Foreign Supplier Verification Program – What Does it Mean for You?

En Espanol

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.

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Customs Agent, FSVP Importer and customer now requires you to 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 includes compliance with a range of new rules, including “Preventive Controls for Human Foods (PCHF)”, “Preventive Controls for Animal Feeds (PCAF)”, Produce Safety regulations, Sanitary Transport and Food Defense.

¿Qué significa esto para su negocio? ¿Qué tipos de documentos se le pedirá proporcionar a su negocio?

What does that mean for your business? What kinds of documents will your business be asked to provide?

Únete al Consultor independiente del Grupo Consultor EAS, el Dr. Gustavo González (experto originario de México), en un seminario sobre las complejidades acerca del programa de verificación de proveedores extranjeros (FSVP) y lo que esto significa para usted como proveedor de alimentos, aditivos y hortalizas exportadas a los Estados Unidos.

Join EAS Consulting Group Independent Consultant, Dr. Gusatvo Gonzalez for a webinar on the complexities of FSVP and what that means to you as a supplier of foods, food additives and produce exported to the United States, presented in Spanish.

El “programa de verificación de proveedores extranjeros (FSVP)” entró en vigor el 26 de mayo de 2017, y las fechas de cumplimiento para empresas pequeñas están ya en efecto. El FSVP requiere que los Importadores a los Estados Unidos verifiquen que sus proveedores extranjeros de alimentos, empaques, ingredientes, suplementos, aditivos y productos alimentarios importados a los Estados Unidos posean el mismo nivel de protección a la salud pública como los productores nacionales.

“Foreign Supplier Verification Program (FSVP)” went into effect on May 26, 2017, and compliance dates for smaller firms are now also in effect. The FSVP requires U.S. importers to verify that their foreign suppliers of food, food packaging, food ingredients, dietary supplements, food additives and/or product imported to the U.S. possess the same level of public health protection as is offered by domestic producers.

Únete a EAS para un webinar exclusivo, presentado en español, donde el Dr. González ayudará a las empresas a entender los requisitos y documentos necesarios para cumplir FSMA y que es lo que los importadores estadounidenses esperan de ustedes.

Join EAS for an exclusive webinar, presented in Spanish, where Dr. Gonzalez will help foreign firms understand the requirements and documents that they will have to meet under FSMA and what U.S. importers will be expecting from them.

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.

In addition to these basic requirements, regulatory US Agents have expertise in providing additional services to foreign clients such as technical reviews of submissions prior to FDA submission, preparation for FDA facility inspections (both through mock-inspections and desk-reviews of documentation), any Corrective Action Plans required by FDA and by providing answers to various questions surrounding the complex FDA regulatory requirements.

This webinar is presented by EAS Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich have covered important basic requirements of the US Agent role as well as opportunities to enhance your understanding of FDA oversight of foreign facilities.

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

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.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

1. 21 CFR 111 GMP Laboratory Overview [View]
2. Using Analytical Instrumentation Appropriately [View]
3. What is a Scientifically Valid Method? [View]
4. Developing Compliant Specification – No “By Inputs” Here
5. How to Select and Qualify a Contract Laboratory [View Below]

Instructor

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

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.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

1. 21 CFR 111 GMP Laboratory Overview [View]
2. Using Analytical Instrumentation Appropriately [View]
3. What is a Scientifically Valid Method? [View Below]
4. Developing Compliant Specification – No “By Inputs” Here
5. How to Select and Qualify a Contract Laboratory [View]

Instructor:

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

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.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

1. 21 CFR 111 GMP Laboratory Overview [View]
2. Using Analytical Instrumentation Appropriately [View Below]
3. What is a Scientifically Valid Method? [View]
4. Developing Compliant Specification – No “By Inputs” Here
5. How to Select and Qualify a Contract Laboratory [View]

Instructor:

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

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.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

1. 21 CFR 111 GMP Laboratory Overview [View Below]
2. Using Analytical Instrumentation Appropriately [View]
3. What is a Scientifically Valid Method? [View]
4. Developing Compliant Specification – No “By Inputs” Here
5. How to Select and Qualify a Contract Laboratory [View]

Instructor:

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

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.

Instructor

Susan Moyers, Independent Consultant

Susan Moyers, Ph.D., MPH, has more than two decades of experience in developing, training and auditing food safety, quality, and dietary supplement management systems. Dr. Moyers is an SQF Certified Consultant and Trainer, a Lead Trainer for FDA’s Preventive Controls and Foreign Supplier Programs, and a consultant, auditor, and trainer for Dietary Supplement cGMPs and HACCP systems.

Kristie Grzywinski, Senior Technical Manager, FMI, SQFI

Kristie Grzywinski, Senior Technical Manager for the Food Marketing Institute’s Safe Quality Food (SQF) Institute, is responsible for delivering education solutions for SQF professionals, including SQF practitioners, consultants, and auditors in support of SQF Institute’s globally-recognized food safety and quality management standard. Grzywinski has made a career of enabling training and education in the foodservice and food manufacturing industries, including 11 years working with the National Restaurant Association’s ServSafe® training program.

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.

What does that mean for your business? What kinds of documents will your business be asked to provide?

Join EAS Consulting Group Independent Advisor for FSMA, Charles Breen and EAS Independent Consultant Dr. Susan Moyers in a webinar directed at foreign embassy staff, and foreign food, food ingredient and food additive firms who export to the United States.

Beginning May 26, 2017, FDA’s “Foreign Supplier Verification Program (FSVP)” goes into effect for large firms; smaller firms may have additional time to comply. The FSVP requires U.S. importers to verify that their foreign suppliers of food, food packaging, food ingredients, dietary supplements and/or food additives imported to the U.S. possess the same level of public health protection as is offered by domestic producers.

In a related FSMA regulation, the FDA is also offering an optional “fast-track” in 2018 for manufacturers who have a documented safety policy and a solid record of safety in their products.

In an exclusive webinar for EAS, Charles Breen and Dr. Susan Moyers will help foreign firms understand the requirements and documents that they will have to meet under FSMA and what U.S. importers will be expecting from them.

EAS Client - Exclusive Webinar

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.

Since the FDA FSMA implementation will place significant regulatory food safety responsibility on a segment of the US food supply chain that had only limited past involvement in food safety regulatory compliance (importers), it is expected there will be both industry implementation and FDA enforcement problems. Any regulatory missteps by importers could trigger FDA import alerts to block importation of foods, food ingredients or food additives from foreign suppliers because of importer non-compliance. US food processors who rely on foreign sourced foods, food ingredients, and food additives could find themselves running short due to FDA blocking imports due to importer/broker regulatory issues related to the FDA FSMA requirements.

In an exclusive webinar for EAS, Independent Consultant Dr. Susan Moyers will discuss the FSVP rules and how to apply them, determining regulatory exposure by both importers and US-based food processors using foreign sources foods, food ingredients, and food additives, identifying exemptions, modified requirements, and documentation requirements.

This 90-minute webinar will offer practical and informative steps to ensure meeting compliance requirements, protecting against adulteration and misbranding as well as corrective actions should something go wrong.

Presenter: Dr. Susan Moyers, EAS Independent Consultant

About the presenter: Dr. Susan Moyers, has over 20 years of experience in developing, training and auditing food and dietary supplement management systems. She consults with facilities to develop and implement the BRC and SQF programs, as well as FDA’s Dietary Supplement cGMP, Preventive Controls, and Foreign Supplier standards. She also investigates and assists in resolving microbiological spoilage and food safety issues. Dr. Moyers is an SQF Registered Consultant and Trainer; a Lead Trainer for FDA’s Preventive Controls and Foreign Supplier Programs, and a consultant, auditor, and trainer for Dietary Supplement cGMPs and HACCP systems.

Dr. Moyers is a native of Philadelphia and received her undergraduate degree at Penn State. She holds a Ph.D. in Food Science and Nutrition from the University of Florida, and a Masters of Public Health degree from the University of South Florida. She currently resides in Tampa, Florida.

Download Slide Handouts

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.

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.”

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 compliance guidance to its inspectors
• The scope of FDA inspectional authority
• Receiving investigators and organizing the opening meeting
• Employee “Do’s” and “Don’ts” during an inspection
• Managing the inspection process
• Wrapping up the inspection and post-inspection follow-up actions

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.

The HARPC rules for human and animal feed are scheduled to be published in August 2015 and will become effective 60 days thereafter, with enforcement to follow 12 to 36 months later, depending on company size.

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.

Ms. Crane is an experienced professional in the pharmaceutical industry specializing in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations on marketing, labeling, and distribution of OTC drugs and dietary supplements.