 21 U.S.C. 1034(a) would be changed to be consistent with current inspection requirements applicable to meat and poultry processing operations such that inspection in egg products plants would be required at least once per shift, instead of during all processing operations.
  • USDA will be accepting comments on the proposed rule for 120 days following its imminent publication in the Federal Register. Keller and Heckman attorneys stand ready to assist interested parties with preparing comments for submission to the Agency and may be reached at fooddrug@khlaw.com.
  • As previously reported on this blog last month, Washington State Department of Natural Resources (DNR) announced the termination of Cooke Aquaculture Pacific’s Port Angeles net pen lease for salmon farming. Canadian-based Cooke Aquaculture (Cooke) filed a lawsuit in Clallam County Superior Court on January 4, 2018, claiming that the decision to terminate the lease was based on erroneous and outdated information about the condition of the facility, and that closing the net pen operations will result in the loss of jobs.
  • As background, DNR approved the transfer of the lease to Cooke in 2016 when it purchased Icicle Seafoods. Since the Commissioner of Public Lands at that time “raised no concerns or objections to the manner in which Cooke’s predecessor company was managing the leased aquatic area,” the announcement to terminate the lease came as a surprise, stated Cooke in a press release.
  • Cooke representatives would like to meet with the current Commissioner of Public Lands, Hilary Franz, to discuss the basis for DNR’s decision to terminate the Port Angeles net pen operations. However, Cooke Vice President for Public Relations Joel Richardson explained, “While we regret the need to file suit before meeting with the Commissioner, we were required to do so in order to protect the company’s legal rights.” Hilary Franz issued a statement on January 5 that stated, in part, “The basis for terminating Cooke Aquaculture’s lease at its Port Angeles facility was made clear to the company and the public. My team will vigorously defend the termination against this meritless lawsuit.”
  • The day after Cooke filed the lawsuit, a bill to address the escape of nonnative fish populations—such as farmed salmon—was introduced in the Washington legislation. HB 2418 would implement a moratorium on new or extensions of leases for net pens for at least two years until a new review and certification process is developed. The review would determine how to protect: the health and safety of Washington waters and marine ecosystems, Pacific salmon health and habitat, and tribal treaty fishing rights. After the moratorium ended, new permits would not be issued unless it could be determined that there would not be any negative impact to those areas.
  • In a press release about the bill, Rep, Mike Chapman (D-Port Angeles) stated, “None of us want to have Atlantic salmon farmed in our waters, but immediately pulling the rug out from under businesses who have contracts is going to result in immediate litigation and at a huge cost to taxpayers. Instead of picking winners and losers, this bill lets businesses determine their best course of action while the state keeps our waters protected.”