Tag Archives: FDA

FDA

FDA Receives Record Turnout As Industry Eager to Discuss New Era of Smarter Food Safety

By Maria Fontanazza
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FDA

Industry from the public and private sector joined for a record turnout during the FDA public meeting yesterday to discuss the agency’s initiative, a new era of smarter food safety. The meeting, which was at maximum capacity for both in-person as well as webcast attendance, began with a call to action from FDA Deputy Commissioner, Office of Food Policy and Response, Frank Yiannas on the importance of all stakeholders in the industry to work together to drive the change. As Yiannas has previously commented, the food industry is in the midst of a revolution. The world is changing faster than ever, and the FDA is challenged with not just creating a safer, more technology-centric and traceable food system, but also getting there faster and more effectively. “I’ve always believed that words we use are important,” he said. As the day’s various discussions would be around the new era of smarter food safety, Yiannas gave the audience a definition to consider: “A new era is a memorable or important date or event, especially one that begins with a new period in our history.”

FDA held breakout sessions centered on areas critical to the initiative:

  • Tech-enabled traceability and outbreak response
  • Smarter tools and approaches for prevention
  • Adapting to new business models and retail modernization
  • Food safety culture

During each session, FDA facilitators asked the audience questions. The following are some key points brought out during the breakouts.

Tech-Enabled Traceability and Outbreak Response

  • FDA should consider all parts of the supply chain when thinking about traceability
  • Take into account considerations for sharing sensitive data along the supply chain
  • Speaking a common language and creating data standards, along with necessary minimum data elements for traceability is critical
  • Better communication related to data sharing as well as more meetings with FDA and stakeholders, especially during outbreaks
  • Show industry the ROI of the data
  • Provide a roadmap or recommendation for companies on where they can begin on their traceability journey
  • Request for unity across government agencies (i.e., FDA, USDA), as it would provide more clarity during an outbreak

Smarter Tools and Approaches for Prevention

  • Trust and transparency are key
  • Safeguards that address privacy concerns and liability
  • Data
    • Data sharing: Concern about retroactive investigations
    • Types of data: With the “treasure trove” of existing data out there, which is the most important and helpful in improving food safety?
  • Environmental assessments and root cause analysis—more dialogue between FDA and industry

Adapting to New Business Models and Retail Food Safety Modernization

  • More need for collaboration
  • Globalization and use of best practices
  • Establishing a common standard to level the playing field
  • Establish best practices for tamper resistance
  • The last mile: Food safety training for food delivery personnel as well as harmonization for last mile delivery
  • More consumer education

Food Safety Culture

  • Emphasis on behavior and humanizing the work: Focusing on what happens within organizations at all levels
  • Clarity and communication are important
  • Leveraging current food safety culture best practices as well as any relevant existing standards (i.e., ISO, Codex)
  • Partnerships are critical, finding the balance between compliance and collaboration

Other Factors FDA Must Consider

The FDA meeting also included panel discussions that drew out the realities FDA must consider in this rapidly changing environment. “These are exciting times and this initiative is recasting our thinking in a whole new light,” said CFSAN Director Susan Mayne, adding, “We need to get ahead of these challenges and not be in reactive mode.”

Consumer awareness and demands for healthy, locally sourced and minimally processed food, for example, are creating increased pressures on food companies and retailers. In addition, the digital savvy and diverse Generation Z (the population born between 1990 and 2010, which will comprise nearly 40% of the U.S. population by 2020) has buying habits and a strong desire for transparency that is shifting how food companies will need to do business, according to Mary Wagner, president of MX Wagner & Associates.

“Trust represents safety, quality and commitment on a much more personal level to our consumers,” said Dirk Herdes, senior vice president at the Nielsen Company, emphasizing the need to communicate with authenticity. “Consumers have never been more informed, but never have been more overwhelmed with information. It’s not data—it’s trust. Trust is the new currency with which we’ll operate.”

FDA and USDA also remain committed to building a stronger relationship between the agencies, said Mindy Brashears, Ph.D., deputy undersecretary for food safety at USDA. “As science moves forward, we have to allow our policies to move forward to keep consumers safe,” she added.

The comments shared during yesterday’s meeting, along with written and electronic comments (with a deadline of November 20), will be considered as FDA puts together its blueprint document for a new era of smarter food safety. More information about providing comments can be found on the Federal Register page.

2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Say What? Perspectives We Heard at the 2019 Food Safety Consortium

By Maria Fontanazza
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2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Last week’s seventh annual Food Safety Consortium brought together a variety of industry experts to discuss key topics around regulation, compliance, leadership, testing, foodborne illness, food defense and more. The following are just a few sound bytes from what we heard at the event. (Click on any photo to enlarge)

Food Safety Consortium, Frank Yiannas, FDA “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency.” – Frank Yiannas, deputy commissioner for food policy & response, FDA. Read the full article on Yiannas’ keynote session

“A typical food company only has about 5% visibility into known supply chain threats.” – Ron Stakland, senior business development, FoodChain ID, Inc.

“For most of us, our supply chain is a big black hole. Why are we so fearful of technology? Is it the implementation itself? What if technology could help us solve some of those perennial problems? There are resources available to help us get there.” – ¬ Jeremy Schneider, business development director, food safety and quality assurance, Controlant

“The records tell the story of how well the facility is being managed. It’s the first thing the regulators are going to look at.” – Glenn Black, Ph.D., associate director for research, CFSAN, FDA, on validation considerations and regulations for processing technologies in the food industry 2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

“We’ll see more robotics enter the food space.” – Gina Nicholson Kramer, executive director, Savour Food Safety International

Melody Ge, Corvium, 2019 Food Safety Consortium “Changes are happening; you can choose to face it or ignore it. We’re at least 10 years behind on technology. Automation/technology is not a new term in aerospace, etc., but to us [the food industry], it is. We will get there.” – Melody Ge, head of compliance, Corvium, Inc., on how industry should prepare for the data-driven transformation occurring in the smarter era of food safety

It’s okay to risk and fail, but how are going to remediate that with your employee? The more learners practice in different scenarios, the less they rely on specific examples. [They] become more adept with dealing with decision making.” – Kathryn Birmingham, Ph.D., VP for research and development, ImEpik, on employee training

“As a contract lab with the vision of testing for foodborne viruses for about 10 years—it wasn’t until about three or four years ago that we had the test kits to turn that into a reality. We also didn’t have a reference method.” – Erin Crowley, chief scientific officer, Q Laboratories, on the viral landscape of testing in the food industry

“You have to be strong and you have to believe in yourself before you get into any situation—especially as a food safety professional.” – Al Baroudi, Ph.D., vice president of quality assurance and food safety at The Cheesecake Factory, on what it takes to earn respect as a food safety professional Jorge Hernandez, Al Baroudi, Ph.D., 2019 Food Safety Consortium

“’See something, say something’ is likely not enough. We recommend that companies develop a formal detection program that includes management buy-in, HR and governance, and policy documents, formal training and an awareness program…While FDA focuses on the insider threat, we feel that using a broader mitigation approach works best.” – R. Spencer Lane, senior security advisor, Business Protection Specialists, Inc. on lessons learned from food defense intentional adulteration vulnerability assessments

“Food safety is a profession, a vocation, [and] a way of life.” – Bob Pudlock, president of Gulf Stream Search

Food Safety Consortium, Frank Yiannas, FDA

Industry in Midst of a Revolution, Tech Must Help Advance Food Safety, Says FDA

By Maria Fontanazza
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Food Safety Consortium, Frank Yiannas, FDA

The industry has evolved quite a bit since FSMA was passed eight years ago, and there’s been an overarching recognition that more modern methods to addressing food safety challenges—especially traceability—are essential. “The agency is at the threshold of a sea change in how we’re going to oversee food safety in the nation’s food supply,” said Frank Yiannas, deputy commissioner for food policy & response at FDA at the 2019 Food Safety Consortium. The first driver is the FDA’s new initiative announced earlier this year, coined the “New Era of Smarter Food Safety”. The agency will be looking at how new and emerging technologies can help advance food safety.

“I believe that we’re in the midst of a food revolution,” said Yiannas, pointing to the level of investment in food globally. “Products will be reformulated… new food sources and production approaches will be realized, and the food system will become increasingly digitized.” It will be the job of food safety professionals to adapt to this changing landscape and to ensure that innovation does in fact happen (and safely) in order to feed the growing population.

FDA is taking a new mindset that builds on the success of FSMA but also leverages a people-led, technology enabled method to get there. Just a few days ago the agency launched FDA-TRACK, a new food safety dashboard through which FDA intends to track and measure the performance of the seven FSMA rules—and these measurements will be publicized and available for all stakeholders. Initial available metrics will be tracking outcomes for the FSMA Preventive Controls and the Foreign Supplier Verification Program related to inspections and recalls.

The second driver of this sea change at the FDA involves a shift in its current approach to FSMA and the evolution of the regulation. While the agency continues to educate while it regulates, this past summer FDA took actions that are indicating a shift in its approach to FSMA compliance. On July 30, FDA issued its first warning letter using FSVP authorities to a tahini importer for lack of FSVP compliance. This was followed a month later by actions surrounding the most recent Salmonella outbreak linked to imported papaya. “If you pause and look back, there have been eight outbreaks in eight years,” said Yiannas. The outbreak involved 500 documented cases, 100 hospitalizations and two deaths. “I thought, enough is enough,” he added, and this prompted Acting FDA Commissioner Ned Sharpless, M.D. and Yiannas to issue a statement asking the papaya industry to do more—and urged them to work together to review their practices and make necessary changes to ensure that the papayas they’re offering to the public are safe. The FDA also issued a warning letter to the papaya importer, with the possibility of barring the company for the next five years. “When there’s a public health hazard, FDA will act decisively,” said Yiannas, stating that parity and oversight is important, and domestic and imported food must be safe. “We regulators, we’re going to strike the right balance, and are committed and as passionate as ever in trying to bend the foodborne illness curve.”

Yiannas added that over the next eight years, the trajectory of papaya-related illness will look very different from the last eight years, thanks to the adoption of better technologies—and that’s part of what the FDA’s New Era of Smarter Food Safety is about. “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency,” said Yiannas. There’s a lack of knowledge in where food comes from, where it’s produced, and the fact that many companies simply don’t know as much about their supply chains as they think. With FSMA, Congress anticipated the need to track and trace food, and now the agency is exploring how new technology can enhance tracking and tracing. With regards to tracking foodborne illnesses, the food industry has been in a race between detection and prevention. “We’re getting so good at finding the needle in the haystack, but we can’t find the haystack,” said Yiannas. “We have to provide the same level of investment for technologies for trace backs….we will do that together.”

Food Safety Consortium, Frank Yiannas, FDA
Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium (Image Credit: amybcreative)

When looking at implementing smarter tools and approaches for prevention, the industry needs to work together at not just collecting the data but also converting this data into actionable information. Yiannas emphasized that the agency is not chasing the shiny object—new technology will not be a distraction; it will help solve industry problems and address the new issues that arise with the evolving food system (i.e., cell-cultured meat, plant-based meat, etc.). The agency is also holding a public meeting on October 21 to encourage discussion between the public and private sector, all surrounding this new initiative on smarter food safety.

“What’s become clear to me is [that] there’s so much we an do working together—the public and private sector… Think. Think about how you can do your work differently,” said Yiannas. “We’re all working for the same boss, the consumer. [We have the] same mission and they’re counting on us.”

FDA

FDA Updates Food Defense Plan Builder to Support Compliance with Intentional Adulteration FSMA Rule

By Food Safety Tech Staff
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FDA

Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:

  • Facility Information
  • Process/Product Description
  • Vulnerability Assessment
  • Mitigation Strategies
  • Food Defense Monitoring Procedures
  • Food Defense Corrective Action Procedures
  • Food Defense Verification Procedures
  • Supporting Documents
  • Signature

The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.

The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
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AFSAP

The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.

July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.

Reason

“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA

Charge

“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA

Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.

A Trend of Increased Import Enforcement?

FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.

The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.

Cannabis, gavel

CBD Marketplace: How Should We Navigate It?

By Richard Blau
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Cannabis, gavel

Retired NFL player Rob Gronkowski, formerly of the New England Patriots, recently signed a deal with Abacus Health Products in Woonsocket, Rhode Island that includes buying a stake in the company and agreeing to promote its products. His decision reflects his belief that cannabidiol or “CBD” products made by the company under the brand CBDMEDIC can help others manage pain the way it has helped him.

Former world champion boxer Mike Tyson is developing a cannabis farm called “Cannabis Resort” for smokers and growers on his 40-acre land in California City. His company Tyson Holistic Holdings also owns Tyson Ranch, his own cannabis strain company and recently launched his CBD brand named CopperGel, which includes roll-on relief items.

Lifestyle maven Martha Stewart has entered into a deal with cannabis and CBD company Canopy Growth to be an adviser to the company. Her role will be to help it develop a new line of CBD-based products for both humans and animals.

Learn more about the direction of the cannabis industry at the 2019 Cannabis Quality Conference & Expo, which is co-located with the Food Safety Consortium Conference & Expo | October 1–3, 2019 | Schaumburg, IL The involvement of these and other celebrities in the emerging CBD industry signals an escalation in the evolution of cannabis as a legal consumer product. CBD products are sold today not only through licensed dispensaries and pharmacies, but also in specialty cafes, smoke shops, grocery stores and general retailers. This reflects the degree to which cannabis has become increasingly integrated into mainstream society.

Thirty-three states and the District of Columbia have legalized medical cannabis products, and 11 states plus D.C. have legalized cannabis for recreational use by adults. Affecting industries as diverse as cosmetics, food and beverage and pharmaceuticals, the exponentially expanding CBD market has generated analyses forecasting that the collective market for CBD sales in the United States will surpass $15–20 billion by 2025, according to the firms BDS Analytics, Arcview Market Research and Cowen & Co.

Cannabis, gavel
Legal Recreational Use of Cannabis: Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington, plus the District of Columbia
Illinois became the second most-populous state (after California) to legalize recreational marijuana in June
Vermont was the first state to legalize marijuana for recreational use through the legislative process. The state law allows for adults age 21 and over to grow and possess small amounts of cannabis. The sale of nonmedical cannabis is not allowed.

Yet, many government officials at the state and local levels, as well as industry members and consumers, justifiably question whether CBD products are legal. For example, in January 2019, New York City’s health department started prohibiting restaurants from adding any CBD supplement to food or drink, saying CBD was not approved by the federal government as a safe ingredient for human consumption. “The Health Department takes seriously its responsibility to protect New Yorkers’ health,” a spokeswoman said in a February 2019 email to media outlet CNBC. “Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD.”

Is CBD legal in America? The answer is: “It’s complicated.”

The Details Behind CBD, Legalization and Marketing

CBD is the acronym for cannabidiol, a chemical compound found in cannabis plants—both hemp and marijuana. Unlike the chemical compound tetrahydrocannabinol (THC), which also is found in those plants, CBD does not induce a “high.”

The main difference between marijuana and hemp is the amount of THC in the plants. If the cannabis plant contains more than 0.3% of THC, federal law defines the plant as “marijuana.” Hemp is a cannabis plant with less than 0.3% of THC. While CBD produced from hemp often is sold as an oil, it actually is a chemical compound.

The Agricultural Improvement Act of 2018 (commonly known as the “2018 Farm Bill”) removed industrial hemp and hemp-derived CBD from Schedule 1 of the Controlled Substances Act. Thus, by legalizing the production of hemp, the 2018 Farm Bill removed hemp and hemp seeds from the schedule of Controlled Substances maintained by the federal Drug Enforcement Administration (DEA). That change effectively legalized hemp-derived CBD, which contains only trace amounts of THC, subject to federal agency health and safety regulations that govern all foods, beverages, supplements and other consumer products marketed in the United States. The new law also allows for increased research and product development of CBD extracted from hemp.

Not waiting for the regulators or scientists, enthusiastic entrepreneurs have produced extraordinary growth in the creation of markets for hemp CBD oil tinctures, topical creams, edibles, pet oil tinctures, vaping-liquids and a host of other consumer products purportedly containing CBD. The increase in CBD-related medical research, as well as the decreasing stigma surrounding CBD, has led to an industry boom, enticing celebrities and generating mass market growth for CBD products and sales.

According to predictive analysis and market research company Brightfield Group, $620 million worth of CBD products were sold last year in the United States. The same research team is projecting year-over-year CBD product sales growth in the United States of 706% in 2019 to reach approximately $5 billion, and sales of $23.7 billion by 2023.

Similarly, cannabis industry research firm BDS Analytics is predicting a compound annual growth rate of 49% by 2024 for all cannabis products across all distribution channels. The industry researchers also project that the CBD market, combined with other cannabis products, will create a total U.S. market of $45 billion for cannabinoids by 2024.

Another data group, New York-based Nielsen, estimates total sales of all legalized cannabis, which includes CBD products, reached $8 billion in the United States in 2018. According to Nielsen, U.S. cannabis sales should reach $41 billion by 2025, with marijuana products accounting for $35 billion, presuming 75% of the U.S. adult population has consistent access to legal marijuana by 2025.

In this context, there was only limited surprise in the marketplace when U.S. cannabis retailer Curaleaf Holdings Inc. disclosed in March 2019 that big-box retailer CVS Health Corp. will carry its line of CBD products. CVS, which is the largest drugstore chain by total sales in the United States, already has started to sell CBD products in eight states, including creams, sprays, roll-ons, lotions and salves.

Follow the link below to access page 2 of the article, which covers Regulatory Oversight and Emerging Enforcement.

Pages: 1 2
FDA

FDA’s Pesticide Analysis Finds Most Foods Tested Below EPA Tolerance Levels

By Food Safety Tech Staff
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FDA

Today FDA released the results of its yearly report on pesticide residues, and the good news is that of the 6504 samples taken, most of them were below EPA tolerance levels. As part of the Pesticide Residue Monitoring Program for FY 2017, FDA tested for 761 pesticides and industrial chemicals in domestic and imported foods for animals and humans. The following are some highlights of the FDA’s findings:

  • Percentage of foods compliant with federal standards
    • 96.2% of domestic human foods
    • 89.6% of imported human foods
    • 98.8% domestic animal foods
    • 94.4% imported animal foods
  • Percentage of food samples without pesticide residues
    • Milk and game meat: 100%
    • Shell egg: 87.5%
    • Honey: 77.3%
  • Percentage of food samples without glyphosate or glufosinate residues
  • Milk and eggs: 100%
  • Corn: 82.1%
  • Soybeans: 60%

“Ensuring the safety of the American food supply is a critical part of the work of the U.S. Food and Drug Administration. Our annual efforts to test both human and animal foods for pesticide residues in foods is important as we work to limit exposure to any pesticide residues that may be unsafe,” said Susan Mayne, Ph.D., director of FDA’s CFSAN, in an agency release. “We will continue to do this important monitoring work, taking action when appropriate, to help ensure our food supply remains among the safest in the world.”

FDA

FDA and NASDA Collaborate on $1.3 Million Produce Safety Program

By Food Safety Tech Staff
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FDA

Yesterday FDA announced a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to enable more support of developing, implementing and improving programs related to the Produce Safety rule. The agreement will provide funding to help NASDA work with state and territorial produce safety regulatory programs to facilitate the safe production of fresh fruits and vegetables, along with better understanding of the Produce Safety Rule and its requirements.

“This advances the agency’s efforts to develop a nationally integrated food safety system by helping to ensure consistency of state and territorial produce safety regulatory programs with the Produce Safety Rule,” FDA stated in a release.

The current program has $1.3 million in funding. During the first two years of the cooperative agreement, NASDA will work with FDA on implementing and updating the On-Farm Readiness Review system with the agency and its partners in state and territorial produce safety programs. During the third through fifth years of the program, NASDA will help FDA in establishing and promoting a “uniform foundation of produce safety” to help create a national produce safety regulatory program.

FDA

FDA Sampling of Romaine Lettuce in Yuma Finds No Widespread STEC or Salmonella Contamination

By Food Safety Tech Staff
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FDA

Following last year’s widespread E.coli O157 outbreak involving romaine lettuce linked to the Yuma, Arizona growing region (Spring 2018), FDA launched a sampling assignment to test romaine lettuce for pathogenic Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp. The microbiological surveillance sampling began on December 18, 2018 in the Yuma region and focused on 26 commercial coolers and cold storage facilities to allow FDA to sample multiple farms from several locations at once. The agency collected and tested a total of 188 samples for both pathogens. It did not detect Salmonella in any sample; STEC was detected in one sample, but additional analysis found that the bacteria was not pathogenic.

“The findings of this assignment suggest that there was no widespread Salmonella or STEC contamination of romaine lettuce from the Yuma growing region during the period when sampling occurred. As a next step, the FDA is working with leafy green stakeholders in the Yuma region to consider a longer-term environmental study to identify and control risks that will prevent future outbreaks, with the ultimate goal of protecting consumers. – FDA

The point of the sampling assignment was to determine whether target pathogens were present, and if so, to respond quickly before contaminated products reached consumers.

Lab grown meat

“Real” Beef: It May Not Be What’s For Dinner Anymore

By Maria Fontanazza
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Lab grown meat

As the consumer craze over plant-based meat continues, cell-cultured meat is next on the list of alternatives to “real meat”. There are several factors driving this market, including increased demand for meat as the world’s population grows and becomes more affluent, and the concern that if more sustainable solutions are not implemented, there won’t be enough protein to feed the world’s population by 2050, according to Paul Mozdziak, professor at NC State University. Mozdziak, who presented his perspective on cell-cultured meat during the IAFP Annual Meeting last month, has been working in the cell-cultured meat space for 25 years. It’s not a new concept, he pointed out, but sustainability issues, concerns over the efficiency of the animal industry (i.e., the biological limits of animals), along with a waning enthusiasm in eating animals have sparked even more interest in animal technologies during the past few years.

Animal cell culture technology involves a controlled growth of animal cells from livestock, poultry, fish or other animals, their subsequent differentiation into various cells types, and their collection and processing into food, according to Roberta Wagner, assistant administrator, Office of Policy and Program Development at FSIS, USDA. Wagner shared the regulatory perspective on this emerging segment at IAFP. And although the session in which Wagner and Mozdziak spoke was titled, “Is Cell-cultured Meat Really Meat?”, neither of them answered this question. Rather, they discussed the status of the sector and the challenges ahead.

Scale Up

“The technology has been around,” said Mozdziak. “The issue is getting it to scale and myogenic to actually produce product.” Muscle cells want to attach to something. The process of making cultured meat involves isolating cells, getting them to grow in suspension and transferring them to a bioreactor to grow. In order to create a fully formed muscle, the cells needs to attach to a scaffold and differentiate, he explained. The bioreactor facilitates a sterile environment, but when scaling up, the challenge is the unknowns (which could introduce food safety issues) during downstream processing. “Once it’s out of the bioreactor and in a non-sterile environment, there are a variety of ways it can be contaminated,” said Mozdziak.

The production process could be cost prohibitive as well. “Currently, serum-based media cost $25 a liter; serum-free is $104 a liter. How much lower can we go from that?” said Mozdziak. “A kilo of turkey at ALDI is $6… therefore the media costs would have to be below $12 a liter for this to ever be profitable.”

How Will It Be Regulated?

In October 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The agencies also started talking about what regulatory oversight might look like. In March of this year the USDA and FDA reached a formal agreement on joint framework for regulating cell-cultured meat and poultry products. FDA will regulate the extraction of cells from live animals and jurisdiction will be transferred to FSIS during the cell harvest stage, and FSIS will oversee production and labeling. “The agreement roughly mirrors our jurisdiction of both agencies for traditionally produced livestock,” said Wagner. She added that regarding FSIS authority over cell-cultured products, the agency does not expect there will be a need for additional legislation nor will there be new regulation to inspect the products (Establishments that harvest cells or process the cells must comply with sanitation, HACCP and any other applicable FSIS regulations). Labeling for cell-cultured meat and poultry products must be approved.

Wagner noted two major challenges ahead in the federal regulation of cell-cultured meat. “We’ve received very little information about the process and technology being developed or used by cell-cultured meat and poultry manufacturers,” she said. “If industry doesn’t share such information, there could be a delay in review of products.” She added that the agency is encouraging industry to come forward sooner than later with this information. The second big challenge involves research and science gaps—more is needed to understand the risks.

So, is cell-cultured meat really meat? “Before we can answer that, someone needs to actually have a product,” said Mozdziak. He believes industry will get there in creating marketable cell-cultured meat, but there is no telling how long it will take.