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!

08/05/11 - Vitamin Lawyer Update eMemo - 8.5.2011

Welcome to our Summer Edition of the Update eMemo
[1] The New FDA NDI Rule: Threat to Your New Products!
[2] Yes, You do Need Clinical Trials…
[3] New Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from us!

http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php

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From a WINHS.org emailing about the FDA NDI Guideline
People in the industry are reacting to the guideline, which, as Dr. Rima points out, threatens ALL dietary supplement improvements since 1994!
This is what our friends at WINHS reported:
 
The amount of documentation and safety information that the Food and Drug administration (FDA) now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified the Dietary Supplements Health and Education Act (DSHEA) in 1994 and now establishes a process “ominously like the one for new food additives,” according to the Council for Responsible Nutrition (CRN).
 
CRN chief executive Steve Mister, in commenting on the Food and Drug Administration's (FDA's) long-awaited draft guidance on New Dietary Ingredient (NDI) notifications, said that the new NDI process now ‘sounds an awful lot like the food additive petition process.’
The Dietary Supplements Health and Education Act was enacted in overwhelmingly negative consumer and industry response to 1993 Congressional efforts to medicalize the supplements industry. It requires firms filing NDI notifications to establish a ‘reasonable expectation’ of safety, whereas those filing petitions for new food additives were required to demonstrate ‘reasonable certainty’ that no harm will result from use of the new food additive.
But if you look at the section on safety requirements in the new NDI guidelines and all of the studies that are now required, it now sounds an awful lot like the food additives petition process, which is exactly what Congress was trying to avoid.
“It is terribly disheartening to see the FDA going in this direction. They had a chance to create a workable system that would incentivize more companies to follow the law, use the NDI notification process and draw a line between responsible companies and those ignoring the whole process completely. “But instead they have come up with a document that stifles innovation and will deny consumers access to new products. We are terribly disappointed,” Mister added.
As to what now constitutes an NDI, the fact that changes to the manufacturing process, new solvents or new extraction methods could turn scores of old dietary ingredients, which were assumed to have been ‘grandfathered in’ under DSHEA into new NDIs was alarming enough. Ironically, the new requirements could force the industry to revert to extraction processes used nearly 20 years ago.
However, the fact that separate NDI notifications for supplements containing the same NDI are required if the supplement is reformulated in any way, and that notifications are required for finished products, not just ingredients, means that the FDA would be “flooded” with NDI submissions if the guidance were not revised.
‘Absolute nonsense with no basis in science’
A section in the new FDA guidelines claims that a synthetic copy of a constituent or extract of a herb or botanical is not a dietary ingredient at all – even if it is chemically identical to its ‘natural’ counterpart – as in the case of a number of higher dose vitamins, is particularly troubling, although not wholly unexpected.
The FDA recently argued that the synthetic organic compound, homotaurine, which was being investigated as a potential treatment for Alzheimer's disease, was not a dietary ingredient even though it is chemically identical to homotaurine from red algae extract. “Again, the FDA is defining incredibly narrowly what constitutes a dietary ingredient, but very broadly what is a ‘new’ dietary ingredient.”
 
Marc Ullman, with the New York law firm, Ullman, Shapiro & Ullman, which represents companies in the supplements industry, said he was particularly frustrated by this aspect of the guidance: “It really is preposterous, absolute nonsense, with no basis in science. If we’re talking about something that is chemically identical to a botanical extract, but is synthesized, there really is no rational basis for taking the position that it is not a dietary ingredient.”
 
Now, more than ever, your papers MUST be in order! Contact me to update your Standard Operating Procedures (SOPs) and Substantiation Note Books.
WHAT? YOU DON’T HAVE SOPs? WHAT ARE YOU WAITING FOR?
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Yes, you do need clinical trials!
 
Several clients are raising funds to invest in Clinical Trials or Clinical Studies; I was asked to prepare a “Comfort Letter” for the clients to use with their potential investors. If you would like a copy addressed to your Company, to raise the funds you need to invest to stay in the market, please email me!
The Red Letter warnings I sent you in recent months from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors?  I told you the 4 essential steps you must take in the last issue of the VL Update. Here, I add estimates of what these essential steps will cost your company. You need to budget now and start to do what you can to be prepared.
HHS Secretary Sibelius admitted that she has a $16 Billion slush fund under Obamacare that can be used to fund activities like the FDA’s 4,000 new inspectors… and FDA has already dramatically increased inspections, without those new bureaucrats!
 
What do you need to survive an FDA inspection? I’ve told you several times!

1. Standard Operating Procedures – in place and up-to-date -from $500. The SOP document not only satisfies FDA, but also helps you organize your business!
2. Product Substantiation Notebook – in place and up-to-date –from $500 plus your research time; this Notebook is a MUST if you get inspected! Part of the Notebook includes copies of the Structure and Function Claims Notices companies are required to file with the FDA within 30 days of marketing any claim. The cost for these notices is from $340.
3. Copy-writers who know how to avoid Red Flag claims & Illegal Testimonials! My webinar on these issues is inexpensive. $99 for the archived CAM Webinar; a private copywriter webinar just for your company copywriters will cost above $500 (the webinar includes an eBook specially written for your company).
4. A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients – This can cost up to several hundred thousand dollars. NCT offers a Minimal Clinical Trial from $35,000.

WHAT SHOULD YOU DO? Contact me NOW!  973.300.4594

The longer you put off addressing any of the above issues,
the more at-risk is your company!

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Archived Cautions for CAM Wellness Practices
http://www.naturalhealthoptions.net/LifeSpiritWebinars.php
"Do you have a CAM “Alternative” health practice? Do you provide nutrients, remedies or health related items to clients?
Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients?
Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices.
I am known as The Vitamin Lawyer, because much of my 36 year legal practice centered around helping people in CAM practices, nutrient purveyors and advanced healthcare teachers. Today I am a Trustee of Natural Solutions Foundation. I can keep you out of trouble and operating smoothly so you can fulfill your mission to help others…"
This $99 PEL Webinar runs about an hour through 32 slides. It includes an 18 page eBook of information and forms all of which would cost over $500 if one on one. This is a Natural Solutions Foundation Benefit Webinar."
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NCT Clinical Trials Center
The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials are beginning shortly! GET YOURS SCHEDULED NOW. The cost of a basic 12-person, one month Clinical Trial with a formal Report signed-off by credentialed professionals is about $40,000.
Prof. Udani on Clinical Trials - If you haven't seen it before, I urge you to watch the short video from Prof. Udani, who says that you need to get your Clinical Trials done if you want to remain in business! See his video from Expo West here:  
http://www.nutraingredients-usa.com/Research/The-secrets-of-success-for-clinical-trials/?c=gbrnO2ewSG2WQC7IuHls2Q%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

NCT Web Site:

www.NaturalClinicalTrials.org  - www.NutritionalClinicalTrials.org

Important Videos on the above web site:
Meet Drs. Laibow and Goodman.

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:
• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements
• These changes also mean you must not -
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"
• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.
The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Center Staff.
“In my opinion, over the next two to three years a company that still wants to be on the market and on the shelves needs to start investing in clinical trials today,” said Dr Udani.

New EU Cosmetics Dossier Service from NCT:http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php

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f so, free Skype.com is one of the easiest ways to contact me, no matter where I may be.
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Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org
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