Tuesday, November 5, 2019

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


Monday, November 4, 2019

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)].

Wednesday, October 23, 2019

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

Tuesday, October 8, 2019

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.

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

Thursday, September 5, 2019

Spam Trigger Terms List

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!
Twitter
Facebook
Website
Copyright © 2019 Vitamin

Wednesday, July 17, 2019

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
 
Copyright © 2019 Vitamin Consultancy, All rights reserved. 

Wednesday, June 12, 2019

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