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  • In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections.
  • The Q&A explains that, unlike HARPC for human food, FDA decided to stagger the compliance dates for HARPC and related Current Good Manufacturing Practice (CGMP) rules for animal food because there had not been longstanding CGMPs for the animal food industry.  FDA wanted to give industry time to focus solely on the foundation of CGMPs before imposing more onerous HARPC requirements.  FDA states that it will not conduct regulatory inspections for small businesses to evaluate compliance with HARPC requirements until the fall of 2019 in light of industry feedback that more time and technical assistance is needed to comply.
  • Of course, FDA will conduct inspections of small businesses “for-cause” before the fall of 2019 if, for example, a facility has a history of violative product or environmental samples, there is a recall, there are significant observations made during a previous inspection, or the facility is the subject of FDA or state enforcement action.  FDA’s delay of routine inspections should not be seen as a delay in the HARPC compliance date for small businesses, which remains September 17, 2018.
  • On July 31 and August 1, 2018, the U.S. Food and Drug Administration (FDA) participated in a meeting of the Leafy Greens Food Safety Task Force that was formed in response to the outbreak of E. coli O157:H7 associated with romaine lettuce from Yuma, Arizona that occurred earlier this year. During the meeting, FDA shared preliminary hypotheses about possible outbreak causes and the actions necessary to prevent a future occurrence. FDA has previously mentioned that samples of canal water in Yuma tested positive for the outbreak strain of E. coli, and that the contaminated water coming into contact with the produce was a viable explanation for the cause of the outbreak. FDA also discussed that the location of the canal is situated close to a Concentrated Animal Feeding Operation (CAFO) and can hold in excess of 100,000 head of cattle at any one time, and that FDA traceback information showed a clustering of romaine lettuce farms nearby.
  • According to foodsafetynews.com, the Task Force suggested tripling the industry-imposed 400-foot buffer zone to separate leafy greens growing fields from animal feedlots. Members of the California and Arizona Leafy Greens Marketing Agreement are accepting comments on the setback suggestion before making a final decision on required buffer zone size. This suggestion demonstrates the produce industry’s interest to have preventive measures in place before the next growing season.
  • On August 6, the FDA publicly released a statement about the CAFO hypothesis, and added that their experts are continuing to work on examining potential links between the CAFO, adjacent water, and geologic and others facts that may explain the contamination and its relationship to the outbreak. FDA will detail its findings in an environmental assessment report, though the exact release date of the report was not given.
  • As our readers may remember, we’ve previously discussed the outbreak, which was declared officially over on June 28. As a result of the outbreak, five people died and more than 200 others across 36 states were confirmed with infections.

U.S. officials watching international outbreak; no illnesses reported here

107 countries received frozen vegetables recalled for Listeria

  • The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) confirmed Friday they are monitoring an outbreak of Listeria monocytogenes infections (listeriosis) linked to frozen vegetables produced and distributed from a facility in Hungary by Greenyard Frozen after nine people in Europe and one in Australia have died from infections by the outbreak strain.  Listeria monocytogenes IVb sequence type (ST) 6 that matches the outbreak strain from victims was isolated from frozen spinach and frozen green beans sampled at the facility.  It was also isolated in a sample from a floor drain at the packaging area confirming the environmental contamination of the Hungarian processing plant.
  • Food safety officials in Europe reported earlier last week that the implicated frozen vegetables had been distributed to at least 107 countries and territories, including the United States and Canada.  FDA has stated, however, that no current recalls in the United States are associated with the frozen vegetables produced and distributed by Greenyard Frozen.
  • Frozen spinach and frozen green beans may be eligible for an exemption from compliance with FDA’s Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce.  Our detailed summary of the rule is available here.
  • Kratom is a botanical substance that grows naturally in Southeast Asia. FDA classifies kratom as an opioid, noting that it is addictive and has been linked to severe health consequences and deaths among users. Nevertheless, the popularity of kratom has grown in recent years despite kratom not being legally marketed as a drug or dietary supplement in the United States. In February 2014, the FDA issued an import alert that allows U.S. officials to detain imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.
  • As reported on this blog, FDA began cracking down on kratom importers with an administrative detention and seizure in January 2016, and escalated enforcement activity two years later with a voluntary recall and destruction announced February 21, 2018 of several kratom products illegally marketed as dietary supplements and May 22, 2018 warning letters against three kratom products making medicinal drug claims.
  • Salmonella risk became a new focus of concern with kratom for FDA with a mandatory recall order (FDA’s first mandatory recall order ever) announced April 12, 2018 against a kratom product associated with salmonellosis. Throughout the year, FDA announced additional kratom recalls due to salmonella contamination of products from multiple different companies and brands.
  • A Statement From FDA on the Ongoing Risk of Salmonella in Kratom Products (July 2, 2018) outlines the scientific basis for FDA’s conclusion that kratom consumption presents a significant risk of exposure to salmonella. According to FDA, salmonella contamination of kratom has probably been occurring at a significant level for some time and is ongoing. A total of 81 samples of kratom were collected and tested as a direct result of FDA’s investigation of 199 cases of salmonellosis linked to kratom consumption as of May 2018 and 42 (52%) were found to be contaminated with salmonella. FDA further found that kratom is grown and harvested mainly under conditions promoting widespread contamination of foodborne pathogens and that further processing steps to manufacture capsules, powders, and herbal remedies do not appear to eliminate microbial contamination.
  • Since FDA considers kratom to be a dangerous and addictive opioid, it is unlikely that any steps to make kratom products safer with respect to microbial contamination would result in reduced FDA enforcement.
  • On  June 28, 2018 the Centers for Disease Control (CDC) announced that the outbreak of E. Coli linked to romaine lettuce is over.  This outbreak, which sickened at least 210 people in 36 states, with at least five deaths attributed, is believed to have been caused by romaine lettuce grown and harvested in the Yuma (Arizona) growing region, though the outbreak cannot be explained by a single grower, harvester, processor, or distributor.
  • Until recently, the source of the contamination was unknown, but the environmental assessment conducted by FDA and CDC has identified the presence of E. coli with “the same genetic finger print as the outbreak strain” in irrigation canal water from the region.  FDA is continuing to investigate.
  • This is the most recent example of FDA’s use of whole genome sequencing to better understand the source of outbreaks.  The possible connection to irrigation water is bound to cause public health advocates to push for a more immediate compliance date for Agricultural Water Standards than the proposed 2022-2024 (depending on farm size) dates currently under consideration.
  • A May 24 letter from nine consumer and food safety groups urges the U.S. Food and Drug Administration (FDA) “to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak.”  The six-page letter was signed by the Center for Foodborne Illness Research & Prevention; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; Food & Water Watch; National Consumers League; The Pew Charitable Trusts; STOP Foodborne Illness; and Trust for America’s Health.
  • As discussed in this blog, FDA and the Centers for Disease Control and Prevention (CDC) are investigating a multistate outbreak of E. coli O157:H7 illnesses linked to romaine lettuce from the Yuma, Arizona growing region.  A June 1, 2018 update to FDA’s website (devoted to the ongoing investigation), indicates the Arizona Leafy Greens Marketing Agreement has confirmed that romaine lettuce is no longer being produced and distributed from the Yuma growing region and the last date of harvest was April 16, 2018 (i.e., well beyond the 21-day shelf life for Romaine).  However, as noted in the May 24, 2018 letter from consumer and food safety groups, the source of the E. coli contamination has not been precisely identified.  Regarding the lack of traceability requirements for produce, the May 24, 2018 letter states “FDA has no means to swiftly determine where a bag of lettuce was grown or packaged.”
  • Farms are entirely excluded from the traceability requirements of the Bioterrorism Act.  Further, while the Food Safety Modernization Act (FSMA) Produce Safety Rule established specific recordkeeping requirements, traceability coding is not a requirement.  FDA completed a study on enhancing traceability and issued a FSMA-mandated Report to Congress in 2016, but has yet to create a list of high-risk foods and issue a proposed rule for enhanced recordkeeping.
  • It is unlikely that FDA will establish traceability requirements for high risk foods or produce a list of high risk foods (which could potentially include leafy greens) within the 6-month timeframe that is requested by the May 24, 2018 letter.  But greater adoption throughout the supply chain of the Produce Traceability Initiative (PTI),  a voluntary industry system introduced years ago, would make it easier for agencies to track supply chains when investigating illness outbreaks.  It is estimated that only 60% of produce is shipped in cases that have PTI labels.  Other companies may use different traceability programs, using their own codes for a field, a season, a production location, or a commodity.  Consistency in traceability programs would improve the speed and accuracy of tracebacks.
  • According to the Wall Street Journal (paywall), the impact of the recent E. coli outbreak in romaine lettuce continues to ripple through the market, causing a 44.5% drop in retail sales of romaine as compared to the previous year and a 27.6% drop in sales of lettuce overall.
  • Retailers, restaurants, and growers are already facing multiple lawsuits arising out of the lettuce recall, which sickened 172 people in 32 states and which resulted in 1 death and 75 hospitalizations.
  • Aside from identifying Yuma, Arizona as the growing area that was the source of the tainted lettuce, FDA has not otherwise identified the primary source of the outbreak.  The lack of traceability has led to discussions as to whether blockchain, a digital ledger system developed originally to verify cryptocurrency transactions, could help with foodborne illness outbreak traceability in the future.
  • On May 22, 2018 FDA announced that it had issued warning letters to three companies marketing kratom products with medical claims.  FDA’s letter asserts that the claims that the products could be used as pain killers, to reduce opioid dependence, to treat diabetes, to lower blood pressure, and to treat other ailments; are medical claims that have not been reviewed by the Agency.  Such claims, when not approved by FDA, render the products unapproved new drugs.
  • FDA Commissioner Gottlieb indicated that these warning letters are part of a concerted effort to fight the opioid epidemic.  The effort by FDA includes a commitment to “make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies.”  Commissioner Gottlieb encouraged kratom manufacturers to provide FDA a new drug submission if the manufacturers have data that can substantiate medical claims.  Commissioner Gottlieb’s call for submissions specifically noted pain treatment or opioid addiction claims.
  • These warning letters come on the heels of widespread salmonella contamination of kratom containing products, resulting in multiple recalls, a 2016 seizure of kratom products promoted with unapproved drug claims, and FDA’s general emphasis on addressing the opioid crisis.  The actions are also consistent with FDA’s recent crackdown on youth tobacco use, another FDA strategic priority.  It is clear that FDA is taking, and will continue to, take, aggressive steps to pursue its strategic priorities.  For manufacturers, distributors, and retailers of products that might be impacted, increased vigilance to ensure compliance with all regulations and laws impacting the your products is in order.  Those wishing to make medical claims on products will need to determine if such claims will render their product a new drug and take actions (potentially including submitting new drug application to FDA) consistent with this assessment.

The Daily Intake will return on Tuesday, May 29.  We extend our best wishes to those of you celebrating the Memorial Day holiday.

  • One week after suggesting that adults and children reduce their intake of trans fatty acids to less than 1% of total energy intake (see our May 8, 2018 blog for details), the World Health Organization (WHO) released a plan aimed at eliminating industrially-produced trans fatty acids from the global food supply. The plan, REPLACE, is in the form of a step-by-step guide.
  • REPLACE consists of six steps:
    • REview dietary sources of industrially-produced trans fats and the landscape for required policy change
    • Promote the replacement of industrially-produced trans fats with healthier fats and oils
    • Legislate or enact regulatory actions to eliminate industrially-produced trans fats
    • Assess and monitor trans fats content in the food supply and changes in trans fat consumption in the population
    • Create awareness of the negative health impact of trans fats among policy makers, producers, suppliers, and the public
    • Enforce compliance of policies and regulations
  • WHO estimates that trans fat leads to more than 500,000 deaths of people from cardiovascular disease each year. WHO is calling on governments to use the REPLACE action package to achieve the elimination of industrially-produced trans fatty acids from the global food supply, which was identified as one of the priority targets of WHO’s strategic plan, the draft 13th General Programme of Work (GPW13). As part of the U.N.’s Sustainable Development Goals, the global community has committed to reducing premature death from noncommunicable diseases by one-third by 2030.
  • As previously reported on this blog, the U.S. Food and Drug Administration issued a final determination on June 16, 2015, revoking the GRAS status for partially hydrogenated oils (PHOs) based on the link between trans fats and health risks. The compliance date is June 18. FDA has in presentations indicated that recalls of products containing PHO’s will not be required where the products were introduced in interstate commerce before that date (IEG Policy – subscription required). Agency officials promise further clarification will also be provided shortly.
  • According to the UN World Health Organization (WHO), South Africa is currently in the middle of the largest listeria outbreak ever seen.  As of this week, the outbreak has sickened almost 1,000, with at least 180 fatalities, and has received extensive press coverage globally (see e.g., here and here).  The cause of the outbreak has been unknown for the past several months.
  • On March 4, 2018, the South African health minister stated that the source of the outbreak was linked to a nationally popular ready-to-eat (RTE) meat product called “polony” manufactured by two unrelated brands. The products are being recalled. Africa’s health ministry is now concerned about the risk of cross-contamination and so has advised members of the public to avoid all processed meat products that are sold as ready-to-eat.
  • This event will inevitably lead the implicated companies to revisit their respective food safety protocols, and could potentially lead regulators in South Africa to consider new approaches to achieving food safety goals with specific regard to RTE meat products.