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/

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.

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.
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[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/

Cost Segregation and Your Business

The Vitamin Consultancy eLetter February Texas Trip, Cost Segregation Systems Processing Integration View this email in your browser

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. VitaminConsultancy.com SystemsProcessingIntegration.com ProfessionalSafetyDossier.com

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: 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.   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. [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. www.VitaminConsultancy.com SAMPLE PRIVATE SITE ENTRY

January 2020 -- Useful Links for the New Year

January 2020 Newsletter New Year Ideas for You and Your Business MY USEFUL LINKS Is this the Year YOU will Get Organized? www.SystemsProcessingIntegration.com Prop 65 / Cosmetic / Amazon Safety Dossier www.ProfessionalSafetyDossier.com New York now has its own Prop 65 Law And New Jersey is about to follow. AND THESE USEFUL LINKS FROM THE FDA Food Facilities Registration: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions FDA Search Databases: https://www.fda.gov/industry/fda-basics-industry/search-databases Medical Device Search: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm "Many organizations that manufacture devices and products for distribution and use in the United States are required to register with the U.S. Food and Drug Administration on an annual basis. Some of this registration information is available to the public – but not all. For example, although food manufacturers are required to register with the FDA, the public is not entitled to their registration information." -- https://legalbeagle.com/5835541-manufacturers-fda-registration-number.html

Cost Segregation -- COST SEG Can Save Your Company Taxes You don't want to pay more taxes than you have to... right? www.Winning-Business-Solutions.com

Winning Business Solutions can help you accelerate your real estate depreciation through an engineered Cost Segregation Study allowing you to expense 10% to 50% of the cost of your building in the FIRST YEAR!  The tax savings is guaranteed to be ten times the cost of the study!  What is Cost Segregation?  Currently, the IRS sees your building as one entity, depreciated using straight line depreciation over 27.5 or 39 years, or, in our analogy, a Big Mac. After an engineered Cost Segregation Study, the IRS will see the components of your building, e.g., decorative lighting or outdoor landscaping, much like we view a Big Mac as two all-beef patties, special sauce, lettuce, cheese, pickles, onions on a sesame seed bun. An engineered Cost Segregation Study allows some components to be moved into 5, 7 or 15-year property depreciation categories – lettuce might be in the 5-year category and the sesame seed bun might be in the 15-year category, just like decorative lighting is 5-year property and landscaping is 15-year property with an engineered Cost Segregation Study. Under the new tax bill, 5-year property, typically where the bulk of the reclassified components go, can be entirely expensed in the first year! Which means, depending on the type of building, 10% to 50% of your building can now be written off in the first year!   How do you start your Cost Seg benefits? Go to www.Winning-Business-Solutions.com Complete the Contact Form

CBD NEWS USDA Approves First State and Tribal Hemp Production Plans Nicholas Saraceno | January 2, 2020 The U.S. Department of Agriculture (USDA) has approved the first set of plans submitted by states and Indian tribes for the domestic production of hemp under the U.S. Domestic Hemp Production Program. The plans were submitted by the states of Louisiana, New Jersey and Ohio, and the Flandreau Santee Sioux, Santa Rosa Cahuilla, and La Jolla Band of Luiseño Indian Tribes. The Agriculture Improvement Act of 2018 (2018 Farm Bill) directed USDA to develop a regulatory oversight program for hemp and include provisions for USDA to approve hemp production plans submitted by states and Indian tribes. Accordingly, on Oct.31, 2019, USDA issued an interim final rule establishing the U.S. Domestic Hemp Production Program and the provisions for USDA to approve submitted plans. State and tribal plans provide details on practices and procedures that enable hemp producers in their jurisdictions to operate according to their individual plans and in compliance with federal laws. To produce hemp, growers must be licensed or authorized under a state, tribe or USDA production program. The program a grower is licensed under depends on the location of the hemp growing facility. If a state or tribe has an approved plan or is in the process of developing a plan, growers must apply and be licensed or authorized under its hemp program. If a state or tribe does not have a plan and does not intend to have a plan, growers can apply for a license from USDA. https://vitaminretailer.com/usda-approves-first-state-and-tribal-hemp-production-plans/ ----------------- https://vitaminretailer.com/congress-punts-on-regulating-cbd-in-year-end-spending-bill/ Congress Punts on Regulating CBD in Year-End Spending Bill Nicholas Saraceno | January 2, 2020 On Dec. 16, Congress punted on legislation to regulate the growing CBD industry and set a safe level of daily consumption. The conference report directs funding for research, policy evaluation, market surveillance and enforcement discretion related to CBD and hemp. Unlike legislation, the conference report does not have the force of law. The Natural Products Association (NPA) supports legislation introduced by Congressman Jerry McNerney (D-CA) that would appropriate $100,000 for the FDA (U.S. Food and Drug Administration) to perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The legislation passed the House of Representatives in June of this year and follows the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe. “While providing funding for testing is a positive first step, unfortunately, today’s action falls short of what is needed to protect consumers. The future of the U.S. hemp industry and the farmers and producers who provide it are directly tied to smart regulations for CBD, which includes FDA establishing a safe level of consumption so consumers are protected,” said Daniel Fabricant, PhD, president and CEO of NPA. “We are concerned that if Congress fails to act next year then we could see another vaping-like public health crisis. While we are proud to be the only association to work on real legislation to regulate the CBD market, we are disappointed that Congress ultimately decided not to act. We appreciate the leadership of Congressman McNerney and look forward to working next year on a way to ensure consumers are protected.” For more information, visit www.npanational.org.

MARKETING DURING THE TRUMP BOOM

December 2019 Newsletter

Natural Product companies marketing regulated products during the Trump Boom require focus on your Brand and your Systems Integration.

The stock-market is reaching extraordinary heights (maybe even moving from Boom to Bubble... to the inevitable Bust?)  while Trump Tariffs are about to double the cost of products such as wines made in the EU. New trade deals, while not Free Trade, at least offer the promise of more trade. The economy, bolstered by low interest rates and by the regulatory reforms which are unleashing the spirit of enterprise, continues to grow.

So how do regulated Natural  Product Companies prepare themselves for the coming year's continuing boom?

One important step is to be aware of the trends in regulation.  I've analysed the FDA's Warning Letters for 2019 and summarized them in a previous newsletter.  You can review that here:  http://vitaminlawyerarchives.blogspot.com/2019/11/fda-warning-letters-specifications.html -- FDA, like all bureaucracies, acts in waves of interest and disinterest.  This past year both warning letters and comments during inspections suggest the written Specifications are a key to the agency's actions.  I've prepared a webinar about Specifications.  If you haven't seen it, I'll provide it to you at super discount.  For just $50 -- email me at ralph.fucetola@gmail.com with Specifications in the subject line.

Really benefiting from the Trump Boom requires going beyond being aware of regulation to being proactive in marketing.

I strongly recommend using the holiday season "down time" to prepare for the coming year by taking two powerful steps:  

1.  GET YOUR BRAND IN ORDER!  Your Brand is an asset!  It is your chief Intellectual Property.  A proper Company Branding Profile adds value to your company. Let me work with you to secure this asset.

2.  INTEGRATE YOUR CONTROL SYSTEMS! -- http://www.systemsprocessingintegration.com 

How do you do these essential tasks?  You contact me at ralph.fucetola@gmail.com 

Happy New Year!

Ralph