Allergen Control for Dietary Supplements Presented at: FDA/ASQ FD&C Division 2 nd Annual Dietary Supplement Consortium CCIC North America Rancho Cucamonga, CA 91730 Presenter: Joy Joseph April 27, 2018
DISCLAIMER This presentation represents my personal views regarding how FSMA rules apply to Dietary Supplements It is not a legal document or view Language from FSPCA training documents for Preventive Controls for Human Food has been included. Details of the final rules may be found in the FSMA rules on the U.S. FDA website < www.fda.gov/food/fsma
Introduction In 2004, the Food Allergen Labeling and Consumer Protection Act(FALCPA) was signed into law. In 2011, the Food Safety Modernization Act (FSMA)was signed into law. Todays presentation is intended to: Describe how the two regulations are interrelated and To address how supplement manufacturers interpret their requirements regarding these laws.
FALCPA vs FSMA Congress passed FALCPA to protect millions of food allergic consumers from foods that contain major food allergens that they must avoid. 30,000 ER Visits Annually 150 Deaths Annually Congress passed FSMA to ensure the safety of the global food supply in order to prevent foodborne illnesses and its consequences.
FALCPA vs FSMA Both regulations address food safety. FALCPA is a labeling regulation to identify foods containing allergens. FSMA regulations identify biological, chemical and physical hazards and requires preventive controls to be put in place. Allergens are chemical hazards. Both regulations define Allergen Cross Contact
8 Major Allergens Milk Eggs Fish (bass, flounder, cod) Crustacean shellfish (crab, lobster, shrimp) Tree Nuts (almonds,walnuts, pecans) Peanuts Wheat Soybeans
Commonly Used in Dietary Supplements Whey Powder (milk) Soy Lecithin Chondroitin (shell Fish) Glucosamine( shell fish)
FALCPA Labeling Requirements Food manufacturers are required to label food products that contain an ingredient that is or contains protein from a major food allergen in one or two ways. Include the name of the food source in parenthesis following the usual name. Example: whey (milk) Or Use the word Contains followed by the name of the food source. Example : Contains Wheat, Milk, etc.
Labeling for Dietary Supplements If the allergen is a dietary ingredient it can be listed in the supplement facts panel. If it is an other ingredient it shall be listed in the Ingredient Statement below the facts panel.
Warning Letters Allergen labeling violations is the number one cited non-compliance issue on FDA warning letters for foods. Citation language: Your product ZXK is misbranded within the meaning of section 403(w) of the Act 21 U.S.C. 343 (w) in that the label fails to declare the presence of a major food allergen present in the product, namely (allergen name)
FSMA Final Rules FSMA Changes the Playing Field Final Rules that most directly affect dietary supplements are: 21 CFR Part 117 - Current Good Manufacturing Practice and Hazard Analysis and Risks Based Preventive Controls for Human Food
FSMA Final Rules And: 21 CFR Part 1, Subpart L - Foreign Supplier Verification Programs (FSVP) Supplement ingredients and finished supplements that contain allergens and are imported into the U.S. are required to have verification of compliance to U.S. allergen regulations.
FSMA - Food Safety Food Safety - FSMA/FALCPA, 21 CFR Part 117 Food Quality - 21 CFR Part 111 What is the difference? Who is responsible? What Changed?
21 CFR Part 117 cgmp & Preventive Controls Rule, Who is Covered Facilities that manufacture, process, pack or hold human food, including: Ingredient manufacturers, packers, or holders must comply with 117 (All subparts as applicable) Dietary Supplement Manufacturers are exempt from 117 Subpart C - Preventive Controls & Subpart G Supply Chain Program
117 Subpart B GMPS Dietary Supplement Manufacturers are NOT exempt from 21 CFR Part 117, Subpart B! Dietary Supplement Manufacturers must comply with Part 111 and with 117 Subpart B, unless they conflict (Preamble of 21 CFR Part 117) Subpart B, allergen requirements are not conflicting with Part 111
Part 117 Subpart C Requires a Hazard Analysis Starts with a process flow chart Analyze each step for introduction or presence of hazards Biological/Micro, Insects etc. Chemical/Allergens Physical/ Wood, glass, rocks, plastic etc
Part 111 Requires Establishing Specifications 111 Requires Specifications for : Component identity Components may be allergens and Limits of contamination Chemicals/allergens, can be in the form of contamination
Compliance Does compliance end with the Allergen Labeling Act? For those allergens that are dietary supplement components, manufacturers have a good understanding of FALCPA compliance. What about Allergen Cross Contact? Where do we stand?
Definition of Cross Contact FALCPA - the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may occur when multiple foods are produced in the same facility. It may occur due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning or from the generation of dust or aerosols containing allergens. FSMA - unintentional incorporation of a food allergen into a food.
Interrelationship between FALCPA and FSMA Since both regulations define cross contact and the FSMA Part 117 preventive controls regulation addresses Allergen Cross Contact Prevention Considerations in Subparts B & C, what does compliance mean, for dietary supplements, which are food by definition?
Part 117 - Subpart B GMPS Part 111 - Subparts B,C,D,E,M Personnel Plants and Grounds Sanitary operations Sanitary Facilities Equipment and Utensils Processes and Controls Warehousing and Distribution
Allergen Cross Contact Prevention Considerations Equipment Cleaning and sanitary design Scheduling Manufacturing and engineering controls Allergenic ingredient control Rework management Personnel practices Employee training relevant to the above
Equipment Cleaning Thorough cleaning between products with different allergens is required to prevent cross-contact Validation of allergen cleaning is not required but may be useful An option may be dedicated tools, surfaces and other devices for specific allergens
Verification of Allergen Cleaning Visually clean Minimum requirement No residue, film or sheen Optional tests Non specific tests, e.g., ATP and protein May not be sensitive enough to detect some allergens Allergen test kits Follow manufacturers instructions Complex tests may be needed in special situations
Scheduling Minimize changeovers Run dedicated or designated systems as much as possible Schedule appropriate sanitation activities Control allergen addition
Manufacturing and Engineering Controls Engineer the line to minimize mixing of allergenic products with non-allergenic products Use physical barriers to separate processing lines Minimize the reuse of water or oil
Maintenance and Engineering Sanitary design principles Monitor and reduce dust levels Minimize use of air compressors Maintain tools
Allergenic Ingredient Control Develop a master list of allergenic ingredients used in the facility Letters of guarantee from suppliers on the presence or absence of allergenic ingredients Accessibility of the master list at the receiving doc Use common names of allergens Apply careful handling at receiving to avoid to avoid cross- contact Identify allergens with icons or colors
Receipt and Storage Review labels and include allergen check as a prerequisite for deliveries Separate allergenic ingredients from non allergenic ingredients to prevent cross contact Use signage in areas used to store allergens Store allergens in sealed intact containers Do not store allergens above non allergens or different allergens on racks or pallets Store allergens with like allergens Have documented clean-up procedures
Allergen Controls During Processing Maintain segregation of unique allergenic Material Weigh powders containing unique allergens in a different area Cover totes during transfer Control ventilation over lines Consider dedicated tools and equipment Proper use and cleaning of containers that previously held other foods
Rework and Product on QA Hold Store allergen containing rework or open production QA hold separately to avoid cross contact Clearly mark rework or open QA hold material with the name and presence of allergens
Personnel Practices Manage employee uniforms and outer garments to avoid cross contact Consider keeping personnel who handle unique allergens out of non-allergen areas Training is essential
Allergen Labeling Label Accuracy Accurate printing of allergen ingredients on the label The right label on the package Ensure all allergens are identified in compliance with the appropriate law Food Allergen Labeling and Consumer Protection Act provides requirements for FDA-regulated foods
Labels and Packages Allergen labeling errors are a primary cause of food product recalls Consider controls that: Ensure accurate printing Ensure the right label or package is used for the product Manage formula changes to ensure that the correct label is used during transition
MAY CONTAIN LABELING May Contain or similar labeling id NOT a substitute for cgmps May Contain precautionary labeling is NOT a Preventive Control Preventive Controls must be verified
Protect the Allergic Consumer QUESTIONS? Joy A.Joseph Joys Quality Management Systems Contact: joy@joysqms.com