Tag Archives: enforcement

Craig Powell, Natura Life ≠ Science
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Standardization of the Cannabis Supply Chain Drives Product Safety and Consumer Trust

By Craig Powell
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Craig Powell, Natura Life ≠ Science

When it comes to mainstream consumer food brands, customers expect to receive the same product each time they buy it. That consistency brings consumers back to the same brands over and over again. Unfortunately, the same can’t be said about products sold in the cannabis industry. Consumers aren’t building long-term relationships with brands because consumers don’t have consistent product experiences and often take their business to other brands.

This inconsistency plaguing the cannabis industry can be attributed to an unreliable supply chain, which plays out in multiple ways.

First, cannabis companies are having difficulty meeting state regulations. This happens because the legal cannabis industry is still relatively young and there isn’t a substantial institutional knowledge about regulatory compliance, nor are there any standardized best practices in place. Regulation is expensive and requires human and financial capital that most cannabis companies don’t have in place. Complicating things further, regulations keep changing, making it more difficult for compliant businesses to keep up, even when they have the best intentions.

Second, testing of cannabis products has been complicated. Because cannabis isn’t federally legal, standardized testing guidelines have not been developed, leaving individual states in charge of dictating their own requirements and enforcement framework. There have been numerous reports in the past few years of labs in California either improperly reporting testing results, or worse, submitting fraudulent results.

Third, problems also arise on production end of the supply chain—not only with consistency, but also with consumer safety. According to an estimate from New Frontier Data, approximately 80% of sales are still conducted through the black market. Many growers are using banned pesticides in amounts way beyond recommended levels. In addition, as the recent vape issue has demonstrated, black market manufactured products are being adulterated with toxic substances that pose significant health hazards to consumers.

Given these consistency challenges, the standardization of the supply chain—especially compliance, testing and safety measures—should be a top priority for new cannabis brands. Luckily, many best practices and standardized procedures can be adopted from the food, agriculture and pharmaceutical industries, where companies have successfully developed protocols to ensure safe and reliable products.

In addition to standardization and best practices, cannabis companies should also utilize the following recent innovations in transaction technology to provide peace-of-mind to both new brands and consumers that cannabis products are tested and safe.

Modernized Retail POS systems. Common in other consumer packaged goods industries, such as food, wine, beverages and soft drinks, RFID tags can be used throughout the supply chain to track products from seed to sale. These tags, like the “chips” on credit cards, hold electronically stored information about a product that can be accessed to verify compliance and safety.

QR Codes. While QR codes are mostly used today as marketing gimmicks, they actually have potential to provide true value for curious customers. Batch-specific QR codes could be applied to cannabis products to show detailed information about when and where it was made, what strains of cannabis were used, and testing results. This technology could be used to increase transparency between companies and to consumers.

Data Informatics. A strong information technology infrastructure can be put in place to collect and store inventory and customer data. That data can then be run through algorithms, AI and machine learning systems to help cannabis brands make better decisions about how to optimize the production of their products and how to achieve better results on future batches.

Video Surveillance. Granted, this is a more ‘low-tech’ approach, but effective, nonetheless. Video cameras can go way beyond security purposes. Footage can be viewed and compared to collected data sets to gain a deeper understanding of product flows, personnel movement and logistics that might impact a company’s final product. Video can also be analyzed automatically using AI to provide important insight to help a company fine tune their business strategies.

Consumers want to know that the cannabis products they purchase are safe, compliant and tested. Consumers also have a right to know what they are buying and expect product consistency over time from companies they trust. Ensuring supply chain consistency is key to making this happen as the industry matures. An experienced and trusted supply chain partner can help companies across different cannabis sectors, ranging from medical to food, and ensure product safety and consumer trust today through standardization and consistency. Ultimately, cannabis businesses want to cultivate a culture of excitement, not fear or uncertainty, to help the market flourish and bring quality products to our customers.

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.

2019 Food Safety Supply Chain Conference

FDA to Provide FSMA Update at 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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2019 Food Safety Supply Chain Conference

EDGARTOWN, MA, April 8, 2019 – Innovative Publishing Co., publisher of Food Safety Tech, has announced three speakers from FDA will kick off the 5th Annual Food Safety Supply Chain Conference on May 29–30. Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN; Andrew J. Seaborn, Supervisory Consumer Safety Officer, Division of Import Operations, ORA; and Lisa L. Ross, Consumer Safety Officer, CFSAN (Office of Food Safety, Multi-Commodity Foods, Refrigerated and Frozen Foods Team) will provide the opening presentations on Wednesday, May 29. An interactive Town Hall with attendees will follow.

Lisa Ross, CFSAN, FDA
Lisa L. Ross, Consumer Safety Officer, CFSAN

Seaborn, Rathnam and Ross will provide FDA perspective on FSVP inspection updates, including outcomes and compliance, the voluntary qualified importer program (VQIP) and where the agency is headed with enforcement activities. They will also take a deeper dive into supply chain requirements as per subpart G of part 117.

“As FDA continues its ‘educate while regulate’ strategy, having FDA officials present to inform attendees of the agency’s latest activities, available resources for industry, and how industry can work together with FDA in achieving compliance provides a crucial benefit,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Supply Chain Conference. “Andrew and Priya added tremendous insights to the conference last year, and I am thrilled to welcome them back, along with the addition of Lisa this year.”

The Food Safety Supply Chain conference takes place May 29–30 in Rockville, MD. Registration is open with a virtual attendee option as well.

Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew J. Seaborn,Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA at the 2018 Food Safety Supply Chain Conference

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

FSMA Checklist: Sanitary Transportation of Human and Animal Food Rule

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

The FSMA rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. Sanitary Transportation is one of seven foundational rules proposed under FSMA since January 2011 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

How much do you know about the Sanitary Transportation Rule? Test your smarts by taking the FSMA IQ Test hereSpecifically, the Sanitary Transportation rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers. It applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicles. Additionally, it impacts shippers in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico) or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the United States, if that food will be consumed or distributed in the United States. These requirements took effect April 2017 for shippers, carriers and receivers subject to the rule.

As the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and to develop programs for compliance, including Sanitary Transportation. This requires companies to document specific verification steps to satisfy regulations and meet food safety transportation requirements.

Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing Sanitary Transportation Requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA Sanitary Transportation rule
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Sanitary Transportation of Human and Animal Foods programs, as required under FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA Sanitary Transportation of Human and Animal Food requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their Sanitary Transportation programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Stephen Ostroff, 2016 Food Safety Consortium

FDA’s Take on Criminal Liability

By Food Safety Tech Staff
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Stephen Ostroff, 2016 Food Safety Consortium

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium | Learn moreCriminal liability has been a hot topic in food safety over the past year. During the 2016 Food Safety Consortium, FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., clarified FDA’s stance on enforcement.

“Our goal is for us to promote food safety, not to resort first and foremost to enforcement actions,” said Ostroff.

For Ostroff’s full comment, watch the video.

Stephen Ostroff, FDA

Pathogens, Partnerships and FSMA: Where FDA Is Headed

By Maria Fontanazza
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Stephen Ostroff, FDA

This year is a big year for food safety at FDA. All seven of the FSMA rules have been finalized, and the first compliance date is right around the corner (compliance with the Preventive Controls for Human Food rule starts in September for large companies). Stephen Ostroff, M.D., just took the helm from Michael Taylor as the agency’s deputy commissioner for foods and veterinary medicine. And finally, FDA is taking a hard line in both improving the tools and methods used to detect outbreaks as well as working with the Department of Justice to prioritize enforcement actions against companies that introduce adulterated foods into the supply chain.

Yesterday Ostroff provided an update on FDA’s recent initiatives and its plan of action to achieve success in FSMA implementation and pathogen detection at the IAFP annual meeting in St. Louis. Ostroff highlighted several tenets of FSMA:

  • Keys to FSMA success will be dependent upon achieving high rates of compliance
  • Domestic and import parity
  • Education before and while regulating (establishment of training and education networks)
  • Taking a risk-based approach to inspection and planning
  • Partnerships are critical
Stephen Ostroff, FDA
FDA’s Stephen Ostroff will be the opening keynote at the 2016 Food Safety Consortium, December 7 in Schaumburg, IL. LEARN MORE

Industry can expect three more rulemakings as required by FSMA in the areas of lab accreditation, a reportable food registry and product tracing. In addition, FDA is working on guidances related to the preventive controls, produce, and foreign supplier verification program rules. “We’re tantalizingly close so stay tuned,” Ostroff said.

Expect to see more program alignment with the Office of Regulatory Affairs as well. The inspection and compliance staff will be trained as specialists and there will be horizontal integration of programs between field activity and agency headquarters. Although the next fiscal year will be a transition year, Ostroff is hopeful that changes that need to be made at the agency, along with program alignment, will be in place by fiscal year 2018.

Other notable actions at FDA over the past year include:

  • In response to the OIG’s conclusion that FDA’s food recall program is not efficient or effective, the agency is ramping up its use of the strategic CORE (Coordinated Outbreak Response and Evaluation) network in order to examine recalls that might not be moving as smoothly or quickly as the agency prefers. FDA is also leveraging greater application of whole genome sequencing (WGS).
  • GenomeTrakr network and WGS. More than 50,000 genome sequences have been added to the database (largely Salmonella). Ostroff called WGS a game changer that holds the opportunity to more quickly identify problems and detect outbreaks while they’re still quite small. In partnership with the CDC, FDA set up a successful module for WGS of Listeria and the agency hopes to expand the model for use with other pathogens.
  • Nutrition (Not just what consumers are eating, but how much of it): The move that declared partially hydrogenated oils as no longer GRAS with compliance required by 2018.  The agency also issued a final guidance on menu and vending labeling in May, issued levels for arsenic in infant rice cereal, made determination for folic acid fortification in corn/masa, made revisions to nutrition facts labels that takes effect in 2018, issued a draft guidance on voluntary sodium reduction, and will continue to exam the terms “natural” and “healthy”.
  • Genetic engineering. FDA approval of GE salmon following one of the longest reviews in the history of FDA (20-year review), along with issuing voluntary labeling guidance.
  • Monitoring antimicrobial resistance through NARMS  (National Antimicrobial Resistance Monitoring System). FDA will be collecting antimicrobial sales by species and, in cooperation with USDA, hopes to release farm-based data about antimicrobial use at the farm level.

Ostroff emphasized FDA’s strategic 10-year plan, released this year, pointing to public health as a first priority, maintaining partnerships as a key to success (including re-establishing overseas offices), continuing research as a foundation, and maintaining transparently.

Michael Taylor FDA

FDA to Weigh In on FSMA Enforcement at Food Safety Consortium

By Food Safety Tech Staff
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Michael Taylor FDA

How will FDA enforce the new FSMA rules? It’s a question that has been circulating throughout industry over the past few months, and it will be answered at this year’s annual Food Safety Consortium conference next month. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA will deliver the opening plenary presentation on November 18, which will be followed by an “Ask the FDA” interactive town hall meeting. During the afternoon,

Roberta Wagner, deputy director of regulatory affairs at CFSAN
Roberta Wagner, deputy director of regulatory affairs at CFSAN

Roberta Wagner, deputy director of regulatory affairs at CFSAN will discuss FSMA implementation and FDA’s strategies for gaining and maintaining industry compliance with the new rules. The agency will also be participating in several conference sessions dedicated to the FSMA rules that will be finalized by November, including:

  • Foreign Supplier Verification
  • Preventive Controls in Human Foods
  • Preventive Controls in Animal Foods
  • Produce Safety
  • Third-Party Auditing
  • Voluntary Qualified Importer Program

During the event, USDA’s Food Safety and Inspection Service (FSIS) will also be answering questions related to regulatory compliance and food safety issues at a Small Plant Help Desk.

Frank Yiannas, vice president of food safety at Walmart
Frank Yiannas, vice president of food safety at Walmart

Beyond FSMA-related topics, the Food Safety Consortium conference will feature several concurrent food safety and quality assurance tracks, workshops and training programs in compliance, food manufacturing and operations, supply chain management, food labs, and foodservice and retail. Food Safety Culture is an especially hot topic right now, and the conference will address the practical ways to actually measure behavior and start taking action. Frank Yiannas, vice president of food safety at Walmart will deliver a keynote presentation, “Food Safety = Behavior” on Wednesday, November 18.