Learn From Our Library of On-Demand Webinars
The detailed technical knowledge of EAS Senior Directors and Independent Consultants sets us apart from the competition and EAS frequently offers webinars in a public forum to provide a regulatory overview of hot topics that enable greater industry understanding. These public webinars are also available on-demand, here on the EAS website. We hope that you find them informative and welcome any questions or comments.
Selecting and Submitting an ANDA Application
The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until an ANDA …
Retail Food Safety in a Post-Pandemic World
The Retail Food Industry is finally beginning to see an opening as many areas of the country are experiencing decreasing cases of COVID-19, meaning businesses can begin to safely scale up. But what does that mean and how can the retail food industry ensure safe operations in this new normal? Do you understand …
Virtual Book Tour – Food Safety Lessons for Cannabis-Infused Edibles
Join EAS for a live virtual book tour as independent consultant, Kathy Knutson launches her new book Food Safety Lessons for Cannabis-Infused Edibles covering the manufacturing evolution as cannabis moves from isolation to regulatory compliance.
The cannabis industry has unique …
Food Safety and Employee Protection for the Food Processing Industry During the COVID-19 Pandemic Presented in Spanish
Inocuidad de los Alimentos y, Protección para Empleados de la Industria que Procesa Alimentos Durante La Pandemia Del COVID-19Presented by Angel Suarez and Veronica Montellano, EAS Independent ConsultantsLa pandemia de COVID-19 ha puesto al mundo frente una amenaza sin precedentes. Como...
Temporary Policies Regarding Preventive Controls and FSVP During the COVID-19 Public Health Emergency
FDA has implemented temporary policies regarding compliance with FSMA’s Foreign Supplier Verification Program during the COVID-19 pandemic. What do these changes mean for your business and how can you best ensure foreign suppliers are appropriately …
Qualifying Suppliers – Dietary Supplements FSVP Requirements in the Era of COVID-19
The COVID-19 pandemic is causing major disruptions of business and the global supply chain across many industries including public health products that are regulated by the FDA. This means there is an additional challenge for these companies to ensure that these …
Fast Tracking Antimicrobial Agents – FDA’s Accelerated Programs
Developers of antimicrobial agents may seek an accelerated FDA review of their products under the accelerated programs such as Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, or Priority Review and gain additional 5 years of …
Dietary Supplement Serious Adverse Events – Traceability Compliance in the Era of COVID-19
In the wake of COVID-19 pandemic, a number of enforcement discretion measures have been put in place by FDA, one of which pertains to the reporting of Serious Adverse Events (SAE) for dietary supplements which, in accordance to the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, require dietary supplement firms to submit all SAE accusations to the FDA within 15 business days of receipt of the complaint.
OSHA Lockout-Tagout – Critical Steps to Employee Safety
Is your manufacturing floor a safe work environment? Do you abide by OSHA controls commonly known as Lockout-Tagout? Employees can be seriously or fatally injured when machinery they clean, service or maintain unexpectedly energizes, starts up, or releases stored energy.
Practical Approaches to FSMA (PCQI, Supply Chain, FSVP) in the Era of COVID-19
A global pandemic does not negate our responsibility and requirement to maintain Food Safety in food production plants and adhere to FSMA policies set forth by the FDA. In fact, in an era of reduced workforce, supply chains may be disrupted, critical contracted services such as cleaning and pest control may unavailable and you may not be able to get critical supplies.
Cutting Edge Methods for Detecting Food Fraud
The challenge of detecting Food Fraud has never been greater nor the economic loss to food manufacturers, importers, retailers and consumers. In the recent past, we have had to rely on the integrity of the supply chain, person to person relationships and trained sensory staff to try and identify food fraud. The supply chain has become long and complicated, person-to-person relationships are not as strong as in the past and the sophistication of those making and selling fraudulent food can fool even a well-trained sensory specialist.
Tips to Streamlining the Drug Master File Process
Presented by Priya Jambhekar The meticulous detail of a Type II Drug Master Files (DMF) enables FDA to review and assess the chemistry, manufacturing, stability, purity, impurity profile, packaging and Good Manufacturing Practices data of Active Pharmaceutical Ingredients (API) or a finished drug...
Codex Opportunities for Food Manufacturers
Can Codex food standards and various food safety, hygiene guidelines and codes of practice positively impact domestic food manufacturers that do not export? The short answer is “YES!”
Codex provides a transparent international platform for food safety and hygiene as well as manufacturing practices, food standards (ranging from dairy products to seafood to pasta), acceptable and unacceptable food additives specific to every food sector, contaminant levels in all foods, etc. Understanding Codex and how to make use of Codex standards, guidelines and codes of practice can benefit every food manufacturing business, whether food products are exported or not.
Dietary Supplements and FSMA Compliance – Fallacy or Fact?
In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of foods, dietary supplements are now subject to seven major regulations to support enforcement of FSMA.
One of the most important of these regulations being 21 CFR 117, Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF), which requires, among other things, that a Preventive Controls Qualified Individual (PCQI) develop a food safety plan. Another FSMA requirement is the need for a Foreign Supplier Verification Program (FSVP) when dietary ingredients and dietary supplements are sourced internationally, (estimated to be over half of all dietary supplement ingredients). Unfortunately, the dietary supplement industry is plagued by lack of compliance with these critical FSMA requirements and the FDA is beginning to crack down on firms with increased enforcement actions.
Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters
Though FDA’s 21 CFR 111 Good Manufacturing Practices (GMPs) for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance. The establishment of specifications for components, in-process materials, and finished products; and then testing to those specifications has continuously been the top observation issued by the FDA. Use of a Master Manufacturing Record (MMR) that is executed for each manufactured and packaged batch, and at every batch size, in a Batch Production Record (BPR) has also been a challenge, despite the detailed list of MMR and BPR requirements provided in Subparts H and I of the regulation, respectively. In addition, having a Quality Unit that reviews and approves these specifications and records, as well as all other processes, and conducts necessary material reviews to make scientifically sound disposition decisions is a vital part of the GMP quality system that is frequently missing or inadequate.
How to be an Effective and Sought-After Expert Witness
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony will play an essential role in mounting the response.
For attorneys, choosing a knowledgeable and experienced expert witness is of paramount importance. Unlike attorneys who are schooled in the world of litigation, experts often come from academia, the government and industry, and are not familiar with the unique skills required to be an effective witness.
Navigating CBP and Prior Notice of FDA’s Imported Products
As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of U.S. consumer and integrity of the food-based products being imported. FDA has historically seen an import rate increase of 5-10% in the last decade and in 2018, 31% of those were food products requiring prior notice.
Understanding how to navigate the FDA and US Customs import process, including how to utilize their programs to expedite the review of paperwork and shipments at the US ports of entry will be covered in some detail in this webinar. Qualifying for these “expedited” programs is critical to meeting shipment timelines in order to maintain successful business relationships with U.S. wholesalers and retailers.
FDA’s Transition from CFR 820 to the ISO 13485:2016 – Instituting a New Quality Management System (QMS)
FDA’s shift to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers. But will those operating under 21 CFR 820 Quality Management Systems make the voluntary switch?
While ISO 13485 is an international standard, its focus on design and development planning and controls, based on risks and outputs differs in many respects to the GMPs under which medical device firms selling products in the U.S. have been operating. Making the shift to ISO standards requires a shift in thinking, planning and execution of manufacturing policies and working procedures.
Food Defense – Untangling the Challenges and Strengthening Opportunities
EAS Independent Advisor for FSMA, Charles Breen and Consultant Kathy Knutson, Ph.D. co-present a webinar on Food Defense. Food Defense is increasingly a worry for firms as our global business climate opens opportunities for intentional harm both domestically and overseas. The ability of food manufacturers to identify and mitigate the impact of intentional attacks that compromise food safety is not only required as part of the Food Safety Modernization Act (FSMA) it makes good business sense to protect consumer health and brand reputation.
Understanding GRAS Submissions and Avoiding Data Pitfalls- Meet FDA Requirements
Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive or determined to be generally recognized as safe (GRAS) for use in food.
Developing a food ingredient so that it is ready for GRAS submission can be a time consuming and costly process. Understanding the major components of a GRAS submission, the details of the required sections, and factors FDA considers when reviewing GRAS submissions are imperative to a successful submission and the receipt of subsequent “No Questions” response from FDA.
Preparing for FDA Inspections, a Look at Recent Observations and Trends
Foreign companies exporting FDA regulated products to the United States can at any time expect an FDA announcement of facility inspection. Looking at the complete safety package from record keeping and retention, to specifications and testing to employee training, FDA ensures foreign firms operate with the same safety standards required of companies operating within the U.S.
A look at trends of inspection findings of foreign manufacturers provides insight into industry challenges concerns garnering FDA’s increased focus.
GMPs for OTCs – Improving Compliance as FDA Eyes Enforcement Actions
With more than 80 therapeutic categories, Over-the-Counter (OTC) drug products play an ever-increasing role in health care. FDA’s Center for Drug Evaluation and Research (CDER) working in conjunction with the Office of Regulatory Affairs (ORA) ensures that OTC products are safe to use, appropriately labeled, adverse events reports are filed and that all products are manufactured under the appropriate quality control measures. Generally, the FDA’s first and best opportunity to assess the quality and compliance conformance of an OTC drug will be during an on-site inspection of the manufacturing facility. From a Good Manufacturing Practices (GMP) perspective, manufacturers must recognize that the FDA applies the same, stringent 21 CFR 210 and 211 drug GMP standards to OTC products just as prescription drugs are held to. Thus, OTC drug manufacturers (and contract manufacturers) must maintain vigilance at all times with all aspects of production quality and documentations. From the physical plant and grounds, employee training, testing and specifications, including Out of Specifications (OOS) results management, compliance expectations with 21 CFR 211 are clearly articulated.
Understanding the Food Fraud Puzzle
With long supply chains that can stretch around the world, Food Fraud is a hot topic for the food industry, consumers and government regulators. Food fraud’s negative impacts cause financial harm to the food manufacturing industry and public harm while fostering consumer mistrust. Examples of food fraud can be found in many food sectors including spices, seafood, meat and dairy as well as more specific examples such as olive oil, honey, coffee and saffron, just a few.
Substituting cheap ingredients and food additives is called “economic adulteration”, a violation of US federal law. In addition, when dangerous ingredients are used, crossing the line into “intentional adulteration” the crime is a felony, with the potential for jail time.
FDA 21 CFR-Part 11 Compliance Audit
Regardless of the type of industry, if you are regulated by the FDA you are bound by the rules around electronic data integrity. Whether preparing to release a finished batch of material, making decisions on data and information that was created and generated electronically or preparing to file a technical dossier with the FDA; your electronic recordkeeping and other electronic data forms require more than just being available for review and inspection. The FDA requires these sources of evidence to be generated, processed and maintained in a manner that provides complete traceability, prevents unauthorized alteration and requires a verified electronic signature that ensures identity and authenticity.
Cosmetics Claims – Words Do Matter
In the competitive cosmetics world, discerning consumers are carefully considering product purchases to determine which offer the results they are hoping to achieve. In response, the pressure on marketing and labeling teams may entice to push the envelope with regards to product claims. However, words do matter, particularly in the eyes of FDA.
The manner in which labels are worded and claims are made can make all the difference in a cosmetic product inadvertently being marketed as an unapproved drug. Once a company has crossed that line, FDA takes notes and immediate changes to the marketing strategy to correct the errors or the product will be forcefully pulled from the market with potential liability risks for the company and product owners.
Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports
The Food Safety Modernization Act, signed into law in 2011, includes an important provision for food importers under the Foreign Supplier Verification Program (FSVP) Final Rule. Namely, Part 1 Subpart L, Section §1.503 requires that importers of human and animal food enlist a Qualified Individual (QI) who has responsibility for developing a program and performing each activity under the program to ensure that the products that they are importing are not adulterated or misbranded (in regards to allergens) and have been produced in accordance with the preventive control regulations for human or animal food (CFR §117 & 507 respectfully), or the Produce Safety Rule (CFR §112).
Regulatory, Technical and Formulations for New Infant Formula Notifications – Challenges and Opportunities
The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies not well-prepared for the rigors of FDA review and assessment.
Cosmetics Labeling and Claims Regulations
Independent Advisor for OTC Drugs and Labeling, Susan Crane, discusses cosmetic labeling and claims in this on-demand webinar.
What Does the 2018 Farm Bill Mean for the Cannabis Industry?
The 2018 Farm Bill answered many questions for the cannabis industry, but its message has also been largely misunderstood. Misinterpretations as to the legality of including cannabis as an ingredient in foods, herbal products, and dietary supplements have erroneously lead firms to begin planning and production of illegal products, and, in the case of those which legally include (by state) CBD ingredients there is often little regard or understanding of how to manage the quality, including product specifications for the production of a consistent and safe product.
OTC Drugs, Labeling and Listing Requirements
Join independent advisor for OTC Drugs and Labeling, Susan Crane, for a look at OTC labeling requirements and drug listing responsibilities.
Developing Vitamin, Mineral and Supplement Products for Commercial and Compliance Success
Product development in the dietary supplement industry has never been more competitive. With new companies and products arriving in the marketplace at rapid speed, the pressure is on to develop something new and exciting for the consumer in order to stay ahead of the competition.
When developing new products, one area that cannot be overlooked is that of regulatory compliance with the Dietary Supplement Health and Education Act of 1994 (DSHEA), and FDA’s Good Manufacturing Practice requirements for dietary supplements per 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,and appropriate labeling of the dietary supplement product in accordance to 21 CFR 101, Food Labeling.
OTC Drug Monographs, Past, Present, and Future
EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future.
Pharma’s Problems with Data Integrity
FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years, indicate that validation is a consistent problem for the pharmaceutical industry. Data integrity, or lack thereof, can have major repercussions for a firm because once FDA finds some data to be unreliable, it considers all of a firms’ data to be unreliable. FDA expects that data to be reliable and accurate, and that crucial and often overlooked validation step can ultimately cost manufacturers untold amounts in R&D, materials, product recalls, submissions, and more.
“Own Label Distributor” Responsibilities
More and more OTC drug and dietary supplement companies are contracting out manufacturing, packaging, laboratory testing, and distribution services. This requires a full understanding of how those contract services are being conducted in order to have complete confidence that their products are meeting quality specifications and regulatory requirements. In addition in the past several years, the FDA has focused more intensely on such companies that they refer to as “own label distributors” (“OLDs”). The result has been an escalating number of FDA inspections, Form 483 inspection observations, and warning letters.
Preparing for Tobacco TPMPs in Cooperation with TMA
Since CTP Director, Mitch Zeller’s announcement at the 2018 TMA Annual Meeting that the Agency is prioritizing a Tobacco Product Manufacturing Practices Rule (TPMPs), the industry has been speculating regarding what these rules may encompass.
While there has been no direct guidance from the FDA to date on what may be included in a TPMP rule, some insight can be gained from the results of the numerous tobacco industry inspections that the Agency has performed over the past 6 years. Based on these inspections there are likely to be numerous requirements regarding TPMPs.
Are Industry-Initiated Environmental Swab-a-Thons a Benefit?
The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in the industry is that of pathogen contamination. It is generally understood that contamination in the processing environment will eventually make its way into the product. Even with the best of safety controls, it is imperative that companies have a robust environmental monitoring program that includes vigilant and regular testing. After all, finished product testing gives limited data and is a small snapshot of the entire lot manufactured. FDA can take hundreds of swabs during inspections, does your environmental monitoring meet that level of testing?
Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application
Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain, (i.e., mandatory and optional ingredients. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit(TMP’s). With TMP’s companies with novel standardized food innovations may apply to market test a food product that deviates from the standard of identity for that particular food, providing FDA with data needed to consider a future petition to amend the standard.
Preparing for Foreign FDA Inspections
Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks.
Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations
As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the Cannabis industry to begin assessing your manufacturing processes and implementing sound and effective quality systems in order to help you begin to prepare for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry.
Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted?
Si usted exporta alimentos, ingredientes, empaques, suplementos o aditivos alimenticios hacia los Estados Unidos, su agente aduanal en los Estados Unidos, importador y clientes le pedirán proporcionar documentación para verificar que su empresa cumple con la Ley de Modernización de la Inocuidad de los Alimentos (FSMA por sus siglas en Ingles) del Departamento de Drogas y Alimentos (Food and Drug Administration o FDA). Esto incluye el cumplimiento de una serie de nuevas reglas, incluyendo “controles preventivos para alimentos humanos (PCHF)”, “controles preventivo de alimentos para animales (PCAF)”, regulaciones de seguridad de los productos agrícolas frescos, transporte sanitario y defensa de alimentos.
The Role of Your US Agent
Foreign entities who operate in US FDA regulated industries must have an appointed US Agent before doing business and importing products into the US. US Agents act as an intermediary between the foreign company and FDA, assisting with two-way communication on requirements and questions such as establishment and facility registrations, product listings as well as submissions such as Foreign Color Manufacturers Testing and Approval through FDA, drug submissions such as IND, DMF, ANDA and their amendments and annual updates, and medical device applications such as 510(k), 513(g), PMA and IDE.
Medical Device Quality Auditing
Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting of adverse events, every detail must be attended to in a thorough and documented quality system. Quality systems are key indicators of a company’s commitment to producing a safe and effective product as well as a company’s good record keeping practices as records are tested and maintained to provide transparency to FDA inspectors in the case of an audit.
Unraveling The Impact of FSMA On Acidified Food Regulations
This webinar hosted by EAS Consulting Group will provide you with these answers. The webinar will be presented by EAS Independent Consultant Omar A. Oyarzabal, Ph.D., a microbiologist processing authority, and FDA Consumer Safety Officer Priya Rathnam with the Office of Compliance/Division of Compliance Policy at FDA’s CFSAN. Specific topics covered include:
How to Select and Qualify a Contract Laboratory
Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.
What is a Scientifically Valid Method?
Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.
Using Analytical Instrumentation Appropriately
Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.
21 CFR 111 GMP Laboratory Overview
Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.
Key Changes in SQF 8.0
While 2017 is a year for manufacturing facilities to augment their FSMA programs for US markets, 2018 will be a year to update their GFSI systems. Beginning in January SQF advances to Edition 8.0. Learn more about these revisions and the impact on SQF 8.0 on facilities who are, or plan to be, certified by SQF.
Foreign Supplier Verification Program – What Does It Mean For Your Business
If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This could include compliance with a range of new rules, including “Preventive Controls for Human Foods (PCHF)”, “Preventive Controls for Animal Feeds (PCAF)”, and Produce Safety regulations.
Foreign Supplier Verification Program, FSMA’s Next Big Challenge
The US Food and Drug Administration’s will require all importers, starting at the end of May 2017 to have on hand for FDA review, significant new food safety documentation at their US office(s) for all foreign suppliers of food, food ingredients, and food additives. The FDA’s “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FDA Food Safety Modernization Act (FSMA) and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. The first step is to make sure all foreign suppliers are registered with FDA.
Quality Agreements in the Complex World of Dietary Supplements
One of the most fundamental concepts in the dietary supplement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the role of the Quality Unit (QU). The QU is responsible for reviewing and approving all controlled processes and documentation; as well as making all disposition decisions for raw materials, packaging components, labels, in-process materials, and finished dietary supplement products. It is therefore essential that these quality responsibilities are clearly defined and assigned to appropriate personnel. This can be readily accomplished with a designated QU department at a single firm. However, the dietary supplement industry is an industry of contractors. Own Label Distributors (OLDs) often use multiple contractors to manufacture product, package and label product, test product, and then hold and distribute product to consumers. Given this complexity, the assignment of QU responsibilities can become quite confusing and even entirely lost. The establishment of a Quality Agreement among the contractors can resolve this by defining the QU obligations and responsibilities of each party involved. Learn what constitutes a Quality Agreement and how to establish one with your contractor in the EAS Webinar, Quality Agreements in the Complex World of Dietary Supplements.
How to Successfully Respond to FDA 483s and Warning Letters
EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how to respond in a way to prevent the issuance of a Warning Letter.”
Managing FDA Inspections
With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in the direction that you help set. To provide you with that knowledge, this webinar will cover:
FDA Strategies to Implement & Enforce the Food Safety Modernization Act
This FSMA webinar will explore FDA’s anticipated enforcement strategy following finalization of the Hazard Analysis and Risk-based Preventive Control (HARPC) regulations for manufactured foods. The final rule will require that each food facility identify a “Qualified Individual” to conduct a multi-factor hazard analysis, then design and implement a written plan to control significant hazards.
Regulatory Compliance Strategies for Marketing Dietary Supplements on Social Media
The widespread use of social media has had an impact on how we interact in our personal and professional relationships. It is also having a profound effect on businesses and their relationships with customers. For those of us in FDA-regulated industries, there are implications for marketing strategies and what companies are allowed to say. While the FDA has provided guidance on such strategies for prescription drugs and medical devices, the rules and regulations for advertising of dietary supplement on social media have not been as clear.
Learn how these FDA guidance documents, along with those from the Federal Trade Commission, can help you to consider social media as you meet regulatory agency expectations in marketing your dietary supplement products.