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

Vitamin Consultancy Services - Discounted

http://www.SystemsProcessingIntegration.com

ALL THE VITAMIN CONSULTANCY SERVICES YOU NEED DISCOUNTED 1/3 FOR THE 2019 'SELLING SEASON'

 
GETTING READY FOR THE HOLIDAY SELLING SEASON?

Vitamin Consultancy Services - 2019

ALL PRICES REDUCED 33%

Some of These Services are with Third Parties

1. www.VitaminConsultancy.com

A. New Product Development Checklist

B. DSHEA, Medical Food and Cosmetic Labels Review

C. Sales Copy Review

D. GMP (Good Manufacturing Procedures) Manufacturer Audit

E. Standard Operating Procedures (SOPs) & Forms

   (1) - SOP Format (41 Pages)
   (2) - Specifications for Master Manufacturing Record Checklist
   (3) - Food Safety Plan Format
   (4) - Site Use Statement Format
   (5) - Waivers (Testimonial, Model, Clinical Trial)
   (6) - Complaint Form
   (7) - CCDS (Company Core Data Sheet) Form
   (8) - Manufacturer Contract Terms
   (9) - Standard Quality Control Contract, Manufacturer

2. www.ProfessionalSafetyDossier.com [with Robert Goodman, PhD]

A. Safety Data Sheet (SDS) Dossier
B. Cosmetic Safety Dossier
C. California Prop 65 Safety Dossier

3. www.SystemsProcessingIntegration.com

A. Operating Procedures Systems (OPS) -- SOP Documentation Private Website
B. Mission and Branding Dossier

4. www.InHeRe.org
Institute for Health Research [with Robert Goodman, PhD]

A. Institutional Review Board (IRB) Services for Clinical Trials
B. Protocol Development for Clinical and Research Studies, and Clinical Trials

5.  www.tinyurl.com/SOPcertification

A. SOP Certifications
B. GMP Certifications
C. PCQI (Preventive Controls Qualified Individual) Certifications
D. The Vitamin Consultancy Webinars
   -- 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
   -- Terms of Use
   -- Testamonials
   -- Therapy is Not Treatment

MY PLEDGE

ONE-THIRD OFF REGULAR PRICES

Until the End of 2019

The Vitamin Consultancy Archive Link

http://vitaminlawyerarchives.blogspot.com/

FDA Warning Letters: Specifications

Sample 2019 FDA Warning Letters. It's About Specifications! As we prepare for the end of the year, it's always good to look back at what issues have been hot button issues for FDA Warning Letters.  Knowing is the first step toward being prepared. There were over three thousand warning letters so far this year.  Many, if not most, are about tobacco or vapping.  But, DSHEA products were, as always, represented.  So were a few cosmetic products, but, I did not notice any warnings involving Medical Foods. I've picked out just a few DSHEA examples which appear typical to me. This year's themes include Specifications, not just for the Product but also for the Components and Label.  Yes, I've developed a new SOP (#25) covering Specifications for Labeling and Packaging. Also, have you seen my Specifications -- Testing -- Samples Webinar?  http://www.vitaminconsultancy.com/webinars.php The sample Warnings are below. After taking a look, review the services The Vitamin Consultancy offers and remember that we are running a 1/3-off year's end sale for all our services.  The services list is here:   https://vitaminlawyerarchives.blogspot.com/2019/11/vitamin-consultancy-services-discounted.html Do you have all of the Specifications the FDA expects to see? If not, it's time to talk to me... Call: 973.300.4594 or email me at ralph.fucetola@gmail.com Here are the Warning Samples (bold added) Revital U International, LLC Office of Human and Animal Food Operations West Division 3 CGMP/Dietary Supplement/Adulterated https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/revital-u-international-llc-585256-10162019 The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... These violations cause your dietary supplement products to be adulterated ... in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You failed to establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement... ------- Paisley Farms, LLC dba Paisley Farm & Crafts Division of Human and Animal Food Operations East V CGMP/Dietary Supplement/Adulterated/Misbranded   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/paisley-farms-llc-dba-paisley-farm-crafts-575934-06042019 The United States Food and Drug Administration (FDA) inspected your facility ... During the inspection we collected product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder products.  Following the inspection... we reviewed your website ...r and your Facebook page...  Your website links directly to your Facebook page, and your Facebook page also links directly to your website, where you take orders for the products ... The claims on your Facebook page establish that the products are drugs ... because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Additionally, the product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder do not bear a statement of identity as a dietary supplement, a Supplement Facts panel, or other information suggesting that the product is intended to supplement the diet. ------------- Herbal Healer Academy, Inc. Division of Human and Animal Food Operations West III Unapproved New Drugs/Misbranded   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/herbal-healer-academy-inc-570957-09122019 FDA reviewed your website ...and has determined that you take orders there for the products HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA Herbalgesic, HHA CoQ10 with Hawthorn Berry, HHA Glucosamine & Chondroitin, Angiostop, HHA Beta Glucans, HHA Prostate Support and The Healing Formula Wound Care. In addition, FDA reviewed your product catalog following an inspection of your facility .... The claims on your website and within your product catalog establish that ... products are drugs ... because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. “Many people have reported relief from crippling arthritis in just 30 days using this product…” “Colloidal Silver has successfully controlled: … blood parasites, boils, candida, chronic fatigue syndrome (CFS), colitis, herpes, lupus, malaria, viral and fungal infections, rheumatoid arthritis, ringworm, shingles, yeast infections…” ---------- Ibitta Enterprises, Inc. Division of Human and Animal Food Operations West V CGMP/Dietary Supplement/Adulterated/Misbranded https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ibitta-enterprises-inc-584337-09272019 The significant violations documented during the inspection include, but are not limited to, the following: 1. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplements... Specifically, you have not established such specifications for the dietary supplements you manufacture. Once you have established the required finished product specifications, you must verify that the specifications are met ..., and you must make and keep records of such specifications and the verification thereof ... 2. You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, including identity specifications and specifications necessary to ensure the purity, strength, and composition of dietary supplements manufactured using the components... Specifically, you failed to establish identity specifications for most of the components you use in your dietary supplements, and you have not established any written specifications to ensure the purity, strength, and composition of your dietary supplements manufactured using the components. 3. You failed to establish specifications for the dietary supplement labels (label specifications)... Specifically, you have no written label specifications for your finished dietary supplement products. ----------- Alternative Laboratories Office of Human and Animal Food Operations East Division IV Dietary Supplement/Adulterated   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alternative-laboratories-586947-09182019 Our review of your product labels revealed that you declared the ingredient 2-amino-5 methylheptane and Octodrine as a dietary ingredient in several of the dietary supplements you manufacture, including Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa. The ingredients 2-amino-5 methylheptane and Octodrine are also called, among other names, 1,5-DMHA, 2-amino-6-methylheptane, 2-aminoisoheptane, 1,5-Dimethylhexylamine, 6- Amino-2-methylheptane, Amidrine, 2-Metil-6-amino-eptano, and 2-Isooctyl amine, and will be referred to hereinafter as DMHA. The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)]. Given that you have declared DMHA as a dietary ingredient in the labeling of your products, we assume you have a basis to conclude that DMHA is a “dietary ingredient” under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. If you have a basis to conclude that DMHA is a “dietary ingredient,” it would also be a “new dietary ingredient” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the Act [21 U.S.C. § 350b(d)].

Vitamin Consultancy Services

Special October Newsletter This Issue: Archive Link, STS Webinar and Discounted VC Services! STS Webinar

My STS webinar focuses on three areas from Part IX of the DSHEA GMPs: Specifications, Testing and Samples. Webinar video (27 minutes), ebook and the New Product checklist included.  The Vitamin Consultancy regular retainer clients have received access to this important webinar.  For all other clients, we have a special (May only) introductory price: Now just $69 for full access, was $99.  Just email me at ralph.fucetola@gmail.com with STS in the subject line and I'll send you a PayPal money request to give you access.

The Vitamin Consultancy Archive Link
http://vitaminlawyerarchives.blogspot.com/

ALL THE VITAMIN CONSULTANCY SERVICES YOU NEED
DISCOUNTED 1/3 FOR THE 'SELLING SEASON'

Vitamin Consultancy Services - 2019

Some of These Services are with Third Parties

1. www.VitaminConsultancy.com

A. New Product Development Checklist
B. DSHEA, Medical Food and Cosmetic Labels Review
C. Sales Copy Review
D. GMP (Good Manufacturing Procedures) Manufacturer Review
E. Standard Operating Procedures (SOPs) & Forms
   (1) - SOP Format (41 Pages)
   (2) - Specifications for Master Manufacturing Record Checklist
   (3) - Food Safety Plan Format
   (4) - Site Use Statement Format
   (5) - Waivers (Testimonial, Model, Clinical Trial)
   (6) - Complaint Form
   (7) - CCDS (Company Core Data Sheet) Form
   (8) - Manufacturer Contract Terms
   (9) - Standard Quality Control Contract, Manufacturer

2. www.ProfessionalSafetyDossier.com [with Robert Goodman, PhD]

A. Safety Data Sheet (SDS) Dossier
B. Cosmetic Safety Dossier
C. California Prop 65 Safety Dossier

3. www.SystemsProcessingIntegration.com

A. Operating Procedures Systems (OPS) -- SOP Documentation Private Website
B. Mission and Branding Dossier

4. www.InHeRe.org
Institute for Health Research [with Robert Goodman, PhD]

A. Institutional Review Board (IRB) Services for Clinical Trials
B. Protocol Development for Clinical and Research Studies, and Clinical Trials

5.  www.tinyurl.com/SOPcertification

A. SOP Certifications
B. GMP Certifications
C. PCQI (Preventive Controls Qualified Individual) Certifications

6. http://www.vitaminconsultancy.com/webinars.php 

The Vitamin Consultancy Webinars

   -- 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
   -- Terms of Use
   -- Testimonials
   -- Therapy is Not Treatment

Safety Data Sheets

October 2019 Vitamin Consultancy Newsletter  Informed Consent Podcast I presented a paper on Informed Consent to the Libertarian Scholars Conference held at Kings College in Manhattan last weekend.  Sharry Edwards, MEd. interviewed me on the presentation for her podcast, so here is the hour-long discussion of the paper, your right of Informed Consent and the powerful forces that want to abrogate your Right. https://www.youtube.com/watch?v=fgaOR11PB_A SAFETY DATA SHEETS WHAT YOU NEED TO KNOW 29 CFR § 1910.1200 - Hazard Communication is the Federal version of California's Proposition 65.  Learn more about that here:  www.ProfessionalSafetyDossier.com  "The purpose of this section is to ensure that the hazards of all chemicals produced or imported are classified, and that information concerning the classified hazards is transmitted to employers and employees. The requirements of this section are intended to be consistent with the provisions of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Revision 3. The transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, safety data sheets and employee training." If you or your contract manufacturer import any chemicals (which includes natural sourced ingredients) you must be able to product an SDS for each during any FDA inspection. Dr. Bob Goodman and I are available to consult with your Company regarding its SDS needs. Just send me an email with SDS in the subject line:  ralph.fucetola@usa.net

SDS Outline 29 CFR 1910.1200 (Appendix D) provides guidance on the contents of the SDS Section 1—Identification:  Product identifier, manufacturer or distributor name, address, phone number, emergency phone number, recommended use, and restrictions on use. Section 2—Hazard(s) identification:  All hazards regarding the chemical and required label elements. Section 3—Composition/Information on ingredients:  Information on chemical ingredients and trade secret claims. Section 4—First-aid measures:  Required first aid treatment for exposure to a chemical and the symptoms (immediate or delayed) of exposure. Section 5—Fire-fighting measures:  The techniques and equipment recommended for extinguishing a fire involving the chemical and hazards that may be created during combustion. Section 6—Accidental release measures:  Steps to take in the event of a spill or release involving the chemical.  Includes:  emergency procedures, protective equipment and proper methods of containment and cleanup. Section 7—Handling and storage:  Precautions for safe handling and storage, including incompatibilities. Section 8—Exposure controls/Personal protection:  OSHA’s permissible exposure limits (PELs), threshold limit values (TLVs), appropriate engineering controls, and personal protective equipment (PPE). Section 9—Physical and chemical properties:  The chemical’s characteristics. Section 10—Stability and reactivity:  Chemical stability and possible hazardous reactions. Section 11—Toxicological information:  Routes of exposure (inhalation, ingestion, or absorption contact), symptoms, acute and chronic effects, and numerical measures of toxicity. Section 12—Ecological information:  How the chemical might affect the environment and the duration of the effect. Section 13—Disposal considerations—describes safe handling of wastes and methods of disposal, including the disposal of any contaminated packaging. Section 14—Transportation information—includes packing, marking, and labeling requirements for hazardous chemical shipments. Section 15—Regulatory information—indicates regulations that apply to chemical. Section 16—Other information—includes date of preparation or last revision. Sections 1-11 and 16 - required; sections 12-15 - not required. https://www.law.cornell.edu/cfr/text/29/1910.1200