The FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.
The guidance documents do not impose legally enforceable requirements, but they can help stakeholders plan for potential changes that may impact their businesses and organizations. The agency anticipates it will publish many of the listed documents by January 2024.
The priority list of draft and final guidance topics include (by category):
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders
Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry
Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry
Public comments on the list of guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553.
Botanical ingredients are important to the food and beverage industries as well as the dietary supplements industry. Botanicals are plants or specific plant parts (leaves, roots, bark, berries, etc.) that are used for particular properties. These properties can be therapeutic or related to color, flavor or other attributes. Botanicals include extracts such as Ginkgo biloba, saw palmetto, and elderberry as well as herbs and spices used in cooking, essential oils, pomegranate juice and extracts, and olive oil. There is a substantial overlap between botanical products used in the herb and supplement industries and those used in foods and beverages. Many “conventional” foods and beverages include botanical extracts or other ingredients to advertise a therapeutic effect.
In 2014, FDA issued a final guidance for industry related to labeling of liquid dietary supplements (vs. beverages). FDA noted, in their rationale for the guidance, two trends:
“First, we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods. Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement…and must meet the regulatory requirements that apply to conventional foods.
Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts. Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods. This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use. Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.”
The American Botanical Council (ABC) has been publishing information on the safe, responsible and effective use of botanicals since 1988, including the quarterly journal HerbalGram and a book of herb monographs The ABC Clinical Guide to Herbs. In order to help combat the increasing problem of adulteration in the industry, the Botanical Adulterants Prevention Program (BAPP) was launched in 2010 by ABC along with the American Herbal Pharmacopeia and the University of Mississippi National Center for Natural Products Research. The goal of BAPP is to educate members of the herbal and dietary supplement industry about ingredient and product adulteration through the publication of documents such as adulteration bulletins and laboratory guidance documents. The information in these documents helps ensure the identity, authenticity and safety of botanicals along the supply chain.
Karen Everstine will be discussing food fraud during the 2020 Food Safety Consortium Virtual Conference Series | An example of the Botanical Adulterants Prevention Bulletin for cranberry is seen in Figure 1. It includes a description of the species that can be labeled as cranberry in the United States, a brief description of the marketplace, information on potential adulterants in cranberry fruit extract and other cranberry products, and guidance on analytical methods to test cranberry products for adulteration.
Decernis has been working with the Botanical Adulterants Prevention Program (BAPP) to integrate links to their expert content into the Food Fraud Database (FFD). This will ensure our users can better develop ingredient specifications, manage risk, and protect their consumers by leveraging this content for food fraud and herbal ingredient fraud prevention. We are currently incorporating three types of BAPP documents into FFD:
Adulterants Bulletins. Information and links to these documents will be entered as Inference records in FFD. We are extracting ingredient and adulterant names (including Latin names as synonyms) from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
Adulteration Reports. Information and links to these documents will also be entered as Inference records in FFD. We are extracting ingredient and adulterant names from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
Laboratory Guidance documents. Information and links to these documents will be entered as both method record and inference records in FFD. We are extracting ingredient and adulterant names from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
Decernis analysts are currently integrating this content into FFD, which will be uploaded to the system between now and early September.
Almost everybody loves chocolate, an ancient, basic, almost universal and primal source of pleasure. “The story of chocolate beings with cocoa trees that grew wild in the tropical rainforests of the Amazon basin and other areas in Central and South America for thousands of years… Christopher Columbus is said to have brought the first cocoa beans back to Europe from his fourth visit to the New World” between 1502 and 1504.1
Unfortunately, the production of chocolate and chocolate products today is as complex as any other global food product with supply chains that reach from one end of the world to the other. The complexity of the supply chain and production, along with the universal demand for the finished product, exposes chocolate to increasing pressure from numerous hazards, both unintentional and intentional. For example, we know that more than 70% of cocoa production takes place in West African countries, particularly the Ivory Coast and Ghana. These regions are politically unstable, and production is frequently disrupted by fighting. While production has started to expand into more stable regions, it has not yet become diversified enough to normalize the supply. About 17% of production takes place in the Americas (primarily South America) and 9% from Asia and Oceania.2
In today’s world of global commerce these pressures are not unique to chocolate. Food quality and safety experts should be armed with tools and innovations that can help them examine specific hazards and fraud pertaining to chocolate and chocolate products. In fact, the global nature of the chocolate market, requires fast reflexes that protect brand integrity and dynamic quality processes supported by informed decisions. Digital tools have become a necessity when a fast interpretation of dynamic data is needed. If a food organization is going to effectively protect the public’s health, protect their brand and comply with various governmental regulations and non-governmental standards such as GFSI, horizon scanning, along with the use of food safety intelligent digital tools, needs to be incorporated into food company’s core FSQA program.
This article pulls information from a recent industry report about chocolate products that presents an examination of the specific hazards and fraud pertaining to chocolate and chocolate products along with ways to utilize this information.
Cocoa and chocolate products rely on high quality ingredients and raw materials, strict supplier partnership schemes and conformity to clearly defined quality and safety standards. During the past 10 years there have been a significant number of food safety incidents associated with chocolate products. The presence of Salmonella enterica, Listeria monocytogenes, allergens and foreign materials in cocoa/chocolate products have been reported on a global scale. Today, information on food safety incidents and potential risks is quickly and widely available by way of the internet. However, because the pertinent data is frequently siloed, food safety professionals are unable to take full advantage of it.
Top Emerging Hazards: Chocolate Products (2013-2018)
Publicly available data, from sources such as European Union RASFF, Australian Competition and Consumer Commission, UK Food Standards Agency, FDA, Food Standards Australia New Zealand (FSANZ), shows a significant increase in identified food safety incidents for cocoa/chocolate products from 2013 to 2018. For this same time period, the top emerging hazards that were identified for chocolate products were the following:
Foreign bodies: 13.83%
Food additives & flavorings: 4.26%
Other hazards: 2.66%
By using such information to identify critical food safety protection trends, which we define to include food safety (unintentional adulteration) and food fraud (intentional adulteration, inclusive of authenticity/intentional misrepresentation) we can better construct our food protection systems to focus on the areas that present the greatest threats to public health, brand protection and compliance.
A Data Driven Approach
Monitoring Incoming Raw Materials
Assessment and identification of potential food protection issues, including food safety and fraud, at the stage of incoming raw materials is of vital importance for food manufacturers. Knowledge of the associated risks and vulnerabilities allows for timely actions and appropriate measures that may ultimately prevent an incident from occurring.
Specifically, the efficient utilization of global food safety and fraud information should allow for:
Identification of prevalent, increasing and/or emerging risks and vulnerabilities associated with raw materials
Comparative evaluation of the risk profile for different raw materials’ origins
Critical evaluation and risk-based selection of raw materials’ suppliers
A comprehensive risk assessment must start with the consideration of the identified food safety incidents of the raw material, which include the inherent characteristics of the raw material. Next, the origin-related risks must be taken into account and then the supplier-related risks must be examined. The full risk assessment is driven by the appropriate food safety data, its analysis and application of risk assessment scientific models on top of the data.
Using food safety intelligent digital tools to analyze almost 400 unique, chocolate product related food safety incidents around the globe provides us with important, useful insights about cocoa as a raw material, as a raw material from a specific origin and as a raw material being provided by specific suppliers. The graph below represents the results of the analysis illustrating the trend of incidents reported between 2002 and 2018. It can be observed that after a significant rise between 2009 and 2010, the number of incidents approximately doubled and remained at that level for the rest of the evaluated period (i.e., from 2010 to 2018), compared to the period from 2002 to 2005.
By further analyzing the data stemming from the 400 food safety incidents and breaking them down into more defined hazards, for incoming raw materials, we can clearly see that chemical hazards represent the major hazard category for cocoa.
Organoleptic aspects: 5.93%
Other Hazards: 4.38%
Foreign bodies: 2.06%
Food additives and flavorings: .77%
Food contact materials: .52%
Using the appropriate analytical tools, someone can drill down into the data and identify the specific incidents within the different hazard categories. For example, within the “chemical hazard” category specific hazards such as organophosphates, neonicotinoids, pyrethroids and organochlorines were identified.
Comparative Evaluation of Risk Profiles for Different Origins of Raw Materials
The main regions of origin for cocoa globally are Africa, Asia and South America. After collecting and analyzing all relevant data from recalls and border rejections and the frequency of pertinent incidents, we can accurately identify the top hazards for cocoa by region.
The top five specific hazards for the regions under discussion are listed in Table I.
Poor or insufficient controls
Table I. Top Five Hazards By Region
After the first level of analysis, a further interpretation of the data using the appropriate data intelligence tools can help to reach to very specific information on the nature of the incidents. This provides additional detail that is helpful in understanding how the regional risk profiles compare. For example, the prevalence of chemical contamination, as either industrial contaminants or pesticides, has been a commonly observed pattern for all three of the regions in Table I. However, beyond the general hazard category level, there are also different trends with regard to specific hazards for the three different regions. One such example is the increased presence of mold in cocoa beans coming from Africa.
The primary hazard categories for cocoa, as a raw ingredient were identified and a comparison among the primary hazards for cocoa by region (origin-specific) should take place. The next step in a data-powered supplier assessment workflow would be to incorporate our use of global food safety data in evaluating the suppliers of the raw materials.
The Role of Global Food Safety Data
This article has been focused on chocolate products but has only touched the surface in terms of the information available in the complete report, which also includes specific information about key raw materials. Let’s also be clear, that the techniques and tools used to generate this information are applicable to all food products and ingredients. As we strive to produce food safely in the 21st Century and beyond, we must adapt our methods or be left behind.
The regulatory environment the food industry must operate in has never been more intense. The threats to an organization’s brand have never been greater. This is not going to change. What must change is the way in which food companies confront these challenges.
Global food safety data can contribute to the establishment of an adaptive food safety/QA process that will provide time savings and improve a quality team’s efficiency and performance.
Based on the continuous analysis of food recalls and rejections by key national and international food authorities, a food safety / quality assurance manager could establish an adaptive supplier verification process and risk assessment process by utilizing the knowledge provided by such data. In that way, QA, procurement, food safety and quality departments can be empowered with critical supplier data that will inform the internal procedures for incoming materials and ingredients (e.g., raw materials, packaging materials) and allow for adaptive laboratory testing routines and compliance protocols. Moreover, food safety systems can become adaptive, enabling quality assurance and safety professionals to quickly update points of critical control when needed, and intervene in important stages of the chocolate manufacturing process.
The following infographic is a snapshot of the hazard trends in nuts, nut products and seeds from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. For the past several weeks, Food Safety Tech has provided readers with hazard trends from various food categories included in this report. This week’s hazard snapshot concludes the series.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.