Tuesday, July 21, 2020

July 2020 - Contemporaneous Log and Texas Trip

The Vitamin Consultancy eLetter
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COVID willing, my trip to Texas to speak at The Woodlands Lunch Forum to inaugurate the Texas office of the Institute for Health Research is now scheduled for the end of August.  This is the third postponement since February, but I do hope to see my Texas friends then. Tickets available through www.InHeRe.org

KEEPING A CONTEMPORANEOUS LOG
MEETING FDA RECORD KEEPING REQUIREMENTS

The most important step that a small or start-up natural product / dietary supplement company can take to meet regulatory requirements is to keep a Contemporaneous Log of all activities relating to the receiving, handling and shipping of its products.  Follow-up records, such as computer inventory systems or even my OPS for SOPs (Operating Procedures System for Standard Operating Procedures) with its private, password protected regulatory compliance web site -- www.SystemsProcessingIntegration.com -- are after-the-fact records.

What FDA tells us is that the product Label Owner "must be in a state of control" of all processes, whether contracted or handled in-house.  Further the Agency tells us that, "if it is recorded that is how it happened; if it is not recorded it did not happen..."

This means that a contemporaneous, handwritten, initialed Receiving, Handling and Shipping Log is exactly what you need to start off right. Below is the format for the Log, but there are more sophisticated Log formats that I have available and am providing to my regular retainer clients.  Those documents are part of the SOP system developed by The Vitamin Consultancy. Let me know if you need more specifics.

The Log:

Thursday, June 18, 2020

June 2020 - Trip to Texas - Labeling and Packaging Specifications Webinar & eBook


The Vitamin Consultancy eLetter
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IN TEXAS JULY 8 - 12

New Tentative Date:
August 28, 2020

I will be visiting Dallas, Austin and Houston. The sponsor of The Woodlands Lunch Forum, Larry Deckerhoff had this to say:
"Meet You After the Pandemic Reopening -- The theme of this Lunch Forum is Advanced Health for the New Millennium, Immunotherapy and Rejuvenation – Focus on Supercharged Immune Systems During Troubled Times. Among our featured speakers will be Ralph Fucetola JD, President of The Woodlands’ own Institute for Health Research. He will be joined by two experts in rejuvenation and immunotherapies. The short presentations will leave plenty of time to reconnect and enjoy the extraordinary cuisine at Amerigo’s Grille.”
Please contact Stephen with questions:
stephen.contreras1@hotmail.com

LABELING AND PACKAGING SPECIFICATIONS
New Vitamin Consultancy Webinar and eBook
Special Newsletter Price:  $99.00

Contact: ralph.fucetola@gmail.com

Wednesday, May 27, 2020

May 2020 Newsletter: Reopening the Natural Economy

The Vitamin Consultancy eLetter
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Although the Declared "Pandemic" is Ending...
EMERGENCY PLANNING SOP & RESTARTING

A couple bits of news...

1.  My trip to Texas to announce the opening of The Woodlands office of the Institute for Health Research - www.InHeRe.org - originally scheduled for February, is now tentatively scheduled for late summer.

2.  The Trump Admin says it is relieving the regulatory burden on businesses to let us get back to work quicker.  My experience has been that FDA has backed-off physical inspections but has continued to push for compliance with previously issued Observation Reports. Use the time you have before the bureaucracy is back to work (well, what they consider "work") and get ready!

3.  I AM AVAILABLE TO CONSULT WITH YOU AS YOU REOPEN.  SPECIAL CONSULTING RATES FOR MAY.  LET ME KNOW -- ralph.fucetola@gmail.com with Consulting in subject line.

No doubt future inspections will put more emphasis on company Emergency Planning.

I have updated my Standard Operating Procedures (SOP) format to add Working Remotely to SOP #13, Emergency Planning.

My regular retainer clients received a copy of the revised SOP last month and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- www.SystemsProcessingIntegration.com -- are having their SOPs automatically updated by me.

Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency! CONTACT ME ABOUT SETTING-UP YOUR OPS 4 SOPs PAGE TODAY!

If you want a copy of SOP #13, the cost is now just $69 -- email me and I'll send you a PayPal money request.
I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP):  "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."

Please let me know how I can help your company as the emergency ends.

Dr. Laibow and I are maintaining a COVID information aggregation site here:  www.TruthAboutCoronavirus.com

We also held a COVID Emergency Health Summit (over 6 hours of podcasting with a half dozen experts) - more information here:  http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/
HERE IS WHAT AN OPS FOR SOPS PAGE CAN INCLUDE:

Thursday, April 30, 2020

April 2020 Newsletter: Quality Counts

April 29, 2020

SPECIAL BONUS eBOOK!
Labeling and Packaging Specs
-----

Here is the LINK where you can download my latest eBook which explains how to keep a Labeling and Packaging Log in conformity with GMPs -- as provided in SOP #25 of the Vitamin Consultancy standard SOP format.

http://www.vitaminconsultancy.com/Labeling-%26-Packaging-Specifications.pdf

-------------------------------

QUALITY COUNTS!
And Increases Your Bottom Line
Nutrient Sales Surge During Declared Pandemic

Quality Counts!
New ETQ Survey shows:  "An important shift is happening. Organizations now treat quality as a strategic initiative. Survey data shows 66% of organizations categorize quality as a strategic growth investment. Treating quality as a strategic business initiative is paying off as organizations see an average return of 23% on their investments."

Since Quality Counts, Quality Control must be a central concern.  Under FDA's GMP there is no question that quality counts and that the product label owner is the responsible party for quality control.  Your company needs to have Quality Control built into its Standard Operating Procedures (SOPs) and you need to have a designated Quality Control Manager.

The Vitamin Consultancy's standard SOPs include strong quality control provisions.  In the vitamin industry, according to numerous FDA Form 483 Inspection Observations that means controlling "identity, purety, strength and composition" of the DSHEA product.

Here is what the SOP says about the QC Manager: "The QC Manager shall review and evaluate with the company managers at least annually complaints, recalls, returned or salvaged products and internal investigations conducted for each."

QC Goals include:
  • Qualifying the Contract Manufacturer as capable meeting quality, strength, purity and identity standards
  • Approving (or rejecting) products manufactured, processed, packed or held under contract by another company
  • Approving (or rejecting) procedures and specifications impacting identity, strength, quality and purity
  • Approving (or rejecting) packaging, labeling and product containers
  • Reviewing and investigating consumer complaints.
Contact me at ralph.fucetola@gmail.com and let's talk about brining your SOPs up-to-date.  During this enforced period of self-shielding is a perfect time for you to get ready to get back to work! 
Learn more about my Systems Processing Integration!
I make being organized easy!
 www.SystemsProcessingIntegration.com
Stay safe and for the latest from Dr. Rima and me on COVID-19 check www.TruthAboutCoronavirus.com (if your browser says the site is "dangerous" it is right, but not a danger to you); alternatively, check www.OpenSourceTruth.com

http://www.opensourcetruth.com/covid-second-wave/

Friday, March 27, 2020

March 2020 Newsletter #2

This Issue:
Pandemic Protective Masks
My Latest OST Article
Planning for After the Pandemic

PANDEMIC!
Dr. Rima: We Have Bulk Protective Masks

Everyone is worried about COVID-19 and every company is impacted by it. And we all want to help.  Dr. Rima has sourced bulk amounts of protective masks.  If you know institutional buyers, now is the time to let them know.

Here is the link:
http://drrimatruthreports.com/save-health-workers-lives-today/

The web page includes a product brochure with full details.

And this link to my earlier March newsletter with an important article about Emergency SOP with Working Remotely provision:
http://vitaminlawyerarchives.blogspot.com/2020/03/march-2020-pandemic-newsletter.html
 

My latest article on Open Source Truth:
http://www.opensourcetruth.com/has-the-covid-curve-peaked/

 

PLANNING YOUR BUSINESS REBOOT AFTER THE PANDEMIC
While you are working from home it's time to plan your post-pandemic come-back.  It may help your planning if you consider your dietary supplement consumer's expressed interests.

https://www.nutraingredients-usa.com/Article/2020/03/25/Worldwide-supplement-survey-highlights-key-consumer-trends

2019 Worldwide supplement survey highlights key consumer trends - 25-Mar-2020 By Danielle Masterson

Glanbia Nutritionals surveyed users from across the globe to better understand consumer motive, usage, and knowledge gaps. US, UK and China consumers who used vitamins regularly.

US users listed top reasons to purchase:

55% - General Health
37% - Heart Health
32% - Healthy Aging
23% - Mental Health


In the 18 - 34 age demographic brain/cognitive health a top concern; 55 - 70 group: healthy aging and sleep support

Top vitamins used worldwide: C, D and Calcium; Q10, K2, choline and biotin had high consumer interest

Now that's some food for thought... or thoughts about nutrient foods. You get it.  Plan from data.

Friday, March 13, 2020

March 2020 Pandemic Newsletter

PANDEMIC!

EMERGENCY PLANNING SOP

Everyone is worried about COVID-19 and every company is impacted by it.

I have updated my Standard Operating Procedures (SOP) format to add Working Remotely to SOP #13, Emergency Planning.

My regular retainer clients are receiving a copy of the revised SOP and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- www.SystemsProcessingIntegration.com -- are having their SOPs automatically updated by me.

Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency!

If you want a copy of SOP #13, the cost is just $99 -- email me and I'll send you a PayPal money request.

But during this emergency, I want everyone to have the information they need to protect their company.  So here is the new section of SOP #13, so you can get ready for remote working if you find your company under lock-down.
---------------------------------------

[2] Working Remotely - It may be necessary for some or all staff to work remotely during an emergency.  In advance of such contingency the Emergency Manager should:
  1. Establish an Online Communication System, such as (1) Skype or Zoom, instructing all staff to have access to the system via cell phone and home computer; (2) a Conference Call Bridge number should also be established and (3) a Push Notice System can be established to text group messages to staff member cell phones.
     
  2. Designate staff members who are essential to operations and who should, if possible, work from the facility.
     
  3. Designate staff members who can continue their work remotely.
     
  4. Designate times and circumstances where staff members should call the Conference Call Bridge for instructions or text instructions to staff members’ cell phones.
I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP):  "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."

Please let me know how I can help your company during this emergency.

Dr. Laibow and I are maintaining a COVID information aggregation site here:  www.TruthAboutCoronavirus.com

We are planning a COVID Emergency Health Summit; more information here:  http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/

Friday, February 14, 2020

Cost Segregation and Your Business

The Vitamin Consultancy eLetter
February Texas Trip, Cost Segregation
Systems Processing Integration
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COVID-19 DELAYS TRIP
I'LL BE IN TEXAS
LATER THIS MONTH

My February Trip to Texas is NOT going ahead as planned. Instead, COVID-19 permitting, I'll be in the Lone Star State from 5 May through 9 May 2020 -- traveling from Dallas through Austin to Houston where I am the featured speaker at The Woodlands Lunch Forum on Friday, May 8th.  More about that event here:   https://www.woodlandsonline.com/npps/story.cfm?nppage=65447 -- if you are going to be in the area, I'd love to see you!
Do you want to save money on your business Income Taxes? 

OF COURSE YOU DO!

Our Financial Services can help you accelerate your real estate depreciation through an engineered Cost Segregation (Cost
Seg) Study allowing you to expense 10% to 50% of the cost of your building in the FIRST YEAR

 
The TAX saving is guaranteed by Urb Financials to be ten times the cost of the study! 
 
What is Cost Seg?  CLICK HERE

How does Cost Seg benefit you?  CLICK HERE
 
What is the IRS’ position on Cost Seg?  CLICK HERE 

"Some taxpayers are reluctant to use cost segregation, equating it with a high-risk tax shelter. In truth, this reluctance is misplaced. If the cost of the components in the engineering report is well- documented, the cost segregation technique is no more aggressive than using a permissible depreciation method under the Internal Revenue Code." Journal of Accountancy
 
Advanced Strategies and FAQs? CLICK HERE 


THE PRELIMINARY COST SEGREGATION ANALYSIS IS FREE.
          CLICK HERE FOR ESTIMATE APPLICATION


Once completed, please return Estimate Application Formn to GET at dannyfucetola@gmail.com and typically within ten business days of receipt of your completed form, we will provide you with a FREE Preliminary Analysis containing the estimate of the income tax benefits and projected cost of a Cost Segregation Study.
SYSTEMS PROCESSING INTEGRATION
DEFINING REGULATORY COMPLIANCE!
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 dietary supplements (including medical foods) and/or providing 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 FDA procedural regulations.
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Wednesday, January 29, 2020

Announcing: SPI Associates

VITAMIN CONSULTANCY NEWSLETTER

January 2020 Second Issue:
INTRODUCING SPI ASSOCIATES
SYSTEMS PROCESSING INTEGRATION
www.SystemsProcessingIntegration.com

The Vitamin Consultancy

SPI ASSOCIATES

Systems Processing Integration
Meeting FDA/FTC Natural Product
Regulatory Requirements
www.SystemsProcessingIntegration.com

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.

www.SystemsProcessingIntegration.com

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


Addenda:

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


[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
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.

[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.  www.ProfessionalSafetyDossier.com

    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.  www.CosmeticSafetyDossier.com
     
  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.  www.SystemsProcessingIntegration.com

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:

SOPs
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:  ralph.fucetola@gmail.com for further information and fees.

IRB SERVICES

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.

 --------------------------
[1] https://www.grandviewresearch.com/industry-analysis/dietary-supplements-market
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.
SAMPLE PRIVATE SITE ENTRY