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
 


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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
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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 

Wednesday, May 15, 2019

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/

Friday, February 15, 2019

February Vitamin Consultancy Newsletter STS WEBINAR


[1] FDA Takes Action Against Products Claiming to Treat Disease

[2] NEW WEBINAR: When must you have batches of your product tested?


------------

[1] The journalists at Vitamin Retailer have been investigating FDA's latest actions and report "On Feb. 11, the U.S. Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions." https://vitaminretailer.com/fda-takes-action-against-products-claiming-to-treat-disease-seeks-to-strengthen-oversight/

Looking more closely at the warning letters and actions, we find that they are mostly about the "claims" being made, not the ingredients (though some disreputable companies have adulterated their vitamin products with unapproved drugs).  The lesson:  be careful what you claim.  Be very careful about the words you use to describe those claims!  For example, one of the valid nutrient ingredients mentioned was Alpha GPC (L-Alpha glycerophosphocholine) --not because it is a "drug" -- but because the claims made were about treating cognitive impairment medical conditions.

The article reports that FDA Commissioner Scott Gottlieb, MD said, “Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful
supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”

Bottom Line:  pay attention to the words you use to state your claims... and have the Vitamin Consultancy review them before you communicate to the public!

------

STS WEBINAR & EBOOK

[2] Here is a Practice Question I often receive from my Vitamin Consultancy clients.

Does FDA require that the Label Owner of a DSHEA Dietary Supplement have finished product batch-tested [in addition to verifying the ingredients]?

Yes.  Here are the batch testing concerns from Subpart C of the GMP regulations:

1.  That the product meets the specifications for the product in 6 specific areas - 21 CFR 111.75(a) through (g)
2.  That an expiration date, if any, is scientifically valid [Such a date is not required by FDA, so I do not recommend expiration dates]
3.  Specific types of tests required - 21 CFR 111.75(h)(2)
4.  Must test for: identity, purity, strength, composition, and the limits on types of contamination that may adulterate - 21 CFR 111.75(c) & (d)
5.  Every finished batch must be tested - 21 CFR 111.75(c)
6.  There are certain exemptions - 21 CFR 111.75(d)

In addition to testing concerns, Part IX also addresses Specifications and Samples. You have to determine what your specifications are for 7 specific areas set forth in Subpart B and, under Subpart C, you have to determine whether your product meets the specifications in 6 specific areas listed there.

Comparison of Subpart B and C Specification Requirements:

B.  Required to Establish

1. control point specifications
2. components
3. in-process
4. labels and packaging
5. finished batch
6. received for packaging and labeling
7. finished product packaging and labeling

C.  Required to Determine Product Meets

1. components
2. in-process
3. finished batch
4. received for packaging and labeling
5. labels and packaging
6. finished product packaging and labeling

[Subpart A is about "General Requirements" and Subpart B is about Requirements to Establish Specifications; Subpart C is about testing. Subpart D* is about specifications and verification of dietary ingredients and Subpart E is about representative and reserve samples]

My new Specifications, Testing and Sampling (STS) Webinar and eBook cover these matters in greater detail with references to the specific regulations and standards required.  Email me with "STS Webinar" in the subject line and we can arrange your access to the webinar and its accompanying ebook.

As always, of course, my monthly retainer clients will automatically receive access to this new Webinar and eBook as soon as they are posted.

Tuesday, January 22, 2019

It's a New Year - Time to Audit Your Compliance to Changing Regulations

It's a New Year - Time to Audit Your Compliance to Changing Regulations
Your Company MUST have a PCQI
New Food Safety Training Webinar

FDA's Food Safety Regulation requires a written plan and a trained PCQI - Preventative Controls Qualified Individual. I have you covered.

I prepared a 15 page Food Safety Plan that closely tracks the Regulation, 21 CFR 117.126. Then I prepared an 18 minute training webinar and eBook, along with a certification test. If you pass, you receive a PCQI Certification of Completion of the training.

The Certification Training Program is structured to introduce the trainee to a standard Food Safety Plan under FDA regulations. All registered food facilities are required to have a written Food Safety Plan in place and in operation. After completing the webinar and reviewing the Food Safety Plan Format and the eBook, contact me to receive the Certification Test, and upon completion and return of the test, the Preventative Controls Qualified Individual (PCQI) Certification will be provided.

Is your company required to register as a food facility [and is therefore required to have a Food Safety Plan]? If you handle food, yes.

This certification program, including the Food Safety Plan, eBook and webinar training, is priced at $600 -- but, for recipients of the Vitamin Consultancy Newsletter, I am offering a 50% Discount, if purchased during the month of January, 2019. Just email me at: ralph.fucetola@usa.net with "FSP" in the subject line.

Says the FDA: “The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On September 17, 2015, FDA published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule) (80 FR 55907). This final rule became effective on November 16, 2015. It creates new requirements for the production of human food by registered food facilities... The intent of this guide is to inform domestic and foreign food facilities about the PCHF regulation and enable them to better understand the requirements of the rule. The rule is binding and has the full force and effect of law.”

The Regulation provides that the Plan shall contain the following Contents:
(1) The written hazard analysis as required by § 117.130(a)(2);
(2) The written preventive controls as required by § 117.135(b);
(3) The written supply-chain program as required by subpart G of this part;
(4) The written recall plan as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls as required by § 117.145(a)(1);
(6) The written corrective action procedures as required by § 117.150(a)(1); and
(7) The written verification procedures as required by § 117.165(b).
The Plan has 22 separate sections. The PCQI must be a manager of the company and must be trained, with proof of training.

-----------------------
Horizon v Jonuzi et al. 
Last month the case survived a Summary Judgment Motion.

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

From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why the Institute for Health Research is sponsoring crowdfunding support for the litigation. [Note: I am not the attorney of record on this case.]

Read more here: https://vitaminlawyerhealthfreedom.blogspot.com/2018/12/provider-nondiscrimination-case.html

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

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

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