This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
INTENTIONAL ADULTERATION FOOD DEFENSE Guidance for Industry Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide
Congress adopted the Food Safety [sic] Modernization Act (FSMA) in 2010 (I was involved in the successful effort to protect DSHEA from some of the provisions of the act). Among other steps, the Act directed the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to, as FDA states, "better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation."
On May 27, 2016, FDA published a final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule) (81 FR 34165), that, the Agency states, "creates new requirements for the production of food by registered food facilities to protect the food supply against intentional adulteration. "
Posted on August 24, 2017 FDA issued a Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). FDA says, "This guidance document is intended to assist small entities in complying with the rule set forth in 21 CFR 121 concerning Mitigation Strategies to Protect Food Against Intentional Adulteration. The rule is binding and has the full force and effect of law."
The good news is that the Guide gives companies several years to comply with the more stringent regulations.
You can read the entire Guide here: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM562223.pdf or you can subscribe to the Vitamin Consultancy's OPS -- Operating Procedures System, to be assured of haveing the tools you need to be in compliance.
Here is what the FDA says is the Primary Requirement:
"The rule requires a written food defense plan for all covered facilities ... (21 CFR 121.5). The written plan must include (21 CFR 121.126):
• A vulnerability assessment to identify - significant vulnerabilities and actionableprocess steps, and associated explanations • Mitigation strategies and associated explanations • Procedures for food defense monitoring • Procedures for food defense corrective actions • Procedures for food defense verification"
Therefore, primarily, you will need to adopt and implement an Intentional Adulteration Avoidance SOP that meets the Primary Requirement and others set out in the Guide. Drafted by the Vitamin Consultancy's experts, you can rest assured that this new Standard Operating Procedure will both meet the letter of the law and be structured so your company can implement effectively within the OPS system.
Starting earlier this year Certificates of Free Sale (COFS) for food products regulated by the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) will be issued online as downloadable PDFs. The change from paper to PDF certificates will make the process of issuing COFS more efficient for both exporters and the agency.
Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. FDA issues COFS for certain CFSAN-regulated food products upon request by an exporter. FDA does not require export certificates to export foods to foreign countries.
The FDA Certificate Application Process (CAP) is CFSAN's web-based application for accepting requests, reviewing, processing, managing, tracking, and administering CFSAN export certificates. To access CAP, log in to FDA Industry Systems at https://www.access.fda.gov/oaa and select the "Certificate Application Process" option from the list of systems available. If you do not have an account with FDA Industry Systems, you will need to create one.
The advantages of CAP include:
Online submission of applications;
Reduction in application processing time;
Online receipt of certificates via PDF;
Real-time status updates via email and online tracking; and
Ability to copy, edit, and resubmit applications.
If exporters are unable to use the new PDF system, they may contact FDA and we will provide assistance.
CFSAN COFS will have a new look, including an updated letterhead and image of the HHS seal. PDF certificates issued directly to the applicant are considered original certificates and the Department of State is able to authenticate the certificates. For each certificate, FDA will provide a unique Certificate Identifier (ID). Foreign government officials authorized by the FDA can use this Certificate ID to verify the authenticity of the certificate. Exporters will need to ensure that the printed certificates are clear and legible. An example of the new look of the certificate is below.
If you have any questions or concerns, please email CFSANExportCertification@fda.hhs.gov or call 240-402-2307.