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

Hemp Rules Changing

Research Opportunity / Congress and Hemp View this email in your browser

RESEARCH OPPORTUNITY FOR YOUR PRODUCTS Dr. Robert Goodman and I have partnered with the Institute for Health Research to support research into natural products and their benefits. The Institute was founded in 1998 and sponsors an online Journal and an IRB system.  Institutional Review Board (IRB) oversight is an essential requirement for valid, publishable research. Dr. Goodman and I have also created a website to support product safety. We provide professional safety dossier services as well as California Proposition 65 compliance oversight. Site:  www.professionalsafetydossier.com A unique feature of our institutional review board structure is that Dr. Goodman and I guide the principal researcher in the development of a compliant Research Protocol and research description that meet standards required for the publication of the research. Dr. Goodman and I can schedule a limited number of introductory consultations to determine company needs. Please call me at (973.300.4594) to schedule time for you. Institute web site:  http://www.InHeRe.org Did Congress and Trump "Legalize" THC in Hemp? USDA Thinks So!     A client just emailed me that he noticed a competitor was no longer advertising its CBD Hemp product, but told its customers they can still order, by phone, but not over the Internet.    Here is what I replied:    This is a hot issue right now.  I can understand why a North Carolina company may be doing this, as they have restrictive state laws.    However, an Opinion by the USDA's Chief Counsel, just a few days ago, says that all that is changing.    Hemp, so long as it has less than .3% THC is no longer on the Controlled Dangerous Substances (CDS) Schedule!  There are no USDA restrictions on the percentage of CBDs.    Shortly no State (or Indian Tribe) will be able to prevent the interstate shipment of hemp. That means .3% THC hemp can be shipped to a state where THC "Marijuana" is legal and can be extracted to any desired potency (most legal THC vap products are over 95% THC). More about that here: https://cbdhempexperts.com/the-usda-legalized-thc-but-no-one-noticed/ https://www.ams.usda.gov/sites/default/files/HempExecSumandLegalOpinion.pdf

Keeping Up with Agency Regulations

November Vitamin Consultancy eNewsletter
Keeping Up with Changing Regulations

http://systemsprocessingintegration.com

[1] FDA on "Natural"

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm

"Although the FDA has not engaged in rulemaking to establish a formal definition for the term "natural," we do have a longstanding policy concerning the use of "natural" in human food labeling. The FDA has considered the term "natural" to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. However, this policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term "natural" should describe any nutritional or other health benefit."

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[2] FDA GMPs -- TEN YEARS OLD

The Natural Products Association is engaging in a tenth year review of the FDA dietary supplement GMPs.  Some valuable information is being developed.  One bottom-line point:  there is a new FDA emphasis on adequate Quality Assurance, which means specific staff members tasked with that role.  QA must sign off on all product batches and the person signing off must not be the person overseeing the production.  This applies to both manufacturers and to the label-owner who is expected to "be in a state of control."

For example, a recent warning letter to a label owner which was sent to me for review cited two violations of QA

"1. Your quality control operations did not include determining whether each finished batch conforms to established product specifications.

2. Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution."

Remember, these points were raised directly with the label-owner, not the manufacturer.  Bottom line:  Do you have Product Specifications? Do you have a person responsible for QA?  Is QA included in your SOPs.

My retainer clients are compliant. Are you?  www.SystemsProcessingIntegration.com

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[3] FDA Mandatory Food Recall Authority

November 5, 2018 - The U.S. Food and Drug Administration has released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).

"The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

https://www.federalregister.gov/documents/2018/11/06/2018-24247/guidance-questions-and-answers-regarding-mandatory-food-recalls

Comment: you may recall that Dr. Laibow and I fought hard in 2010 and 2011 to preserve Section 1011 of the food "safety" bill, a section that exempted DSHEA dietary supplements from the "enhanced" authority of the law.  We were denigrated when we worked through one late-nights weekend to get over 150,000 emails to the congressional conference committee, assuring that the exemption clause would stay in the law.  Now we see the results:  "mandatory" recalls based on mere "reasonable probability..." will become the norm for most foods, but not for DSHEA products!

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[4] TWO IMPORTANT STORIES YOU WON'T SEE ANYWHERE ELSE!

[1] What Happened to that Sore on My Chest?

I love to tell my list about success stories in the natural products market.  Dr. Walter Wolf is one of those geniuses that I've had the privilege to know.  He is an alchemist and naturopath.  His new product, Divine Wellness, is amazing!

Ethically harvested ovine placenta, CBD hemp oil and Nano Gold.  This is an immune boosting rejuvinater nutrient combination.

But I want to tell you about an "off label" use of the product.  A few months ago I noticed a "beauty mark" on my chest had begun to enlarge and become lesion-like. That was concerning so I started putting a varying combination of CBD hemp oil, apricot seed extract, tea tree oil and nano silver on it.  The growth stopped, but it remained.  Then, a few days ago, I begin putting Divine Wellness on the spot.

As the series of images show, it quickly puffed-up, became quite dark, and is now flaking-off.

Amazing!  Learn more about this natural product as a dietary supplement here:  https://www.divinewellnessclub.com/idevaffiliate/idevaffiliate.php?id=103  -- yes, you can join the affiliate program.

[2] Horizon v Jonuzi et al. This may be the most important lawsuit pending in the USA regarding Insurance Industry reimbursement for holistic and integrative treatments and therapies... including dietary supplements as Medical Foods.  This pending litigation can construe the Affordable Care Act to forbid insurance carrier discrimination against holistic and integrative practitioners, permitting proper insurance coding for such therapies.

From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why I've helped to set up a crowdfunding effort.

Read more here: http://www.inhere.org/2018/11/06/making-health-insurers-follow-the-rules/

Please read about it, and help our crowdfunding effort.  This case is quite important! 

Donate here:  https://fundly.com/support-natural-therapies

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And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers.  http://www.inhere.org/institutional-review-board/

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.

TIME RAN OUT

If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are wrong. The new rules 2 months ago. If you think your product does not get into California, think again. If you think no one will notice, remember that Prop 65 is enforced by a hoard of private lawyers looking to grab fees and penalties from your company.

More information on how Dr. Goodman and I can help:  www.ProfessionalSafetyDossier.com

Here is my article about all this, posted at Open Source Truth: http://www.opensourcetruth.com/proposition-65-california-ratchets-up-cancer-repro-harm-warning-rules/