FSMA & The Dietary Supplements Industry

Transcription

1 FSMA & The Dietary Supplements Industry

2 Overview FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) Foreign Supplier Verification Programs (FSVP) Produce Verification activities for FSMA compliance Takeaways: prevention, proactive, scientific, risk-based

3 Before We Begin This webinar is being recorded. A copy of the slides and recording will be available in 2 business days. Q&A to follow the presentation.

4 Submitting Questions Type question + Enter key

5 Eurofins Mission and Vision Mission: Contribute to global health and safety through our high quality services Delivering customer satisfaction by listening to and exceeding customer expectations and seeking innovative solutions to help our customers achieve their goals

6 FSMA and the Dietary Supplement Industry Larisa Pavlick VP, Global Regulatory & Compliance United Natural Products Alliance July 19, 2018

7 2018 UNPA Poll

8 Food Safety Modernization Act (FSMA) Seven parts of FSMA, also known as foundational rules: 1. Preventive Controls for Human Food 2. Foreign Supplier Verification Programs 3. Produce Safety Rule 4. Preventive Controls for Animal Food 5. Sanitary Transport of Human and Animal Food 6. Intentional Adulteration 7. Accredited Third Party Certification UNPA 2018

9 Food Safety Modernization Act (FSMA) enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. UNPA 2018

10 FSMA: The evolution of modern food regulations Melamine recalls Since March 16, 2007, more than 150 brands of pet food have been voluntarily recalled by a number of companies. FDA UNPA 2018

11 2018 UNPA RegulationsOutbreaks and emergencies Food Safety Modernization Act (FSMA)

12 RegulationsOutbreaks and Emergencies Food Safety Modernization Act (FSMA) 2018 UNPA

13 Radiological hazards 2018 UNPA

14 Botanical potential hazards: Regulations Food Safety Modernization Act (FSMA) Literature review biological 2018 UNPA

15 Regulations Why FSMA-PC Rule? Food Safety Modernization Act (FSMA) UNPA

16 What is in a name? Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food (21 CFR Part 117) Also known as: PC PCHF Referred to as the Preventive Controls for Human Food regulation UNPA 2018 ~10

17 FSMA: PCHF rule is intended to ensure safe manufacturing/processing, packaging, and holding of food products for human consumption in the U.S. UNPA 2018

18 Applicability of PCHF Food, including raw materials used in food products, and dietary ingredients used in dietary supplements Other examples: Meal replacements, shakes, nutritional powders or greens. Also includes bars, gummies, drinks or any product marketed with a nutritional label UNPA 2018

19 FSMA: PCHF Compliance Dates: o Large (>500 employees): September 2016 o Small (<500 employees): September 17, 2017 o Very small (<$1M/year): September 2018 UNPA 2018

20 cgmp, Hazard Analysis, and Risk-based Preventive Controls for Human Food (21 CFR Part 117) Subpart A: General Subpart B: Good Manufacturing Practice (GMP) Subpart C: Hazard analysis and risk-based Preventive Controls Subpart D: Modified Requirements Subpart E: Withdrawal of Quality Facility Subpart F: Records Subpart G: Supply Chain Program UNPA 2018

21 Dietary supplement finished-products exemption 21 CFR section 117.5(e) and reads in part, DS are exempt from: If Subpart C (hazard analysis and preventive controls requirements) and Subpart G (supply-chain program requirements) UNPA 2018

22 PCHF: DS exemption (cont.) in compliance with the requirements of: 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements and Serious Adverse Event Reporting for Dietary Supplements [Section 761 of the FD&C Act (21 USC section 379aa-1)] UNPA 2018

23 Regulations Food Safety Modernization Act (FSMA) FSMA = The new food GMPs 21 CFR Part 110 cgmp for Human Food 21 CFR Part 117, Subpart B - Current Good Manufacturing Practices (GMPs) 2018 UNPA

24 Hazard Analysis and Preventive Controls: Regulations Food Safety Modernization Act (FSMA) food and/or ingredients Hazard: Any biological, chemical, (including radiological) or physical agent that has the potential to cause illness or injury UNPA

25 Adulteration and Botanicals: Heavy Metals UNPA 2018 Lead in Species, Thomas Tarantelli, New York State Depart of Agriculture

26 Adulteration and Botanicals: Colors UNPA

27 Regulations Outbreaks and Emergencies: Kratom Food Safety Modernization Act (FSMA) 2018 UNPA

28 Regulations FDA and Dietary Supplement Recalls Food Safety Modernization Act (FSMA) 2018 UNPA

29 Regulations Hazard requiring a Preventive Control Food Safety Modernization Act (FSMA) Known or reasonably foreseeable hazard Identified by a person knowledgeable about the MFG, processing, packaging, or holding of food In the absence of a preventive control (PC), the hazard could result in illness or injury PC is designed to reduce or eliminate the hazard 2018 UNPA

30 PCHF and dietary supplements Subpart A: General o Specific training is required to meet 117.4, including PCQI Subpart B: Good Manufacturing Practice (GMP) o Allergens text Subpart C: Hazard analysis and risk-based Preventive Controls exempt Subpart D: Modified Requirements Subpart E: Withdrawal of Quality Facility Subpart F: Records: Training Records Subpart G: Supply Chain Program Exempt UNPA 2018

31 Regulations DS Ingredient and biological hazards Food Safety Modernization Act (FSMA) Produce Rule (21 CFR Part 112) FDA Facts Sheet Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts and herbs. Photo compliments of: 2018 UNPA

32 Regulations DS ingredient and biological hazard Food Safety Modernization Act (FSMA) Produce Rule (21 CFR Part 112) Produce that is used in the production of spices, ingredients of dietary supplements, or food additives, to the extent it is covered produce (i.e., it is not excluded under 112.2(a)), may be eligible for exemption under 112.2(b) if it meets the criteria set forth in that section. Such produce is not exempt by virtue of its use in spices, dietary supplements, or food additives; such produce may be exempt only if it meets the criteria in 112.2(b) (i.e., it receives commercial processing that adequately reduces the presence of microorganisms of public health significance and the covered farm takes the required steps set forth in that section) UNPA Fed. Register Vol. 80, No. 228 Page 74386

33 Foreign Supplier Verification Programs (FSVP) UNPA 2018

34 Foreign Supplier Verification Programs (FSVP) The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. UNPA 2018

35 Foreign Supplier Verification Programs (FSVP) Applicability Human food imported for consumption in the U.S., including: DI Raw material used in DS Dietary supplement Food products marketed with a Nutrition Facts panel UNPA 2018

36 Foreign Supplier Verification Programs (FSVP) Who? Importers This rule requires importers of human food to verify: 1. Their foreign suppliers are producing the imported food in a manner, which meets the expectations of U.S. safety standards, and 2. Is not adulterated 3. Or misbranded (allergens) UNPA 2018

37 Foreign Supplier Verification Programs (FSVP) When: Compliance Dates If not subject to PC rule (AKA DS FP): May 30, 2017 If subject to PC rule (RM, DI, food products): *Small or very small as defined in Small < 500 Full Time Equivalent Employees March 19, 2018 Very Small < $1,000,000 in sales/inventory, per year, for 3 years March 18, 2019 Other Not small or very small May 30, 2017 UNPA 2018

38 Foreign Supplier Verification Programs In a nutshell: U.S. companies required to qualify their foreign suppliers FSVP must be conducted by a qualified individual FSVP works in tandem with PCHF, except you must have a unique importer identification UNPA 2018

39 FDA Guidance Published May The DUNS number is available free of charge to all importers, and can be obtained by contacting D&B by phone at or via at or by visiting D&B s Web sites at or UNPA 2018

40 Foreign Supplier Verification Programs Modified Requirements for Dietary Supplements: Found in Based on operation type Three subcategories Are you, or your customer, required to establish and verify a specification for components and labels [111.70(b & d)] and verification ( and )? UNPA 2018

41 Foreign Supplier Verification Programs Modified Requirements for Dietary Supplements: 13 sections in the FSVP rule FSVP Rule Subcategories based on type of DS operations (a) MFG (b) RM distributor selling to MFG (c) DS finished product 8-10 FSVP Sections which may apply UNPA 2018

42 Foreign Supplier Verification Programs Training September Sandy, Utah UNPA 2018 Visit unpa.com/events

43 UNPA 2018

44 Summary FSMA Basics 1. PCHF 2. FSVP 3. Produce Take away: prevention, proactive, scientific, risk-based What next? Obtain training!

45 Larisa E. Pavlick United Natural Products Alliance unpa.com Thank you! 2018 UNPA

46 Verification Activities for Dietary Supplements Gary Smith Vice President of Food Safety Services Role of the PCQI Conversion of HACCP to the food safety plan Verification activities for FSMA compliance

47 Training Requirements management must ensure that all individuals are qualified to perform their assigned duties Qualified individual have education, training or experience necessary to perform assigned tasks Receive training in the principles of food hygiene and food safety Records maintained Preventive controls qualified individual (PCQI) Attend preventive control training course (FDA recognized) OR Qualified through job experience

48 Preventive Controls Qualified Individual Definition A qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system. Standardized curriculum recognized as adequate by the FDA

49 Requirements of Preventive Control Qualified Individuals ( ) A preventive controls qualified individual* must do or oversee the following activities: 1. Preparation of the food safety plan 2. Validation of the preventive controls 3. Determine if validation is not required 4. Review of records within 7 days 5. Reanalysis of food safety plan (at least every 3 years) *Individual does not need to be an employee of the facility

50 Preventive Controls Qualified Individual Training Human food and animal food supplement facilities would need separate training courses. Eurofins offers both PCQI training courses. Examples of classes is listed below: PCQI Human Food - August 1-3 Milwaukee, WI - Sept Des Moines, IA - Oct Minneapolis, MN - Nov Fresno, CA - Nov Dallas, TX - Dec Kansas City, MO PCQI Animal Food - August Atlanta, GA - Sept Wolverhampton, UK - Sept Brussels, BE - Sept Dallas, TX - October Des Moines, IA

51 Preparation of the Food Safety Plan Traditional HACCP Process Plan (HACCP) FSMA Process PC Allergen Control Plan Sanitation Control Plan (SSOP s) Supplier Approval Program Recall program Allergen PC Sanitation PC Supplier-chain PC Recall PC

52 Verification vs. Validation Verification The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan. 21 CFR Are the preventive controls in the Food Safety Plan actually being properly implemented in a way to control the hazard? Validation Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards. 21 CFR Can the Food Safety Plan, when implemented, actually control the identified hazards?

53 Environmental Testing Requirements Is testing required? FDA preamble If the facility produces RTE food, the RTE food is exposed to the environment and there is a risk of environmental contamination (3) Environmental Monitoring Be scientifically valid Identify the test microorganism Specify the locations for the samples to be collected with number of sites Identify the timing and frequency for collecting samples Identify the test to be conducted Identify the laboratory conducting the testing Include the corrective action

54 Who Can Perform Supplier Verification? Supplier Testing; provide 3 rd party audit Another Entity (e.g., broker) Receiving Facility Receiving facility must document review and assessment of documents

55 Appropriate Supplier Verification Activities Conduct one or more of the following verification activities before using and periodically thereafter: Onsite audit Sampling and testing By the supplier or the receiving facility Review supplier s food safety records for the ingredient Other if applicable

56 Onsite Audit Requirements For serious hazards requiring a supply-chain-applied control Documented onsite audit before using the raw material At least annually after the initial audit Exception You document that other verification activities or less frequent auditing provides adequate assurance

57 Onsite Audits Who and What Must use a qualified auditor Review supplier s written HACCP or other Food Safety Plan and implementation documents for hazard identified in your hazard analysis

58 Sampling and Testing May be conducted: by the supplier at an outside lab or by the receiving facility Can communicate results in a COA Methods used must be fit for purpose Consult references on appropriate tests for different types of products Indicator tests may be more useful than pathogen tests to assess effectiveness of overall controls, e.g., coliforms in dietary supplement products

59 Gary M. Smith Vice President of Food Safety Services (515)

60 Questions