Vitamin Consultancy September 2016 Newsletter

Mail Chimp Version CDC dangerous quarantine and treat/vax regulation FDA offers 102 page NDI guidance

From: Ralph Fucetola JD Welcome to the September 2016 Vitamin Consultancy eNewsletter. The banner above, featuring yours truly and my co-trustees at Natural Solutions Foundation, Rima Laibow MD and Maj Gen Bert Stubblebine (US Army, Ret.) points to a very important and urgent matter. The CDC has proposed a draconian quarantine and forced treatment/vaccination regulation, giving the public until October 19th to file comments. Under the Administrative Procedures Act, this is a necessary step for agency action, or for litigation testing the validity of the new rules. What does the rule say about Informed Consent? It says your consent "shall not be considered as a prerequisite..." “§70.18 – Agreements. CDC may enter into an agreement with an individual, upon such terms as the CDC considers to be reasonably necessary, indicating that the individual consents to any of the public health measures authorized under this part, including quarantine, isolation, conditional release, medical examination, hospitalization, vaccination, and treatment; provided that the individual’s consent shall not be considered as a prerequisite to the exercise of any authority under this part.” Read more here:  http://drrimatruthreports.com/statement-in-opposition-to-proposed-cdc-regulation/ TAKE ACTION HERE:  http://tinyurl.com/InformedConsentProtection

FDA NEW DIETARY INGREDIENT (NDI) GUIDANCE The FDA's guidelines for what is a New Dietary Ingredient (NDI) were issued in 2011. Last month an updating was proposed as FDA continues to implement a policy of making Dietary Supplement rules more like Pharmaceutical Rules rather than the food-standard regulation that Congress determined to be public policy in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The new document is 102 pages. The Devil, as they say, is in the Details. As is the deviltry... This note is just to acquaint you with the fact that the rules are being made tougher. Bottom line: [1] what is an NDI and [2] how much harder will it be to have one approved by FDA? [1] The definition, set by statute has not changed. The FDA now phrases it this way: "On October 25, 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub.L. 103-417) was signed into law. DSHEA amended the FD&C Act by adding, among other provisions, (1) section 201(ff) (21 U.S.C. 321(ff)), which defines the term “dietary supplement”; and (2) section 413 (21 U.S.C. 350b), which defines the term “new dietary ingredient” and requires the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, to submit a premarket notification to FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction into interstate commerce, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered” (21 U.S.C. 350b(a)(1))." [2] How much harder? That of course translates into, how expensive? The more restrictions, the more expense. Being "grandfathered" and thus exempt from the NDI process is not easy, for example: "A notification is not required when the NDI and all other dietary ingredients in the dietary supplement have been present in the food supply as articles used for food in a form in which the food has not been chemically altered. ... FDA interprets the phrase “present in the food supply” to refer to the conventional food supply. Accordingly, we interpret a dietary ingredient that has been “present in the food supply as an article used for food” to mean a conventional food or conventional food ingredient. We do not consider prior use in dietary supplements to constitute presence in the food supply." More directly impacting cost is what are the requirements to prove the safety of the NDI? "That standard provides that a dietary supplement containing the NDI is adulterated unless there is adequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury." What evidence is sufficient to meet this standard? "A notification should provide evidence of a history of safe use; other evidence of safety, including clinical testing, animal testing, or both; or some combination of history of use and other evidence of safety. The submitted data should provide the basis for a conclusion that there is a reasonable expectation of safety under the proposed conditions of use of the dietary supplement containing the NDI." And, to the wise this interesting hint: "FDA expects that when history of use evidence alone is adequate to support the safety of the NDI in the supplement, notifiers will prefer to use that route. Compared to the cost and time needed to conduct clinical or animal toxicology studies, it is generally less expensive and faster to gather historical information and to conduct chemistry studies to establish the identity of the historically used materials." So, as your vitamin business moves ahead, you will need guidance in dealing with New Dietary Ingredients. The Vitamin Consultancy is here to help with all aspects of new product development, from concept through testing, labeling, claim writing and the rest of your product presentation needs. Standard Operating Procedures Dietary Supplement and Natural Products Development, Training & Deployment ANNOUNCING THE VITAMIN CONSULTANCY REGULATORY COMPLIANCE CERTIFICATION PROGRAM! “...documentation of employee training is necessary” This web site, www.SOPCertification.com provides access to my Standard Operating Procedures certification program, specially designed for the industry, with special emphasis on small and start-up companies, but any company that has its own labels needs this program! You need my 36 years’ experience as The Vitamin Lawyer and half-century in the nutrient industry! I can save your company hundreds of thousands of dollars in regulatory costs! Just embrace my three simple steps to regulatory compliance: [1] PROCEDURE – I work with your CEO to tweak my Standard Operating Procedures and Good Manufacturing/Marketing Practices for your company [2] CLAIMS – I work with your company for proper claims control, definition & substantiation... and the FDA required S&F Claims Notice. [3] TRAINING - It's not enough to have procedures, says FDA: train your team and prove they are qualified - through my Three Step Program: Presenting, Training, Certifying. That third step is what this Certification program is designed to accomplish: meeting FDA training requirements. Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained." Federal Register, page 34811 The Gold Standard - Vitamin Lawyer Consultancy Certification Program!

Summer FDA Inspection Season

VITAMIN CONSULTANCY UPDATE eMEMO

Memorandum from Ralph Fucetola JD June 2, 2014 To: Vitamin Lawyer Contact List: Some reminders as we head into the Summer FDA Inspection Season... This winter was difficult and the bureaucrats mostly stayed home. Now that the weather is getting better, they are on the prowl again. There are 400 people on this email list. Nearly all are involved in the natural products or services market. That means the people on this list are also on the FDA inspection list! Are you ready for your inspection? If you manufacture products or own a label you will be visited by the FDA, or by a State Inspector under contract to the FDA (yes, that is happening) likely this Summer. Are you ready for your inpection? Since only a relatively few on this list have availed themselves of my critical services, I can answer that question: YOU ARE NOT READY. [1] YOUR PAPER WORK MUST BE IN ORDER. My SOP service and Webinar System make sure that will happen. www.SOPcertification.com. [2] A reminder about Virtual FDA cGMP Facility Audits... When FDA visits you, as a label-owner, the agents will remind you that, just because your manufaturer is registered with them, and has been inspected by them, doesn't mean the manufacturer is GMP-compliant. They will say that you must show the FDA that the manufacturer is compliant... "When did you last audit your manufacturer? More about that here:   http://www.RegulatoryComplianceNetwork.com [3] Below is an important link from Dr. Rma regarding CBD Hemp Oil and Nano Silver... The Foundation of Health™.  Dr. Rima now has High Potency CBD Hemp Organic Chocolate bars available! CBDs and Chocolate! What's not to love? And when you add Nano Silver... Ebola and MERS haven't a chance. Regards, Ralph Fucetola JD High Potency CBD Hemp Oil™ and Nano Silver Here: http://drrimatruthreports.com/dr-rima-recommends-two-natural-solutions/ YES, WE HAVE CBD CHOCOLATE! If you want to consider the CBD Affiliate Program, go here: http://tinyurl.com/HempOilNow

Link to My Vital Connection University Intro Webinar
"Alternative Medicine" or Advanced Health Care?
http://www.vitalconnectionuniversity.com/course/category.php?id=4

Dr. Rima on GHSI: This is a threat to your business or practice!

http://drrimatruthreports.com/agenda-21-in-a-syringe-global-health-security-initiative/

The First Ten Years Video
Featuring General Bert, Doctor Rima and Counsel Ralph
http://youtu.be/dtWoKqrb8eY
 

The Vitamin Lawyer Infographic

VITAMIN CONSULTANCY UPDATE eMEMO

INFOGRAPHIC
Vitamin Consultancy: Pulling It All Together

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Memorandum from Ralph Fucetola JD February 24, 2014 To: Vitamin Lawyer Contact List: Here is an Infographic that summarizes my special offerings for 2014.

[Right Click and Open In New Tab for Full Size Image.]

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Link to My Vital Connection University Intro Webinar
"Alternative Medicine" or Advanced Health Care?
http://www.vitalconnectionuniversity.com/course/category.php?id=4

Natural Solutions Tenth Anniversary Webinar Series
Shaken Baby Syndrome, Elder Abuse or Vaccine Injuries?
http://tinyurl.com/SBShoax

The First Ten Years Video
Featuring General Bert, Doctor Rima and Counsel Ralph
http://youtu.be/dtWoKqrb8eY

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SOP Certification Program Options

SOP Certification Program Options

 

At Global Healing Center, Houston

Date:  10.24.13 From: Sher Komisar Certification Program Coordinator #914.966.8053 SOPclienthelp@gmail.com Ralph asked me to send you this short video explaining how the Vitamin Lawyer Webinar Training System works: http://www.youtube.com/watch?feature=player_embedded&v=FRPgPlaYml0 And below is an outline of Program Options. Regards, Sher

PROGRAM DESCRIPTIONS
The Program that is Right for Your Company

For individual Webinar offerings and pricing see:http://vitaminlawyercertification.weebly.com/program-options.html

Index:
[I] Supplement Company Certification Programs
[II Health Care Practitioner Certification Program
[III] Minister Practitioner Certification Program

[I] Supplement Company Programs

[3] CERTIFICATION PROGRAM THREE: Customized Gold Standard

      Access to the Webinars, Documents, Certification Test and Update Forum; time with your staff online [includes up to  TEN Certifications without extra charge]. Counsel Ralph works with your CEO to complete the SOP document and provides a live online, recorded discussion with your staff as part of the training. Your recording is for your use only.

[2] CERTIFICATION PROGRAM TWO: Customized

      Access to the Webinars, Documents, Certification Test and Update Forum [includes up to  FOUR Certifications without extra charge]. Your CEO and Counsel Ralph discuss customizing the SOPs.

[1] CERTIFICATION PROGRAM ONE: Bare Bones

      Access to the Online Webinars, Documents, Certification Test and SOP Format [includes ONE Certification without extra charge].

All levels include the Four Certification Webinars and the Bonus Record Keeping Webinar.

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[II] Health Care Practitioner Certification Program

If you own your own labels, even if you contract with suppliers, manufacturers, encapsulators, bottlers, labelers, shippers, even customer service... YOU must be in "a state of control..." by having Standard Operating Procedures (SOPs) that required proper contracts. If you carry-on any of these processes "in house'you must have appropriate SOPs, must train your staff in those SOPs and prove it.

This program does just that.

Includes: SOP Format, eBooks and the following Webinars:

DS and Medical Foods in Physicians’ Practice
Therapy is Not Treatment
Record Keeping

With a Bonus Webinar:

CAM Cautions
Lawful Copywriting

[III] Minister Practitioner Certification Program

This program is designed for ministers engaged in healing ministries. Professional Education.

The program includes  eBooks with extensive addenda and these Webinars:

Minister's Healing Practices
CAM Cautions
Therapy is Not Treatment
Lawful Copy Writing

Counseling / Training / Certification www.VitaminIndustryCompliance.com   From the FDA’s GMP Regulation: “…final Sec.  111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained.” - Federal Register, page 34811 Commit 10 Hours to Your Company’s Protection Today! "The FDA showed up unannounced. Said they’d be here for at least six days.  We showed them the SOPs Counsel Ralph prepared for us. They left after two days. It was comforting to know we could call Ralph any time during this, and he was there for us." A. C. Company CEO