Wednesday, January 20, 2021

January 20, 2021 Newsletter


Vitamin Consultancy Newsletter
www.VitaminConsultancy.com

Logo

While the declared “pandemic” has slowed bureaucracy to a crawl, one appeals court recently made a decision that supports commercial freedom of speech regarding dietary supplements. Reuters reports:

A class action lawsuit accusing big box retailer Target Corp and nutritional supplement makers International Vitamin Corp and Perrigo Co of falsely marketing biotin, a nutritional supplement, as promoting healthy hair and skin is preempted by federal law, a federal appeals court has ruled.

A unanimous panel of the 9th U.S. Circuit Court of Appeals held Wednesday that the claims made on the supplement’s label were protected by the federal Food, Drug and Cosmetic Act (FDCA) as general claims about the structure and function of biotin, and that the product included appropriate disclaimers, affirming a lower court order dismissing the case.

What this means is that States like California cannot impose stricter “false advertising” rules than the Federal Government imposes. It means there is a national standard for claims. When general structure and function claims are made — with appropriate disclaimers — Federal law protects the claims.

Isn’t it time for us to review your claims and make sure your disclaimers are in order? Just email me: ralph.fucetola@usa.net with “Review” in the subject line. Ten percent off my regular rates if you email your questions.

Time to Try Some Crypto

"The times they are a changing..." Never thought I'd see the Banana Republic spectacle of the new regime being installed in Washington, DC by 25,000 soldiers carefully vetted by the deep state, contrary to the actual electoral will of the people. Sad days coming -- the promised "dark winter."

One thing for certain, the US dollar will evaporate as the artificial COVID boom pops. The Fed Debt is about to accelerate as the new regime tries to "stimulate" itself out of the disaster. Where to go for protection? Maybe now's the time to put a toe into crypto.

I've joined HoneyMiner which is an easy way to begin to experience Bitcoin. The system is a small program that runs in the background on your computer whenever it is on. It uses your excess processing capacity to mine crypto with you and the company sharing the crypto.

Start with 1,000 Satoshis free.

More here: https://honeyminer.com/referred/5tviv

Friday, December 11, 2020

December 2020 Newsletter

 

The Vitamin Consultancy Newsletter
11 December 2020
Ralph Fucetola JD

Systems Processing Integration

It's Time to Get Ready for What’s Next

GETTING READY FOR THE NEW YEAR AND NEW REGIME
Now more than ever “your papers must be in order.”

But First… Are You Interested
in Cryptocurrency?
OF COURSE YOU ARE!

Join Honey Miner

It is a no-cost (except the cost of your computer time) BTC miner that uses your excess CPUs to generate crypto even while you are not using your computer. 

I've already earned a couple dozen Satori (a Satori is 1/1,000,000 BTC) in the four hours I've been a member.  This program was recommended by my nephew Jeff Giles who is very savvy about crypto. 

You can put all your computers on the system and the program will keep track of your Satori rewards. Easy download and set-up.

Join now and get 1,000 Satoris to start. 

You can earn more crypto by asking others to join.  Once your HM Wallet is set up you can receive and send BTC to others... in other words, you are part of the crypto revolution!

Join through me here:  https://honeyminer.com/referred/5tviv

Wednesday, October 14, 2020

October 2020: Rounding Rules

 

The Vitamin Consultancy eLetter
Link to Newsletter Archives
View this email in your browser
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...

---------------------
[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
Link to Newsletter Archives
View this email in your browser
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

 

The Vitamin Consultancy eLetter
Link to Newsletter Archives
View this email in your browser
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

The Vitamin Consultancy eLetter
Link to Newsletter Archives
View this email in your browser
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


The Vitamin Consultancy eLetter
Link to Newsletter Archives
View this email in your browser

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