The dietary supplement industry was greeted with a number of new regulations in 2016. But one of them, the Food Safety Modernization Act (FSMA), has particularly broad compliance implications for industry, especially one component of the law that requires a specially trained individual in your facility to oversee new safety systems. FSMA, published as a final rule in September 2015, is the largest change to U.S. food regulations in more than 70 years. FSMA creates a modern food-monitoring system focused on introducing proactive measures during harvest, storage, processing and distribution to ensure that hazards are eliminated and controlled.
FSMA applies to all companies manufacturing, processing, packaging and holding food products for human consumption in the United States, including dietary supplements, ingredients, raw materials and functional foods & beverages.
FSMA is comprised of seven parts and has a tangled web of compliance dates. The compliance dates for all of these parts are different depending on the section and the size of your company.
Within FSMA, there are seven parts or “foundational rules,” including:
1. Preventive Controls for Human Food
2. Preventive Controls for Animal Food
3. Produce Safety Rule
4. Foreign Supplier Verification Program (FSVP)
5. Accredited Third-Party Certification
6. Sanitary Transport of Human and Animal Food
7. Intentional Adulteration
FSMA creates the evolution of the current Good Manufacturing Practices for food (21 CFR Part 110) and shifts it to the modern version, 21 CFR Part 117. The new regulation is called Current Good Manufacturing Practice, Hazard Analysis and Risk-based Preventive Controls for Human Food. It is more commonly known as Preventive Controls for Human Food Regulation.
Products marketed as dietary supplements, and the companies that manufacture, package, hold or distribute them, are exempt from FSMA if the facility is in compliance with other applicable laws and regulations for dietary supplements.
The applicable laws and regulations for dietary supplements include:
• 21 CFR part 111 (Current Good Manufacturing Practice in the manufacturing, processing, packaging, labeling, holding and Operations for Dietary Supplements)
• 21 USC Section 379aa-1 (Serious Adverse Events Reporting for Dietary Supplements)
For large companies, the initial compliance date for 21 CFR Part 117 was September 2016. The regulation allows additional time for small and very small companies. Small companies must reach compliance by September 2017 and the smallest group by September 2018.
The definitions of small and very small provided by the FDA are:
• Small: Less than 500 full-time employees
• Very small: Less than $1 million per year in annual sales of human food
Dietary ingredients used in dietary supplements are subject to the new preventive controls for human food, including:
• Subpart B: current Good Manufacturing Practice (cGMP)
• Subpart C: Hazard Analysis and Risk-based Preventive Controls
• Subpart G: Supply Chain Program
• Subpart F: Record Keeping
The regulation requires that certain activities must be completed by a “Preventive Controls Qualified Individual” or PCQI. FDA’s definition of PCQI reads:
The course, developed by Food Safety Preventive Controls Alliance (FSPCA), is the “standard curriculum” recognized by the FDA. Successfully completing this course is the primary way to meet the requirements to become a PCQI.
I completed this FSPCA course while working for the FDA as an investigator. Additionally, in March 2017, I completed the Food Safety Preventive Controls Alliance course to become a Preventive Controls Qualified Individual lead instructor.
At UNPA, we are excited to announce that we will be providing PCQI and FSVP training throughout 2017. The UNPA training will provide case studies developed specifically to dietary supplement products, including nutrients, botanicals and other key categories in various finished-product matrices, including tablets, capsules, tinctures and more. See the box for more information on these training sessions.
The responsibilities of a PCQI (21 CFR part 117.180) include:
• Preparation of the Food Safety Plan
• Validation of the preventive controls
• Records review
• Reanalysis of the Food Safety Plan and other activities as appropriate for the “food”
A Food Safety Plan is a written plan based on science and food safety principles and includes:
• Hazard analysis
• Establishing and monitoring for preventive controls (PC)
• Establishing and monitoring your supply chain
• Developing monitoring procedures for PCs
• Establishing and implementing corrective action plans for failures
• Verification of the food safety system
• The requirement to have a recall plan if a food safety hazard has been identified and a preventive control is in place
Hazards to be considered in a food safety plan include chemical, physical, microbiological, radiological, food allergens and economic fraud of food safety significance.
FSMA also requires food testing be carried out by an accredited laboratory.
With the full implementation of FSMA, FDA will have new regulatory tools, including mandatory recall, expanded administrative detention and suspension of registration.
We appreciate that FSMA and its various components present new challenges to dietary supplement companies, and UNPA is pleased to provide trainings that will help companies be in full compliance with these new regulations.
Larisa Pavlick spent 12 years in industry as a buyer and QA/QC
specialist before her eight-plus years as an investigator in FDA’s
Denver District. She joined UNPA in November.