In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of food, called “dietary supplements,” which created a new subcategory of FDA-regulated foods. Many parts of the Food, Drug and Cosmetic Act (FD&C) still apply to dietary supplements; however, DSHEA carved out unique regulatory exemptions and requirements for dietary supplements. Achieving a correct and complete understanding of the FDA regulatory requirements applicable to dietary supplements versus other general foods can be challenging and confusing.
Foods are defined in the FD&C as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. Dietary supplements are defined as a product taken by mouth that contains a dietary ingredient intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites; or extracts or concentrates of any of these. Dietary supplements can be in many dosage forms such as tablets, capsules, soft gels, gel caps, gummies, liquids, powders, and bars if they do not represent the product as a conventional food or sole item of a meal or diet.
The primary method for identifying a product as a dietary supplement versus a general food is to ensure it meets the definition above and for the product label to declare that the product is a “dietary supplement.” It is also required dietary supplement labels include a Supplement Facts panel, rather than a Nutrition Facts panel, which is required for almost all FDA-regulated foods. Both general foods and dietary supplements must comply with similar and also different labeling requirements, all found in 21 CFR 101, Food Labeling. Both general foods and dietary supplements could be identified by FDA as misbranded when they fail to meet applicable label claims or labeling requirements provided in the 21 CFR 101 regulation. If used, structure/function claims for dietary supplements and general foods must be truthful and not misleading. Specific to dietary supplements, the following disclosure statement is required to ensure that the dietary supplement product also does not represent itself as a pharmaceutical drug.
- “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Although dietary supplement labels are not required to be pre-approved by FDA, the product owner of a dietary supplement must provide FDA, a notification with the text of the structure/function claim no later than 30 days after marketing the product. General foods have no such FDA notification requirement for product labeling.
DSHEA also requires FDA to promulgate GMPs (good manufacturing practices) for the dietary supplement industry. This resulted in the issuance of 21 CFR 111, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in 2007. Note: FDA issued the “Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in December 2010, which also has important information on FDA’s regulatory and enforcement expectations.
The DSHEA regulation itself addresses aspects of the manufacturing, packaging, and distribution of a dietary supplement product for distribution to the consumer. The comparable general food regulations are found in the relatively new FDA “Preventive Controls for Human Foods” regulation found in 21 CFR 117.
Comparison of Dietary supplement (21 CFR 111) and General Food Good Manufacturing (21 CFR 117) Requirements
|21 CFR 111
|Description Summary||21 CFR 117 Subpart|
|B||Personnel||B – 117.10|
|C||Physical Plant and Grounds||B – 117.2, 117.20, 117.35, 117.37, 117.140 a‐d|
|D||Equipment and Utensils||B – 117.40, 117.35a, 117.37d,e, 117.40 a‐e|
|E||Production and Process Controls – Specifications||B – 117.80; C; G|
|F||Quality Control||B – 117.80|
|G||Components, Packaging, and Label Controls||B – 117.80|
|H||Master Manufacturing Records||B – 117.80 & F|
|I||Batch Production Records||B – 117.80 & F|
|J||Laboratory Operations||B – 117.40|
|K||Manufacturing Operations||B – 117.80|
|L||Packaging and Labeling Operations||B – throughout this Subsection|
|M||Holding and Distribution Operations||B – throughout this Subsection|
|O||Product Complaints||Part of 117.155 but not specifically mentioned –|
Shortly after the beginning of enforcement of 21 CFR 111 by the Center for Food Safety and Applied Nutrition (CSFAN), in 2010, the Food Safety Modernization Act (FSMA) was passed by the United States Congress in 2011. FSMA has been referred to as the most sweeping and significant legislation for the protection of public health regarding safety, efficiency and security of foods, drugs, and cosmetics (the mandate of the FDA) since the first set of laws were passed with FD&C in 1938. It was in reaction to numerous cases of food-borne illness and product recalls, particularly for pathogens (undesirable microorganisms) and allergen cross-contact and contamination issues in general foods. Pathogenic microorganisms of most notable concern are Escherichia Coli, Salmonella, Staphylococcus aureus and Listeria monocytogenes. Allergens are foreign substances that, in some consumers, can cause an abnormal immune system response that, at its most dangerous extreme, can result in death. In the United States, by law, eight food allergens must be identified; these are known as the “big eight”, i.e., milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Seven major regulations have been issued by FDA to support enforcement of FSMA. The most important of these being 21 CFR 117, “cGMP and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF).” Interestingly, dietary supplements are exempt from many of the requirements in these seven FSMA-based regulations, but not all.
The challenge: in late 2018, FDA is committed to full enforcement of all provisions of FSMA-based PCHF and by mid-2019, of the Foreign Supplier Verification Program (FSVP). Both have parts applicable and enforceable on the dietary supplement industry. Which new parts of the PCHF and FSVP regulations will impact the dietary supplement industry? Unfortunately, simply reading both regulations may not provide the insight and understanding necessary for dietary supplement manufacturers to adjust their regulatory programs for these new challenges.
The PCHF regulation, in accordance with 21 CFR 117.5(e), does not apply to any facility with regard to the manufacturing, processing, packaging or holding of a dietary supplement that is in compliance with the requirements in 21 CFR 111. For example, for general foods, Subpart C of 21 CFR 117 states that a hazard analysis must be conducted to identify and evaluate microbiological, chemical and physical hazards. Preventative controls must then be developed and implemented to ensure that these hazards will be significantly minimized or prevented, and the food will not be adulterated or misbranded. Subpart G of 117, also applicable to general foods, requires a written, risk-based supply chain program to ensure control of these same hazards in incoming raw material and other ingredients. Since these are already addressed in the dietary supplement regulations (21 CFR 111, particularly Subpart E), Subparts C and G of 117 are not applicable to dietary supplement manufacturers. Subpart B of 21 CFR 117 is the cGMP for general foods has its counterpart in 21 CFR 111 for dietary supplement manufacturers; however, the cGMPs are enforced by FDA for dietary supplement manufacturers as well as the dietary supplement GMPs found in 11. Allergen control is discussed at length in 21 CFR 117, but 21 CFR 111 never specifically dictates the need for allergen control or testing, however, all components must be demonstrated to meet established limits of potential contaminants, and the big eight food allergens certainly qualify as potential contaminants.
The other FSMA-based regulation, FSVP is also applicable to dietary supplement manufacturers, in some cases. The rule provides several exceptions to the standard FSVP requirements for certain types of importers. First, for dietary supplements and dietary supplement components/ingredients, importers that establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) under the dietary supplement cGMP regulations will not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. The same exception would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements. In contrast, importers of other dietary supplements would be required to comply with most of the standard FSVP requirements, but would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier follows the dietary supplement cGMP regulation, rather than verifying that hazards requiring a control are significantly minimized or prevented, as required under the standard supplier verification activity provisions. For foreign suppliers exporting a food ingredient to the United States that could be used as a dietary supplement, all the FSVP requirements apply. If this same supplier exported the same component/ingredients for use only as a dietary component/ingredient, then few of the FSVP requirements apply. However, if FDA discovers that the component/ingredient imported as a dietary ingredient, is being used by general food manufacturers, then it is likely that FDA will take regulatory action against the FSVP Importer and could potentially declare the food that the dietary component/ingredient was used in “adulterated,” which could trigger recalls as well as other FDA regulatory actions.
In addition, the FSVP regulation has a requirement of using a “qualified individual” for general foods also applies to dietary supplement manufacturers conducting the following operations:
- 506(a)—procedures to ensure the importation of food from approved suppliers
- 509—identification of the importer at entry
- 511(c)(2)—procedures to ensure the importation of dietary supplements from approved suppliers
- 512(b)(5) —recordkeeping by very small importers
A few years into the future we will all have “muscle memory” related to which parts of the FSMA-based regulations apply to dietary supplement manufacturers and understand the regulatory requirement differences between dietary supplements and general foods. Until then, it is important to rely on knowledgeable, experienced people in the industry, FDA and the consulting world as the enforcement threshold is “now,” and any uncertainty could result in noncompliance and FDA actions against dietary supplement manufacturers.
Tara Lin Couch, Ph.D., is an analytical/organic chemist with more than 20 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. She is a senior consultant with EAS Consulting Group.
Allen Sayler is the senior director for food consulting services at EAS. Sayler’s expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products, and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF). Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee.
This article was reprinted with permission from Natural Products Insider.
EAS Independent Consultant Heather Fairman contributed to a Q&A in Natural Products Insider on Successfully Choosing and Maintaining a Contract Manufacturing Partnership. Heather was part of a panel of experts that discussed contract manufacturing aspects that brand owners should evaluate in a potential contract manufacturer, what should be outlined in an agreement and what ongoing quality assurance (QA) checks a brand owner should conduct during the partnership.
EAS Independent Consultant, Rob Carper, has written an article on how audits are an integral part of the food safety system for Food Quality and Safety Magazine. “Food safety plans must be monitored and verified throughout the year, making sure the entire written food safety program is being supported with detailed records at the right frequency, capturing operational data,” Carper says. Also, he says, annual audits protect the company and the consumer by ensuring products are manufactured using adequate Food Safety Fundamentals (prerequisite programs and other requirements); Food Safety Plans, such as HACCP; and Quality Plans (a requirement for SQF Level 3 certification).
EAS staff and independent consultants are presenting numerous topics for Consumer Healthcare Products Association (CHPA)’s OTC Academy Webinar Series.
On March 6th, Senior Director of Dietary Supplements, Tara Lin Couch, Ph.D. will present on Conducting a Scientifically Sound Out of Specification (OOS) Investigation. Our Senior Director for Pharmaceuticals, Bryan Coleman, will present on Managing FDA Inspections on March 27th and EAS Senior Advisor, Robert Fish will discuss Responding to 483s and Warning Letters on April 17th.
Through EAS’ partnership with HACCP Consulting Group, we are pleased to announce a number of additional SQF courses on Developing and Implementing SQF Systems. Upcoming courses include Stillwater, OK April 10-11and in Philadelphia, PA on May 21-22.
This two-day seminar Developing and Implementing SQF Systems provides instruction, examples, exercises, and tools necessary for successfully implementing an SQF System. It is one step in the qualification process for SQF Practitioners and an excellent choice for all food safety team members.
The Center for Food Safety and Applied Nutrition has released the 2017 Food Code Book which includes science-based guidance for reducing known risks of foodborne illness. Originally designed for foods offered at the retail and food service locations, it has been widely adopted by the state, local, tribal and territorial regulatory agencies that regulate restaurants, retail food stores, vending operations and food service operations in schools, hospitals, nursing homes, and child care centers. EAS Consulting Group offers services to the retail and food service industries and would be glad to discuss your specific questions on regulatory compliance and enhanced food safety. Contact Allen Sayer, Senior Director of Food Consulting Services at firstname.lastname@example.org
USDA has launched a new a new electronic data platform that includes Market News Information by commodities such as dairy, fruits and vegetables, livestock and tobacco. The platform also includes resources which are of interest to USDA and FDA regulated industries, such as the pesticide data program, organic reports, and food safety. EAS would be glad to help you to better understand data found them in the reports and how they pertain to your business. Contact Allen Sayler at email@example.com
Steve Armstrong will present a session on innovative claims at the third annual law conference in Denver, April 19-20, 2018. Steve will be part an esteemed group of speakers including Susan T. Mayne, PhD, Director, Center for Food Safety and Applied Nutrition (CFSAN) at FDA and US Food and Drug Administration (FDA) and Peter Lurie, MD, MPH, Executive Director and President for the Center for Science in the Public Interest. Learn more about innovative foods and other hot topics in food law.
EAS Consulting Group is honored to be a member of the Food Drug Law Institute and is pleased to be invited speakers to a number of upcoming events.
Independent Consultant, Mark Nelson, will present an introductory session on Overview of U.S. Food Law and Regulation of Food at the Intro to Food Lawon April 10th from 8:35-9:35 am. This event will take place at the law firm of Hogan Lovells US LLP. Mark is the retired Director of Scientific Affairs at Nestle where he oversaw a wide range of FDA and USDA regulated products.
Kaiser Aziz speaking at Introduction to Biologics and Biosimilars on New, Emerging, and Continually Interesting Issues – March 21, 2018, 1:45 pm – 3:30 pm This event will be held at the law firm of Holland and Knight in Washington, D.C. Dr. Aziz has been an independent consultant for EAS since 2012 and spent his career at FDA working his way to the position of Director, Division of Mechanics and Material Science in FDA’s Office of Science and Technology where he developed guidance for FDA bio-mechanical, material and Toxicology Research Testing programs.
Welcome to the EAS-e-News, a free newsletter dedicated to those companies who work in FDA regulated industries.
FDA and USDA have been busy with new initiatives this month including a new FSMA Landing Page on the FDA’s website, new CDRH guidance for RTA’s for 510(k)s, a new Food Code Book for the retail sector, a new USDA electronic data platform and of course FDA’s Voluntary Qualified Importer Program (VQIP). More details on the CDRH guidance can be found in this month’s Drug/Device Corner and information on the Food Code Book and USDA electronic Data Platform can be found in the What’s New on FDA’s Website. It goes without saying that EAS independent consultants have been studying the new initiatives and are ready to assist with practical solutions to sometimes complicated questions.
I’ll take just a few moments to highlight the Voluntary Qualified Importer Program (VQIP) here. VQIP, is a voluntary, fee-based program for importers that allows for those enrolled to have expedited review and importation of human and animal foods into the U.S. The VQIP program is only available to those applicants who have a three year unblemished history of importing foods into the U.S., demonstrating achievement and maintenance of a high level of control over the safety and security of their supply chains. VQIP is also only applicable for companies who import foods from a facility (or farm) certified under FDA’s Accredited Third-Party Certification. EAS offers numerous services in the area of FSMA including readiness checks and helping companies prepare for the application and backup documentation for VQIP. The process is stringent, but for those companies who meet FDA’s requirements, the expedition of imports can facilitate smoother business practices and a greater level of transparency of your company’s food safety systems.
Our FSMA Perspective this month discusses additional new initiatives under FSMA, specifically the upcoming March 19th compliance dates for Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF); Importers of animal food whose Large Business Foreign Supplier is subject to the Preventive Controls (PC) requirements in PCAF, but not to CGMP requirements; and Importers of animal food whose Small Business Foreign Supplier is subject to PCAF CGMP requirements. Understanding whether your company fits in the spectrum can be tricky and our Independent Advisor for FSMA, Charles Breen, lays out the specifics, as well as some exemptions here.
Our issue of the month is on the Twentieth Anniversary of Seafood HACCP and is particularly timely in light of numerous warning letters related to seafood imports recently. I hope you enjoy Tim Hansen’s trip down memory lane and appreciate the urgency with which these HACCP requirements still apply.
EAS welcomes two new independent consultants this month who work in the food industry: Rudy Westervelt and Kathy Knutson. We are also delighted to have Dr. Robert “Robbie” Burns back with us on a full-time basis. EAS has a long tradition of bringing the best in industry talent on board as independent consultants and these three are no exception. I encourage you to read their bios in the Who’s Who section.
FDA has released several guidance documents related to the Nutrition Facts label final rule, including a final guidance explaining how the FDA evaluates the scientific evidence supporting citizen petitions to add certain isolated or synthetic non-digestible carbohydrates to the regulatory definition of dietary fiber. This Final Guidance for Industry contains information pertinent to those who submit scientific evidence to FDA for use in the determination of whether added non-digestible carbohydrates meet the definition of “dietary fiber” as part of the regulations for nutrition labeling of food for declaring the amount of dietary fiber on the Nutrition and Supplement Facts labels. Final Guidance for Industry was also issued for a number of products where serving sizes can be reasonably consumed in one sitting. Draft Guidance for Industry was also released regarding the agency’s intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol “†” on single-ingredient packages and/or containers of pure honey or pure maple syrup and on certain dried cranberry and cranberry juice products. The comment period for this draft guidance is now open and comments are due to the agency in the next 60 days.
Thank you for your interest in EAS and as always we encourage you to share this newsletter with your colleagues.
EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants and Senior Directors will answer one question sent in by readers (edited if applicable to remove identifying information). If you’d like to submit a question, please use the “contact us” link on our website.
This month’s Ask the Expert question is on training requirements in a manufacturing facility is answered by EAS Independent Consultant, Karen Dixon.
Karen has a strong focus on the development and implementation of FDA readiness programs including processes, compliance considerations, and integration within all levels of an organization. Her unique combination of expertise in operations, training systems, finance, product quality, Quality Management Systems, regulatory affairs, and ISO-9001-2015 makes her a valuable asset to EAS clients. She has held positions such as Manager, Quality Management System at Altria and Philip Morris USA and is a Certified Quality Auditor (CQA) with the American Society for Quality.
Question: How can I ensure our company offers effective training for all levels of employees at our manufacturing facility?
Dixon: In an FDA regulated manufacturing environment, the importance of a solid training program is critical to meeting your quality system requirements. Most manufacturing companies are faced with ‘doing more with less’ and often training is a burden. There are several solutions that can address training efficiencies and enhance the overall knowledge base of your employees. After all, your employees are your most important asset.
First, no training program should be one-size fits all program. Your procedure/process should be designed for flexibility in training delivery while ensuring you meet critical requirements. Developing a level or class system within your training SOP will aid the manufacturing process when there are competing opportunities. For example, a level 1 could be defined as the employees’ immediate job function and the work instructions associated with it. Level 2 would be your ‘read to understand’ material, and/or quality procedures designed for understanding. Level 3 training could be those materials and/or courses developed to enhance employees’ capability, i.e. business writing classes. This categorization would allow the firm to focus priority. Training an employee in their immediate process in order to produce a quality product is more pressing than a continuing education class for example.
For your infrastructure, implement a training procedure with these requirements clearly defined.
- Type of training (Level 1, 2, 3)
- Platform (i.e., computer-based, classroom, on-the-job or read-to-understand)
- Trainer (i.e., buddy system, subject matter expert, certified trainer)
- Record keeping requirement (roster, training assessment)
It is important to remember that the FDA Inspector will want to see evidence that an employee has been provided the appropriate training for the tasks they are performing; therefore, good documentation is imperative. There are a number of training options, of course. One is a “canned” Learning Management Systems (LMS). Another is attending public courses to meet your training requirements. Depending on the topic, some public courses have been vetted and certified to offer continuing education units (such as EAS Consulting Group’s Food Labeling Compliance Seminar), others, though not providing specific CEUs meet the training requirements required by FDA, (such as EAS’ Dietary Supplement Good Manufacturing Practices Seminar). Still, a third option is to bring outside trainers into your facility to provide a customized approach to your specific business and training needs. Customized programs offer an opportunity to bring in experts familiar with your type of business as well as the federal, state and industry regulations with which you must comply so that those in-house programs developed to meet your needs exactly.
Steps to Achieving Effective Manufacturing Training
No matter the type of learning environment, online, public or in-house, there are some basic steps needed to achieve optimum adult learning:
Here are a few points to consider about each step:
Design: During this phase of development, you should focus on the need for the training or conducting a ‘needs analysis’. Considering the business goals or metrics behind the topic of the training. Create clear learning objectives to uncover topics that are influencing the training.
Develop: Points to consider under development: 1) stay true to the plan developed during the Design phase, don’t drift into another topic or focus area, 2) Gather credible sources of information for the training. Use facts, input from Subject Matter Experts, and guidance from seasoned employees.
Deliver: Consider your audience through a leaner-centric approach. Delivering learner-centric material means you are delivering to adult learners who learn very differently than adolescents. Clients should consider investing in a full-time training developer who has been trained in adult learning principles. Most clients already have an employee or employees dedicated to training, even as part of a job. There are many inexpensive courses available that would enhance their ability on understanding adult learning. Investing in a two to the three-day course would bring a return on investment quickly.
Evaluate / Continuous Improvement: Your training program will never be complete. Continuously evaluating the health of your program through metrics is important. Whether it is a simple measure of percent complete trained, evaluation of non-conforming product incidents, or waste percentages there is always a way to measure the health of your training program. Revisit your initial training material and improve as needed.
To learn more about training design and developing a flexible training program, contact EAS Consulting Group. Our independent consultants can provide a perspective your company needs to ensure processes and procedures are accurately in place to support full compliance with current and future FDA requirements while also providing counsel on how your infrastructure can work for you in meeting production goals.
Medical Device manufacturers and importers, please make note of the upcoming FDA Adverse Event codes update. Per the FDA eMDR System Enhancements website, the list of FDA Adverse Event codes accepted in F10 and H6 will be updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. This update will affect the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not currently accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to FDA codes. FDA codes that are being retired during this update will be rejected by eMDR once this update is deployed. The current non-harmonized hierarchies and the future IMDRF-harmonized hierarchies are currently posted at MDR Adverse Event Codes. The scheduled date of this production update is 6 April 2018.
Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman has summarized a new agency guidance on Refuse to Accept (RTA)’s for 510(k) Medical Device applications. In this summary, Bryan discusses FDA’s newly produced checklists enabling submitters to ensure all required data is complete prior to submission. This should better facilitate FDA’s ability to complete a substantive review by assuring all preliminary information is included. EAS offers services with 510(k) submissions including the review of data and assistance with compiling submissions to the process of submitting to FDA. Please contact Bryan at firstname.lastname@example.org
Guidance Document updates on the FDA website:
- Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment
- Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment
- Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older
- Migraine: Developing Drugs for Acute Treatment
- Regulatory Classification of Pharmaceutical Co-Crystals
- BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment
- Microbiological Data for Systemic Antibacterial Drugs – Development, Analysis, and Presentation
- Qualified Infectious Disease Product Designation Questions and Answers
- Hypertension: Developing Fixed-Dose Combination Drugs for Treatment
The next FSMA/FSVP compliance date is March 19, 2018. FDA enforcement activities begin with:
- Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF);
- Importers of animal food whose Large Business Foreign Supplier is subject to the Preventive Controls (PC) requirements in PCAF, but not to CGMP requirements;
- Importers of animal food whose Small Business Foreign Supplier is subject to PCAF cGMP requirements
Importers are already being inspected for the adequacy of their FSVP. A quick look at the most recent FDA inspection citations with data through January 15, 2018, shows nearly 100 Foreign Supplier Verification Program (FSVP) violations since FDA started inspecting importers last year. The citations made show that in many cases there is a clear lack of understanding, not only of the requirements but the implications for lack of compliance. FDA can stop an importer from importing food for which there is no evidence that the food complies with FDA requirements.
For anyone keeping score, March 19th marks the compliance date for 30th, 31st and 32nd FSMA rules, and the seventh, eighth and ninth for FSVP-specific rules so far.
It is important to also note that even though seafood, juice beverages, infant formula, dietary supplements, and Low Acid Canned Foods (LACF) foods may not be subject to significant parts of the FSMA preventive controls regulation, USDA regulated products are completely exempt, no FDA-regulated food has a complete exemption. When companies are producing foods that combine USDA and FDA regulated foods, whichever agency regulates the final food product may not be the only one regulating some of the ingredients of this final food. These companies need to check to be sure their food safety programs meet the requirements of either USDA, FDA or in a few cases, both. EAS has the expertise and regulatory knowledge to assist companies in navigating these sometimes-murky regulatory waters.
USDA’s various inspection Acts, (poultry products, egg products, the Federal Meat Inspection Act) have jurisdiction over these imported products at the time of U.S. entry. While USDA and FDA requirements are gradually coming into closer alignment, each agency’s requirements are still quite different. Understanding both sets of requirements is warranted for those whom this applies.
So, back to the March 19th deadline and what it means for you. First – does your company even need to comply with FSVP? Is your foreign food supplier aware that in order to comply fully with FSVP, they must first comply with the FSMA Preventive Controls regulations (human food and animal foods as applicable)? FDA has developed a handy flow-chart to help you make that determination. Even so, it’s not always so simple to understand the correct regulatory path to compliance – particularly in the case of seafood, juice beverages, infant formula, dietary supplements, and LACF foods – when and what FSVP rules must be followed, comply with FSVP.
The size of a business is a factor in whether companies need to comply, as is the case with those that meet the definition of a “very small businesses” (i.e., earned less than $1 million per year on average in the preceding three calendar years, adjusted for inflation from 2011, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale; or in the case of Animal Food – $2.5 million per year for three years in sales of animal food, combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee)). FDA provides a useful tool to help calculate inflation. For example, $1 million in 2011 is adjusted to $1,078,242 in 2016.
There are other exemptions in addition to those mentioned above. Imported food from Canada, New Zealand and Australia are still required to meet FSVP requirements. However, those who import foods from these countries may document FSVP compliance by relying on inspections by officially recognized food safety inspections in those countries. Their food safety systems are deemed to be comparable to that of FDA. Companies must clarify that imported food is within the scope of that official recognition or equivalency determination. For example, baked goods are food by definition, but are regulated by Health Canada. The mutual recognition with Canada is between FDA and CFIA, not HC. The details of this FDA recognition are still being worked out and food companies from Canada, New Zealand and Australia should consult with their US customs agents or EAS for the latest information on this moving target.
The many components of FSMA Preventive Controls regulations and the detailed technical aspects of FSVP alone are challenging to understand and implement. Addressing those challenges from two interwoven US regulations may sometimes require the assistance of outside experts, such as those at EAS, who can help you navigate the requirements and determine a course of action.
EAS offers FSMA services in all areas of food – from Dairy to Juice to Produce, Seafood, LACF, Infant Formula and dietary supplement manufacturers who fall under FSMA and FSVP requirements, workings with manufacturers, processors, holders and packers and transporters of products as well as their retailers.
EAS services in the area of FSMA and FSVP can save time and eliminate confusion. Understanding what rules apply to whom and how to develop compliant procedures can make all the difference when FDA inspectors arrive at your door. Don’t let your company be part of the next FDA inspection citations list or find your company on the FDA Import Alert list. Whether with the help of EAS or working independently with your own internal staff, make sure your FSVP compliance documentation is in good working order.
Kathy Knutson, Ph.D. is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry as she educates on issues surrounding cannabis-infused food products for sale in states with medical and recreational use legislation. Kathy has a Ph.D. in Food Science from the University of Minnesota and prior to consulting worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.
Rudy Westervelt works in foods with a particular focus on solving problems related to dairy food quality, loss reduction, employee safety results, throughput, and cost control. Rudy is a Board Member of World Food Trace, Inc., a non-profit creating a tool to instantaneously trace products through the global food supply chain and is a member of the Global Food Traceability Pilot Project which developed a universal coding system for manufactured food products with a searchable database for rapid identification of source in cases of contamination. Rudy has a Masters of Science in Meat Science and Muscle Biology from the University of Connecticut and an undergraduate degree in Animal Science from Cornell University. Prior to consulting, Rudy spent his career at the Kroger Company.
EAS Independent Consultant Tim Hansen is a former director of the seafood division in FDA’s Center for Food Safety and Applied Nutrition and a former director of the seafood inspection program for the National Oceanic and Atmospheric Administration (NOAA) Fisheries. He previously served in other roles in NOAA’s seafood program, prior to which he was a product supervisor for the Fleischmann’s Yeast Division, Nabisco Brands, in Sumner, WA. Earlier in his career, he served as a supervisor in the New England Fish Company, Seattle, WA and subsequently as a QA manager for British Columbia Packers in South Bend, WA and in Naknek, Alaska. Tim consults with clients on all matters of HACCP, with a particular focus on seafood.
HACCP, of course, stands for Hazard Analysis Critical Control Point, is a highly effective preventive control system for foods and other commodities. “Have a cup of coffee and pray” was how one skeptical USDA union official described HACCP implementation in meat and poultry processing plants when it was implemented in the early 2000’s. It is an example of some of the reservations public health officials had as early as 1980. FDA implemented this systematic control system in seafood effective December 1997. Although controversial its implementation proved to be a tremendous success for the agency and public health in general.
First, let me provide a little history. In the early 1980’s there was a developing trend towards exercise and healthy eating. A nutritionist named Anne Fletcher published a highly popular book about the nutritional benefits from eating seafood entitled Eat Fish, Live Better. This book received a tremendous amount of attention in the media that spurred the consumption of seafood as part of a healthy lifestyle. However, the seafood industry at the time had some systemic quality control problems that allowed significant amounts of low-quality seafood on the market. Most of these quality problems were hygienic in nature and did not pose a food safety problem. However, it did cause concern in the media about seafood safety and the public began to believe that seafood was good nutritionally but not always safe.
Congress at the time also became concerned about seafood safety and offered various legislative bills for so-called mandatory inspection of seafood. Congress also provided money for a Model Seafood Surveillance Project whose mission was to determine what governmental regulations were needed to address these issues. NOAA Fisheries conducted the project and dozens of workshops with industry to garner feedback about what would address the issue of safety and would work best for them. The conclusion of that report was that the implementation of mandatory HACCP was the best way forward. Circa 1990 President H.W. Bush ordered FDA and NOAA Fisheries’ Seafood Inspection Program to work together on a voluntary joint program to implement HACCP principles into the seafood industry and under President Bill Clinton, then FDA Commissioner Kessler decided that FDA would develop its own mandatory program for Seafood HACCP.
The resulting Seafood HACCP rule can be best understood and implemented by referencing the FDA drafted complex guidance document called the Fish and Fishery Products Hazard Guide (FFPHG). It is used worldwide as the, most authoritative, comprehensive guide to the science behind HACCP and FDA policies related to seafood.
While seafood HACCP regulations have been in place for 20 years, there is always work to do and vigilance to keep with regards to the safety of our food sources as the volume of seafood imported to the United States continues to increase. In 2009, 80 percent of the seafood in the U.S. food supply was imported, and by 2015, more than 90 percent was imported. A quick review of FDA warning letters at any point in time demonstrates this challenge, with as of this writing, six out of ten of the most recent FDA warning letters pertaining to seafood HACCP. Challenges such as implementing and verifying that seafood is processed, held and transported insanitary conditions; that regular inspection records verify their safe handling, both before they reach US shores and when they are a domestically distributed are areas where FDA inspectors are working diligently.
Over the years the guidance and FDA policy thinking was refined and the regulation became a tremendous success. Seafood safety and quality improved, scientific thinking was imbued into the seafood industry through the FFPHG which promoted the health of consumers, consumers were less worried about safety issues and seafood HACCP became a template for the Food Safety Modernization Act of 2010 that would apply preventive control principles to the manufacturing of all food commodities. That’s quite an accomplishment. So let’s have a cup of coffee and praise the FDA for their fine work in improving food safety standards for seafood.
Though not a new independent consultant for EAS, we are pleased that Robert “Robbie” Burns, Ph.D., an expert in infant formula is now more readily available to EAS clients after stepping down from the Grocery Manufacturers Association as former Vice President of Health and Nutrition Policy. Dr. Burns is an asset to EAS Clients looking to develop infant formula and his readiness to assist clients greatly enhances our roster of food science experts. Prior to GMA, Dr. Burns was the former Global Nutrition and Scientific Affairs Director at Cadbury Schweppes where he worked to establish consistent global standards and strategies for the improvement of new product pipelines and capacities to reliably deliver nutrition-based product and communication initiatives. Prior to Cadbury, he was at Mead Johnson Nutritionals where he worked with Pediatric Nutritionals. Robbie has a Ph.D. in Nutritional Biochemistry from Queens University in Belfast, Ireland with Postdoctoral Research Fellowships at the Universities of Nottingham and Illinois, Urbana-Champaign. He is the author of nearly 50 papers and articles and has been an invited speaker at dozens of international symposiums and conferences.