Wednesday, January 29, 2020

Announcing: SPI Associates


January 2020 Second Issue:

The Vitamin Consultancy


Systems Processing Integration
Meeting FDA/FTC Natural Product
Regulatory Requirements

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. [1] 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.

[1] Standard Operating Procedures.  This document tracks FDA concerns and includes 43 pages of procedures, formats and forms.  Included:

            1.  Introduction / Index
            2.  Refund, Delivery & Returns Policies
            3.  Standard Disclaimers; Site Use Statement
            4.  Standard Waivers
            5.  Email Privacy Policy
            6.  Document Retention Policy
            7.  Quality Control / Claims / Complaints / Food Safety
            8.  Contract Manufacturer Agreement
            9.  Password and Internet/Program Access Controls
            10.  Order Processing Procedure
            11.  Bookkeeping and Account Management
            12.  Order Record and Retrieval; AER Reporting
            13.  Emergency Planning and Crisis Management
            14. Payment Card Industry Data Security System
            15. Private Labeling / Labels
            16. Receiving, Handling, Shipping & Storage
            17. Recalls
            18. Complaint Form
            19. Change Controls / New SOPs
            20. CAPA
            21. OPS (Operations Procedure System) / CCDS
            22. New Employee Qualification and Training
            23. Official Inspections: Procedures
            24. New Product Development; Product Retirement
            25. Labeling and Packaging Specifications


Site Use Statement
Complaint 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:

Quality Control Manager (QCM)
Preventive Controls Qualified Individual (PCQI)
Emergency Manager (EM)
SOP & CCDS Manager
Customer Service Manager
Warehouse Manager

[2] 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
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.

[3] 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:

  1. Proposition 65 Safety Dossiers.

    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.
  2. 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.
  3. 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.

[4] Systems Processing Integration.

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
Safety Dossiers
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.

Contact: for further information and fees.


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 and search the IRB drop-down tab.

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.

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