Successfully Navigating U.S. FDA Requirements when Importing a new Dietary Supplement into the U.S. Presented by Nutritional Products International,Scott Gould and Rosemarie Sunderland on a live Webinar. For more information on marketing your product in the US visit www.nutricompany.com
The U.S. Food and Drug Administration (FDA) regulates most foods and medical products. It aims to protect public health by ensuring foods are safe and properly labeled, and that medicines, medical devices and cosmetics are reasonably safe and effective. The FDA oversees a large number of companies and conducts facility inspections to ensure compliance with regulations. It can pursue legal action if regulations are violated.
RECENT GROWTH OF NUTRACEUTICAL IN REGIONAL MARKETShruti Motwani
The presentation highlights the results of a market survey conducted in Nagpur region of Maharashtra to estimate the growth of nutraceutical market in the region. This survey was conducted as a part of curricular project for completion of B.Pharm. The following presentation may help the viewer to get an idea about the growth trends of nutraceutical market in urban regions of the country(nagpur region here). The importance of such surveys has been clearly mentioned and the details regarding survey procedures and results may guide students in conducting such small scale surveys in future.
This document provides guidelines for quality specifications of herbal medicinal products and traditional herbal medicinal products. It discusses guidelines for qualitative and quantitative particulars of active substances, descriptions of manufacturing processes, control of starting materials and finished products, stability testing, and definitions. The guidelines are intended to ensure herbal medicinal products and traditional herbal medicinal products meet quality standards.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The US FDA regulates medical devices to ensure they are safe and effective. There are three classes of medical devices with increasing regulatory controls based on risk. Class I devices have general controls, Class II devices have general and special controls, and Class III devices require premarket approval. To market a device in the US, manufacturers must classify their device, submit the appropriate premarket notification or application, and complete an establishment registration and device listing. The FDA reviews submissions to ensure devices reasonably assure safety and effectiveness.
Import and export regulations laws of usaSanjay Yadav
This document discusses FDA regulations regarding the import and export of medical products. It outlines the authorities FDA has to examine imported foods, drugs, and other products. It provides details on import documentation and entry requirements. It also discusses requirements for exporting over-the-counter drugs and unapproved new drugs in accordance with Section 802 of the Federal Food, Drug, and Cosmetic Act.
Successfully Navigating U.S. FDA Requirements when Importing a new Dietary Supplement into the U.S. Presented by Nutritional Products International,Scott Gould and Rosemarie Sunderland on a live Webinar. For more information on marketing your product in the US visit www.nutricompany.com
The U.S. Food and Drug Administration (FDA) regulates most foods and medical products. It aims to protect public health by ensuring foods are safe and properly labeled, and that medicines, medical devices and cosmetics are reasonably safe and effective. The FDA oversees a large number of companies and conducts facility inspections to ensure compliance with regulations. It can pursue legal action if regulations are violated.
RECENT GROWTH OF NUTRACEUTICAL IN REGIONAL MARKETShruti Motwani
The presentation highlights the results of a market survey conducted in Nagpur region of Maharashtra to estimate the growth of nutraceutical market in the region. This survey was conducted as a part of curricular project for completion of B.Pharm. The following presentation may help the viewer to get an idea about the growth trends of nutraceutical market in urban regions of the country(nagpur region here). The importance of such surveys has been clearly mentioned and the details regarding survey procedures and results may guide students in conducting such small scale surveys in future.
This document provides guidelines for quality specifications of herbal medicinal products and traditional herbal medicinal products. It discusses guidelines for qualitative and quantitative particulars of active substances, descriptions of manufacturing processes, control of starting materials and finished products, stability testing, and definitions. The guidelines are intended to ensure herbal medicinal products and traditional herbal medicinal products meet quality standards.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The US FDA regulates medical devices to ensure they are safe and effective. There are three classes of medical devices with increasing regulatory controls based on risk. Class I devices have general controls, Class II devices have general and special controls, and Class III devices require premarket approval. To market a device in the US, manufacturers must classify their device, submit the appropriate premarket notification or application, and complete an establishment registration and device listing. The FDA reviews submissions to ensure devices reasonably assure safety and effectiveness.
Import and export regulations laws of usaSanjay Yadav
This document discusses FDA regulations regarding the import and export of medical products. It outlines the authorities FDA has to examine imported foods, drugs, and other products. It provides details on import documentation and entry requirements. It also discusses requirements for exporting over-the-counter drugs and unapproved new drugs in accordance with Section 802 of the Federal Food, Drug, and Cosmetic Act.
This document discusses natural health products (NHPs) in Canada, including regulatory requirements and market opportunities. NHPs include vitamins, minerals, herbal remedies, probiotics, and other supplements. Health Canada regulates NHPs through product licensing, site licensing, and good manufacturing practices. There are three classes of NHPs with different approval pathways and timelines. While Canada has a large NHP market and export opportunities due to Health Canada's reputation, herbal medicines face challenges due to variability and innovation is limited for Class I and II products. A SWOT analysis identifies strengths, weaknesses, opportunities and threats for the Canadian NHP industry.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
The highlights of this presentation covers importance of drug labeling, general labeling provisions, labeling requirements for prescription drugs and/or insulin, labeling requirements for over-the-counter (OTC) drugs, exemptions from adequate directions for use, and labeling claims for drugs in drug efficacy study.
Nearly 8 in 10 prescriptions filled in the U.S. are for generic drugs. The FDA requires that generic drugs have the same active ingredients, strength, dosage form and administration as the brand name drugs. Generic manufacturers must prove their drugs are bioequivalent to the brand name drugs and meet the same quality standards in manufacturing. On average, generic drugs cost 80-85% less than their brand name counterparts and saved $158 billion in 2010 alone.
labelling requirements and label claims for dietary supplements in USAnavyasribandaru
The document discusses labeling requirements and claims for dietary supplements in the US. It notes that regulatory agencies include the Dietary Supplement Health and Education Act of 1994 and the Federal Trade Commission. Labels must include the name and quantity of ingredients, net weight, part of plant ingredients come from, and manufacturer information. There are three types of claims allowed: health claims which describe a nutrient-disease relationship and must be FDA approved; nutrient content claims which describe a nutrient level; and structure/function claims which describe a supplement's role but do not need FDA approval if truthful and not misleading.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
The Food and Drug Administration (FDA) is organized into 8 centers that regulate specific products and conduct research. The centers are:
1. The Center for Biologics Evaluation and Research regulates vaccines, blood, and gene therapies.
2. The Center for Devices and Radiological Health oversees medical devices and radiation-emitting products.
3. The Center for Drug Evaluation and Research regulates prescription and over-the-counter drugs.
4. The Center for Food Safety and Applied Nutrition regulates food, dietary supplements, bottled water and cosmetics.
5. The Center for Tobacco Products regulates cigarettes and smokeless tobacco.
6. The Center for Veterinary Medicine regulates
This document provides an overview of the regulatory aspects of herbal medicines in India, Europe, and the United States. It discusses the key regulatory bodies and guidelines around herbal medicines in each region. In India, herbal medicines are regulated by the Ayush Ministry, ICMR, and Drugs and Cosmetics Act. In Europe, herbal medicines fall under European directives and are evaluated by the EMA and HMPC. In the US, herbal products are classified and regulated differently depending on if they are considered a dietary supplement, food, or drug.
This document discusses Investigational New Drug (IND) applications and New Drug Applications (NDA). It provides details on the process for approval of new drugs in the US and India. Some key points include:
- An IND must be filed with the FDA before beginning clinical trials of an investigational new drug in humans. It contains information on pre-clinical studies, manufacturing, and clinical protocols.
- In India, a similar process involves submitting an application on Form 44 to the Central Drugs Standard Control Organization along with required documents and fees.
- An NDA is submitted to formally request approval to market a new drug after Phase III trials. It contains extensive data from non-clinical and clinical studies in a
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Regulatory requirements for otc drugs as per usfdaKhushboo Bhatia
Over-the-counter (OTC) drugs are medicines that can be sold directly to consumers without a prescription. In the US, the FDA regulates OTC drugs to ensure they are safe and effective for use without medical supervision. The FDA approves OTC drugs either through the OTC monograph system, which regulates well-established ingredients by therapeutic class, or through the new drug application process for products that do not fit existing monographs. Regulations cover manufacturing, clinical testing, facility registration, importation, safety monitoring, and risk management for both OTC and prescription drugs.
The document provides an overview of medical device regulations in ASEAN countries. It discusses the ASEAN Medical Device Directive (AMDD), which provides harmonized regulations across ASEAN nations. It outlines the medical device classification system and regulatory registration procedure, including requirements for quality systems and clinical evaluation/investigation. Key aspects covered are the ASEAN Common Submission Dossier Template for product registration and ISO 13485 standards for quality management systems.
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
The document provides an overview of U.S. FDA regulations for exporting food and beverages to the U.S., including the Food Safety Modernization Act. It discusses the FDA's jurisdiction and structure, key food regulations on labeling, ingredients and claims. It also summarizes provisions of the FSMA relating to prevention of food hazards, mandatory inspections, import safety through programs like the Foreign Supplier Verification Program. The seminar aims to help exporters understand and comply with complex U.S. food safety rules.
FDA & Health Canada (CFIA) Requirements to Sell Foods in North AmericaQuality Smart Solutions
This food compliance webinar focuses on food labelling requirements, TMAL, requirements to import or export food. U.S Agent, FSVP agent and more.
Visit:
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
This document discusses natural health products (NHPs) in Canada, including regulatory requirements and market opportunities. NHPs include vitamins, minerals, herbal remedies, probiotics, and other supplements. Health Canada regulates NHPs through product licensing, site licensing, and good manufacturing practices. There are three classes of NHPs with different approval pathways and timelines. While Canada has a large NHP market and export opportunities due to Health Canada's reputation, herbal medicines face challenges due to variability and innovation is limited for Class I and II products. A SWOT analysis identifies strengths, weaknesses, opportunities and threats for the Canadian NHP industry.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
The highlights of this presentation covers importance of drug labeling, general labeling provisions, labeling requirements for prescription drugs and/or insulin, labeling requirements for over-the-counter (OTC) drugs, exemptions from adequate directions for use, and labeling claims for drugs in drug efficacy study.
Nearly 8 in 10 prescriptions filled in the U.S. are for generic drugs. The FDA requires that generic drugs have the same active ingredients, strength, dosage form and administration as the brand name drugs. Generic manufacturers must prove their drugs are bioequivalent to the brand name drugs and meet the same quality standards in manufacturing. On average, generic drugs cost 80-85% less than their brand name counterparts and saved $158 billion in 2010 alone.
labelling requirements and label claims for dietary supplements in USAnavyasribandaru
The document discusses labeling requirements and claims for dietary supplements in the US. It notes that regulatory agencies include the Dietary Supplement Health and Education Act of 1994 and the Federal Trade Commission. Labels must include the name and quantity of ingredients, net weight, part of plant ingredients come from, and manufacturer information. There are three types of claims allowed: health claims which describe a nutrient-disease relationship and must be FDA approved; nutrient content claims which describe a nutrient level; and structure/function claims which describe a supplement's role but do not need FDA approval if truthful and not misleading.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
The Food and Drug Administration (FDA) is organized into 8 centers that regulate specific products and conduct research. The centers are:
1. The Center for Biologics Evaluation and Research regulates vaccines, blood, and gene therapies.
2. The Center for Devices and Radiological Health oversees medical devices and radiation-emitting products.
3. The Center for Drug Evaluation and Research regulates prescription and over-the-counter drugs.
4. The Center for Food Safety and Applied Nutrition regulates food, dietary supplements, bottled water and cosmetics.
5. The Center for Tobacco Products regulates cigarettes and smokeless tobacco.
6. The Center for Veterinary Medicine regulates
This document provides an overview of the regulatory aspects of herbal medicines in India, Europe, and the United States. It discusses the key regulatory bodies and guidelines around herbal medicines in each region. In India, herbal medicines are regulated by the Ayush Ministry, ICMR, and Drugs and Cosmetics Act. In Europe, herbal medicines fall under European directives and are evaluated by the EMA and HMPC. In the US, herbal products are classified and regulated differently depending on if they are considered a dietary supplement, food, or drug.
This document discusses Investigational New Drug (IND) applications and New Drug Applications (NDA). It provides details on the process for approval of new drugs in the US and India. Some key points include:
- An IND must be filed with the FDA before beginning clinical trials of an investigational new drug in humans. It contains information on pre-clinical studies, manufacturing, and clinical protocols.
- In India, a similar process involves submitting an application on Form 44 to the Central Drugs Standard Control Organization along with required documents and fees.
- An NDA is submitted to formally request approval to market a new drug after Phase III trials. It contains extensive data from non-clinical and clinical studies in a
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Regulatory requirements for otc drugs as per usfdaKhushboo Bhatia
Over-the-counter (OTC) drugs are medicines that can be sold directly to consumers without a prescription. In the US, the FDA regulates OTC drugs to ensure they are safe and effective for use without medical supervision. The FDA approves OTC drugs either through the OTC monograph system, which regulates well-established ingredients by therapeutic class, or through the new drug application process for products that do not fit existing monographs. Regulations cover manufacturing, clinical testing, facility registration, importation, safety monitoring, and risk management for both OTC and prescription drugs.
The document provides an overview of medical device regulations in ASEAN countries. It discusses the ASEAN Medical Device Directive (AMDD), which provides harmonized regulations across ASEAN nations. It outlines the medical device classification system and regulatory registration procedure, including requirements for quality systems and clinical evaluation/investigation. Key aspects covered are the ASEAN Common Submission Dossier Template for product registration and ISO 13485 standards for quality management systems.
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
The document provides an overview of U.S. FDA regulations for exporting food and beverages to the U.S., including the Food Safety Modernization Act. It discusses the FDA's jurisdiction and structure, key food regulations on labeling, ingredients and claims. It also summarizes provisions of the FSMA relating to prevention of food hazards, mandatory inspections, import safety through programs like the Foreign Supplier Verification Program. The seminar aims to help exporters understand and comply with complex U.S. food safety rules.
FDA & Health Canada (CFIA) Requirements to Sell Foods in North AmericaQuality Smart Solutions
This food compliance webinar focuses on food labelling requirements, TMAL, requirements to import or export food. U.S Agent, FSVP agent and more.
Visit:
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
The document provides background information on the U.S. food safety system. It discusses the main federal regulatory agencies that oversee food safety - the USDA and FDA. The USDA regulates meat and poultry products while the FDA regulates all other foods, including imports. Other agencies like CDC and EPA also play roles. The agencies have different statutory authorities that influence their oversight approaches. The U.S. system relies on cooperation between federal, state, and local authorities.
David Acheson's Webinar Slides on Food Safety LegislationLeavitt Partners
The Food Safety Modernization Act is the most sweeping reform of U.S. food safety laws since 1938. It seeks to shift the focus from responding to contamination to preventing it. Key provisions include mandatory inspection frequencies for food facilities based on risk, expanded access to food facility records, and new mandatory recall authority for FDA. The act increases regulation and oversight of both domestic and imported food. Full implementation will require additional resources and take time. Facilities, importers, laboratories and other stakeholders must understand and prepare for coming changes to food safety laws and oversight.
This document provides an overview of U.S. regulations for novel food ingredients, including food additives, GRAS substances, dietary supplements, and case studies on specific emerging technologies like genetically modified plants, cell-based and plant-based meats, and animal food ingredients. It describes the regulatory authorities of the FDA and USDA and various approval pathways including food additive petitions, GRAS notifications, and AAFCO new ingredient definitions.
This document provides information about ABC Research Laboratories and their services for resolving FDA import detentions. It discusses the detention process, including why products may be detained under import alerts and the "red list" and "green list" system. It outlines the documents needed for sampling and testing, the testing process, and how to submit results to the FDA. It also explains that importers need 5 consecutive clean entries and to file a petition to be removed from the "red list," which may require working with an import attorney. The document encourages subscribing to their blog for more food safety information and ends thanking attendees.
Are you searching for a Regulatory Compliance Consultant that can help you acquire a Natural Product Number (NPN) for your NHP product? If so, Quality Smart Solutions is the right place. QSS is a renowned global consulting firm with a successful track record of registering more than 5,000 NPNs since inception. This company helps meet compliant bilingual label requirements and an Importer of Recorder. Get assistance in preparing a Product license application (PLA), Electronic Product License Application (ePLA) for a class 1 or 2 NHP, Electronic Product License Application for a class 3 NHP, an Evidence Summary Report (it includes information for safety and efficacy support) and a finished product specification form.
For more information about Regulatory Compliance Service at Quality Smart Solutions, visit the official website https://qualitysmartsolutions.com/.
The Food Safety Modernization Act grants the FDA new authorities to regulate food safety, including mandatory recall authority, expanded access to facility records, and increased oversight of imported foods. Key changes include increased inspection frequencies for domestic and foreign facilities based on risk factors. The FDA will also be able to require certification of imported foods by third-party auditors. Facilities that produce, process or distribute food will need to implement food safety plans and be prepared for greater regulatory scrutiny of their operations and records. The new law aims to shift the FDA's focus from response to prevention of foodborne illness outbreaks.
Manufacturers that export FDA-regulated products such as drugs and medical devices from the US are oftentimes required to provide a certificate prepared by the FDA which confirms the product’s regulatory and marketing status...
How FSMA Changes The Status Quo For Food Businesseskmodza
This document summarizes how the Food Safety Modernization Act (FSMA) changes regulations for food businesses. Key points include:
1. FSMA brings the most expansive changes to food safety law since 1938 with new enforcement powers for the FDA, import requirements, and program activities.
2. Some provisions like increased records access authority, mandatory recall authority, and more frequent inspections are already in effect.
3. Soon, additional changes will take effect regarding preventative controls, traceability, foreign supplier verification, and import certification.
4. Food businesses need to update practices like supplier and recall plans, recordkeeping strategies, and insurance to minimize risks under FSMA.
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, vaccines, and other products in the United States. The FDA is responsible for protecting public health by ensuring the safety and security of these products. It evaluates the safety and efficacy of new drugs and monitors approved drugs for safety issues. The FDA aims to provide accurate science-based information to the public and encourages participation in its regulatory process through public dockets. It works with international authorities like those in India to ensure safety standards for products exported to the US.
The document provides information about the US Food and Drug Administration (FDA):
- The FDA is a regulatory agency within the US Department of Health that is responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, and other products.
- The FDA regulates a wide range of products including biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronics, veterinary products and tobacco.
- The agency is organized into centers that focus on specific regulatory areas like drugs, biologics, foods and medical devices. Major regulations are codified in the Code of Federal Regulations Title 21.
China has passed a new, stricter Food Safety Law in 2015. Key changes include:
- Stricter penalties for violations, including revoking certificates and banning imports.
- Imported foods must meet Chinese standards and be accompanied by inspection certificates. Importers must verify exporters' compliance.
- Authorities have increased supervision of imported foods in the domestic market and cooperation between agencies.
- Exporters, agents, importers and overseas producers must register with authorities. Those providing false information can be removed from registration lists.
An expert presented on key changes to China's new Food Safety Law and implications for imported foods:
1) Authority over food safety has been consolidated under the National Health and Family Planning Commission, with stricter standards, fines, and penalties for non-compliance.
2) Imported foods must meet national food safety standards and be accompanied by inspection certificates, with importers responsible for verifying exporters' compliance. Recalls are now required if imported foods are found to be non-compliant.
3) For foods without Chinese standards, importers must register alternative standards and China may develop its own. Importers must also keep detailed records and maintain good credit to avoid import restrictions.
The document provides an overview of the Food and Drug Administration (FDA) in the United States. It discusses that the FDA regulates food, drugs, medical devices, cosmetics and more. It outlines the various centers and offices within the FDA focused on specific areas. It also summarizes some of the key acts and laws that provide the FDA's legal authority. Finally, it discusses cGMP guidelines and regulations under 21 CFR that pharmaceutical manufacturers must follow.
To legally sell dietary supplements, natural health products, foods, cosmetics, or over-the-counter drugs in Canada, various regulatory requirements must be met including obtaining licenses, submitting notifications, and ensuring label compliance. Quality Smart Solutions assists companies in navigating these regulations by reviewing product formulas and labels, preparing and submitting necessary license and notification applications to Health Canada, and providing importation services where required.
Dietary Supplements, Combination Products, and Veterinary MedicineMichael Swit
Presentation to San DIego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Test Review Course, on key issues relating to regulation of dietary supplements, Combination Products, and Veterinary Medicine.
Proactive FSMA Compliance: What 2022 Taught Us to Better Plan AheadSafetyChain Software
With the second half of 2022 before us, we will look back at how food manufacturers navigated recent shifts in FDA requirements to help better prepare for compliance deadlines later this year.
Join Eric Edmunds, Food Safety Director at The Acheson Group, as he walks through FDA enforcement discretion for labeling issues caused by supply chain disruptions and new FDA sesame declaration requirements, how the FDA is enforcing FSVP after COVID, what food manufacturers can learn from the recent Delta 8 ruling impacting the 2018 Farm Bill, and how to become more “recall ready” in line with FDA’s recent guidance for voluntary recalls.
Similar to How to Successfully Import Natural Products to the USA (20)
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
Navigating the world of forex trading can be challenging, especially for beginners. To help you make an informed decision, we have comprehensively compared the best forex brokers in India for 2024. This article, reviewed by Top Forex Brokers Review, will cover featured award winners, the best forex brokers, featured offers, the best copy trading platforms, the best forex brokers for beginners, the best MetaTrader brokers, and recently updated reviews. We will focus on FP Markets, Black Bull, EightCap, IC Markets, and Octa.
Company Valuation webinar series - Tuesday, 4 June 2024FelixPerez547899
This session provided an update as to the latest valuation data in the UK and then delved into a discussion on the upcoming election and the impacts on valuation. We finished, as always with a Q&A
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
FIA officials brutally tortured innocent and snatched 200 Bitcoins of worth 4...jamalseoexpert1978
Farman Ayaz Khattak and Ehtesham Matloob are government officials in CTW Counter terrorism wing Islamabad, in Federal Investigation Agency FIA Headquarters. CTW and FIA kidnapped crypto currency owner from Islamabad and snatched 200 Bitcoins those worth of 4 billion rupees in Pakistan currency. There is not Cryptocurrency Regulations in Pakistan & CTW is official dacoit and stealing digital assets from the innocent crypto holders and making fake cases of terrorism to keep them silent.
An introduction to the cryptocurrency investment platform Binance Savings.Any kyc Account
Learn how to use Binance Savings to expand your bitcoin holdings. Discover how to maximize your earnings on one of the most reliable cryptocurrency exchange platforms, as well as how to earn interest on your cryptocurrency holdings and the various savings choices available.
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
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Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
Evgen Osmak: Methods of key project parameters estimation: from the shaman-in...
How to Successfully Import Natural Products to the USA
1. How to Successfully Import Natural
Products to the United States
How to Navigate FDA Requirements, U.S. Customs and the Food
Safety Modernization Act for Successful Importation of Foods and
Dietary Supplements to the USA.
August 23, 2012
Rick D. Quinn, J.D., Principal, FDAImports.com, LLC
Originally presented at Natural Products Expo Asia
2. Outline
• Understanding the U.S. Agencies
• Understanding the Import Process
• Importing Foods & Dietary Supplements
• The Food Safety Modernization Act
4. Who are the Federal Agencies?
• U.S. Food and Drug Administration (FDA)
o Foods, drugs, biologics, medical devices, animal foods and
drugs, cosmetics, & electronic radiation emitting products
• U.S. Department of Agriculture (USDA) (& Customs Ag)
o Meat (beef and poultry), meat containing products, eggs, plant
pests
• Environmental Protection Agency (EPA)
o Pesticides (Tolerances on Food Commodities)
• Customs and Border Protection (Customs)
• FTC, USFW, and U.S. States
5. What Is A Dietary Supplement ?
• Dietary Supplement: means a product (other than tobacco)
intended to supplement the diet that bears or contains one
or more of the following dietary ingredients:
Vitamin, mineral, an herb or other botanical, an amino acid, a
dietary substance for use by man to supplement the diet by
increasing the total dietary intake or a concentrate, metabolite,
constituent, extract, or combination of any ingredient described
above
7. Pre-Shipment/Pre-Arrival
• Certain issues you must verify before you
import FDA-regulated products – or you
will find FDA refusing admission.
o FDA Food Facility Registration
o FDA Product Code and Prior Notice
o Labeling Compliance
o Approvals: New Dietary Ingredient Notification
o Ingredients: Regulatory Safety Compliance
o Multi-agency and State issues
• Customs: Tariff Classification, Valuation
• States: e.g., California's Proposition 65
9. Principal import authorities
• 21 U.S.C. 381(a) (FDCA sec. 801(a))
o Sampling Authority – given notice, importer,
owner or consignee may appear to give
testimony regarding admissibility of imported
products
o Covers import examinations, inspections, label
reviews, records reviews and physical sampling
and testing
10. FDA's Legal Authority to REFUSE
21 USC 381
• U.S. Law (Food Drug & Cosmetic Act)
• If it “appears” from the examination of samples “or
otherwise” that an imported product:
o (1) was manufactured, processed, packed under
insanitary conditions
o (2) is forbidden or restricted in sale in the country in
which it was produced or from which it was exported
o (3) is adulterated, misbranded, unapproved
• Then such article “shall be refused admission”
11. FDA’s Import Authority
• FDA “shall refuse” admission to a regulated
product if “it appears from the examination of
samples or otherwise” to violate legal
requirements. (21 USC 381(a))
• “Appearance” of a violation – FDA does not have
to prove the article is in violation.
• “Or Otherwise” – Import Alerts
12. After Refusal
• Once FDA refuses a shipment it must be
o Destroyed Unless Exported
o Within 90 days of the Refusal
o Under Supervision of the Customs Importation Bond
• Customs issues a “Demand for Redelivery”
pursuant to the Bond Agreement
• Failure to Redeliver (export or destroy FDA
refused goods) results in Customs issuing a
“Claim for Liquidated Damages”
o 3x import value up to the limit of the bond
13. FDA Import Procedure
• FDA receives information from U.S.
Importer about the imported product
o Description of product
o FDA “Product code”
o Name/address of manufacturer & shipper
(exporter)
o FDA Registration numbers & Listing numbers
Drug, Device, Food facilities
o Commercial invoice and shipping records
14. FDA Import Procedure (2)
• FDA Reviews information to decide:
o “May Proceed” or “Release” shipment
o Inspect shipment, examine or sample product
and its labeling
o “Detain” based upon info supplied (perhaps
based upon an Import Alert)
o Release shipment after inspection, examination,
sampling/testing, or based upon the information
supplied at the initial declaration
15. FDA Import Procedure (3)
• If FDA determines the article “may be subject to
refusal”
• FDA “detains” the shipment, sends a written
notice to the importer to correct problems or
prove that the problems do not exist
Importer might do something to remove the
violation (cook food, segregate and retest it,
relabel it): Reconditioning
Importer might provide evidence that the violation
does not exist (submit required information or lab
reports)
16. FDA Detentions / Refusals
• FDA has authority to detain and refuse imported
products if the food or the manufacturer “appears” to
be in violation of the law
• FDA evidence for detention can come from:
o Documents provided to FDA at entry
o Inspections of foreign facility
o Testing imported product; reviewing its label
o Reviewing prior shipments of product from the same
manufacturer
o Foreign Governments, news releases
17. FDA Import Alerts (“or otherwise”)
• If FDA believes a foreign manufacturer or
its products are not in compliance with
FDA requirements, FDA may issue:
o Import Alerts
o All future shipments “automatically detained” of
that product from that manufacturer
o Importer and manufacturer must prove each
shipment complies
o Can be expensive
o THESE CAN BE FIXED!
18. FDA Import Alerts (2)
• Different kinds of import alerts include:
o Product appears to be adulterated or
misbranded (prior testing, label review)
o Manufacturer appears to be in violation of
Good Manufacturing Practices so its product
appears to be adulterated
o Country/Region appears to have ongoing
safety problem related to food manufacturing,
growing, or harvesting
19. FDA Import Alerts (3)
• Companies listed on or affected by an FDA
Import Alert can petition FDA to be
removed from the Import Alert.
o Identify the problem
o Correct the problem
o Prove the corrections were implemented
o Prove the corrections worked
o Prepare, submit and prosecute the petition
21. FDA Law
• Adulteration – DS imported into the U.S. must be
unadulterated
o Microbiological (Salmonella, E. coli, Listeria, etc.)
o Chemical (pesticides or antibiotic residues, illegal or
uncertified color additives)
o Physical (Filth, Decomposition)
• Misbranded – DS imported into the U.S. must be
properly labeled
o Easiest violation for FDA to find is a labeling violation
o It is right there in front of them – no testing
22. New Dietary Ingredients
Before 1994 dietary supplements were subject to the
same regulatory requirements as other foods.
What is a New Dietary Ingredient (NDI)?
“A new dietary ingredient (NDI) is a dietary ingredient
that was not marketed in or as a dietary supplement in
the United States prior to October 15, 1994. ” - Section
413, FFDCA
23. New Dietary Ingredients (2)
Because no safety information exists on the use of NDIs in or as dietary
supplements, a dietary supplement which contains an NDI will be deemed
adulterated unless
(1) It has been used for food in a form in which the food has not been
chemically altered, or
(2) Evidence of safe use 75 days before introducing the supplement into
interstate commerce, with premarket notification to FDA
24. NDI Notifications
FDA requires the submission of a premarket notification to the Agency
before an NDI is introduced into interstate commerce.
An NDI will only be exempt from premarket notification if:
(1) it was present in the food supply prior to October 15, 1994 as an article
used for food in a form in which the food has not been chemically altered,
(2) it has been listed or affirmed as GRAS for direct addition to food or
approved as a direct food additive in the U.S., it has been used in the food
supply, and is to be used as an NDI without chemical alteration.
FDA’s July 2011 Guidance discusses:
• The steps for determining whether an NDI notification is necessary;
• What to Include in an NDI notification; and
• Notification Procedures and Timeframes
25. FDA and “Organic”
The USDA and FDA share oversight of organic products
• USDA’s National Organics Program (NOP) has
published organic standards for production and labeling
• FDA has no such regulations for organics
• FDA simply requires organic claims to comply with
USDA NOP regulations
26. FDA and “Natural”
FDA has no formal definition for the term “natural.” FDA
does not object to the term as long as the product:
• Is truthful and not misleading in its labeling
• Does not contains color additives, artificial flavors,
chemical preservatives or synthetic substances
27. Food Facility Registration
• FDA Food Facility Registration - owner, operator, or agent in
charge of a domestic or foreign food facility must register the
facility with the FDA.
• Law exempts farms from registration but requires foreign
manufacturers, processors, packers, and storage facilities to
register.
• Registration is not required for foreign facility if another facility
performs additional processing before the food is exported to the
U.S.
• Food Safety Modernization Act (FSMA) now requires food
facilities to renew their registrations every two years
28. U.S. Agents for FDA
• Foreign food facilities must also appoint a U.S.
Agent when they register with FDA
• “U.S. Agent” acts as official correspondent for
FDA
• Provides assistance to FDA and to the foreign
facility by facilitating communications for
inspections, records requests, concerns of FDA
regarding imported foods
30. Basics of the FSMA
• Enacted: January 4, 2011
• Applicability
– Specifically Designed for “food”
– Implication for Pharma Industry
• Did not include appropriations
• Congressional hostility
31. Food Industry Generally
Hazard Analysis & Risk Preventive Controls
Facility Inspections
Mandatory Recall Authority
Reportable Food Registry
Facility Registrations
Record Inspection & Maintenance
Other Information
32. Hazard Analysis & Risk Preventive
Controls (HARPC)
• Akin to the already established HACCP standards
• Requirements:
– Conduct hazard analysis, develop and implement
preventive controls, and monitor the control’s
effectiveness
– Develop a written plan for controlling hazards
– Reanalyze for potential hazards at least every three years
– Verify the effectiveness of the controls
– Maintain records of the verification process
33. HARPC Cont.
• Facilities Exempt from HARPC Requirement:
– Facilities subject to Standards of Produce Safety
– Facilities subject to the HACCP requirement and
low-acid canned food standards
– Facilities subject to dietary supplement cGMPs
Effective Date: July 4, 2012 (unless small or
very small business)
34. Facility Inspections
• Domestic Food Facilities
– High Risk Facilities: Once by January 2016
• (then every three years)
– Non-High Risk Facilities: Once by January 2018
• (then every five years)
• Foreign Food Facilities
– 600 inspections by January 4, 2012
– 19,200 inspections by January 4, 2017
• Import Alert or Registration Suspension for foreign
facilities refusing or delaying FDA inspection
35.
36. Mandatory Recall Authority
• Initial Burden
– Reasonable probability the food is adulterated or
misbranded by failing to disclose major food
allergens
– Reasonable probability the food will cause
serious adverse health consequences or death
37. Reportable Food Registry
• FDA may require responsible party to submit
consumer-oriented information:
–Description of food
–Affected product’s identification code
–Contact information
–Any other information deemed necessary
38. Reportable Food Registry Cont.
• FDA must prepare a standardized one page
summary of reportable food & publish it on the
internet.
• Grocery stores (with more than 15 locations) must:
– Post notification of reportable food within 24 hours of
report
– Display notification for no less than 14 days
• FDA must establish this reportable food system not
later than July 4, 2012.
39. Facility Registration
• Bi-annual registration requirements
• Additional information required with listing:
Contact Person & Email Address
• FDA Authority to revoke registration
– For causing a class 1 recall situation
– For refusing or delaying a foreign inspection
– For failing to renew registration as required
40. Record Inspection & Maintenance
• Two Routes:
– Adulterated food
– Use of or exposure to food
• Both routes allow FDA greater access to records
– “an article…and any other…affected in a similar manner”
• Both routes act as a ‘stepping stone’ for
– Revoking a facility registration
– Initiating a mandatory food recall
41. Record Inspection & Maintenance Cont.
• FDA requires additional record keeping for
“High-Risk Foods”
– FDA to designate “high-risk foods” by January 4,
2012
– FDA to propose regulations by January 4, 2013
42. Other Information
• Administration Detention of Food: Lower Burden
– FSMA reduces detention threshold by changing language
from “credible evidence to believe” that a food is likely to
“cause serious adverse health events” to “reasonable
belief” that food is “adulterated or misbranded”
• FDA to establish regulations by July 4, 2012
– Protection against international adulteration
– Sanitary Transportation of Food
43. Importers & Imported Food
• Foreign Supplier Verification Program
• Qualified Importer Program
• Other Information
44. Foreign Supplier Verification Program
• Every importer must establish a plan that verifies:
– That the foreign supplier complies with HARPC or
Standards for Produce Safety
– That the food is not adulterated or misbranded by failing
to disclose major food allergens
• Importer must maintain records for no less than 2
years
• Noncompliance is grounds for refusal of an imported
article
45. Foreign Supplier Verification Program Cont.
• Exemptions:
– Facilities required to comply, and are in
compliance, with
• Seafood HACCP requirements
• Juice HACCP requirements or
• Low-acid food package standards
• Effective date: January 4, 2013
46. Qualified Importer Program
• FDA must establish voluntary program in order
to expedite importation.
• Eligibility is determined by overall safety of food
offered for import.
• Importers must obtain certification by third-party
auditors (designated by FDA).
47. Qualified Importer Program Cont.
• FDA to review importers eligibility no less than
once every three years.
• Effective Date: FDA to establish regulations by
– January 4, 2012
48. BEWARE! FSMA “Time Bombs”
What is a “Time Bomb”?
• Not a headliner
• Vague statutory language
• Ignored due to context of FDCA
• Bioterrorism & “National Security”
• The “Foreign Supplier”…Who?
• International Trade: Bilateral?
• Reinforced Import Alert Powers
• Which Hazards/Risks?
49. Other Information
• Importation Certificates
– Grants FDA authority to require certification for
certain foods based on risks associated with either
• The food or
• The country of origin of the food
• Prior Notice
– Prior to importation, importers must notify FDA if any
country has refused admission of the food
– Effective Date: July 3, 2011
50. Implementation Timeline
February 2013
January 2012 July 2012 July 2013
February 2012 January 2013
v v v v v v
* Specific guidance, rulings and reports due each key date
51. Conclusions
• Immediate effect on industry is limited
• FDA has a lot of guidance, regulations and standards
to develop
• Establishes greater emphasis on Prevention
– HARPC & Standards for Produce Safety
• Establishes greater industry responsibility
– New industry standards
– Importers verifying foreign suppliers
52. FDAIMPORTS.COM
810 Landmark Drive
Suite 126
Glen Burnie, MD 21061
USA 410-220-2800 (Phone)
443-583-1464 (Fax)
info@fdaimports.com
www.fdaimports.com
EXPORTTOUSA.COM.CN
Bing 402, Today Business Building
No. 10 Shandong Rd.
CHINA Qingdao, China 266000
Phone: 0532-86676270
Fax: 0532-86676250
sli@fdaimports.com
www.exporttousa.com.cn