09.05.12 - What Happens When The FDA Inspects: A Case Study

… Vitamin Lawyer.com Consultancy
Update eMemo – 9.05.2012

What Happens When The FDA Inspects: A Case Study

Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...

[1] Vitamin Lawyer Update eMemo Archives Updated!
[2] A VITAMIN LAWYER CLIENT WAS JUST INSPECTED BY THE FDA
[3] Yes, You do Need Clinical Trials…
[4] Vitamin Lawyer Connections: All the Links You Need!
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[1] Vitamin Lawyer Update eMemo Archive Updated!

            I confess I outsourced finally bringing the Vitamin Lawyer Update eMemo Archives up to date. Over the next couple weeks you will find more of the past memos posted as blogs at: http://vitaminlawyerarchives.blogspot.com/ . Bookmark this page! The entries will be indexed for ease of searching.

[2] What Happened Last Week when a VL Client was Inspected by the FDA

At first, the FDA agents announced the inspection would probably take six days… then the Vitamin Lawyer-drafted SOPs (Standard Operating Procedures) documentation was provided to the agents. Two days later (four days less than predicted) the agents left, more satisfied than not. Just 5 minor Observations were issued, requiring changes in the SOP. This client’s experience will benefit all, as I have now updated the SOPs to cover the observations and to make other changes that will strengthen the process when other Vitamin Lawyer clients are inspected; as all will be, more regularly than in the past.

Observation 1:  To have documented qualifications of contract manufacturers and to institute a process to receive documentation from the manufacturer that each lot is approved prior to release.

Observation 2:  Document a quality control person in charge and to have written procedures for quality control responsibilities.

Observation 3:  Document procedures for holding and distributing operations in the proper environment and organizational procedures to prevent error or contamination.

Observation 4:  Develop an employee training manual and document training of employees.

Observation 5:  Document established procedures and operations to conduct when a product is returned and keeping records of returned products.

These changes are documented in revisions to the Standard Operating Procedures (SOPs). A specific Contract Manufacturing Agreement has also been developed, meeting GMP requirements. Vitamin Lawyer monthly retainer clients will receive the updated SOPs. Any others who have not yet completed their SOPs are reminded that “having one’s papers in order” is more necessary now than ever before.

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[3] Yes, you do need clinical trials! Further Services You Need!

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 pastt 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. The FDA has already dramatically increased inspections, without those new bureaucrats!

[4] Vitamin Lawyer Connections

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."

Vitamin Lawyer Connections…

Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be.

My Skype handle is: vitaminlawyer

Our new affiliation site: www.naturalhealthoptions.net

Do you have an affiliation program? We’d like to list it.

If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …

And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www.youtube.com/watch?v=wWPvzpn0YgA
www.powerpicturesllc.com – Airing on: www.telostv.com

Follow me on Twitter - www.twitter.com/healthfreedomus 

ralph …

Ralph Fucetola JD

www.NaturalHealthOptions.net
www.vitaminlawyer.com
http://vitaminlawyerarchives.blogspot.com
http://vitaminlawyerhealthfreedom.blogspot.com
www.HealthFreedomPortal.org

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06/25/11 - Vitamin Lawyer Update eMemo - 6.25.2011

Welcome to our second June edition of the Update eMemo
[1] Who Needs Vitamins? Almost everyone!
[2] List of Spam Trigger Words: http://www.therightlist.com/triggerwords.htm
[3] Warnings for Natural Products Companies: Clinical Studies Needed!
[4] And, if you are looking for a safe haven for your natural product profits: www.NSFGreenFund.org
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http://www.nutraingredients.com/Industry/Supplements-Who-needs-them-Er-around-85-of-working-adults-say-stats/?c=gbrnO2ewSG197jkdpl91ew%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
Supplements – Who needs them? Er, around 85% of working adults, say stats
The UK and European food supplements Industry has hit back at a recent UK National Health Service (NHS) report that largely cast supplements as being ineffective, and recommends ‘a balanced diet’ as the best way to achieve optimum nutrition.
The NHS backs the balanced diet, but stats show it fails to provide adequate nutrient levels
In backing ‘regular’ dietary sources for key nutrients, the NHS report then questioned supplement safety and scientific backing, stating there often did not exist enough “robust research” and “robust testing”.
“Overall it is clear that we may be placing our hope in products that require far more testing,” the report, called ‘Supplements – Who needs them?’, concluded.
The UK Health Food Manufacturers' Association (HFMA) pointed to UK Food Standards Agency (FSA) statistics that showed only 13% of men and 15% of women aged 19 to 64, ate the government-recommended five portions of fruit and vegetables every day….
“But evidence from the National Diet and Nutrition Survey shows that a significant proportion of the UK population simply doesn’t achieve nutritional sufficiency through diet alone.”
Keen pointed to FSA research that showed only 11 adverse reactions to food supplements over an 11 year period, "the majority of them in the lowest category of harm. Compared to other foods or medicines, food supplements have an enviable record.”
He added: “One must remember that the natural health industry and HFMA members already operate in one of the toughest regulatory environments in the world. …
“…However, daily supplements provide important nutritional insurance for millions of users looking to safeguard their nutritional intake.” …
Julie Hayward, the executive secretary of the UK Council for Responsible Nutrition (CRN), said the NHS suggestion that adequate nutrition could be achieved through a balanced diet, “is flawed.”
Excerpts from article by Shane Starling, 08-Jun-2011
-----------------------------Warnings for Natural Product Companies!
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.
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Vitamin Lawyer Connections…
Notice of Fee Increase: New rates: $340 standard and $285 discounted.
Do you Skype? I
f so, free Skype.com is one of the easiest ways to contact me, no matter where I may be.
My Skype handle is: vitaminlawyer
Our new affiliation site: www.naturalhealthoptions.net
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesinc.net/store.html
Follow me on Twitter - www.twitter.com/healthfreedomus  
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Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org
If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

06/28/07 - Randomized Clinical Trials; cGMPs posted

VLUeM – 06.28.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. RCT (Randomized Clinical Trials) and nutrients
2. New cGMPs now available on net
3. http://www.vitaminlawyerhealthfreedom.blogspot.com
4. CRUSH media release: Silver Safety Standard
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1. RCT (Randomized Clinical Trials) and Nutrients

This article by Dr. Melton is cogent and worth reading. The article goes to the heart of the coming cGMPs – how will you substantiate the claims you make about your products? How will you prove the identity and quality of the ingredients? If you have the time to think about what your company will be doing in two years when the cGMPs become effective for small companies, this is something you need to think about… and, yes, you do need to start thinking now…

Clinical trials - gold standard or white elephant?

25/06/2007 - Randomised clinical trials are the ultimate. Forget what the observational studies tell us, if the RCT gives us an answer it must be the final word, right? Wrong.

The value of such trials for the food industry is undeniable, but too often nutrients are pulled out of context, following the same methodology as used for the testing of drugs.

But let's not forget that by following the drug model we are supplementing the diet with one or two nutrients, each at a single dose, for a set period of time. Can a time-constrained randomised trial really capture a lifetime of consumption with respect to chronic disease?

Randomised clinical trials work by randomly assigning a group of volunteers to receive an active compound, be it a drug or nutrient(s), or a non-active comparison, be it an inactive form of the active compound or a placebo. Observational studies, as the name suggests, observe a population and relate dietary intakes of food and nutrients to the occurrence of disease.

We need to consider the science as a whole and not blinker ourselves with results of one big clinical trial, regardless of how much money it costs and what universities were involved.

For food items that do not normally form part of the usual food chain, randomised clinical trials are the best of the best because such compounds can be tested and retested successfully.

Phytosterols, probiotics, or botanical supplements, for example, fit into this category.
Indeed, clinical trials on phytosterols have shown time and again that daily consumption of 1.5 to 3 grams of phytosterols/-stanols can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease.

Studies looking at how these results transfer into real free-living populations have backed up the clinical trials, showing a stabilisation of cholesterol levels in certain populations.

So we know the benefit of clinical trials. But when we start using this approach for vitamins, minerals, antioxidants and other nutrients, we come a little unstuck.

Some may say that I'm over-reacting, but let's just look at the report published in the New Scientist magazine that slammed antioxidant supplements as myth.

Despite a vast body of observational/ epidemiological studies linking an increased dietary intake of antioxidants from fruits and vegetables to reduced risks of a range of disease, including cancer, cardiovascular disease and diabetes, when such antioxidants have been extracted and put into supplements, the results, according to RCTs, do not produce the same benefits and may even be harmful.

So the author of the article, Dr. Lisa Melton from the London-based registered charity, the Novartis Foundation, concluded that antioxidant supplements are too good to be true.

Is this really the answer or is it due to poor study design? Would a two-year trial of vitamin E, let's say, really produce a reduction in the risk of a chronic disease?

To illustrate this point further, we only need to go back to last year's Women's Health Initiative (WHI) trial that followed 18,176 post-menopausal women taking calcium (1000 mg) and vitamin D (400 IU) supplements. A similar population (N=18,106) was given a placebo. The subjects were followed for about seven years and the researchers reported that the supplements 'had no effect' on the risk of colorectal cancer.

None of the women had the cancer at the start of the study and colorectal cancer has a long latency period of 10 to 20 years, which begs the question - could we really have expected to see an effect?

We also need to remember that nutrients often work in synergy with one another and exert effects on multiple body tissues, unlike pharmaceuticals.

Additionally, many randomised clinical trials look at the effect of nutrients in diseased populations. Surely the damage of a lifetime's poor nutrition has already been done. When we obtain negative or null results from such trials, should we really be surprised?

The power of nutrients is in the prevention, not cure, of disease.

So what should we do? I don't pretend to have any answers. These are for ladies and gentlemen with infinitely bigger brains than me.

Realistically, there are no viable alternatives out there at present. Randomisation is the best way of limiting bias that creeps into every study, and controlling, specifically with placebo, is the best way to make comparisons.

For those times where randomised trials clearly aren't the best option, then we probably need to look at the observational studies and mechanistic studies in greater depth, and place more value on them.

The research community as a whole must work together to re-evaluate how to get the most from research into nutrition. Lots of different types of studies are out there. Let's make the most of what we already have.

Stephen Daniells is the Food Science Reporter for NutraIngredients.com and FoodNavigator.com. He has a PhD in Chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.

If you would like to comment on this article please contact stephen.daniells'at'decisionnews.com
http://www.nutraingredients.com/news/ng.asp?n=77611&m=1NIE625&c=jegwylrviswtnqa

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2. FDA publishes Current Good Manufacturing Practices for Dietary Supplements

I’m reading them, but so can you, at: http://www.cfsan.fda.gov/~lrd/fr07625a.html (467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).

Here are some comments by FDA, from the commentary preceding the new rule, that tell us a lot about where the present administration of FDA is taking us: “…we disagree with the comments asserting dietary supplements have a track record of safety such that dietary supplement CGMP requirements are unnecessary. Section 402(g) of the act does not require us to establish a ‘bad’ track record of safety in the manufacture of dietary supplements before we may issue a dietary supplement CGMP rule. Furthermore, we disagree with the comments comparing dietary supplement safety to drug safety; there are different statutory requirements, different regulatory requirements, and different safety evaluations for dietary supplements and drugs.”

We can hope there will be a change of Agency attitude when the Administration changes in about a year and a half; especially if the good doctor from Texas replaces the current Texan occupying the White House. I’ll provide more tidbits as I read the materials.

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3. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com

I just posted a link there to an 8 minute presentation I taped for Natural Solutions Foundation, for use with health-friendly delegates at next week’s Codex Commission meeting in Rome.

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4. CRUSH Silver Safety Standard

The Committee on the Responsible Use of Silver in Health (of which I am a member) is releasing the final version of its Silver Safety Standard (The “12 for 25 Rule). The media release will be posted on PRWeb shortly and can be seen at www.silverfacts.com or on my Blog.