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

Three New Vitamin Consultancy Videos

Three New Videos Updating Regulations View this email in your browser

3 Vitamin Consultancy Videos My summer blockbusters will help preserve your natural product business.  Three videos -- two of which are my gift to you for being on this email list -- are Continuing Education (CEs) for the natural products industry. The first features Robert Goodman PhD and me talking about our Cosmetic Safety Dossier service. In both the US and the EU third party safety certifications are an important part of successful cosmetics marketing. You can see the video on the CSD web site; click here:   The second is my explanation of the new OPS -- the Operating Procedures System -- which makes it simple to use your company's SOPs to actually run the business efficiently and in compliance with FDA requirements. This training video will be added to the Vitamin Consultancy Webinar system, but here it is for you now, gratis. Click here:   The third is my new Webinar on Quality Control The 26 slide presentation covers both FDA QC requirements and the qualifications needed for your QC Manager. Don't have a QCM? You need to watch this video. If you are the person who acts as QCM in your company, you need to watch it even moreso! Please email me for access: ralph.fucetola@usa.net with QC Webinar in the subject line. Have a great balance of the summer... winter holiday marketing starts soon! Regards, ralph ... Ralph Fucetola JD

Personal Importation / Antioxidant Claims / Cosmetic Dossiers...

VITAMIN CONSULTANCY UPDATE eMEMO

June 16, 2015

Memorandum from Ralph Fucetola JD

To: Vitamin Consultancy Contact List: Personal Importation  / Antioxidant Claims / Cosmetic Dossiers...

But first: With Rima Laibow MD, Jim Turner JD and Larry Becraft JD's help I just filed a formal Petition with FDA regarding Informed Consent. Read and support here:

http://tinyurl.com/InformedConsentPetition

[1] Personal Importation... wrote about that years ago here: http://www.lifespirit.org/perimport.html

Recently prepared a Certification Format for personal importation. That format is at the bottom of this email.

[2] Many vitamin purveyors want to make Antioxidant Claims about their products. Free-radical quenching nutrients are of great significance in achieving and maintaining a healthy status...

So it shouldn't surprise us that FDA has restrictive regulations on using the term "Antioxidant" -- restrictions of which very few in the industry are aware.

Here is the central relevant regulation language [there are other requirements which I can discuss with you if you are interested]:

"(g) Nutrient content claims using the term "antioxidant." A nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when: (1) An RDI has been established for each of the nutrients; (2) The nutrients that are the subject of the claim have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions..."

Primarily, the restriction that often causes issues for herbal antioxidants and other nutrients is that they do not have a RDI -- Recommended Daily Intake -- and thus cannot qualify under the Regulation. So what is the work-around?

Since the Vitamin Consultancy is here to make sure you have a way around bureaucratic restrictions, this is my suggestion for an alternative rubric to express your products' antioxidant claims if they do not qualify under the Regulation:

"Supports Normal Antioxidant Function" -- SNAF.

Of course, "the devil is in the details" and I'm here to work with you on those. Valid substantiation is required. Just let me know how I can help.

[3] If you are on this elist, you are most likely involved in the Natural Products market. And, if so, a number of you have, in addition to dietary supplement products, some cosmetic products.

And... if so... have you considered marketing your natural cosmetic products in the European Union? The EU Cosmetic Dossier requirements are similar to the FDA's Section 740 safety dossier requirements.

These are special rules that easily let you do just that!

Rima Laibow, MD and Robert Goodman, PhD have teamed-up with me to provide the required third-party Cosmetic Dossier services for you.

What is that?

Take a look at the short slide presentation here:

http://vitaminconsultancycertification.weebly.com/eu-cosmetic-dossiers.html

You will be pleasantly surprised.

[3] And remember that my full SOP Training Webinar System is available for your use: www.SOPcertification.com. Does your manufacturing facility need a Virtual Audit? More about that here: www.RegulatoryComplianceNetwork.com.


If you need me, you know how to reach me... 973.300.4594

Regards,

Ralph

Petition for Regulatory Discretion
Certification of Personal Importation Pursuant to
FDA RPM Ch. 9-71, Coverage of Personal Importation

[Name], [Address], [Phone], [eMail], as though sworn under Oath, states:

1.     I am a resident of [State] and a United States citizen.
2.     I was diagnosed by [Name], MD with [Medical Condition], Stage [#]. My treating physician is [Name], MD.
3.     I have researched my options and have made the Informed Consent decision to engage in a course of therapy with [Name], a remedy not available in the United States.
4.     I have personally ordered a 90 day supply of same for my personal use.
5.     The remedy is intended for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means, and it is not considered to represent an unreasonable risk.
6.     I am a person who has made my own arrangements for obtaining an unapproved drug from foreign sources.
7.     To the best of my knowledge this remedy has not been commercially promoted in the United States.
8.     I therefore request that FDA exercise discretion and permit this personal importation, Order No. ________________________.

I certify that the above statements made by me are true to the best of my knowledge and belief. I am aware I am subject to punishment as for perjury if any are willfully false.

[Date]

                                                                   ___________________________
                                                                   [Name]

[The Certification to be included by the Shipper in the shipment.]
Prepared by: Ralph Fucetola JD - www.vitaminconsultancy.com

08/16/12 - Daily Value and “Excellent Source” Claims; Your PAD App!

Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
 
[1] Daily Value and “Excellent Source” Claims
[2] Yes, You do Need Clinical Trials…
[3] EU Cosmetics Dossier
[4] Vitamin Lawyer Connections: All the Links You Need!
--------------------------
[1] Daily Value and Excellent Source Claims
 
States FDA in one warning letter: 
 
“Nutrient content claims that use the defined terms “rich in,” “excellent source,” or “high,” (“superb source” is an unauthorized synonym for “excellent source”) may be used in the labeling of a food only if the food contains 20 percent or more of the daily value (DV) of that nutrient per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)].  Such claims may not be made about a nutrient for which there is no established DV…”
 
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm239410.htm
 

---

---

[2] Yes, you do need clinical trials! Further Services You Need!

Several clients are raising funds to invest in Clinical Trials or Clinical Studies; I was asked to prepare a “Comfort Letter” for the clients to use with their potential investors. If you would like a copy addressed to your Company, to raise the funds you need to invest to stay in the market, please email me!
 
The Red Letter warnings I sent you in recent months from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors?  I told you the 4 essential steps you must take in the last issue of the VL Update. Here, I add estimates of what these essential steps will cost your company. You need to budget now and start to do what you can to be prepared. The FDA has already dramatically increased inspections, without those new bureaucrats!

www.NaturalClinicalTrials.net 

WHAT SHOULD YOU DO? Contact me NOW!  973.300.4594

The longer you put off addressing any of the above issues,
the more at-risk is your company!

---

[3] New Service for EU Cosmetics Dossiers

You can sell in the EU without prior governmental approval, if you have a Dossier from NCT! Please take a look at our new Webinar linked from this web page: http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php.
 
Announcement: For information about the SEC-filed Fund for Natural Solutions: 

 wwwFundforNaturalSolutions.org (offering only by Private Placement Memorandum, available upon request: just email me at ralph.fucetola@usa.net with “Fund” in the subject line). Our first proposed investment: an off-shore (Panama/Hong Kong) compounding pharmacy. Doing good while doing well… think about the possibilities!

---

[4] Vitamin Lawyer Connections

Vitamin Lawyer Connections…
Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be.
My Skype handle is: vitaminlawyer
Our new affiliation site: www.naturalhealthoptions.net
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesllc.com – Airing on: www.telostv.com
Follow me on Twitter - www.twitter.com/healthfreedomus  
ralph …
Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org

Click here to unsubscribe from the Health Freedom Action eAlerts: http://www.demaction.org/dia/organizations/healthfreedomusa/unsubscribe.jsp

Click here to manage your subscription: http://salsa.democracyinaction.org/o/568/profile/login.jsp?redirect=%2Fo%2F568%2Fprofile%2Findex.jsp

We respect your right to privacy. View our policy.