Wednesday, October 14, 2020

October 2020: Rounding Rules

 

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Sodium and the DSHEA Label
Listing Sodium in the Supplement Facts Box

     Sodium Chloride -- table salt -- is listed as Generally Recognized As Safe (GRAS) as are a number of other forms of sodium.[1] 

     Sodium as a nutrient must be shown on the Nutrition Facts label [2]

     Sodium, like other nutrients, has a Daily Value  -- the DV is under 2300 mg/day.  The regulations require you to disclose the level of sodium in the product. You regularly see sodium disclosed on the Nutrient Facts Label for ordinary foods.

     For a DSHEA product Supplement Facts Label there is a list of what must be included at  21 CFR 101.36(b)(2)(i)(B).  This requirement includes disclosing Sodium if present.

     However, whether something is present may depend on how it is measured and how the measurement is rounded.  There are rounding-down rules for the SF label. [3] 

     So, if the product has less than 5 mg per daily serving (which is about 1/3 of 1% of the DV) the percent can be rounded down to zero and does not need to be included. (pg 129)

     How much sodium is in a serving of your product? That is the question. I can help you figure that out. -- for sodium or any other ingredient. For my regular retainer clients I am adding an SOP section on rounding rules...

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[1] https://www.fda.gov/food/food-additives-petitions/food-additive-status-list
[2] https://www.fda.gov/media/84261/download
[3] https://www.fda.gov/media/81606/download / 21 CFR 101.9(c)
Patricia Finn, Esq. filed the SCOTUS vaccine mandate Petition last week.  This is the first time in a century that this issue has come squarely before the Court.  Read more about this landmark case:  
http://www.opensourcetruth.com/will-scotus-decide-to-hear-vaccine-mandate-case-this-year/

YOUR URGENT SUPPORT FOR THIS CASE WILL MAKE A POWERFUL DIFFERENCE!
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. 

Wednesday, September 2, 2020

September 2020: The Woodlands Lunch Forum

 

The Vitamin Consultancy eLetter
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UPDATE
September 10th Live Stream ARCHIVE Link
https://facebook.com/WoodlandsOnline/videos/3230794120372858/


THE WOODLANDS
LUNCH FORUM

Dr. Rima and I are speaking in Texas this
Thursday (me in person; her by Skype) at
The Woodlands Lunch Forum 
(my trip delayed from February)
We will be livestreamed
Thursday - September 10, 2020
at 11:30 AM CDT  
Live Stream here:
http://www.woodlandsonline.com/vmps/videolisting.cfm?vdoid=4248
Event:
http://www.inhere.org/the-woodlands-lunch-forum/

Calendar it and Join Us There!
PLEASE SHARE THIS MESSAGE

Wednesday, August 12, 2020

August 2020 - Unique Facility Identifier

 

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At The Woodlands
Lunch Forum
Thursday
September 10, 2020
I'd Love to See YOU in Texas!

UFI
UNIQUE FACILITY IDENTIFIER

Every other year all food processing facilities must renew their registration (between October and December).  This year, 2020, is one of those years.  This time, though, there will be an added twist:  you will need to obtain a "UFI" -- a Unique Facility Identifier number. However, FDA has not yet set up the system to generate the number.  Bureaucracy at work!  So I asked FDA about this new requirement.  Here is the communication.  I will let all the clients of The Vitamin Consultancy know how to meet the requirements.  Remember, if you handle any food product, such as dietary supplements or herbs, you must be registered.

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. 

Tuesday, July 21, 2020

July 2020 - Contemporaneous Log and Texas Trip

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COVID willing, my trip to Texas to speak at The Woodlands Lunch Forum to inaugurate the Texas office of the Institute for Health Research is now scheduled for September 10th.  This is the third postponement since February, but I do hope to see my Texas friends then. Tickets available through www.InHeRe.org

Archive Link:
https://facebook.com/WoodlandsOnline/videos/3230794120372858/

KEEPING A CONTEMPORANEOUS LOG
MEETING FDA RECORD KEEPING REQUIREMENTS

The most important step that a small or start-up natural product / dietary supplement company can take to meet regulatory requirements is to keep a Contemporaneous Log of all activities relating to the receiving, handling and shipping of its products.  Follow-up records, such as computer inventory systems or even my OPS for SOPs (Operating Procedures System for Standard Operating Procedures) with its private, password protected regulatory compliance web site -- www.SystemsProcessingIntegration.com -- are after-the-fact records.

What FDA tells us is that the product Label Owner "must be in a state of control" of all processes, whether contracted or handled in-house.  Further the Agency tells us that, "if it is recorded that is how it happened; if it is not recorded it did not happen..."

This means that a contemporaneous, handwritten, initialed Receiving, Handling and Shipping Log is exactly what you need to start off right. Below is the format for the Log, but there are more sophisticated Log formats that I have available and am providing to my regular retainer clients.  Those documents are part of the SOP system developed by The Vitamin Consultancy. Let me know if you need more specifics.

The Log:

Thursday, June 18, 2020

June 2020 - Trip to Texas - Labeling and Packaging Specifications Webinar & eBook


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IN TEXAS JULY 8 - 12

ARCHIVE
https://facebook.com/WoodlandsOnline/videos/3230794120372858/



I will be visiting Dallas, Austin and Houston. The sponsor of The Woodlands Lunch Forum, Larry Deckerhoff had this to say:
"Meet You After the Pandemic Reopening -- The theme of this Lunch Forum is Advanced Health for the New Millennium, Immunotherapy and Rejuvenation – Focus on Supercharged Immune Systems During Troubled Times. Among our featured speakers will be Ralph Fucetola JD, President of The Woodlands’ own Institute for Health Research. He will be joined by two experts in rejuvenation and immunotherapies. The short presentations will leave plenty of time to reconnect and enjoy the extraordinary cuisine at Amerigo’s Grille.”
Please contact Stephen with questions:
stephen.contreras1@hotmail.com

LABELING AND PACKAGING SPECIFICATIONS
New Vitamin Consultancy Webinar and eBook
Special Newsletter Price:  $99.00

Contact: ralph.fucetola@gmail.com

Wednesday, May 27, 2020

May 2020 Newsletter: Reopening the Natural Economy

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Although the Declared "Pandemic" is Ending...
EMERGENCY PLANNING SOP & RESTARTING

A couple bits of news...

1.  My trip to Texas to announce the opening of The Woodlands office of the Institute for Health Research - www.InHeRe.org - originally scheduled for February, is now tentatively scheduled for late summer.

2.  The Trump Admin says it is relieving the regulatory burden on businesses to let us get back to work quicker.  My experience has been that FDA has backed-off physical inspections but has continued to push for compliance with previously issued Observation Reports. Use the time you have before the bureaucracy is back to work (well, what they consider "work") and get ready!

3.  I AM AVAILABLE TO CONSULT WITH YOU AS YOU REOPEN.  SPECIAL CONSULTING RATES FOR MAY.  LET ME KNOW -- ralph.fucetola@gmail.com with Consulting in subject line.

No doubt future inspections will put more emphasis on company Emergency Planning.

I have updated my Standard Operating Procedures (SOP) format to add Working Remotely to SOP #13, Emergency Planning.

My regular retainer clients received a copy of the revised SOP last month and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- www.SystemsProcessingIntegration.com -- are having their SOPs automatically updated by me.

Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency! CONTACT ME ABOUT SETTING-UP YOUR OPS 4 SOPs PAGE TODAY!

If you want a copy of SOP #13, the cost is now just $69 -- email me and I'll send you a PayPal money request.
I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP):  "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."

Please let me know how I can help your company as the emergency ends.

Dr. Laibow and I are maintaining a COVID information aggregation site here:  www.TruthAboutCoronavirus.com

We also held a COVID Emergency Health Summit (over 6 hours of podcasting with a half dozen experts) - more information here:  http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/
HERE IS WHAT AN OPS FOR SOPS PAGE CAN INCLUDE:

Thursday, April 30, 2020

April 2020 Newsletter: Quality Counts

April 29, 2020

SPECIAL BONUS eBOOK!
Labeling and Packaging Specs
-----

Here is the LINK where you can download my latest eBook which explains how to keep a Labeling and Packaging Log in conformity with GMPs -- as provided in SOP #25 of the Vitamin Consultancy standard SOP format.

http://www.vitaminconsultancy.com/Labeling-%26-Packaging-Specifications.pdf

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QUALITY COUNTS!
And Increases Your Bottom Line
Nutrient Sales Surge During Declared Pandemic

Quality Counts!
New ETQ Survey shows:  "An important shift is happening. Organizations now treat quality as a strategic initiative. Survey data shows 66% of organizations categorize quality as a strategic growth investment. Treating quality as a strategic business initiative is paying off as organizations see an average return of 23% on their investments."

Since Quality Counts, Quality Control must be a central concern.  Under FDA's GMP there is no question that quality counts and that the product label owner is the responsible party for quality control.  Your company needs to have Quality Control built into its Standard Operating Procedures (SOPs) and you need to have a designated Quality Control Manager.

The Vitamin Consultancy's standard SOPs include strong quality control provisions.  In the vitamin industry, according to numerous FDA Form 483 Inspection Observations that means controlling "identity, purety, strength and composition" of the DSHEA product.

Here is what the SOP says about the QC Manager: "The QC Manager shall review and evaluate with the company managers at least annually complaints, recalls, returned or salvaged products and internal investigations conducted for each."

QC Goals include:
  • Qualifying the Contract Manufacturer as capable meeting quality, strength, purity and identity standards
  • Approving (or rejecting) products manufactured, processed, packed or held under contract by another company
  • Approving (or rejecting) procedures and specifications impacting identity, strength, quality and purity
  • Approving (or rejecting) packaging, labeling and product containers
  • Reviewing and investigating consumer complaints.
Contact me at ralph.fucetola@gmail.com and let's talk about brining your SOPs up-to-date.  During this enforced period of self-shielding is a perfect time for you to get ready to get back to work! 
Learn more about my Systems Processing Integration!
I make being organized easy!
 www.SystemsProcessingIntegration.com
Stay safe and for the latest from Dr. Rima and me on COVID-19 check www.TruthAboutCoronavirus.com (if your browser says the site is "dangerous" it is right, but not a danger to you); alternatively, check www.OpenSourceTruth.com

http://www.opensourcetruth.com/covid-second-wave/