Welcome to our Summer Edition of the Update eMemo
 The New FDA NDI Rule: Threat to Your New Products!
 Yes, You do Need Clinical Trials…
 New Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from us!
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CRN chief executive Steve Mister, in commenting on the Food and Drug Administration's (FDA's) long-awaited draft guidance on New Dietary Ingredient (NDI) notifications, said that the new NDI process now ‘sounds an awful lot like the food additive petition process.’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?
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!
- 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!
- 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.
- 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).
- 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.
the more at-risk is your company!
Archived Cautions for CAM Wellness Practices
"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."
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:
Meet Drs. Laibow and Goodman.
• 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.
Vitamin Lawyer Connections…
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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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