This private blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
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.  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.
We do this by integrating several services that support your business structure.
 Standard Operating Procedures. This document tracks FDA concerns and includes 43 pages of procedures, formats and forms. Included:
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
 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.
 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:
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.
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:
CCDS (Company Core Data Sheet) for each product
FDA-required Structure and Function Claim Post-Market Notices
Commonly-used SOP forms
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.
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.
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.
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
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!
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.
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.”