Monday, May 21, 2018

Summer Reg Changes Coming and Branding Basics

The Vitamin Consultancy eLetter
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It's Summer Soon...
Bureaucracy Getting Edgy!

[1] Daily Values -- DVs -- for Dietary Supplements Changing
[2] Branding Profiles and my new Systems Processing Integration Site
[3] Proposition 65 Changes: Running Out of Time!


[1] FDA Extends Compliance, But Now is the Time to Plan!

It has been reported that the new regulations on dietary supplement and food label "Facts Boxes" have been delayed a bit, but the time to get ready is NOW! The good folks at [*] have made this detailed information available:

"FDA made a significant number of changes to several Dietary Reference Values (DRV) and many Reference Daily Intakes (RDI) [for Nutrient Facts panel for regular foods -rf]. As previously mentioned, the DV for dietary fiber was increased to 28g and a new DV of 50 g for added sugars was established. Other DV's that changed include:

    DRV for fat was increased to 78 g
    DRV for carbohydrates was decreased to 275 g
    DRV for sodium was decreased from 2,400 mg to 2,300 mg

Most vitamins and minerals had their RDI for adults and children age four and older revised. The vitamins and minerals for which the RDI was reduced include:

    Biotin has decreased from 300 mcg to 3 mcg.
    Chloride has decreased from 3,400 mg to 2,30 mg.
    Chromium has decreased from 120 mcg to 35 mcg.
    Copper has decreased from 2 mg to 0.9 mg.
    Molybdenum has decreased from 75 mcg to 45mcg.
    Pantothenic acid has decreased from 10 mg to 5 mg.
    Riboflavin has decreased from 1.7 mg to 1.3 mg.
    Thiamin has decreased from 1.5 mg to 1.2 mg.
    Niacin has decreased from 20 mg to 16 mg.
    vitamin B-6 has decreased from 2 mg to 1.7 mg.
    vitamin B-12 has decreased from 6 mcg to 2.4 mcg.
    Selenium was decreased from 70 mcg to 5 mcg.
    Zinc has decreased from 15 mg to 11 mg.

The following vitamins and minerals had their RDI for adults and children age four and older increased:

    Calcium has increased from 1,000 mg to 1,300 mg.
    Magnesium has increased from 400 mg to 420 mg.
    Manganese has increased from 2 mg to 2.3 mg.
    Phosphorus has increased from 1,000 mg to 1,250 mg.
    Potassium has increased from 3,500 mg to 4,700 mg.
    Vitamin c has increased from 60 mg to 90 mg.
    Vitamin k has increased from 80 mcg to 120 mcg.

Further, several vitamins will now need to be declared using different units of measure. In the case of vitamins A, D and E, International Units (IU) will be replaced by metric units, such as micrograms of Retinol Activity Equivalents (mcg RAE) for vitamin A; micrograms for vitamin D and mg for vitamin E. For vitamin D, however, IU may continue to be used in addition to mcg. Also, folate must now be declared as micrograms of "Dietary Folate Equivalents" (mcg DFE) instead of simply mcg.

The revised RDIs for these four vitamins are:

    vitamin A 900 mcg RAE (from 5000 IU)
    vitamin D 20 mcg (800 IU) (increased from 10mcg or 400 IU)
    vitamin E 15 mg (from 30 IU)
    folate 400 mcg DFE (from 400 mcg)"

[Note: these changes will have to be integrated into your label Supplement Facts boxes over the next 18 months. This website can help you with those pesky Supplement Facts calculations: - rf]




What is a Company Branding Profile (CBP)? It is an organized document that is part of the Intellectual Property of the company.

The Branding Profile adds value to the company by better defining the company brand.  It is a company IP asset.

The CBP needs to have a prominent position in the Company Culture since it defines, for all the Company Team Members, the details of the Brand the Company promotes and defends.  It is posted as part of the Operating Process System (OPS) and is a key element in Systems Processing Integration.

The Profile covers such core marketing issues as:

Patents and Trademarks
Trade Names and Logos
Precisely what colors represent the company
What typeface fonts
What types of images
The "look and feel" of the labeling and sales copy
Trade Dress and Branding Indicia

Substantiated advertising language should be cataloged.

The Company Mission Statement should be included.

One Branding Agency [] lists:

"The brand codification process typically involves defining and aligning elements like:
Target audience / segments
Target beliefs & perceptions
Target options / competitors
Value proposition
Speaking points
Selling points
Tone & manner
Visual profile
Brand persona
Brand architecture
Vision, mission, goals"

The Branding Profile is intended to offer guidance to the copywriters and customer service people in the company, as well as the planners and managers.

That is why this essential part of the company culture rightfully belongs in the OPS, as one of the chief expressions of the company's Mission.

More at:


[3] Proposition 65 Changes Just 2 Months to Go! Is Your Company Ready?

Proposition 65 Coming at YOU!

Thursday, May 3, 2018

May 2018 eNewsletter: What We Can Learn from FDA Court Order


What Companies Can Learn From the Riddhi Vitamins' Cease and Desist Order*

Riddhi USA is a wholesale dietary supplement manufacturing company.  It manufactures products for label-owning marketing companies, like many of the Companies that receive the Vitamin Consultancy Newsletter.

After an inspection the violations were considered so egregious that a Federal Judge was asked to order Riddhi to stop all activities until it could meet GMP requirements.  Needless to say, all of its customers, Companies like yours, are scrambling to find new manufacturers.

What are the lessons we need to take from this regulatory action?

Let's start by listing what FDA thought were the most serious violations:
"-[1] failing to establish product specifications
    -- for the identity, purity, strength and composition of the finished dietary supplements

-[2] inadequate master manufacturing and batch production records

-[3] lack of quality control procedures

-[4] lack of procedures to investigate product complaints

-[5] products’ labeling failed to declare dietary ingredients, allergens and place of business."
These are nearly all Standard Operating Procedures violations. 

Either Riddhi did not have the written procedures or failed to implement them.  That also means the customers of Riddhi failed to "be in a state of control" -- the requirement that applies to all label-owners.

Specifications. Records. Procedures...

You need to have them. You need to implement them.  FDA publicized the Riddhi case as a warning to all companies that the agency can shut you down if you fail to adopt SOPs, train employees in their use, and actually implement them.

The Vitamin Consultancy provides up-to-day procedures and the OPS 4 SOPs system that enables you to implement the specifications, records and procedures required.

It is up to the Company's senior management to take the lead in careful implementation.

The SOP introduction indicates:

"The following Positions in the Company are listed in these SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager. The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO..."

That is:
Customer Service Manager
Warehouse Manager
The Vitamin Consultancy offers "refresher" training sessions where staff members assigned to the different positions mentioned in the SOPs can recommit to following the SOP procedures.

More information here:

Practice Note: Reading the FDA Regulation changing the way conventional food labels are configured.  The new Regulation is being delayed until 2020 (good news!).

     Yes, I was reading down the hundreds of Comments in the Regulation, and FDA's Responses. This one, #431, got a raised eyebrow, since it is contrary to what FDA has said elsewhere: "
We agree there is a difference in biological activity between synthetic and naturally derived β-carotene. "

     In the past FDA would object if any vitamin company said "natural" was better than "synthetic." Does that irrational rule still hold? If your naturally derived nutrient ingredient has been shown to be better than synthetic versions, it seems the old rule may no longer hold.


Proposition 65 Coming at YOU!

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