May 2021 Regulatory Update | 2 of 2

These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from May 16-June 11, 2021. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business.

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FDA UPDATES

  • FDA Releases Results of FY20-FY21 Romaine Lettuce Sampling Assignment MUST READ
  • FDA Requests $6.5B for FY22 Budget MUST READ
  • FDA Launches Challenge to Encourage Development of Food Traceability Tools

FDA WARNING LETTERS (MAY)

  • FDA Sends Warning Letter to MnM Spices Corporation for Foreign Supplier Verification Program (FSVP) Violation
  • FDA Sends Warning Letter to Lux Commercial Group LLC for Foreign Supplier Verification Program (FSVP) Violation

OTHER DEVELOPMENTS

  • Court Issues Consent Decree Against Real Water Inc. MUST READ
  • Multiple Enoki Mushroom Products Recalled for Potential Listeria monocytogenes Contamination

FDA UPDATES

FDA Releases Results of FY20-FY21 Romaine Lettuce Sampling Assignment
May 25:FDA released the findings of its sampling assignment to detect pathogens linked to outbreaks of foodborne illness, specifically Salmonella spp and pathogenic Shiga toxin-producing E. coli (STEC), in raw agricultural commodity romaine lettuce from the Salinas, California, and Yuma, Arizona growing regions. Sample collection and testing took place between November 2019 and December 2020, with a pause from March through October 2020 due to the COVID-19 pandemic.

According to FDA’s sampling assignment report, “[t]he agency prioritized sample collection at FDA-registered facilities and farms identified in traceback investigations as possible suppliers of romaine lettuce linked to outbreaks of foodborne illnesses from 2017 to 2019. FDA investigators collected samples from wholesalers, distribution centers, on-farm holding locations, and commercial cooling and cold storage facilities...No samples were collected from farm fields.”

All 279 of the romaine lettuce samples that FDA tested were negative for Salmonella spp. and strains of E. coli capable of causing serious illness. In its discussion of the results, the agency concluded that “[t]he findings of this assignment suggest that microbial contamination – to the extent that it may have been present – was not widespread at the 137 FDA-registered facilities and farms where agency investigators collected samples during the period of this field activity.” FDA did note the shortcomings of its assignment, however, acknowledging its relatively small sample size. 

Read FDA’s Constituent Update here and sampling assignment results here.

 

FDA Requests $6.5B for FY22 Budget
May 28: FDA requested a total budget of $6.5 billion for its fiscal year (FY) 2022 budget, which covers the period from October 1, 2021 through September 30, 2022. The agency’s request would reflect an approximately 8% ($477 million) increase from its FY 2021 funding level and would include budget authority increases in a few key areas.

In its budget request, FDA proposed $185 million for investments in the agency’s critical public health infrastructure, including “enterprise-wide data modernization, improvements to its federal buildings and facilities, expanded laboratory safety efforts and increased internal capacity to support the agency’s growing workforce of over 18,000,” according to FDA’s Constituent Update.

FDA’s budget request also included $97 million for investments in its core food and medical product safety programs, including “funding to support implementation of the New Era of Smarter Food Safety Blueprint…strengthening animal food safety oversight…increasing drug safety surveillance and oversight; and improving animal drug safety and predictive technologies.”

Additionally, FDA requested $61 million for investments in strategies to address public health needs, including “increasing safe and secure inspections, promoting health equity and addressing the opioid crisis by supporting development of new therapies and smarter enforcement.”

Read FDA’s Constituent Update here and the FDA Fiscal Year 2022 Fact Sheet here (PDF).

 

FDA Launches Challenge to Encourage Development of Food Traceability Tools
June 1: FDA announced its launch of the “New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge,” which will advance a major goal set forth in its July 2020 New Era of Smarter Food Safety blueprint: encouraging the development of low- to no-cost tech-enabled food traceability solutions.

According to FDA’s News Release, the challenge invites submissions of “food traceability solutions that utilize economic models that are affordable, with costs that are proportional to the benefits received and can scale to encourage widespread adoption.”  Specifically, the agency is seeking “tech-enabled solutions that address the traceability needs and challenges unique to one or more segments of the human and animal food supply chain,” i.e. primary producers, importers, manufacturers and processors, distributors, and retailers.

Challenge contestants may submit solutions based on new or innovative models that would be affordable for smaller businesses or based on “existing or new scalable and cost-effective hardware, software or data analytics platforms.”

FDA will accept submissions from June 1 through June 30, 2021, after which it will announce up to 12 challenge winners. Challenge winners will not receive cash prizes, but they will be given the opportunity to present their work publicly in a September 2021 webinar. 

Read FDA’s News Release here. Visit the challenge registration page here.


FDA WARNING LETTERS (MAY)

FDA Sends Warning Letter to MnM Spices Corporation for Foreign Supplier Verification Program (FSVP) Violation 

May 18:FDA sent a warning letter to Illinois-based food importer MnM Spices Corporation for its “significant” violation of the Foreign Supplier Verification Program (FSVP) regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the importer failed to develop, maintain, and follow FSVPs for any of its imported foods, including its imported plain steamed rice, dates, shelled pine nuts. Furthermore, the company had not made any corrections to its prior FSVP violation, which FDA had noted at the conclusion of its initial FSVP inspection in August 2018.

FDA gave MnM Spices Corporation 15 working days from its receipt of the letter to address its violations.

Read FDA’s warning letter here. Read the FSVP final rule here and learn more about it here.

 

FDA Sends Warning Letter to Lux Commercial Group LLC for Foreign Supplier Verification Program (FSVP) Violation 

May 18:FDA sent a warning letter to Texas-based food importer Lux Commercial Group LLC for its “significant” violation of the Foreign Supplier Verification Program (FSVP) regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the importer failed to develop, maintain, and follow FSVPs for any of its imported foods, including its imported mango drink, corn chips, and corn flour. Furthermore, the company had not responded to the form on FSVP Observations that it received at the conclusion of FDA’s initial FSVP inspection in March 2019. 

FDA gave Lux Commercial Group LLC 15 working days from its receipt of the letter to address its violations.

Read FDA’s warning letter here. Read the FSVP final rule here and learn more about it here.


OTHER DEVELOPMENTS

Court Issues Consent Decree Against Real Water Inc.
June 1:The District Court of Nevada entered a consent decree of permanent injunction between the U.S. and shareholders and representatives of Real Water Inc., a Nevada-based bottled water manufacturer whose “Real Water” brand alkaline water was linked to an outbreak of acute non-viral hepatitis reported to FDA in March 2021. The consent decree requires Real Water Inc. to cease its operations until it takes specific steps to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

In the Department of Justice’s (DOJ) complaint filed on FDA’s behalf, DOJ alleged that Real Water Inc. had violated the FD&C Act by failing to control food hazards; failing to follow current good manufacturing practice (CGMP) requirements for bottled water; failing to declare the common name of each ingredient in its product labels; and preparing, packing, or holding its products under insanitary conditions that could lead to contamination.

The consumption of “Real Water” brand alkaline water was linked to at least 16 cases of acute non-viral hepatitis in children and adults between March 2021 and the issuance of the consent decree. FDA issued an outbreak advisory about the “Real Water” product on March 16, 2021, and on March 24, 2021, Real Water Inc.’s Arizona and Nevada locations issued a recall.

Under the consent decree, Real Water Inc. may not resume its operations until it takes various corrective actions. Specifically, it must hire a qualified independent expert to inspect its facilities to ensure compliance with the FD&C Act. Furthermore, it must “establish and implement procedures that are adequate to ensure continuing compliance with CGMP and preventive controls requirements and receive authorization from the FDA,” according to FDA’s Constituent Update.

Read FDA’s News Release here. Read about the March 2021 outbreak of acute non-viral hepatitis linked to the consumption of “Real Water” brand water in our April 2021 (Part 2) regulatory update here.

 
Multiple Enoki Mushroom Products Recalled for Potential Listeria monocytogenes Contamination
Between May 28 and June 1, 2021, five companies recalled enoki mushroom (also called “seafood mushroom”) products because of their potential contamination with Listeria monocytogenes, a bacterium that can cause life-threatening illness or death. Some of these recalls were a direct response to the California Health Department’s notification that routine testing had revealed the presence of the bacterium in one 150g package of enoki / seafood mushrooms.

Mushrooms from two of the companies – Rainfield Marketing Group, Inc. (Vernon, CA) and Concord Farms (Vernon, CA) – were sourced from Korea, while mushrooms from Sun Hong, Inc. (Montebello, CA) and California Terra Garden Inc. (Commerce, CA) were sourced from China. FDA did not provide the source of the enoki mushroom product recalled by Marquis Worldwide Specialty Inc. (City of Industry, CA.)

As of May 28, 2021, no illnesses linked to any of the recalled products had been reported or confirmed.

Access FDA’s current Recalls, Market Withdrawals, & Safety Alerts here

 

 

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