The Food Safety Modernization Act (FSMA) reaches across the entire food industry, not just conventional foods. Stakeholders and consumers rarely think of dietary supplements as foods, even though they are defined as such in law.
Since the Food Safety Modernization Act (FSMA) was signed into law in January of 2011, there have been many proposed changes that have now been finalized under Title 21 of the Code of Federal Regulations (here now known as 21 CFR). With many of the final rules finally in place, now is a good time to look at the responsibilities of dietary supplement companies in today’s regulatory environment since FSMA.
The following Parts of 21 CFR have an impact on the food industry as a whole:
- PART 110 – Current GMPs In Manufacturing, Packing, Or Holding Human Food
- PART 111 – Current GMPs In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements
- PART 117 – Current GMPs, Hazard Analysis, And Risk-Based Preventive Controls For Human Food
- PART 120 – Hazard Analysis And Critical Control Point (HACCP) Systems
- PART 121 – Mitigation Strategies To Protect Food Against Intentional Adulteration
Food and supplement manufacturers have been working with several of the above for many years.
Part 117 contains FDA’s new human food safety rules (“Hazard Analysis and Preventive Controls for Human Foods”, or HARPC), based on FSMA. FSMA rules provide a proactive approach to controlling a safe food supply chain.
Part 117 appears as seven subparts:
- General provisions
- Current GMP
- Hazard Analysis and Risk-Based Preventive Controls
- Modified Requirements
- Withdrawal of a Qualified Facility Exemption
- Requirements Applying to Records
- Supply-Chain Program
Dietary Supplement Products and Manufacturers
FSMA spells out an exemption for finished dietary supplements to subpart C, because they must comply with 21 CFR Part 111. The exemption also covers Adverse Event Reporting, since this is also required under Part 111. FSMA also spells out an exemption to subpart G, Supply-Chain Program. The exemptions are only for finished dietary supplement products and dietary supplement companies need to understand what Subparts C and G dictate to suppliers, both domestic and foreign.
Although supplement companies are exempt from Subparts C and G, supplement companies have responsibility for compliance under Subparts A, B, and F. (Subparts D and E apply to very small companies and start-ups who file and receive or stand to lose “Qualified” status, and are not under discussion here).
For supplement manufacturers that also make a few food products for humans or animals in addition to their supplement production, the FDA has stated that where Parts 111 and 117 are in conflict, the supplement manufacturer would comply with Part 111. However, the exemption does not apply to foods held in a dietary supplement facility. If a company makes food products in a supplement facility, they will need to ensure that food production complies with Part 117 (Subparts A, B, C, F, and G) while still maintaining compliance with Part 111 for their supplement production.
Now in effect for all but the smallest food manufacturers, Part 117 Subpart B covers current GMP for food and it replaces all of 21 CFR 110. Part 110 will be archived in September of 2018 and by then, all companies producing, packaging, labeling, and/or holding dietary supplements must comply with both Part 111 and Subpart B of Part 117. Use of GMPs in Parts 111 and 117, together, lead to a robust system for food safety.
Dietary supplement manufacturers will want to pay particular attention to Part 117 B GMPs for responsibilities relative to controlling allergens. Everyone (ingredient manufacturers and handlers at all points, including supplement manufacturers and packagers) must be proactive and implement controls according to the new cGMPs. The only products outside the requirements for allergen controls are those secured in their finished goods packaging in warehouses dedicated to labeled and sealed finished goods.
Dietary Ingredient Manufacturers
Dietary Ingredient (DI) manufacturers are directly affected by FSMA. They are allowed an exemption to HARPC if they are compliant with Part 111. Currently, ingredient manufacturers are not required to comply with 21 CFR Part 111 for dietary supplements, but with 21CFR Part 110 for conventional foods, and the revised GMPs under HARPC in Part 117.
The potential for dual compliance arises when an ingredient manufacturer could distribute an ingredient of the same batch or lot, partially to a conventional food company and partially to a dietary supplement manufacturer. Part 111 is not all-inclusive for dietary supplement ingredient manufacturers, nor is Part 111 specific enough to control food borne health hazards without the implementation of more specific preventive controls that include hazard analyses, monitoring and validation. As mentioned above, Part 110 will be archived in September of 2018, after which time food and ingredient manufacturers must comply with Part 117.
Dietary ingredient manufacturers therefore need to undertake hazard analyses in preparation for developing, implementing and monitoring their risk-based preventive controls. They also need to review dates for their supply chain programs, as these interact with FSVP requirements.
Dietary ingredient manufacturers have the following basic obligations:
- Using approved suppliers
- Determining how to verify suppliers
- Ensure preventive controls are being implemented and are effective
- Adequately documenting all the above
Foreign Supplier Verification Programs (FSVP), Third Party Auditors Program, & Importers
The FSVP and Certification of Third Party Auditors Program will also impact the ingredient manufacturers supplying both dietary supplement and food companies. FSVP places responsibility for foreign supplier compliance upon the importers. Importers would be required to analyze the hazards associated with each food they import.
The bottom line is that finished dietary supplements are required to have FSVP in place to be imported into the United States, and ingredient manufacturers will need at least third party oversight to ensure food safety plans are in place and have been verified to provide the same level of protection as those required under the preventive controls. They must also verify the ingredients are not misbranded regarding allergen labeling.
Activities under the Food Safety Modernization Act (FSMA) regulations continue at a fast pace, and industry and stakeholders need to keep fully abreast of all these developments. We encourage anyone having difficulties in this area or in the general area of Food Safety or regulatory compliance to reach out to dicentra for further discussions.
dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products. We can be reached at 1-866-647-3279 or email@example.com.