Friday, July 6, 2018

Categories of DSHEA Claims - July 2018 Newsletter

Less Than 2 Months to Deadline!

www.ProfessionalSafetyDossier.com
Call Me! 973-300-4594 No Time to Delay!
----------------------------------------------------
Categories of DSHEA Claims

While you are thinking about August's Proposition 65 Deadline, here is a summary of the FDA's web page on the types of claims that can be made for foods and supplements. [1]

Among the common claims that can be used on food ("Nutrition Facts") and dietary supplement ("Supplement Facts") labels are three categories of claims that are defined by statute and/or FDA regulations:

          Health Claims
          Nutrient Content Claims
          Structure/Function Claims


As I've said many times... beneficial formulas are "easy."  Lawful and powerful claims are not. Without being able to persuasively explain the benefit, even the best formula will not sell.

Health Claims

"Health Claims" describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition.  They require prior FDA approval.

Ther are 3 ways a health claim may be used on a label or in labeling (the sales information that makes up the "extended label" according to FDA) for a conventional food or dietary supplement:

1) the 1990 Nutrition Labeling and Education Act (NLEA) allows FDA to regulate  health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative (the Neuro Food Defect Claim is an example);

2) the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research -- FDA has 120 days after application to allow or not; can be used during application period;

3) as described in FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (Pearson v Shalala Claims), the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling. There are about two dozen approved Qualified Claims. The Vitamin Consultancy offers a Health Claims Webinar describing each.  http://www.vitaminconsultancy.com/webinars.php

Nutrient Content Claims

"The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not otherwise "characterize" the nutrient level may be used to describe the amount of a nutrient present. However, a statement such as "only 200 mg of sodium" characterizes the level of sodium by implying that it is low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient content claim or carry a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Most nutrient content claim regulations apply only to those nutrients that have an established Daily Value... Healthy is an implied nutrient content claim that characterizes a food as having "healthy" levels of total fat, saturated fat, cholesterol and sodium, as defined in the regulation authorizing use of the claim. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe the percentage level of a dietary ingredient in a dietary supplement and may refer to dietary ingredients for which there is no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." ..."

Structure/Function Claims and Related Dietary Supplement Claims

"The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease. Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States. These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

When you need to find your way through the bureaucratic maze that is claim-making, remember the Vitamin Consultancy... we are here to help! 


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[1] https://www.fda.gov/food/labelingnutrition/ucm111447.htm

Wednesday, June 6, 2018

Bureaucracy Getting Edgy - June 2018 Newsletter

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 RAPS.org [*] 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: https://www.recipal.com/ - rf]

[*] https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/10/preparing-for-dietary-supplement-label-changes-under-the-final-rule-for-nutrition-and-supplements-fa

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

[2] BRANDING BASICS
COMPANY BRANDING PROFILE
www.SystemsProcessingIntegration.com


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
  • Slogans
  • 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 [http://duffy.agency/insight/what-is-a-brand-profile/] lists:

"The brand codification process typically involves defining and aligning elements like:
  • Target audience / segments
  • Target beliefs & perceptions
  • Target options / competitors
  • Category
  • Value proposition
  • Position
  • Speaking points
  • Personality
  • Selling points
  • Tone & manner
  • Visual profile
  • Backstory
  • 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: www.SystemsProcessingIntegration.com

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

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


Proposition 65 Coming at YOU!
www.ProfessionalSafetyDossier.com

Monday, May 21, 2018

Summer Reg Changes Coming and Branding Basics

The Vitamin Consultancy eLetter
View this email in your browser

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 RAPS.org [*] 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: https://www.recipal.com/ - rf]

[*] https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/10/preparing-for-dietary-supplement-label-changes-under-the-final-rule-for-nutrition-and-supplements-fa

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

[2] BRANDING BASICS
COMPANY BRANDING PROFILE
www.SystemsProcessingIntegration.com

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
Slogans
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 [http://duffy.agency/insight/what-is-a-brand-profile/] lists:

"The brand codification process typically involves defining and aligning elements like:
Target audience / segments
Target beliefs & perceptions
Target options / competitors
Category
Value proposition
Position
Speaking points
Personality
Selling points
Tone & manner
Visual profile
Backstory
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: www.SystemsProcessingIntegration.com

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

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

Proposition 65 Coming at YOU!
www.ProfessionalSafetyDossier.com

Thursday, May 3, 2018

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

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:
CEO/COO
QCM
EM
SOP/CCDA Manger
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: http://vitaminconsultancycertification.weebly.com/ops-4-sops.html

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603111.htm
===================================

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.

https://www.federalregister.gov/documents/2018/05/04/2018-09476/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels-and-serving-sizes-of-foods-that

==================

Proposition 65 Coming at YOU!
www.ProfessionalSafetyDossier.com

------------------------
Need Transcription Services?
Try this: https://www.rev.com/ 

Friday, April 13, 2018

Time Is Running Out: Prop 65

TIME IS RUNNING OUT.

      If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are probably wrong.
      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 your company here:  www.ProfessionalSafetyDossier.com


Here is my article about all this, posted recently at Open Source Truth: http://www.opensourcetruth.com/proposition-65-california-ratchets-up-cancer-repro-harm-warning-rules/
TIME IS RAPIDLY RUNNING OUT!

Thursday, February 15, 2018

The Meme Wars

With Memes the Medium is the Message

We know from 20th Century media guru Marshall McLuhan that "the medium is the message..." [1] The medium that carries the information is its own message. That seems especially true of our 21st Century hyper-connected Internet virtual reality.

I recently read Josh Weltman's book Seducing Strangers, which I highly recommend. [2] In it he makes a fascinating observation, one of many, starting with a term from Aristotle's Rhetoric, "Enthymeme." [3]

He connects the term to Internet "memes" - a word that was originally a play on the term "gene." [4]  A meme is an idea (embodied as a catchphrase, image or the like) which spreads throughout a society in a fashion not unlike the way genes spread through a population.

The point he makes, and the reason for this blog entry, is that there is a certain pattern to the use of Internet Memes that makes them powerful persuasive tools.  "If the first part... confuses, the second part must explain. And if the first part explains, the second part should confuse." [5]

Aristotle's Enthymeme is a logical construct where the "first term" of the syllogism is assumed to be understood by the listener.  The the second and third terms of the argument are more persuasive since the first is already in the minds of the listener.

For Internet image memes this can be generalized to: If the image confuses (or shocks, or astounds or amuses = surprises) then the words should explain; if the image explains, the words should surprise.

To a degree the image above is an example of the process. The retro-image is typical '60s California and carries with it the whole meme complex of California Living.  The words pull it into the present, starting with the current year date and become a warning to those doing business in California that the changing rules will impact them and require attention. www.ProfessionalSafetyDossier.com

The average attention span of the average Internet user is very short. Just seconds. [6] Notice mainstream TV, for example. The editing cuts (especially for ads) are often the length of a heartbeat, sometimes two or three. Hardly ever more.

Thus the Internet Meme, with its rhetorical tension between image and word, is an ideal tool to get the message through the medium and into the minds of your audience.

Internet communication is becoming a battleground of memes.  My Millennial Connections tell me they call it The Meme Wars. Some of the most popular Facebook groups are built around what are called "Dank Memes" [7] The more dissonance between the image and the words, the better. And so it goes.

If the image astounds, the words explain. If the image explains, the words astound...


-----------

[1] https://en.wikipedia.org/wiki/The_medium_is_the_message - "The medium is the message is a phrase coined by Marshall McLuhan meaning that the form of a medium embeds itself in any message it would transmit or convey, creating a symbiotic relationship by which the medium influences how the message is perceived."

[2] Workman Publishing, 2015 - ISBN 978-0-7611-8495-9 (Co-producer of the TV series, Mad Men)

[3] https://en.wikipedia.org/wiki/Enthymeme - "An enthymeme (Greek: ἐνθύμημα, enthumēma) is a rhetorical syllogism ... used in oratorical practice."

[4] https://en.wikipedia.org/wiki/Internet_meme - "In 2013 Dawkins characterized an Internet meme as being a meme deliberately altered by human creativity—distinguished from biological genes and Dawkins' pre-Internet concept of a meme which involved mutation by random change and spreading through accurate replication as in Darwinian selection."

[5] Weltman, - see page 25.

[6] http://time.com/3858309/attention-spans-goldfish/ - You Now Have a Shorter Attention Span Than a Goldfish

[7] https://www.facebook.com/groups/1715753248636816/ - Gary Johnson's Dank Meme Stash

Thursday, February 1, 2018

California Prop 65 Services

CALIFORNIA REGULATIONS IMPACT ALL BUSINESSES


California's Proposition 65 changes will cost you money.  You can hire Dr. Goodman and me to manage the changes, or you can risk large fines and legal expenses if you do nothing. Act today!
 

Remember, even if you do not sell directly into California, so long as your product or service is used in California, the regulation applies.


Are you required to give the Prop 65 Warning? If you are and you fail to do so, any California consumer can sue you in California, recover legal fees and get a share of the fine for bringing the case... there is a growing cottage industry in California where people identify and sue unsuspecting companies... like yours!

Go to http://www.ProfessionalSafetyDossier.com and learn how we can help you avoid a costly mistake. Check our FAQs page there.

Robert Goodman, PhD (Biochemistry) and I will search the 900 chemicals on the Prop 65 List and if you have one of those ingredients, determine if you have under the "Safe Harbor" limit or otherwise are below the No Adverse Reaction Level and then Certify that you do not need to give the warning. Unless you do... But, remember, there are loopholes within the loopholes.

Here is the link to a short video explaining our services:  
https://youtu.be/qm6aQnlaKk8