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.
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.
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.
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.”
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.
Following last year’s widespread E.coli O157 outbreak involving romaine lettucelinked 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.
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.
Northfork Bison Distributions, Inc. has issue a voluntary recall of its Bison Ground and Bison/Buffalo Burgers following a multistate outbreak of E. coli O121 and E. coli O103 linked to its ground bison. The ground bison was produced between February 22, 2019 and April 30, 2019, and has expiration dates through October 8, 2020.
Thus far, 21 people have become ill, and eight have been hospitalized, with cases reported in Connecticut, Florida, Mississippi, Missouri, New Jersey, New York and Pennsylvania.
The FDA regulates bison meat, as the authority is not assigned to USDA’s FSIS. Several images of the affected products have been posted on the agency’s website.
During the investigation, the FDA and CDC used traceback and epidemiological information to link to affected ground bison to Northfork Bison, which the agency noted was quick to initiate the recall.
The 2019 Food Safety Consortium Conference & Expo kicks off on Tuesday, October 1 and is packed with two-and-a-half days of informative sessions on a variety of topics that are critical to the food safety industry. We invite you to check out the full agenda on the event website, but below are several event highlights that you should plan on attending.
Opening Keynote: Frank Yiannas, Deputy Commissioner for Food Policy and Response, FDA
Recalls Panel Discussion: Led by Rob Mommsen, Director of Global Quality & Food Safety, Sabra Dipping Company
Food Defense Panel: Led by Steven Sklare, REHS, CP-FS, LEHP. Invited Panelists include Jason P. Bashura, MPH, RS, Sr. Mgr., Global Food Defense, PepsiCo and Jill Hoffman, Director, Global Quality Systems and Food Safety at McCormick & Company and Clint Fairow, M.S. Global Food Defense Manager, Archer Daniels Midland Company
“Validation Considerations and Regulations for Processing Technologies”: General Session presented by Glenn Black, Ph.D., Associate Director for Research, Division of Food Processing Science and Technology (DFPST), Office of Food Safety (OFS), CFSAN, FDA
“Food Safety Leadership: Earning respect – real-life examples of earning and maintaining influence as a Food Safety leader”: Panel Discussion moderated by Bob Pudlock, President, Gulf Stream Search
Supply Chain Transparency Panel Discussion: Led by Jeanne Duckett of Avery Dennison
Taking an Aggressive Approach to Sanitation: Planning for a Contamination Event: Presented by Elise Forward, President, Forward Food Safety
Three Breakout Tracks: Food Safety Leadership; Food Testing & Analysis and Sanitation and Operations
Register by September 13, 2019 for a special discount!
Watch this video from when Frank Yiannas was the vice president of food safety at Walmart. He presented at the 2015 Food Safety Consortium.
Watch this video of Steven Sklare speaking with Aaron Biros of Cannabis Industry Journal at the 2017 Food Safety Consortium.
View the range of content associated with the Food Safety ConsortiumThe 2019 Food Safety Consortium Conference & Expo attracts some of the most influential stakeholders in the industry. This year’s event, which runs October 1–3, will not disappoint, with several features that provide a maximum networking and educational benefit to attendees.
The following is a snapshot of just a few of the benefits of attending this year’s Food Safety Consortium:
The Food Defense Consortium Meeting. This pre-conference workshop is open to all participants of the Food Safety Consortium
FSSC 22000 North American Information Day. This pre-conference workshop takes place on the morning of Tuesday, October 1 and is open to all Food Safety Consortium participants
A complimentary Sanitation Pre-conference Workshop (Tuesday, October 1)
Keynote Plenary Session by Frank Yiannas, FDA deputy commissioner for food policy and response
Recalls panel led by Rob Mommsen, director of global quality & food safety, Sabra Dipping Company
Food defense panel led by Steven Sklare, president of The Food Safety Academy; participants include Jason Bashura, senior manager of global food defense at PepsiCo
Focused breakout tracks on food safety leadership, food testing & analysis, and sanitation and operations
King Arthur Flour is voluntarily recalling 14,218 cases of product.
Another customer of ADM Milling Co., King Arthur Flour, Inc., is voluntarily recalling its five-pound bags of unbleached all-purpose flour due to potential contamination with E. coli O26. The recall affects 14,218 cases of product with six specific lot codes and “best used by” dates of 12/07/19, 12/08/19 and 12/14/19. According to a King Arthur Flour company announcement, ADM Milling notified them that certain wheat used to make the above-mentioned product lots has been linked to an ongoing E.coli outbreak. King Arthur Flour states that this recall does not affect its products sold through the company’s website, Baker’s Catalogue or its Baker’s Store in Norwich, VT.
Just a couple of weeks ago, ADM Milling expanded its flour recall to include all five-pound bags of Bakers Corner All Purpose Flour, which is packaged by ALDI.
Consumers are advised to discard the product or return them to the place of purchase for a credit or refund.
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