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

11/23/11 - Social Network Marketing

Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
 
[1] Dr. Rima, Gen. Bert & I will be back in Houston December 9, 2011
[2] SEO and Social Networking: Your Most Powerful Marketing Yet!
[3] Yes, You do Need Clinical Trials…
[4] Vitamin Lawyer Connections
 
New Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from us! Please take a look at our new Webinar linked from this web page:

http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php

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[1] I'll be joining Dr. Rima & Gen. Bert in Houston 12.09.11 ...

Here's Your Chance to Meet With Dr. Rima & Gen. Bert - In Person! Sushi & Wine... and our Valley of the Moon All Natural Beyond Organic Coffee™!

We're Celebrating the opening of the Fund for Natural Solutions office in The Woodlands, TX!
Media Release and New Video:http://tinyurl.com/Houston120911

Contact me if you want to attend in person or online.ralph.fucetola@usa.net

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[2]   SEO and Social Networking: Your Most Powerful Marketing Yet!

Website Online Marketing Services Available For Your Business

I know you are ready to take your business to the next level using SEO, SEM, Social Networking, and other online marketing techniques for your website tailored to your business’s requirements.  I know you are looking to dramatically increase your client, patient, or customer base and profits in an exponential way!

I urge you to call is Virtually Local.  Virtually Local, a premier Internet Marketing business, is owned and operated by Lynda Leibowitz.  She is also the author of “Lynda A Leibowitz’s Guide To Marketing Your Business: Harness the Power of the Internet to Boost Your Profits”.*  

She is one of the good folk who have helped Natural Solutions achieve the high Google ranking and strong social networking that put it among the top fifteen thousand web sites world-wide.

Affordable with real ROI. What choice do you have?

Visit Virtually Local today or call (973)498-8497.

Direct URL: http://www.virtually-local.com

*Now being sold on Amazon.com

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[3] Yes, you do need clinical trials!
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!
 
What do you need to survive an FDA inspection? I’ve told you several times!

1. Standard Operating Procedures – in place and up-to-date -from $500. The SOP document not only satisfies FDA, but also helps you organize your business!
2. Product Substantiation Notebook – in place and up-to-date –from $500 plus your research time; this Notebook is a MUST if you get inspected! Part of the Notebook includes copies of the Structure and Function Claims Notices companies are required to file with the FDA within 30 days of marketing any claim. The cost for these notices is from $340.
3. Copy-writers who know how to avoid Red Flag claims & Illegal Testimonials! My webinar on these issues is inexpensive. $99 for the archived CAM Webinar; a private copywriter webinar just for your company copywriters will cost above $500 (the webinar includes an eBook specially written for your company).
4. A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients – This can cost up to several hundred thousand dollars. NCT offers a Minimal Clinical Trial from $35,000.

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!

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[4] Vitamin Lawyer Connections
Archived Cautions for CAM Wellness Practices
http://www.naturalhealthoptions.net/LifeSpiritWebinars.php
"Do you have a CAM “Alternative” health practice? Do you provide nutrients, remedies or health related items to clients?
Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients?
Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices.
I am known as The Vitamin Lawyer, because much of my 36 year legal practice centered around helping people in CAM practices, nutrient purveyors and advanced healthcare teachers. Today I am a Trustee of Natural Solutions Foundation. I can keep you out of trouble and operating smoothly so you can fulfill your mission to help others…"
This $99 PEL Webinar runs about an hour through 32 slides. It includes an 18 page eBook of information and forms all of which would cost over $500 if one on one. This is a Natural Solutions Foundation Benefit Webinar."

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Vitamin Lawyer Connections…
Notice of Fee Increase: 2011 Rates: $340 standard and $285 discounted.
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.powerpicturesinc.net/store.html
Follow me on Twitter - www.twitter.com/healthfreedomus  

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Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org
If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

06/28/07 - Randomized Clinical Trials; cGMPs posted

VLUeM – 06.28.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. RCT (Randomized Clinical Trials) and nutrients
2. New cGMPs now available on net
3. http://www.vitaminlawyerhealthfreedom.blogspot.com
4. CRUSH media release: Silver Safety Standard
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1. RCT (Randomized Clinical Trials) and Nutrients

This article by Dr. Melton is cogent and worth reading. The article goes to the heart of the coming cGMPs – how will you substantiate the claims you make about your products? How will you prove the identity and quality of the ingredients? If you have the time to think about what your company will be doing in two years when the cGMPs become effective for small companies, this is something you need to think about… and, yes, you do need to start thinking now…

Clinical trials - gold standard or white elephant?

25/06/2007 - Randomised clinical trials are the ultimate. Forget what the observational studies tell us, if the RCT gives us an answer it must be the final word, right? Wrong.

The value of such trials for the food industry is undeniable, but too often nutrients are pulled out of context, following the same methodology as used for the testing of drugs.

But let's not forget that by following the drug model we are supplementing the diet with one or two nutrients, each at a single dose, for a set period of time. Can a time-constrained randomised trial really capture a lifetime of consumption with respect to chronic disease?

Randomised clinical trials work by randomly assigning a group of volunteers to receive an active compound, be it a drug or nutrient(s), or a non-active comparison, be it an inactive form of the active compound or a placebo. Observational studies, as the name suggests, observe a population and relate dietary intakes of food and nutrients to the occurrence of disease.

We need to consider the science as a whole and not blinker ourselves with results of one big clinical trial, regardless of how much money it costs and what universities were involved.

For food items that do not normally form part of the usual food chain, randomised clinical trials are the best of the best because such compounds can be tested and retested successfully.

Phytosterols, probiotics, or botanical supplements, for example, fit into this category.
Indeed, clinical trials on phytosterols have shown time and again that daily consumption of 1.5 to 3 grams of phytosterols/-stanols can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease.

Studies looking at how these results transfer into real free-living populations have backed up the clinical trials, showing a stabilisation of cholesterol levels in certain populations.

So we know the benefit of clinical trials. But when we start using this approach for vitamins, minerals, antioxidants and other nutrients, we come a little unstuck.

Some may say that I'm over-reacting, but let's just look at the report published in the New Scientist magazine that slammed antioxidant supplements as myth.

Despite a vast body of observational/ epidemiological studies linking an increased dietary intake of antioxidants from fruits and vegetables to reduced risks of a range of disease, including cancer, cardiovascular disease and diabetes, when such antioxidants have been extracted and put into supplements, the results, according to RCTs, do not produce the same benefits and may even be harmful.

So the author of the article, Dr. Lisa Melton from the London-based registered charity, the Novartis Foundation, concluded that antioxidant supplements are too good to be true.

Is this really the answer or is it due to poor study design? Would a two-year trial of vitamin E, let's say, really produce a reduction in the risk of a chronic disease?

To illustrate this point further, we only need to go back to last year's Women's Health Initiative (WHI) trial that followed 18,176 post-menopausal women taking calcium (1000 mg) and vitamin D (400 IU) supplements. A similar population (N=18,106) was given a placebo. The subjects were followed for about seven years and the researchers reported that the supplements 'had no effect' on the risk of colorectal cancer.

None of the women had the cancer at the start of the study and colorectal cancer has a long latency period of 10 to 20 years, which begs the question - could we really have expected to see an effect?

We also need to remember that nutrients often work in synergy with one another and exert effects on multiple body tissues, unlike pharmaceuticals.

Additionally, many randomised clinical trials look at the effect of nutrients in diseased populations. Surely the damage of a lifetime's poor nutrition has already been done. When we obtain negative or null results from such trials, should we really be surprised?

The power of nutrients is in the prevention, not cure, of disease.

So what should we do? I don't pretend to have any answers. These are for ladies and gentlemen with infinitely bigger brains than me.

Realistically, there are no viable alternatives out there at present. Randomisation is the best way of limiting bias that creeps into every study, and controlling, specifically with placebo, is the best way to make comparisons.

For those times where randomised trials clearly aren't the best option, then we probably need to look at the observational studies and mechanistic studies in greater depth, and place more value on them.

The research community as a whole must work together to re-evaluate how to get the most from research into nutrition. Lots of different types of studies are out there. Let's make the most of what we already have.

Stephen Daniells is the Food Science Reporter for NutraIngredients.com and FoodNavigator.com. He has a PhD in Chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.

If you would like to comment on this article please contact stephen.daniells'at'decisionnews.com
http://www.nutraingredients.com/news/ng.asp?n=77611&m=1NIE625&c=jegwylrviswtnqa

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2. FDA publishes Current Good Manufacturing Practices for Dietary Supplements

I’m reading them, but so can you, at: http://www.cfsan.fda.gov/~lrd/fr07625a.html (467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).

Here are some comments by FDA, from the commentary preceding the new rule, that tell us a lot about where the present administration of FDA is taking us: “…we disagree with the comments asserting dietary supplements have a track record of safety such that dietary supplement CGMP requirements are unnecessary. Section 402(g) of the act does not require us to establish a ‘bad’ track record of safety in the manufacture of dietary supplements before we may issue a dietary supplement CGMP rule. Furthermore, we disagree with the comments comparing dietary supplement safety to drug safety; there are different statutory requirements, different regulatory requirements, and different safety evaluations for dietary supplements and drugs.”

We can hope there will be a change of Agency attitude when the Administration changes in about a year and a half; especially if the good doctor from Texas replaces the current Texan occupying the White House. I’ll provide more tidbits as I read the materials.

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3. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com

I just posted a link there to an 8 minute presentation I taped for Natural Solutions Foundation, for use with health-friendly delegates at next week’s Codex Commission meeting in Rome.

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4. CRUSH Silver Safety Standard

The Committee on the Responsible Use of Silver in Health (of which I am a member) is releasing the final version of its Silver Safety Standard (The “12 for 25 Rule). The media release will be posted on PRWeb shortly and can be seen at www.silverfacts.com or on my Blog.