dicentra Global Certifications offers a complete suite of certification, testing and GMP compliance services to the dietary supplement and natural product industries.
Our certification program provides onsite audits to verify that manufacturers are in compliance with Current Good Manufacturing Practice (cGMP).
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
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.
Summary
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 info@dicentra.com.