Monday, August 30, 2010

08/30/10 - 60% of FDA Warnings are about SOPs

 
0.  Blogs & News – FDA Warning Letters; (sic) “Food Safety” bill…
1.  FDA Warning Letter and SOPs
3.  Private Vitamin Lawyer Ad Copy Webinar!
4.  Natural Clinical Trials Center
5.  Vitamin Lawyer connections…
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0. Blogs & News –

Recent issues of this Memo have covered such topics as recent Claims Surveys, Trademark “Fair Use”, CCDS (Company Core Data Sheets), Trends in FDA Warning Letters; the new FTC testimonial Rule and the FDA Rule regarding “expiration” dates and “best if used by” dates.

Access to the Vitamin Lawyer Webinars and more; videos, major site updates:
www .NaturalHealthOptions .net

News: Senate has not passed the fake “Food Safety” bill, S.510… yet:
URGENT ACTION ITEM; www .healthfreedomusa. org/?p=6269

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1. FDA Warning Letters… SOPs

This just in from FDA News:
“What problem is cited in 60% of all FDA warning letters?
Hint #1: It's a process issue — within your power to control and change.
Hint #2: It spans multiple departments or divisions of your company.
Hint #3: It's likely to be something you use every week.

Give up?
It's SOPs. Not the lack of them, but how poorly they're written, communicated, monitored and enforced.
One former top FDA official recalls walking into dozens of companies and being shown stacks of SOPs hot off the photocopier. But when he talked to lab and plant staff, the response was always the same. "What SOPs?" or, "Yeah, we saw them, but we're not sure what they mean." …
It is becoming increasingly clear that FDA and FTC want the Natural Products Industry to conform to standards that are in place for the toxic drug industry. While this level of regulation is neither necessary nor beneficial, companies must begin to “Render unto Caesar…” by having Standard Operating Procedures.
Additionally, having effective SOPs will actually help your company operate more effectively… you might even be able to take a vacation knowing that your staff has a clear set of guidelines to follow…
If you haven’t already engaged me to work with your staff on developing SOPs… it is getting late! Better act now rather than after the FDA visit! FDA agents have been bragging at various industry events that they’ve been given large amounts of “stimulus” money to drastically increase their inspection visits to companies large and small.
If the FDA hasn’t visited you in the past year… they will soon! ACT NOW! Call me: 973.300.4594
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2.  New Vitamin Lawyer Ad Copy Webinar – Private for Your Company, via Internet…

I am offering a private, two hour internet webinar, with Powerpoint visual aids and ebook, about writing lawful natural product ad copy, specifically including the new FTC testimonial rule. I will do the presentation over the net and answer any questions from your staff. Email me if your company is interested.

Webinar covers:

DSHEA and Nutrient Claims
Three Levels of Allowed Claims
FDA Guidance on Claims Substantiation
Allowed and Disallowed Terms (detailed lists!)
Common Mistakes
New FTC Testimonial Rule
Varieties of Substantiation
Traditional Uses
Substantiation & Other Resources


Sample: Slide #4

“Dietary Supplement products are governed by a complex of statutes and regulations.  The primary source of marketing rules for nutrient claims is the Dietary Supplement Health & Education Act of 1994 (DSHEA).  This Act is now part of the Food, Drug and Cosmetics Act that empowers the Food and Drug Administration (FDA).  DSHEA codified the right of marketers to make certain kinds of Claims about Dietary Supplements while forbidding others.

In any event, allowable Claims must also be, under Federal Trade Commission (FTC) rules, “truthful and not misleading” which means, there must be a certain level of substantiation for any Claim a marketer wants to make. On the horizon are several layers of international regulations, including the controversial Codex Alimentarius’ Vitamin and Mineral Guidelines that may restrict international trade in supplements and their ingredients.”

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3.  Natural Clinical Trials Center

The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials can begin shortly! GET YOURS SCHEDULED NOW. Check out the Videos and PPT Webinar on the Site!

www .NaturalClinicalTrials .org

• 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.

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4. 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. powerpicturesinc. net/store.html

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

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

Ralph Fucetola JD
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
http:// vitaminlawyerhealthfreedom.blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

Monday, August 2, 2010

08/02/10 - Survey Shows Claims Ads Outweigh Risk Disclosures for DS Products

 
0.  Blogs & News – Urgent Plea for Health Freedom Funding!
1.  Survey: Claims Language Resonates More than Risk Revealing
3.  Private Vitamin Lawyer Ad Copy Webinar!
4.  Natural Clinical Trials Center
5.  Vitamin Lawyer connections…

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0. Blogs & News –  
Recent issues of this Memo have covered such topics as Trademark “Fair Use”, CCDS (Company Core Data Sheets), Trends in FDA Warning Letters; the new FTC testimonial Rule and the FDA Rule regarding “expiration” dates and “best if used by” dates.  
I’ll be traveling from NJ to the beautiful, bountiful, temperate Highlands of Panama from August 4 through August 13 to celebrate the Grand Opening of the Dr. Rima Institute! You can learn more about the Institute at www .DrRima .net -- I will be available for client contact via email, ralph.fucetola@usa.net or via Skype: vitaminlawyer  
Access to the Vitamin Lawyer Webinars and more; major site updates:
www .NaturalHealthOptions .net

 
URGENT! SPECIAL PLEA FOR HEALTH FREEDOM FUNDING!  
If there were EVER any moment when YOU, personally or your company needed to SUPPORT Health Freedom, THAT TIME IS NOW.  As summer gets ready to end, several important cases are OPENING NEW LEGAL TERRITORY FOR YOUR HEALTH AND YOUR HEALTH FREEDOM… IF we can raise the funds to make that happen. We need to raise at least ten thousand dollars for litigation costs needed during the next 90 days.  
CODEX meetings cost a lot to attend too.   Switzerland is painfully expensive for Americans and that's where the last Codex Commission meeting was held. Big Pharma, Monsanto and the US Govt have not problem finding the money to pay the costs of attending. WE DO. The bills from our attendance at the last Codex meeting have come in and we need your help. Our shortfall for the Codex attendance is another ten thousand dollars,needed immediately.  
LEGAL CASES ARE IN PROGRESS TO SAFEGUARD YOU AND YOUR LOVED ONES.  Our lawyers work mostly pro bono but their office and litigation expenses are still significant.  URGENTLY, we need to continue the CoMeD “mercury in vaccines is toxic” case (actually, this case is about how the FDA fails to abide by its own rules and the Law requiring that vaccine additives not be “toxic to the recipient”) – the Judge dismissed the case for the usual reason, lack of “standing” and we MUST raise funds for this most important appeal.  
But that’s not all. There is also the West Virginia “religious exemption” appeal to ESTABLISH THE RIGHT OF EACH OF US TO A RELIGIOUS EXEMPTION TO VACCINATION, the Ear Candling case to STOP THE FDA from declaring anything that we want to use for our natural healthcare as either an untested drug or device which is therefore illegal (SO FAR, THEY'VE GONE AFTER NANO-SILVER, CHERRIES, WALNUTS, EAR CANDLES, OZONE, ETC., ETC., ETC.!) and the Stop the Shot case (which is about PREVENTING THE FDA FROM APPROVING AND USING UN-SAFE AND UN-TESTED INFLUENZA VACCINES).  
That case needs to be refilled FOR THE THIRD TIME (we won the other two rounds on narrow grounds but the FDA's illegal vaccine policy eluded our grasp) now that FDA has just approved the seasonal flu vax with H1N1 swine flu added! UNLESS WE 'STOP THE SHOT' millions of live virus mist vax doses will spread the disease and if squaline or similar substances are added, INFERTILITY and DEVASTATING CHRONIC DISEASE WILL RESULT. We need about five thousand dollars to get this case filed in time for the new flu vax season.  
SO YOUR HELP, YOUR PARTICIPATION, IS MORE URGENT THAN EVER BEFORE.  
What can you do? Your company can donate up to 5% of its profits annually. You personally can set up your TAX DEDUCTIBLE RECURRING DONATION to help shoulder the burden along with everyone else who understands how important HEALTH FREEDOM, OUR FIRST FREEOM, IS TO YOU AND YOUR FUTURE.  Let’s be frank: Natural Solutions Foundation NEEDS your support!  
If your company is ready to support Health Freedom, to ensure your tax-deductible donation is properly earmarked, please email me so we can make the arrangements needed for that purpose. We need significant funding now.  
THE WELLNESS INDUSTRY, AND OUR PERSONAL WELLNESS, IS SLATED FOR EXTINCTION.   NOW IS THE TIME TO ACT SO THAT WE CAN ACT FOR YOU.  
COMPANIES DONATING A PORTION OF THEIR PROFITS WILL BE LISTED ON OUR MAIN PAGE, www. HealthFreedomUSA.org and ON OUR VIRTUAL MALLS, AS CORPORATE SPONSORS with a message urging our huge email list, and our site visitors, to support our sponsors because they SUPPORT HEALTH FREEDOM. ARE YOU READY TO ACT?  
Contact me at ralph.fucetola@usa.net NOW!  
[Please note: URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
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1. Survey Shows Claims Ads Outweigh Risk Disclosures  
Bottom line: disclose all potential risks, if any… consumers pay attention to Claims, not disclaimers!  
“ Messages of potential risk or scientific uncertainty of functional food products has little impact on peoples’ willingness to purchase them, according to a study conducted using Danone’s Danacol cholesterol-reducing yoghurt… the lab experiment found that basic health information on functional foods encourages consumers to pay more for products, even if they are not the target population for the product in question. In addition, warning language on the products does little to deter consumers from paying the extra charge for the product. … Using a series of questionnaires, blind taste tests and selective information disclosure, participants were asked at various stages how much they were willing to pay for two products: a plant sterol-enriched yoghurt (Danone’s Danacol) and a natural yoghurt (Danone’s Nature). … Participants were provided with a series of information on the products, starting with the health benefits (helps reduce LDL (bad) cholesterol), and culminating with the potential risks (difficult absorption of vitamins A and E as explained in cholesterol reduction and scientific uncertainty).
 
The researchers found that participants expressed little interest for complete information about sterols and that ambiguity of the health information has only a limited impact on their choice and willingness to pay (WTP).
 
“Results show a statistically significant and positive influence of information about the cholesterol reducing effects on WTP. Interestingly, participants with no cholesterol also positively react to the information. Conversely, information about scientific uncertainties regarding the impact of sterols on the reduction of cardiovascular risks is not statistically influential among consumers with cholesterol,” they wrote.”
 
www. nutraingredients. com/content/view/print/313475
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2.  New Vitamin Lawyer Ad Copy Webinar – Private for Your Company, via Internet…  
I am offering a private, two hour internet webinar, with Powerpoint visual aids and ebook, about writing lawful natural product ad copy, specifically including the new FTC testimonial rule. I will do the presentation over the net and answer any questions from your staff. Email me if your company is interested.  
Webinar covers:  
DSHEA and Nutrient Claims
Three Levels of Allowed Claims
FDA Guidance on Claims Substantiation
Allowed and Disallowed Terms (detailed lists!)
Common Mistakes
New FTC Testimonial Rule
Varieties of Substantiation
Traditional Uses
Substantiation & Other Resources
 
Sample: Slide #4  
“Dietary Supplement products are governed by a complex of statutes and regulations.  The primary source of marketing rules for nutrient claims is the Dietary Supplement Health & Education Act of 1994 (DSHEA).  This Act is now part of the Food, Drug and Cosmetics Act that empowers the Food and Drug Administration (FDA).  DSHEA codified the right of marketers to make certain kinds of Claims about Dietary Supplements while forbidding others.
 

In any event, allowable Claims must also be, under Federal Trade Commission (FTC) rules, “truthful and not misleading” which means, there must be a certain level of substantiation for any Claim a marketer wants to make. On the horizon are several layers of international regulations, including the controversial Codex Alimentarius’ Vitamin and Mineral Guidelines that may restrict international trade in supplements and their ingredients.”  
-----------------------------------------------------  
3.  Natural Clinical Trials Center  
The Natural Solutions Center in Volcan , Panama is opening August 7, 2010, so Clinical Trials can begin shortly thereafter. Check out the Videos and PPT Webinar on the Site!  
www .NaturalClinicalTrials .org  
• 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.  
----------------------------------------------  
4. 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. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter. com/healthfreedomus  
------------------------------------------------  
Ralph Fucetola begin JD ...
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
http:// vitaminlawyerhealthfreedom.blogspot .com
www .globalhealthfreedom. org
If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.