Sunday, November 11, 2018

Keeping Up with Agency Regulations

November Vitamin Consultancy eNewsletter
Keeping Up with Changing Regulations

[1] FDA on "Natural"

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm

"Although the FDA has not engaged in rulemaking to establish a formal definition for the term "natural," we do have a longstanding policy concerning the use of "natural" in human food labeling. The FDA has considered the term "natural" to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. However, this policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term "natural" should describe any nutritional or other health benefit."

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

[2] FDA GMPs -- TEN YEARS OLD

The Natural Products Association is engaging in a tenth year review of the FDA dietary supplement GMPs.  Some valuable information is being developed.  One bottom-line point:  there is a new FDA emphasis on adequate Quality Assurance, which means specific staff members tasked with that role.  QA must sign off on all product batches and the person signing off must not be the person overseeing the production.  This applies to both manufacturers and to the label-owner who is expected to "be in a state of control."

For example, a recent warning letter to a label owner which was sent to me for review cited two violations of QA
"1. Your quality control operations did not include determining whether each finished batch conforms to established product specifications.

2. Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution."
Remember, these points were raised directly with the label-owner, not the manufacturer.  Bottom line:  Do you have Product Specifications? Do you have a person responsible for QA?  Is QA included in your SOPs.

My retainer clients are compliant. Are you?  www.SystemsProcessingIntegration.com

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

[3] FDA Mandatory Food Recall Authority

November 5, 2018 - The U.S. Food and Drug Administration has released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).

"The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

https://www.federalregister.gov/documents/2018/11/06/2018-24247/guidance-questions-and-answers-regarding-mandatory-food-recalls

Comment: you may recall that Dr. Laibow and I fought hard in 2010 and 2011 to preserve Section 1011 of the food "safety" bill, a section that exempted DSHEA dietary supplements from the "enhanced" authority of the law.  We were denigrated when we worked through one late-nights weekend to get over 150,000 emails to the congressional conference committee, assuring that the exemption clause would stay in the law.  Now we see the results:  "mandatory" recalls based on mere "reasonable probability..." will become the norm for most foods, but not for DSHEA products!

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

[4] TWO IMPORTANT STORIES YOU WON'T SEE ANYWHERE ELSE!

[1] What Happened to that Sore on My Chest?

I love to tell my list about success stories in the natural products market.  Dr. Walter Wolf is one of those geniuses that I've had the privilege to know.  He is an alchemist and naturopath.  His new product, Divine Wellness, is amazing!

Ethically harvested ovine placenta, CBD hemp oil and Nano Gold.  This is an immune boosting rejuvinater nutrient combination.

But I want to tell you about an "off label" use of the product.  A few months ago I noticed a "beauty mark" on my chest had begun to enlarge and become lesion-like. That was concerning so I started putting a varying combination of CBD hemp oil, apricot seed extract, tea tree oil and nano silver on it.  The growth stopped, but it remained.  Then, a few days ago, I begin putting Divine Wellness on the spot.

As the series of images show, it quickly puffed-up, became quite dark, and is now flaking-off.


Amazing!  Learn more about this natural product as a dietary supplement here:  https://www.divinewellnessclub.com/idevaffiliate/idevaffiliate.php?id=103  -- yes, you can join the affiliate program.

[2] Horizon v Jonuzi et al. This may be the most important lawsuit pending in the USA regarding Insurance Industry reimbursement for holistic and integrative treatments and therapies... including dietary supplements as Medical Foods.  This pending litigation can construe the Affordable Care Act to forbid insurance carrier discrimination against holistic and integrative practitioners, permitting proper insurance coding for such therapies.

From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why I've helped to set up a crowdfunding effort.

Read more here: http://www.inhere.org/2018/11/06/making-health-insurers-follow-the-rules/

Please read about it, and help our crowdfunding effort.  This case is quite important! 

Donate here:  https://fundly.com/support-natural-therapies

------------------------
And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers.  http://www.inhere.org/institutional-review-board/

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.

TIME RAN OUT

If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are wrong. The new rules 2 months ago. 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:  www.ProfessionalSafetyDossier.com

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




Sunday, September 30, 2018

Your Food Safety Plan - September 2018 Newsletter

September 2018 Newsletter


Your Food Safety Plan

Two years ago the FDA promulgated new food safety rules, citing the risks of terrorism and food-carried disease. The time to adopt a formal Food Safety Plan is running...

If you handle food in your facility, you need a written Food Safety Plan.  If you contract with a company to manufacture for you, as the label-owner, you must be in a "state of control" which means, you need to know and document that your contract manufacturer has a Food Safety Plan.  That's your responsibility according to FDA.

I've prepared a carefully structured Food Safety Plan Format, directly from 21 CFR 117 -- the food safety regulation.  


Contact me to obtain your Food Safety Plan:  ralph.fucetola@usa.net

Here is the outline of the Food Safety Plan requirements:

The Regulation says the Plan shall contain the following Contents:

(1) Hazard analysis - § 117.130(a)(2)
(2) Preventive controls - § 117.135(b)
(3) Supply-chain program - subpart G
(4) Recall plan - § 117.139(a)
(5) Procedures for monitoring the controls implementation - § 117.145(a)(1);
(6) Corrective action  - § 117.150(a)(1); and
(7) Verification procedures - § 117.165(b).


The Contents of
My Food Safety Plan Format


[1] Status.
[2] Hazard analysis.
[3] Hazard identification.
[4] Hazard evaluation.
[5] Preventive controls.
[6] Process controls.
[7] Food allergen controls.
[8] Sanitation controls.
[9] Supply-chain controls.
[10] Recall plan.
[11] Other controls.
[12] Preventive control management components.
[13] Monitoring.
[14] Corrective actions and corrections.
[15] Verification.
[16] Validation.
[17] Verification of implementation and effectiveness.
[18] Environmental monitoring
[19] Reanalysis.
[20] Requirements: preventive controls qualified individual (PCQI) / qualified auditor.
[21] Implementation records required for this Plan.

CA PROP 65
TIME HAS RUN OUT

If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are wrong. 
The new rules started a few days ago. 
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:  www.ProfessionalSafetyDossier.com


Here is my article about all this, posted at Open Source Truth: http://www.opensourcetruth.com/proposition-65-california-ratchets-up-cancer-repro-harm-warning-rules/
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.
Here is a summary of the FDA's web page on the types of claims that can be made for foods and supplements.

https://www.fda.gov/food/labelingnutrition/ucm111447.htm

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.

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."

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.'

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


New FDA Guidance

Friday, July 6, 2018

Categories of DSHEA Claims - July 2018 Newsletter

NEW RULES IN EFFECT AUGUST!

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! 


--------
[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

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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

Monday, January 15, 2018

FDA 2017 WARNING LETTERS


FDA IS CONCERNED ABOUT QUALITY CONTROL
AND SO SHOULD YOU BE...


Over the year I see a number of FDA Form 486 Inspection Observations and Warning Letters. It is my practice in January to look back at the FDA's published Warning Letters as well. They are published here: https://www.fda.gov/iceci/enforcementactions/warningletters/2017/default.htm

Each year it is possible to see the trends in FDA inspections and concerns. This practice note looks at some of the typical letters that show us what those concerns have been in recent months.

There are four main areas that I've noted:

[1] Citing medical journal "disease claim" articles to support claims is not allowed.

"When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use."

[2] Failure to establish a system of process and production controls must be addressed.

"...a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record..."

[3] Making medical claims for DSHEA products is never allowed.

"...regular consumption ... may help stave off disease…." / "...reduced inflammation..."

[4] Quality Control / QC Manager issues are primary.

"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement..."

Here are some more detailed excerpts from the Warning Letters reviewed that show you in detail how FDA approaches these issues, followed by my recommendations.

[A] Vita Purity

(i) Disease Claim Citations

"Your website also includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease...

(ii) Production and Process Controls

...You failed to establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). Specifically, you had no written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103, and no written procedures for approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).

You receive finished, packaged and labeled dietary supplements from a manufacturer that manufactures the dietary supplements on your behalf (your contract manufacturer). You hold and distribute the dietary supplements. You state that you specify the active ingredients and their proportions for each of your products. You design and approve the product labels and have them printed and shipped to your contract manufacturer. You sometimes procure dietary ingredients and supply them to your contract manufacturer. You state that you assume your contract manufacturer is responsible for preparing a master manufacturing record, exercising quality control functions, and verifying that the finished products meet specifications. You state that you assume your contract manufacturer is complying with 21 CFR Part 111 because you are unaware of any problems at the plant. You state that you do not have a written agreement with your contract manufacturer, and have not performed any audit or engaged in any other activity to determine the acceptability of the manufacturer to manufacture your dietary supplement products, or to ensure the quality of the dietary supplements received and that the products are packaged and labeled as specified in the master manufacturing record.

As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. [1] In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2))."

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm559804.htm

[B] Maine Natural Health

(i) Disallowed claims

“Vitamin D [an ingredient in the product] may improve heart health…. heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient.”

“Benefits of fish oil [an ingredient in the product] include: reduced inflammation”

“[T]he omega-3 fatty acids in fish oil [an ingredient in the product]…have shown beneficial results for a variety of health problems….like high blood pressure and arthritis. This means regular consumption of fish oil may help stave off disease….”

(ii) Master Manufacturing Record Required

"You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection we noted that you are not preparing master manufacturing records that are unique to the batch sizes being manufactured for each of your dietary supplements. For example, our review of your records indicated that on May 5, 2016, you manufactured one batch of Vanilla Recovery Whey Protein using (b)(4) with a final batch size of (b)(4) and on July 5, 2016, you manufactured another batch of the same product using (b)(4) with a final batch size of (b)(4) following the same master manufacturing record for each batch.

Additionally, in preparing your master manufacturing records for all dietary supplements you manufacture, you must ensure that they meet the requirements of 21 CFR 111.210. For example, the current master manufacturing record for [redacted] Whey Protein does not include the strength, concentration, weight, or measure of each dietary ingredient for each batch size, as required by 21 CFR 111.210(a)."

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590003.htm

[C] Brain Alert

(i) Ultimate Responsibility for Your Own Labels

"Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements [see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)]. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations. "

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589575.htm

[D] Dynamic Technical Formulations

(i) Quality Control Personnel

"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement [see 21 CFR 111.105(a)]. Additionally, the personnel you identified to perform quality control operations do not have the education, training, or experience to perform quality control functions, as required by 21 CFR 111.12(c). Specifically, you identified yourself to our investigator as the quality manager, but admitted that you were not familiar with the Dietary Supplement GMPs and had not received any training to perform the duties associated with quality control.

To fulfill the requirements for quality control operations, your firm must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65."

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589584.htm

BOTTOM LINE -- RECOMMENDATIONS FOR ACTION

We can see from these warnings that the industry is being held to ever higher standards of conduct, as FDA seeks to impose strict Quality Controls. The position of Quality Control Manager is very important. FDA prefers that the QCM is not the Chief Operating Officer, the COO, but reports to, and has immediate access to, the COO and CEO. Each company needs to appoint and train a QCM (and be able to substantiate that training).

My quarter-hour Quality Control webinar (with eBook) covers the duties and qualifications of your QCM. If you want to see my 26 slide presentation, please let me know. I'd be happy to send you the link to the eBook, which has just been posted with the Webinar. If you have access to my Webinar System you can find it there. If not, why not? http://www.vitaminconsultancy.com/webinars.php

These newsletters are archived here: http://vitaminlawyerarchives.blogspot.com/



THE CLOCK IS TICKING... 
CALIFORNIA PROP 65 WILL IMPACT YOUR BUSINESS THIS YEAR!

Tuesday, January 2, 2018

UK and USA Governments Attack Homeopathy and Herbal Remedies


FDA ATTEMPTING TO KILL HOMEOPATHY [HERBS NEXT!]
IN ILLEGAL ACTION WE MUST STOP!
The UK's National Health "Service" used to run special homeopathic hospitals and herbal dispensaries. Not any more, now that the "one payer" will no longer pay for either and they are being closed. [1]

Unsurprisingly, the FDA is following suit, despite the fact that Homeopathy and the US Homeopathic Pharmacopoeia (USHP) are protected by specific statutes in the US.

Did Health Freedom end when 2017 made its exit? Yes, if the FDA has its way!

Bottom Line: If you and your company are ready to take action to protect natural remedies, read on, then email me:

We have until March 20th to file formal comments with FDA.  Docket FDA-2017-D-6580 -- comment here: https://www.federalregister.gov/documents/2017/12/20/2017-27157/drug-products-labeled-as-homeopathic-draft-guidance-for-food-and-drug-administration-staff-and

This past year the DEA and the FDA came out publicly saying, for example, that Cannabidiol, CBD, a neurotransmitter produced by mammalian (including human) bodies, was not a lawful nutrient, although the agencies have stopped short of raiding health food stores [as FDA used to do in the 1990s, before the Dietary Supplement Health and Education Act (DSHEA)] to enforce their dictate. [2] 

Right now, although there is a century of laws protecting homeopathy, FDA is attacking homeopathy to “protect” you. They are the government and they are here to "help" — Big Pharma.

On December 18th of this past year FDA issued new regulations that attack homeopathic oral and injectable remedies despite the fact that they are protected by long-standing law. This blatant attack on your health freedom choices is part of a long-term, well-financed conspiracy and, sadly, comes as no surprise. [3]

On your behalf we told FDA, when they started their “regulatory review” of homeopathy to let our natural remedies alone! The attack began “innocently enough” during the previous presidential administration.  FDA asked for comments on how it should “modernize” homeopathy regulations. That’s the government’s first step toward ratcheting-up control. That’s the step to which we had previously replied, telling them, among other things:

"FDA does not have authority from Congress to interfere with traditional homeopathy, nor does Congress have authority to permit such interference. Individuals have the right, under international humanitarian law binding on the United States, of Informed Consent to exercise their Freedom of Choice in health care without government burdening that fundamental right." [4] 

These new regulations followed similar recent action in the UK by its “one payer” nationalized health care system. The UK National Health “Service” has ended its long-standing history of support for safe, gentle and effective homeopathy and herbalism (the UK even has special homeopathic hospitals and homeopathic/herbal dispensaries) in favor of dangerous, deadly and ineffective pharmaceuticals. This trend for medical tyranny has “crossed the pond” as the FDA has attacked legally protected homeopathy in the USA.

This was done in three steps that I have documented. 

First in 2015, when the FDA asked for public comments about regulating homeopathy. That's when we submitted the comments referenced above. By the way, by submitting comments telling FDA they were acting illegally, we preserved the legal right to complain to the courts; we preserved "standing to sue."

Second, as noted in a blog entry I posted last January, FDA was toying with the idea of requiring "disclaimers" on homeopathic products, disclaimers not required by the statute that protects homeopathy in the USA [5].

Third, the most recent action, which illegally attempts to treat HPUS standard homeopathic remedies as unapproved pharmaceutical drugs, requiring a "risk/benefit analysis" which will effectively ban many, if not most, homeopathic remedies. This pseudo-scientific analysis starts with the false claim that homeopathic remedies have no benefit and alleges a "risk" that people using such remedies will fail to use Big Pharma's government approved, dangerous, "side-effect" drugs. 

Such a risk! Since government approved drugs are the main cause of preventable death in the USA, what risk? [6]

The natural product industry has two choices: let Big Pharma and the globalists have their way or force them back, step by step.  I am sure that large producers of homeopathic remedies will have no choice but to challenge the regulation.  

Since we have preserved the right to object to this latest FDA action, cooperation between the industry and the health freedom movement during 2018 may be the only way to preserve our access to homeopathy, and, while dodging the FDA's left punch, we'll need to watch it's right arm for the next attack on herbs and other nutrients, like CBDs.  

The new President, failing to keep his promise to "drain the swamp" seems to be appointing swamp-creatures to run the FDA and empower it to further attacks!

We must choose to force them back. I know you will want to do so, too.  

To start, use and share this link to make your opinion about the FDA attack heard:   https://fans.vote/ACsU7n6KLLo  


Download, print and post this poster at your local health food store:



Then take these steps:

1. Make a generous, tax deductible donation now to Institute for Health Research, here:   http://www.InHeRe.org

2. Show your support directly to the Natural Solutions Foundation as a potential litigant against the FDA (not tax exempt) here:  https://www.nsfmarketplace.com/product/support-the-work-of-natural-solutions/

3. Contact me directly if you or your company want to be part of the advocacy and litigation that will likely be needed to stop this latest FDA outrage. Our half century of health freedom advocacy positions us to coordinate this urgent action. Email me here: ralph.fucetola@usa.net


4.  File your comments here: https://www.federalregister.gov/documents/2017/12/20/2017-27157/drug-products-labeled-as-homeopathic-draft-guidance-for-food-and-drug-administration-staff-and

——————–

[1]  
http://www.telegraph.co.uk/news/2017/07/21/nhs-ban-homeopathy-herbal-medicine-misuse-resources/


[4]  We told FDA to leave our natural remedies alone; when they started this latest attack on Homeopathy, back in 2015, here are the comments I filed with FDA: http://vitaminlawyerhealthfreedom.blogspot.com/2015/06/comments-to-fda-re-homeopathy-fda-has.html