• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

1-6 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)

1-6 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)

     1-6-1 - Office of Compliance (HFS-600)
     1-6-2 - Office of Cosmetics and Colors (HFS-100)
     1-6-3 - Office of Food Additive Safety (HFS-200)
     1-6-4 - Office of Food Safety (HFS-300)
     1-6-5 - Office of Regulatory Science (HFS-700)
     1-6-6 - Office of Nutrition, Labeling, and Dietary Supplements (HFS-800)  

  1-6 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN) 

  1-6-1 - Office Of Compliance (HFS-600)


  1. Office of the Director

    1. Serves as the primary contact between the Center and FDA’s field organization, including the Field Food Committee;
       
    2. Has primary responsibility for management of compliance programs, field assignments, and work plans;
       
    3. Initiates and/or coordinates the planning, development, publication and promotion of field guidance documents for CFSAN-regulated food and cosmetic products to implement sound public health practices, food safety/security interventions, compliance/enforcement strategies, and regulatory programs; provides information, training and technical assistance to implement guidance and regulations;
       
    4. Reviews proposed regulatory actions and recalls for adequacy of evidence and consistency across programs. Oversees the development of compliance and enforcement strategies for emerging compliance challenges;
       
    5. Monitors and mines information from internal and external sources to identify trends or emerging compliance and enforcement related issues that may influence the Center’s area of regulatory responsibility. Provides data and other information on field accomplishments to support the Center’s evaluation of programs and assignments, development of new assignments, assessment of the industry or any other relevant Agency purpose;
       
    6. Oversees, monitors, and evaluates the food facility registration database; and,
       
    7. Plans and develops approaches to administer regulatory responsibilities in the Interstate Travel Program and provides information, problem-solving and technical assistance to Agency and external organizations within this program.  

      There are two Divisions within the Office of Compliance:

      1. Division of Enforcement
      2. Division of Field Programs and Guidance
     
  2.  Division of Enforcement (HFS-605)

    1. Serves as the Center’s point of contact for enforcement policy and priority inquires, including recalls, from other agency units, industry, and other parties;
       
    2. Manages reviews of regulatory actions recommended by agency field offices and other Agency components. Guides field offices activities, when necessary, in developing scientifically and legally supportable actions. Participates in case development strategy calls with the field and other Agency components;
       
    3. Works with other Center and Agency units to develop compliance and enforcement strategies to address cross-cutting regulatory issues or emerging compliance challenges. Develops innovative enforcement solutions to novel, complex, and precedent-setting regulatory problems;
       
    4. Evaluates import and domestic inspectional, investigational, and analytical evidence and determines whether to pursue a regulatory action or alternative remedy;
       
    5. Evaluates recall recommendations, obtains scientific and technical support to document health risk associated with recalled products, and ensures that recall actions are consistent with Agency and Center policies;
       
    6. Assists agency legal offices and field units and the Department of Justice developing legal documents including declarations, obtaining experts, responding to interrogatories, and providing trial or other requested assistance. Represents the Center at enforcement negotiations; 
       
    7. Serves as an expert resource on foreign product compliance and participants in agency discussions, decisions, and fact finding for import and international issues for foreign country, product, and industry assessments; and,
       
    8. Serves as the Center focal point for consumer complaints and daily Reportable Food Registry (RFR)/Risk Control Review activities. Maintains the Center RFR database and guides field follow-up to RFR reports.

      There are two teams and one branch within the Division of Enforcement:

      1. Recall and Product Reconditioning Team
      2. Labeling and Dietary Supplement Compliance Team
      3. Food Adulteration Assessment Branch
     
  3.  Division of Field Programs and Guidance (HFS-615)

    1. Serves as the focal contact point within the Center for compliance programs, field assignments, and work plans. Plans and implements these activities working closely with the agency field organization and Center offices to reflect a risk-based approach;
       
    2. Actively manages compliance programs and field assignments and provides information, based on its monitoring and data reporting activities, to other Center offices to support Center evaluation of programs and assignments;
       
    3. Provides Center leadership and coordination for Compliance Policy Guides and works closely with other Center offices and agency headquarters and field offices in Compliance Policy Guide development and issuance;
       
    4. Maintains the compliance management and reference systems and works closely with agency information technology offices and the field organization to provide effective compliance information management concerning foods and cosmetics. Implements and provides monitoring and evaluation of the food facility registration data base;
       
    5. Plans and develops approaches to administer regulatory responsibilities in the Interstate Travel Program. Provides information, problem-solving, and technical assistance to Agency and external organizations within this program to maintain an effective and consistent interstate travel program in the interstate travel industry;
       
    6. Monitors and mines information from internal and external sources to identify trends or emerging compliance and enforcement related issues that may influence the Center's area of regulatory responsibility and brings the information to the attention of other Center offices for consideration and action when necessary; and,
       
    7. Plans and coordinates strategy for Foreign Food Inspections program. Manages firm selection and contact process and data mining procedures. Transfers and tracks submissions made to field organizations.

      There are two branches within the Division of Field Programs and Guidance:

      1. Field Programs Branch
      2. Compliance Information Branch

 

   1-6-2 - Office of Cosmetics and Colors (HFS-100)


  1.  Office of the Director

    1. Develops guidelines, regulations, and policies for cosmetics and color additives; 
       
    2. Provides expert scientific and technical support for cosmetics and color additives;
       
    3. Communicates this information to the public, affected industry, and international regulatory bodies;
       
    4. Provides expert scientific and technical advice and support on cosmetic products and ingredients and color additives;
       
    5. Administers the Color Certification Program, including methodology research and quality control; 
       
    6.  Administers the Voluntary Cosmetic Registration Program; and
       
    7. Provides leadership and works closely with other agency units in the area of nanotechnology.

      There is one Staff and one Division within the Office of Cosmetics and Colors:

      1. Cosmetics Staff
      2. Division of Color Certification and Technology
     
  2.  Division of Color Certification and Technology (HFS-105)
     
    1. Administers the agency Color Certification Program, including methodology research and quality control;
       
    2. Provides expert scientific and technical advice and support on color additive methodology; and
       
    3. Identifies substances and issues of safety concern for certifiable color additives and their raw materials.

      There is one team and one branch within the Division of Color Certification and Technology:  

      1. Color Technology Team
      2. Color Certification Branch
     
  3.  Cosmetics Staff (HFS-125)

    1. Develops guidelines, regulations, and policies for cosmetics and color additives;
       
    2. Provides expert scientific and technical support for cosmetics and color additives; 
       
    3. Administers the Voluntary Cosmetic Registration Program; and
       
    4. Communicates policy, guidance, and information for cosmetics and color additive certification and supports other units in this area.

      There is one team within the Cosmetic Staff:

      1. Cosmetics Activities Team 

 

  1-6-3 - Office of Food Additive Safety (HFS-200) 


  1. Office of Food Additive Safety

    1. Serves as the Center focal point for scientific and policy support for the development of Agency-initiated regulations on matters pertaining to the provisions of the food and color additive sections of the Federal Food, Drug, and Cosmetic Act;
       
    2. Manages the Center's petition review processes (both those conducted in-house and under extramural contract) for food additives and color additives, and consultation/notification processes for GRAS (Generally Recognized As Safe) substances, food contract substances, and foods and food ingredients derived from recombinant DNA biotechnology. Evaluates safety information, compiles the administrative record supporting actions on petitions and other agency actions, and prepares Federal Register documents relating to petitions;
       
    3. Prepares and/or reviews documentation required by the Center to implement the National Environmental Policy Act (NEPA). Coordinates the Center review of documents prepared under NEPA by other Federal agencies;
       
    4. Serves as the principal Agency liaison on safety testing methodologies and protocol standards needed to evaluate the safety of food ingredients and on other aspects of regulatory decisions;
       
    5. Develops compliance policy, position papers, procedural regulations, regulatory guidelines, and advisory opinions on issues related to the safe uses of food additives, food contract substances, color additives, GRAS substances, biotechnology derived foods, and prior sanctioned substances. Responds to stakeholder inquiries and processes Freedom of Information requests in a timely and efficient manner. Consults with FDA laboratories regarding research relevant to the regulation of food and color additives and food ingredients;
       
    6. Manages the Agency's review and monitoring of identity, probable human exposure to, and toxicity information on food additives and color additives, food contract substances, and GRAS substances in current use. Recommends enforcement action or regulatory change as needed. Provides expert scientific and technical advice to other Office, Center, and Agency components as needed;
       
    7. Provides evaluation and participates in bioresearch monitoring of non-clinical laboratory studies and facilities to assure quality and integrity of data submitted to the Agency in accordance with good laboratory practices.
       
    8. Serves as the Center’s focal point for scientific and policy support for the development of Agency-initiated regulations on matters pertaining to the provisions of the food additive and color additive sections of the Federal Food, Drug, and Cosmetic Act;
       
    9. Ensures the scientific integrity and consistency of the Center's petition review processes (both those conducted in house and under extramural contract) for food additives and color additives, and consultation/notification processes for generally recognized as safe (GRAS) substances, food contract substances, and foods and food ingredients derived from recombinant DNA biotechnology;
       
    10. Consults with FDA laboratories regarding research relevant to the regulation of food and color additives and food ingredients;
       
    11. Ensures that the Agency’s compliance policy, position papers, procedural regulations, regulatory guidelines, and advisory opinions on issues related to the safe uses of food additives, food contract substances, color additives, GRAS substances, biotechnology derived foods, and prior sanctioned substances are consistent and based on sound science;
       
    12. Ensures the Agency's review and monitoring of identity, probable human exposure to, and toxicity information on, food additives and color additives, food contract substances, and GRAS substances in current use. Recommends enforcement or regulatory change as needed. Provides expert scientific and technical advice to other Office, Center, and Agency components as needed;
       
    13. Provides toxicology, chemistry, and pathology expertise to the Center, develops guidelines for toxicological studies and establishing specifications of identity and purity of food additives and estimating dietary exposure, and monitors newly developed testing methodologies that may prove useful in toxicological assessments of novel food additives and other food ingredients and contributes to the Agency’s overall safety assessment of food ingredients; and
       
    14. Provides evaluation and participates in bioresearch monitoring of non-clinical laboratory studies and facilities to assure quality and integrity of data submitted in accordance with good laboratory practices.

      There is one policy staff, one support team, and three divisions within the Office of Food Additive Safety:

      1. Senior Science & Policy Staff
      2. Stakeholder Support Team
      3. Division of Biotechnology and GRAS Notice Review
      4.  Division of Petition Review
      5.  Division of Food Contact Notifications
     
  2. Senior Science & Policy Staff (HFS-205) 

    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for food and color additives, food contact substances, generally recognized as safe (GRAS) ingredients and bioengineered food; 
       
    2. Provides expert guidance for CFSAN officials and other Agency components, Federal and State officials, and industry concerning regulatory requirements and their implementation for food and color additives, food contact substances, generally recognized as safe (GRAS) ingredients and bioengineered food;
       
    3. Reviews regulatory actions, including information about proposed enforcement actions that are provided by the Office of Compliance, to determine if those actions within OFAS’s purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance does not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions;
       
    4. Develops and maintains OFAS knowledge management systems (e.g., information technology, bioinformatics, and computational toxicology); and
       
    5. Provides animal pathology services to the Center for Food Safety and Applied Nutrition.    
     
  3. Stakeholder Support Team (HFS-206)

    1. Provides administrative support to OFAS;
       
    2. Prepares Certificates of Free Sale;
       
    3.  Tracks and finalizes Freedom of Information Act requests and controlled correspondence;
       
    4. Maintains OFAS internet and intranet sites; and,
       
    5. Administers and maintains the CFSAN Thesaurus for the Center for Food Safety and Applied Nutrition.  
     
  4. Division of Biotechnology and GRAS Notice Review (HFS-255)

    1. Provides Center guidance and coordinates the technical evaluation of regulatory and scientific issues regarding food additives, GRAS (Generally Recognized as Safe) substances, other food ingredients, and bioengineered food, including industry actions;
       
    2. Evaluates toxicological, nutritional and microbiological data and information, and chemical data (including data on probable human exposure) and information, submitted to the Agency that pertain to the safety of food ingredients, GRAS substances and bioengineered food. Develops guidelines and monitors newly developed techniques pertaining to the safety assessment of food additives, GRAS substances, and bioengineered food;
       
    3. Consults with prospective notifiers prior to submission, concerning proposed uses of food additives, GRAS substances, other food ingredients, and bioengineered food, advising on content of submissions and approaches to meet statutory standards. Advises notifiers and other interested parties of any inadequacies that may preclude requested action for submissions reviewed by this Division;
       
    4. Writes and amends, as needed, procedural regulations, food ingredient regulations, and guidelines to implement relevant provisions of the Federal Food, Drug, and Cosmetic Act;
       
    5.  Develops and redirects, as necessary, current policies, compliance efforts, and research dealing with GRAS substances and bioengineered food matters;
       
    6. Develops and maintains information for assessment and monitoring of food additives, GRAS substances, other food ingredients, and bioengineered food. Responds to stakeholder inquires and processes Freedom of Information requests in a timely and efficient manner;   
     
  5. Division of Petition Review (HFS-265)

    1. Provides Center guidance and coordinates the technical evaluation of regulatory and scientific issues regarding direct food additives, food irradiation, and color additives, including industry actions;
       
    2. Evaluates toxicological, nutritional, and microbiological data and information, and chemical data (including data on probable human exposure) submitted to the agency by petitioners or from other sources, that pertain to the safety of direct food additives, irradiated food, and of color additives in foods, drugs, medical devices, or cosmetics;
       
    3. Consults with prospective petitioners prior to filing, concerning proposed new uses of direct food additives and color additives, advising on petition content and approaches to meet statutory standards. Advises petitioners and other interested parties of any inadequacies that may preclude requested action on petitions reviewed by this Division;
       
    4. Writes and amends, as needed, direct food additive and color additive regulations, procedural regulations, and guidelines to implement the provisions of the Federal Food, Drug, and Cosmetic Act specific to direct food additives and color additives;
       
    5. Develops and redirects, as necessary, current policies, compliance efforts, and research dealing with direct food additive and color additive issues; and,
       
    6. Develops and maintains information on the safety and use of direct food additives and color additives. Responds to stakeholder inquires and processes Freedom of Information requests in a timely and efficient manner.  
     
  6.  Division of Food Contact Notifications (HFS-275)

    1. Provides Center guidance and coordinates the technical evaluation of regulatory and scientific issues regarding food contact substances including industry actions;
       
    2. Evaluates toxicological data and information and chemical data and information (including data on probable human exposure), submitted to the agency by notifiers, petitioners, or from other sources, that pertain to the safety of food contact substances;
       
    3. Consults with prospective notifers and petitioners prior to submission concerning proposed uses of food contact substances, advising on notification or petition content and approaches to meet statutory standards. Advises notifiers, petitioners and other interested parties of any inadequacies that may preclude requested action for submissions reviewed by this Division;
       
    4. Writes and amends, as needed, procedural regulations and guidelines to implement the provisions of food contact substance sections of the Federal Food, Drug, and Cosmetic Act;
       
    5. Develops and redirects, as necessary, current policies, compliance efforts, and research dealing with food contact substances; and,
       
    6. Develops and maintains information for assessment and monitoring the safety of food contact substances. Responds to stakeholder inquires and processes Freedom of Information requests in a timely and efficient manner.  

 

  1-6-4 - Office of Food Safety (HFS-300)


  1.  Office of the Director

    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for issues related to food safety within the scope of the responsibility of the Office;
       
    2. Conducts food safety assessments of chemical or microbial contamination;
       
    3. Provides toxicological evaluations and quantitative risk assessments related to the presence of industrial chemicals, process-induced toxicants and toxic elements in food;
       
    4. Provides expert advice to the Center Director, Deputy Center Directors, and other Center, Agency, and government officials, as well industry, international and other organizations on food safety programs and policies;
       
    5. Provides expertise in acidified and low acid food technologies, including the registration and evaluation of filed processes; and,
       
    6. As necessary, reviews industry petitions and regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within OFS's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance does not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions.

      There is one team within the Office of the Director, Office of Food Safety:

      1. Food Processing Evaluation Team

      There are two Staffs and four Divisions within the Office of Food Safety:

      1. Produce Safety Staff
      2. Retail Food & Cooperative Programs Coordination Staff
      3. Division of Plant and Dairy Food Safety
      4. Division of Seafood Safety
      5. Division of Seafood Science & Technology
      6. Division of Food Processing Science and Technology
     
  2.  Produce Safety Staff (HFS-317)

    1. Develops, collects, and interprets data regarding the microbial safety and defense of fresh and fresh-cut produce;
       
    2. Develops policy, regulations, regulatory guidelines, advisory opinions, position papers, and compliance strategies and policy on the microbial safety of fresh and fresh-cut produce;
       
    3. Reviews petitions on the microbial safety of fresh and fresh-cut produce related to this office;
       
    4. Serves as the agency focal point for the development and evaluation of programs and the implementation of the laws and regulations related to this office regarding microbial safety of fresh and fresh-cut produce;
       
    5. Serves as the principal Center liaison on microbial fresh and fresh cut produce safety programs and policies with industry, Federal, State, and foreign governments, and other organizations outside the Agency;
       
    6. Provides expert program policy, scientific and technical advice, and assistance to the Center Director, FDA senior officials, FDA field and external stakeholders on microbial fresh and fresh-cut produce safety and defense issues, field programs, produce initiatives, the conduct of international activities including the development and implementation of bilateral agreements, and other related activities; and,
       
    7. Reviews proposed regulatory actions referred by the Office of Compliance for program policy considerations and provides technical evaluation and necessary scientific support on cases related to the microbial safety of fresh and fresh-cut produce.
       
  3.  Retail Food & Cooperative Programs Coordination Staff (HFS-320)

    1. Supports interaction and collaboration among Federal and State partners in each of the three cooperative program areas which are shellfish safety, milk safety and retail food protection, and coordinates activities in support of the Partnership for Food Protection;
       
    2. Maintains the Interstate Certified Shellfish Shippers List, the Interstate Milk Shippers List, and the list of jurisdictions enrolled in the Voluntary National Retail Food Regulatory Program Standards;
       
    3. Serves as Agency liaison with State partners, other Federal agencies, and industry associations in administering the federal portion of the federal/state cooperative retail food protection program;
       
    4. Develops and promotes the adoption and implementation of the FDA Food Code, the National Retail Food Regulatory Program Standards, and related agency policy for sound public health practices;
       
    5. Identifies and characterizes existing emerging and potential health hazards associated with preparation and service of food at the retail level; and
       
    6. Provides technical support, geographic information systems capacity, and outreach to FDA staff and other Federal, State, and Local officials on the  Food Code and other agency guidance related to retail food protection.  
     
  4.  Division of Plant and Dairy Food Safety (HFS-315)

    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for issues related to the safety, defense, composition, and quality of plant foods, dairy foods, eggs, game meats, and beverages;
       
    2. Provides expert advice to the Center Director, other Centers, FDA, and government officials. Serves as principal Center liaison to industry, international and other organizations on issues related to plant foods, dairy foods, eggs, game meats, and beverages;
       
    3. As necessary, reviews industry petitions and regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within the Division's purview are supported by relevant science and established program priorities, policy, and guidance. Determines, where policy or guidance do not exist, whether the Division can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions;
       
    4. Reviews and accepts or rejects the sanitary design and construction standards for milk equipment;
       
    5. Standardizes, certifies, and evaluates FDA, and State staff, i.e. ORA regional milk specialists, state regulatory agencies and international third parties relevant to standardizing and certifying the evaluation of state and international milk programs; and,
       
    6. Collaborates with other parts of the Agency to identify emerging needs, and to plan, develop, and coordinate compliance programs, field assignments, and work plans, as related to food safety.

      There are two branches within the Division of Plant and Dairy Food Safety:

      1. Dairy and Egg Branch
      2. Plant Products Branch 
     
  5.   Division of Seafood Safety (HFS-325)

    1. Develops regulations, guidance, policy, programs, position papers and advisory opinions, and recommends research priorities for issues related to the safety of seafood;
       
    2. Examines and appraises the implementation of seafood regulations, domestic and foreign programs, and bilateral agreements;
       
    3. As necessary, reviews industry petitions and regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within the Division's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Division can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions;
       
    4. Provides expert advice to key stakeholders and serves as principal Center liaison to industry, international and other organizations on issues related to seafood safety; and,
       
    5. Develops model regulations, and provides scientific/technical support, training, evaluation and certification for State and international shellfish programs.

      There are two branches within the Division of Seafood Safety:

      1. Shellfish and Aquaculture Policy Branch
      2. Seafood Processing and Technology Policy Branch 
     
  6.  Division of Seafood Science & Technology (HFS-400)

    The Division of Seafood Science & Technology, in conjunction with federal, state, academic, and public partners is responsible for providing the scientific basis for Agency policy, regulation and compliance programs which promote and protect the public’s health by ensuring that the nation’s seafood supply is safe, sanitary and secure.

    1. Identifies and characterizes existing, emerging and potential health hazards in seafood;
       
    2.  Determines exposure thresholds, consumer health effects, and recommends guidance levels for health hazards in seafood;
       
    3. Develops, optimizes and validates surveillance/monitoring methods for detection of health hazards in seafood;
       
    4. Promotes surveillance/monitoring method standardization and trains federal and state public health personnel in their applications and use;
       
    5. Evaluates strategies and technologies for mitigation of health hazards in seafood;
       
    6. Provides scientific information and technical support for Center components and other federal, state and international public health agencies;
       
    7. Responds to regional, national, and international seafood disease outbreaks and emergency/threat situations; and,
       
    8. Maintains scientific capability and currency with emerging technologies and the scientific community at-large.

      There are two branches within the Division of Seafood Science and Technology:

      1. Chemical Hazards Science Branch
      2. Microbiological Hazards Science Branch
     
  7.  Division of Food Processing Science and Technology (HFS-450)

    1. Conducts food safety, nutrition and defense research in food processing, food packaging and food technology; as it relates to food production and handling principles;
       
    2. Participates, in conjunction with the Office of Analytics and Outreach (OAO) and others, in educational and informational programs on contemporary food safety and security issues;
       
    3.  Evaluates and accredits Grade “A” Milk laboratories and certifies state laboratory evaluation officers;
       
    4. Conducts proficiency testing program for milk, shellfish, Food Emergency Response Network/Laboratory Response (FERN/LRN); and,
       
    5. Provides consultation to FDA and outside organizations on laboratory equipment, apparatus, methods, and facilities problems associated with laboratory examination of foods;

      There are two branches and one team within the Division of Food Processing Science and Technology:

      1. Process Engineering Branch
      2. Food Technology Branch
      3.  Laboratory Proficiency and Evaluation Team

 

  1-6-5 - Office of Regulatory Science (HFS-700)


  1.  Office of the Director

    1. Conducts laboratory science and research that supports the FDA regulatory agenda;
       
    2. Develops laboratory based methods to support regulations and related policy developments;
       
    3. Provides technical support and expert advice on scientific issues related to policy and regulations;
       
    4. Originates, plans, and conducts research in the areas of food processing and packaging, food chemistry, food toxicants, dietary supplement ingredient analysis, food nutrient analysis, food microbiology, and cosmetic component studies; and
       
    5. Reviews regulatory actions for adequacy of evidence and accuracy of the science and technical procedures and findings.

      There are three Divisions within the Office of Regulatory Science:

      1. Division of Analytical Chemistry
      2. Division of Microbiology
      3. Division of Bioanalytical Chemistry  
       
  2.  Division of Analytical Chemistry (HFS-705)

    1. Performs laboratory analysis of samples and provides technical support and expert advice in cooperation with other Center and Agency components to support research and policy development and to assess sample compliance with laws and regulations enforced by the Agency;
       
    2. Develops, extends, refines, and validates analytical chemistry based methods for food defense threat agents, food additives, pesticides, dietary supplements, seafood toxins, and industrial chemicals that may be present in or contaminate CFSAN-regulated food and cosmetic products; recommends analytical methods for field use in monitoring and enforcement programs for these chemicals;
       
    3. Provides specialized infrared, near-infrared, Raman, surface Plasmon resonance, nuclear magnetic resonance and electron spin resonance spectroscopy, and mass spectrometry support to the Agency;
       
    4. Provides specialized protein analysis and proteomics support to the Agency;
       
    5. Conducts research to develop and refine the application of specialized and field portable instrumentation to Agency problems;
       
    6. Originates, plans and documents research to ascertain the nature and magnitude of chemical contamination of CFSAN-regulated food and cosmetic products via environmental and other routes for risk assessment and policy development purposes;
       
    7. Develops analytical testing protocols for evaluating the migration of food packaging components to foods or food stimulants in order to facilitate submission and safety evaluation of indirect food additive petitions and notifications; and,
       
    8. Supports food defense measures through special research projects and scientific support during threat situations.
       
    9. Supports food safety through the development of DNA-based methods for plant and animal species identification.

      There are two branches within the Division of Analytical Chemistry:

      1. Methods Development Branch
      2. Spectroscopy and Mass Spectrometry Branch  
     
  3.  Division of Microbiology (HFS-710) 

    1. Develops, optimizes and validates methods for recovery, detection, identification, and quantization of pathogens and/or toxins from foods and cosmetics, and the processing environment;
       
    2. Accomplishes the standardization and general acceptance of FDA-developed methodology by field personnel in their use and application, and supports compliance where questions of microbial methodology arise;
       
    3. Maintains FDA's food-related gateway to the PulseNet System; develops and applies subtyping methods to further enhance data generated for PulseNet, strain identification, and molecular epidemiological investigations; and,
       
    4. Supports food security defense measures through special research projects and scientific support during threat situations.

      There are two branches within the Division of Microbiology.

      1. Microbial Methods and Development Branch
      2. Molecular Methods and Subtyping Branch  
     
  4.  Division of Bioanalytical Chemistry (HFS-715)

    1. Conducts laboratory investigations in the broad areas of elemental analysis, natural toxins, nutrients in food, ingredients in dietary supplements, and ingredients in cosmetics;
       
    2. Develops analytical methods and provides technical support of regulations and related policy developments in areas of Division expertise;
       
    3. As necessary, reviews regulatory actions for adequacy of analytical evidence in support of CFSAN and Agency compliance programs. Reviews regulatory actions for adequacy of evidence in support of Agency compliance programs;
       
    4. Serves as the focal point for expertise in the development and dissemination of methods of analysis for elements and radionuclides in foods, including dietary supplements;
       
    5. Identifies substances and issues of safety concern for cosmetic products and their raw materials and contaminants; develops and evaluates methods to identify and quantify potentially harmful ingredients and contaminants;
       
    6. Provides expert scientific and technical advice and assistance to the Center Director, Deputy Center Directors and other Center components, as well as and other FDA officials on the conduct of international seafood activities, including the development and implementation of bilateral agreements; and develops technical content for and participates in programs designed to improve compliance by industry through problem prevention; and,
       
    7. Originates, plans, and conducts laboratory research related to the scope of responsibilities of the Office; develops appropriate methods for analysis of nutrients in food and ingredients in dietary supplements; reviews and evaluates chemistry information and data provided in New Dietary Ingredient Notifications and Infant Formula Notifications; maintains the Center's analytical capability for food labeling compliance.

      There are two branches within the Division of Bioanalytical Chemistry:

      1. Chemical Contaminants Branch
      2. Bioanalytical Methods Branch

 

  1-6-6 - Office of Nutrition, Labeling and Dietary Supplements (HFS-800)


  1.  Office of the Director

    1. Primary responsibility for policy development and management of food and nutrition labeling, conventional foods, dietary supplements, special nutritionals (include infant formula and medical foods) and associated educational initiatives;  
       
    2. Develops, regulations, compliance policy, position papers, regulatory guidelines and advisory opinions for matters within the scope of the responsibility of the Office;
       
    3. Provides expert advice to the Center Director, other key officials, and directs major agency and Department nutrition labeling and dietary supplements initiatives and is the Delegate to national and international forums and conferences;
       
    4. Manages and provides scientific review on issues related to infant formula and medical foods including petitions and notifications, and provides advice to key agency components as well as international bodies;
       
    5. Provides clinical and scientific expertise on the design and conduct of clinical trials, risk assessment, adverse event reports, and educational initiatives related to infant formula and medical foods.

      There are two Staffs and one Division within the Office of Nutritional Labeling and Dietary Supplements:

      1. Division of Dietary Supplement Programs
      2. Food Labeling and Standards Staff 
      3. Nutrition Programs Staff  
         
  2.  Division of Dietary Supplement Programs (HFS-810)

    1. Has primary responsibility for policy development and strategic management of the dietary supplement program, which includes safety assessment and compliance strategy for the New Dietary Ingredient Notification Program, implementation and execution of Dietary Supplement Good Manufacturing Practices, structure-function notifications, Certificates of Export safety assessments for dietary supplement policy, responses to petitions and industry-related notifications, post- market adverse event evaluations, and issues related to dietary supplement safety and nutrition;
       
    2. Enforcement of the dietary supplement requirement of the DSHEA Act of 1994 and other relevant statutes to ensure the safe and truthful labeling of dietary supplements;
       
    3.  Provides expert advice for officials and other agency units on good manufacturing practices (GMP), field programs, compliance and enforcement issues and related activities, and provides assistance to Federal and State agencies and industry concerning regulatory requirements and compliance policies;
       
    4. Provides guidance to the Field in cooperation with agency unites in handling regulatory actions and assistance in the development, management, and coordination of enforcement/compliance cases;
       
    5. Evaluates adverse events and other sources of signals related to the safety of dietary supplements;
       
    6. Provides clinical/scientific/regulatory expertise in the assessment of risk of dietary supplements for related compliance activities, clinical responses to petitions, and in the evaluation of safety information provided in New Dietary Ingredient Notifications; and,  
       
    7. Provides guidance to agency scientific units and affiliated scientific units on activities related to compliance and regulatory activities and strategies.

      There is one branch and one team within the Division of Dietary Supplement Programs:

      1. Dietary Supplement Regulations Implementation Branch (divided into a labeling team and a cGMP team)
      2. NDI Review Team
     
  3.  Food Labeling and Standards Staff (HFS-820)

    1.  Has primary responsibility for policy and regulatory development and management of the conventional food labeling program (other than nutrition labeling), including NLEA, FALCPA and other FD&C and FPLA labeling requirements. Also manages the Standards of Identity program;
       
    2. Provides scientific and technical review of and response to petitions and notifications related to all aspects of conventional food labeling. Determines compliance with existing food standards and common or usual name, regulations, and issuance of temporary marketing permits to allow manufacturers to test market new foods. In addition, provides scientific and technical review of enforcement and compliance materials for all conventional foods (including infant formula and medical foods), such as inspection reports, analytical reports and other pertinent records and provides policy and enforcement decisions for misbranding charges on for all domestic and import actions, including infant formula and medical food manufacturers;   
       
    3. Provides expert guidance for officials and other agency units, Federal and State officials, industry and consumers  concerning regulatory requirements and compliance policies on conventional food labeling (including infant formula, medical foods and nutrition-related labeling) and reviews proposed enforcement/compliance actions referred by other agency units;
       
    4. Provides expert technical advice for participation in international forums;
       
    5. Reviews food product labeling (including infant formula, medical foods, and nutrition labels) for adherence to regulations and appropriateness of claims and manages the Small Business Nutrition Labeling Exemption Notification Program; and,  

      There are two teams within the Food Labeling and Standards Staff:

      1. Product Evaluation and Labeling Review Team
      2. Labeling Regulations Implementation Team 
     
  4.  Nutrition Programs Staff (HFS-830)

    1. Conducts scientific review and analysis of relevant information for making science-based decisions for policies, regulations, research priorities, position papers, and advisory opinions on issues related to nutrition and nutrition labeling, dietary guidance recommendations, and other nutrition science issues;
       
    2. Conducts scientific and regulatory review of health claim petitions, qualified health claim petitions, nutrient content claim petitions, FDA Modernization Act notifications for health claims and nutrient content claims, and for providing regulations for the Nutrition and Supplements Facts labels;
       
    3. Provides expert advice and assistance to key officials and coordinates with other domestic and international government agencies and scientific bodies on efforts related to nutrition and health;
       
    4. Identifies program priorities for, provides content design input to, and analysis of large-scale databases of food consumption, food composition, food ingredients, sales of processed packaged food products and product label information; and,
       
    5. Develops methods for monitoring U.S. populations and special subgroups relative to use and safety of conventional foods and dietary supplements.

      There are two teams within the Nutrition Programs Staff:

      1. Nutrition Assessment and Evaluation Team
      2. Nutrition Science Review Team