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

The Vitamin Consultancy eLetter http://vitaminlawyerarchives.blogspot.com/ View this email in your browser

September 2019 Newsletter

SPAM TRIGGER TERMS LIST One of the companies I work with is The Right List.  These eblast professionals have provided excellent services to Vitamin Consultancy clients and I have no hesitancy in recommending them  Here is their Spam Terms List.  This list differs from my Vitamin Consultancy "Forbidden Words" list in that it covers a broad range of words that will get your social media postings or eblasts labeled -- and suppressed -- as "spam" while my list focuses on terms that FDA considers "Red Flag" for natural products companies.  So here is The Right List's list. From:   The Right List -- http://therightlist.com/ THE WORST SPAM FILTER TRIGGERS $$$ 100% free Ad Affordable Amazing stuff Apply now Auto email removal Billion Cash bonus Cheap Collect child support Compare rates Compete for your business Credit Credit bureaus Dig up dirt on friends Double your income Earn $ Earn extra cash Eliminate debt Email marketing Explode your business Extra income F r e e Fast cash Financial freedom Financially independent Free Free gift Free grant money Free info Free installation Free investment Free leads Free membership Free offer Free preview Guarantee ‘Hidden’ assets Home based Homebased business Income from home Increase sales Increase traffic Increase your sales Incredible deal Info you requested Information you requested Internet market Leave Limited time offer Make $ Mortgage Rates Multi level marketing No investment Obligation Online marketing Opportunity Order Now Prices Promise you Refinance Remove Reverses aging Save $ Search engine listings Serious cash Stock disclaimer statement Stop snoring Thousands Unsubscribe Web traffic Weight loss SPAM FILTER TRIGGERS 4U Accept credit cards Acceptance Accordingly Act now! Don’t hesitate! Additional income Addresses on CD All natural Amazing Apply Online As seen on Auto email removal Avoid bankruptcy Be amazed Be your own boss Being a member Beneficiary Beverage Big bucks Bill 1618 Billing address Billion dollars Brand new pager Bulk email Buy direct Buying judgments Cable converter Call free Call now Calling creditors Cancel at any time Cannot be combined with any other offer Can’t live without Cash bonus Cashcashcash Casino Cell phone cancer scam Cents on the dollar Certified Check or money order Click below Click here link Click to remove Click to remove mailto Compare rates Compete for your business Confidentially on all orders Congratulations Consolidate debt and credit Copy accurately Copy DVDs Credit bureaus Credit card offers Cures baldness Dainty Dear email Dear friend Dear somebody Diagnostics Different reply to Dig up dirt on friends Direct email Direct marketing Discusses search engine listings Do it today Don’t delete Dormant Drastically reduced Earn per week Easy terms Eliminate bad credit Email harvest Email marketing Expect to earn Fantastic deal Fast Viagra delivery Financial freedom Find out anything For free For instant access For just $ (some amt) Free access Free cell phone Free consultation Free DVD Free grant money Free hosting Free installation Free investment Free leads Free membership Free money Free offer Free preview Free priority mail Free quote Free sample Free trial Free website Full refund get it now Get paid Get started now Gift certificate Great offer Guarantee Have you been turned down? Hidden assets Home employment Human growth hormone If only it were that easy In accordance with laws Increase sales Increase traffic Insurance Investment decision It’s effective Join millions of Americans  Laser printer Limited time only Long distance phone offer Lose weight spam Lower interest rates Lower monthly payment Lowest price Luxury car Mail in order form Maintained Marketing solutions Mass email Medium Meet singles Member stuff Message contains disclaimer MLM Money back Money making Month trial offer More Internet traffic Mortgage rates Multi level marketing Name brand New customers only New domain extensions Nigerian No age restrictions No catch No claim forms No cost No credit check No disappointment No experience No fees No gimmick No inventory No investment No medical exams No middleman No obligation No purchase necessary No questions asked No selling No strings attached Not intended Off shore Offer expires Offers coupon Offers extra cash Offers free (often stolen) passwords Once in lifetime One hundred percent free One hundred percent guaranteed One time mailing Online biz opportunity Online pharmacy Only $  Opportunity Opt in Order now Order status Orders shipped by priority mail Organization Outstanding values Paste Pennies a day Percent Perpetual Please read Potential earnings Presently Print form signature Print out and fax Produced and sent out Profits Promise you …! Pure profit Real thing Reciprocal Refinance home Removal instructions “Remove” Remove subject Removes wrinkles Reply remove subject Requires initial investment Reserves the right Reverses aging Risk free Round the world S 1618 Safeguard notice Satisfaction guaranteed Save $ Save big money Save up to Score with babes Section 301 Sincerely Somebody Special promotion Statements Stop snoring Urgent Provided Privately to The Vitamin Consultancy Newsletter List www.VitaminConsultancy.com 5 September 2019   Ralph Fucetola JD PRESENTING AT THE LIBERTARIAN SCHOLARS CONFERENCE Paper: Informed Consent SEPTEMBER 28, 2019 - New York City https://mises.org/events/libertarian-scholars-conference-2019   Let Me Help Your Company Organize for Success!

Copyright © 2019 Vitamin

Quality Control Contract / Scholars Conference

Quality Control Contract / Claims Research Scholar's Conference Paper View this email in your browser

July 2019 Vitamin Consultancy Newsletter

Ralph Fucetola JD Presenting at the Libertarian Scholars Conference    I will be presenting a paper at the newly revived Libertarian Scholars Conference this September.  The LSC was a regular feature of the libertarian world during the 1970s - 1990s, held at least annually in New York City or Princeton.  Mises Institute has revived the tradition with a conference to be held in New York City.  Let me know if you are planning on attending.  My paper will be on Informed Consent.   YOUR COMPANY NEEDS A QC CONTRACT FOR YOUR CONTRACT MANUFACTURER I've recently developed a 3-page Quality Control Contract for your contract manufacturer, to go along with the ten paragraph GMP terms that can be attached to your Purchase Orders to your contract manufacturer (found in the Appendix to my standard SOPs), so your company can be "in a state of control" of the process, as required by the FDA.  If you need this contract format please contact me.  I will prepare the format for your company for a half hour fee; retainer clients, just ask and it shall be done.   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   www.SystemsProcessingIntegration.com

Copyright © 2019 Vitamin Consultancy, All rights reserved.

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

Specifications, Testing and Samples Webinar

May 2019 Newsletter

This Issue:  New STS Webinar and New Product Checklist

The Vitamin Consultancy

STS Webinar My new 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 will automatically receive access to this important webinar.  For all other clients, we have a special (April only) introductory price:  $99 for full access.  Just email me at ralph.fucetola@gmail.com with STS in the subject line and I'll send you a PayPal money request and give you access.   NEW PRODUCT CHECKLIST The essential elements in my new webinar are summarized in the New Product Checklist, consisting of 6 pages. The checklist takes you from the idea for a new product through all the specification, testing and regulatory requirements for a new DSHEA product. The Vitamin Consultancy regular retainer clients have received the checklist. The Checklist is available to all others for a nominal fee of $25. If you want a copy, please email me at ralph.fucetola@gmail.com with "Checklist" in the subject line and I will send you a PayPal invoice.

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 started 6 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/