This private 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.
Systems Processing Integration Associates is a project of The Vitamin Consultancy. It includes Ralph Fucetola JD, Robert Goodman, PhD and other professionally qualified associates who collaborate to meet natural product company Operating Procedure System needs.
The dietary supplement, natural remedy, natural personal care markets are exceeding one hundred billion dollars annually, in the USA alone.  As the market has grown the original natural product pioneers are being succeeded by entrepreneurs and managers who are committed to protecting their companies’ Intellectual Property by organizing their processing systems in conformity with regulatory requirements.
At the same time the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are ratcheting-up enforcement and regulations. Although Congress told the FDA, when the Dietary Supplement Health and Education Act (DSHA) was adopted in 1994, that dietary supplement regulations should be like food regulations, the agency has consistently pushed for regulations that are much more like the highly restrictive requirements that apply to drug companies.
FDA says that if your company owns the Label, as the Label Owner, your company must be “in a state of control” over the entire process of producing, storing, shipping and customer service. You can contract out each of these steps, but you must remain in control of them, by having carefully constructed Standard Operating Procedures (SOPs), by training your staff in operating the company under formal SOPs, and by being able to prove that your staff has been so trained.
With recent FDA inspection emphasis on Quality Control (requiring a Quality Control Manager), Preventive Controls Qualified Individual (requiring a certified PCQI manager to sign-off on all new product runs) and renewed interest in seeing your company’s Specifications and Product Testing records, making sense of your process controls and organizing your systems, what I call Systems Processing Integration, must take a top priority to effectively manage your business.
Our goal is to bring my half century of experience in the natural products industry, and that of my associates, to bear on the question of integrating and coordinating the various systems that you need in place to control your business, minimize control expenses, and enhance your capacity to compete in a tough market.
We do this by integrating several services that support your business structure.
 Standard Operating Procedures. This document tracks FDA concerns and includes 43 pages of procedures, formats and forms. Included:
Site Use Statement Waivers Complaint Form CCDS Form Contract Terms Social Media Schedule Program Access Safety Contract Food Safety Plan Label & Packaging Specifications
Within the structure of the SOPs are provisions for the Food Safety Plan, an increasing concern of Federal Regulators.
The staff positions contemplated by recent FDA inspections include:
CEO COO Quality Control Manager (QCM) Preventive Controls Qualified Individual (PCQI) Emergency Manager (EM) SOP & CCDS Manager Customer Service Manager Warehouse Manager
 Webinar Training Program. With two dozen webinars, we cover a range of training necessary to implement an integrated processing system. The SOP training webinars cover the documents and the records which companies are required to keep.
Current webinars include:
CAM Cautions Cosmetic Safety Dossier Introduction DS & Medical Foods for Physicians Food Safety Plan - PCQI Training Health Claims Lawful Copy Writing Minister CAM Practices NGO Formation OPS 4 SOPs Quality Control Record Keeping for GMPs Second Opinion Wellness Coaching SOP1: Introduction SOP2: Section 1 SOP3: Section 2 SOP4: Conclusion SOPs Certification Test SOPs Certification Test for HCPs SOPs for Health Care Practitioners STS: Specifications, Tests, Samples
Successful completion of training programs results in issuance of Certificates of Completion.
 Third Party Certifications and Dossiers. Federal and State Regulators have a number of other regulatory concerns, some of which can be met through the services of third party certifiers which we coordinate. These include:
California increased its “Prop 65” program requiring stricter warnings for potentially toxic or cancer-causing substances in the marketplace. New York and New Jersey have just adopted similar regulations. The regulation allows companies to rely upon third party safety research and certifications.
Cosmetic Product Safety Dossiers (for both USA and EU regulations).
In the USA cosmetic labels must carry a “not safety tested” warning unless the product was safety tested or a qualified third party certifies that the ingredients are safe. The EU has a similar requirement. www.CosmeticSafetyDossier.com
Safety Data Sheets.
While not yet formally required by FDA, Amazon now wants to see a formal Safety Data Sheet for many personal use products. Third Party Certified data sheets meet the requirement.
Bringing all the above data together, in one protected online location, ready for the inevitable FDA inspection, is the goal of Systems Processing Integration.
Your private, password-protected SPI site includes copies of:
CCDS (Company Core Data Sheet) for each product
FDA-required Structure and Function Claim Post-Market Notices
Commonly-used SOP forms
Mission Statement and Branding Dossier
Food Safety Plan
FDA Food Facility Registration
Key Manager Certifications (QCM, PCQI, etc.)
SPI Associates, in cooperation with The Vitamin Consultancy, oversees and maintains your SPI site and its contents. There is a modest set-up fee and an annual or monthly maintenance fee.
An allied service which can further support product claim substantiation is the Institute for Health Research's IRB service.
A clinical trial is the best evidence supporting claims, but the trial must start with a formal Protocol that meets IRB (Institutional Review Board) Informed Consent standards, or the results may not be eligible for publication and may be rejected as substantiation.
Dr. Goodman and I provide, through the Institute, assistance in preparing a Protocol which will comply with IRB standards, designing the trial with the Principle Investigator (PI).
Unless you ask the right questions at the start the clinical trial will most likely not provide the data you need for legal substantiation. For more about the IRB services go to www.InHeRe.org and search the IRB drop-down tab.
SYSTEMS PROCESSING INTEGRATIONDEFINING REGULATORY COMPLIANCE!
SPI Associates -- Providing Specialist Support to Your Organization and its Integrated Standard Operating Procedures [SOPs], Operating Procedures Systems [OPS], Mission and Branding Policies.
We develop and maintain a private, password protected, OPS for SOPs web site for your Company. Just when you need access to your documentation the most urgently [for example, during a storm or a surprise FDA inspection] you will be very happy your Company worked with Systems Processing Integration to establish your Private Site. When you need your regulatory compliance documentation available it will probably be too late to benefit from this program. Act now. Contact us here: CONTACT
My experience will strengthen your company! I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations.