Wednesday, May 26, 2021

May 2021 Newsletter: Defining 'Healthy'

 

Vitamin Consultancy May 2021 Newsletter

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Are Your Products “Healthy”?

FDA posted the following Notice earlier this month.

The U.S. Food and Drug Administration is issuing a procedural notice on the preliminary quantitative consumer research it plans to conduct on symbols that could be used in the future to convey the nutrient content claim “healthy.” As part of the Paperwork Reduction Act, Federal agencies are required to publish notice in the Federal Register on each proposed information collection and to give the public the opportunity to comment.

The FDA is conducting the research in conjunction with the development of a proposed rule the FDA intends to later publish that would update when manufacturers may use the “healthy’ nutrient content claim on food packages. The symbol would be a stylized representation of the nutrient content claim.

The update to the definition and creation of a symbol for the “healthy” nutrient content claim are part of the FDA’s Nutrition Innovation Strategy (NIS). The NIS is intended to reduce the burden of nutrition-related chronic diseases, which are experienced at a disproportionately higher rate by communities of color. One of the elements of the NIS is to modernize claims, which serve as quick signals for consumers about what benefits a food or beverage they choose might have. Claims and symbols can also help consumers better understand nutrition information and can encourage companies to reformulate products to improve their nutritional value.

The FDA is seeking comment on ways to enhance the quality, usefulness, and clarity of the information to be collected. Comments on the notice are due 60 days following publication in the Federal Register. Submit comments electronically to https://www.regulations.gov. Written comments should be addressed to: Dockets Management Staff (HFA-305) / Food and Drug Administration / 5630 Fishers Lane, Rm. 1061 - Rockville, MD 20852

Please consider filing your suggestions with the FDA at the indicated link.

Source: https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-procedural-notice-consumer-research-healthy-symbol

Vitamin Consultancy Services

As your business gets ready for the end of the lockdowns you need to review your regulatory status. There are new rules… I am available to work with your company to make sure your SOPs and other procedures are up-to-date. Just give me a call! 973.300.4594

SPECIAL REOPENING RATES!
www.SystemsProcessingIntegration.com

Friday, March 12, 2021

March 2021 Newsletter: Commercial Freedom Of Speech

 


Systems Processing Integration

Vitamin Consultancy Newsletter
www.VitaminConsultancy.com

12 March 2021 — The Federal Appeals Court that serves the West Coast 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 …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@gmail.com with “Review” in the subject line. Ten percent off my regular rates if you email your questions.

While claims are the key for marketing natural products, including dietary supplements, careful consideration of claims is not enough to keep you in business.

Your processing system must be “in order” and, as FDA says, you “must be in a state of control” at all times.

My SPI System allows you to meet the state-of-the-market requirements for transparency and traceability. Please check out my www.SystemsProcessingIntegration.com web site and let’s talk about what parts of the SPI System you can start to implement first.

The sooner, the better… 973.300.4594

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Wednesday, January 20, 2021

January 20, 2021 Newsletter


Vitamin Consultancy Newsletter
www.VitaminConsultancy.com

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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
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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
Link to Newsletter Archives
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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

 

The Vitamin Consultancy eLetter
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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.