0. Blog & News
1. eMail Marketing Metrics
2. Vitamin Lawyer Webinars
------------------------------------------------------
- Blog & News – New Vitamin Lawyer Video
NEW VITAMIN LAWYER VIDEO
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter.com/healthfreedomus
Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
“>Americans spend $34B for alternative medicine
>
>July 30, 2009 4:31 PM EDT
>
>ATLANTA - Americans spend more than a 10th of their out-of-pocket health care
dollars on alternative medicine, according to the first national estimate of
such spending in more than a decade.
>
>Chiropractors, massage therapists, acupuncturists and herbal remedies are
commanding significant consumer dollars as people seek high-touch care in a
high-tech society, the report released Thursday by the government shows.
>
>Altogether, consumers spent an estimated $34 billion on those and other
alternative remedies in 2007, the report found.”
www. newstin. com/rel/us/en-010-016784061
From the invite for the Fourth FDA Inspection Summit:
“The FDA is gearing up and cracking down. Here are a few highlights of the agency's FY10 plans:
- More than double the number import field examinations
- 346 new hires for the signature Safer Products initiative
- A 43 per cent increase in foreign GMP surveillance inspections
- New
field offices in New Delhi, Beijing, Shanghai, Mexico, Costa Rica and
other overseas hot-spots, manned by at least 60 staffers ”
[Please note: all URLs in this memo are "broken" with spaces inserted
after the www. to avoid the memo being treated as "spam" by certain
email service providers.]
-----------------------------------------------
- eMail Marketing Metrics - www. addme. com/blog/promotional-resources/email-marketing/is-email-marketing-dead.htm
“How do you measure an effective email campaign? There are 3 ways(apart from conversions):
Delivery - how many emails were sent out to the list
Open Rate - how many emails were read…
Click through Rate - how many readers then clicked through … to a landing page
“These
metrics can be skewed however. Open rates are often measured by the
amount of times a tracking image is loaded, however most email clients
by default don't load images. Some subscribers also choose to receive
text emails, this again makes it difficult to measure as it's not
possible to embedded an image into a raw text email.
“A
recent study by www. emarketer. com and www. epsilon. com I found to be
very interesting, and shows that email marketing is still alive and
doing very well. Top level figures report that with the correct creative
and a clean targeted list you can achieve very good results …
“Q1 2009 Email Trends and Benchmarks
Delivery Rate 94.1%
Open Rate 22.1%
Click Through Rate 6.1%”
------------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Setting up a Student Account at VCU is free and relatively easy:
www. VitalConnectionUniversity. com
[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A
PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. $49.95 - Includes eBook
with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169
[2] CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84
[3] Bringing New Natural Products to Market
Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
[4] Sustainable IRA
Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)
Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time!
The Foundation Trustees lead you through an interesting slide
presentation that will help you make important decisions about where you
want to be in the event conditions in the US continue to deteriorate.
Free Webinar ($25 donation suggested). With eBook.
Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95
Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
0. Blog & News
1. Multivitamins are Good for YOU!
2. FTC Targets “Cancer Cures”
3. Vitamin Lawyer Webinars
4. Important Article from MLM Legal Guru
------------------------------------------------------
- Blog & News – New Vitamin Lawyer Video
NEW VITAMIN LAWYER VIDEO
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$14.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter.com/healthfreedomus
Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
[Please note: all URLs in this memo are "broken" with spaces inserted
after the www. to avoid the memo being treated as "spam" by certain
email service providers.]
-----------------------------------------------
- Multivitamins are Good for YOU!
Multivitamins may lower heart disease death risk
By Stephen Daniells, 20-Jul-2009
“Long-term
regular consumption of a multivitamin may reduce the risk of dying from
heart disease by 16 per cent, according to a new study from the US.
Intakes
of vitamin E over 215 milligrams per day over the course of ten years
were also associated with a 28 per cent reduction in the risk of death
from cardiovascular disease, according to findings published in the American Journal of Epidemiology.
The
news supports the use of multivitamins and particularly vitamin E,
much-maligned and linked to increased risk of ‘all-cause mortality’ in a
controversial meta-analysis in the Annals of Internal Medicine in 2004.
The
new study, led by Gaia Pocobelli from Fred Hutchinson Cancer Research
Center at the University of Washington, also contradicts conclusions
from a controversial meta-analysis published originally in the Journal of the American Medical Association
(2007, Vol. 297, pp. 842-857). The meta-analysis reported that
supplements of vitamins A and E, and beta-carotene may increase
mortality risk by up to 16 per cent. On the other hand, vitamin C did
not have an effect on mortality.
In
terms of other causes of death, Pocobelli report that multivitamins did
not decrease the risk of either total mortality, or cancer mortality.
On the other hand, vitamins C and E were associated with small decreases
in risk of total mortality.
According
to a National Institutes of Health (NIH) State-of-the-Science Panel,
half of the American population routinely use dietary supplements, with
their annual spend estimated at over $20 billion.
Recent
results of the National Health and Nutrition Examination Survey showed
that 35 per cent of the US adult population regularly consumes one or
more types of multivitamin product (Am. J. Epidemiol., 2004, Vol. 160, Pages 339-349).” Continued…
www. nutraingredients. com/content/view/print/253959
-----------------------------------------------
2. FTC Targets Cancer Cures: FTC spells out enforcement priorities for deceptive ads
By Lorraine Heller, 23-Jul-2009
“Bogus
weight loss products and cancer ‘cures’ have been amongst the top
priorities of the US Federal Trade Commission (FTC) in its attempts to
police product marketing, the Senate heard yesterday.
“In
a testimony before the Senate Committee on Commerce, Science, and
Transportation’s Subcommittee on Consumer Protection, Product Safety,
and Insurance, FTC described its recent enforcement efforts to address
deceptive marketing.
“
‘Developments in science and technology, as well as in marketing
strategies, have led to a proliferation of products and services and a
parallel burgeoning of advertising claims about how these products will
make us thinner, better looking, and healthier; improve the quality of
our lives; make us richer; and even improve our environment,’ said David
Vladeck, director of the FTC’s Bureau of Consumer Protection.
“Health and safety claims is an area of “particular importance” to the commission’s current enforcement agenda, said Vladeck.
“
‘Marketers of dietary supplements and other products have become very
bold in the medical benefit claims they are making to sell their goods.
Many are going far beyond the basic structure/function claims that are
permitted under the Dietary Supplement Health and Education Act,’ he
said.
“Over the last year, FTC launched what it called a ‘major law enforcement initiative targeting bogus cancer cures’.”
www. nutraingredients-usa. com/content/view/print/254427
------------------------------------------------
3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A
PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. - Includes eBook
with forms.
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
www. healthfreedomusa. org/?page_id=2002
(this page links to VitalConnnectionUniversity.com).
Once at Vital University, at the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past and the new webinar as well.
Other Webinar Archives [follow instructions above to reach these]
A. CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook with forms.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
C. Sustainable IRA
Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)
Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time!
The Foundation Trustees lead you through an interesting slide
presentation that will help you make important decisions about where you
want to be in the event conditions in the US continue to deteriorate.
Free Webinar ($25 donation suggested). With eBook.
Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95
Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources).
----------------------------------------------
4. Important Article from MLM Legal Guru
Gerald
P. Nehra, Esq. is a very well known MLM lawyer. While I don’t usually
reproduce whole articles in the VL Update eMemo, this one is a must read
for all MLM people, so it is reproduced below.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
----------------------------------------------
Gerald P. Nehra
Attorney at Law
What follows is from the legal perspective of an attorney who has had
to defend M/L/M companies from regulatory scrutiny and attack. The
creative genius of entrepreneurs is not discussed or highlighted in
the following analysis. The marketing view is missing. The hype and
the fluff and the attention-grabbing bells and whistles are left to be
discussed by authors writing from a marketing perspective. This
article does, however, take into account the internet and e-commerce.
The laws in this area have not kept pace with technology, but
technological advances have not suspended the application of the laws.
When all extraneous twists and turns are scraped away, what is legally
left needs to look something like this, or the M/L/M operation will
not be allowed to continue long term in the United States or Canada.
A. The company brings a product or service to the marketplace that
1. is retailable, and
2. is being retailed, and
3. does not include a right to bring more participants to the
company. A service that contains the right to bring customers to the
company, like a shopping mall, can qualify, but not if it also
contains the right to bring more income opportunity seekers (legally,
“participants”) to the company. Multilevel income opportunities
CANNOT be sold in the United States or Canada.
B. The product or service reaches the end user through efforts of
direct sales representatives (independent contractors), rather than
through traditional retail establishments or other channel of
distribution choices like mail order or telemarketing. This channel
definition is driven, not by any e-commerce techniques, but rather by
the payment of money to an independent contractor for producing a
result. Another characteristic of this channel is a lack of employees
(involved in selling) to whom W-2s are issued but rather the presence
of independent contractors to whom 1099s are issued.
C. The company’s compensation plan
1. is designed to reward representatives for the sales of the
product or service they are involved in, and
2. includes an incentive and reward for the representative to be the
“new representative finder” (legally, another “participant”)
in the form of payment to a representative who introduces an
additional representative to the company, BASED ON the sales volume of
the second representative.
It is the presence of the design plan feature described in C2 above
that subjects a single-level direct selling company to multilevel laws
and regulations, whether or not the company chooses to use the term
“multilevel” in its literature. Not all companies or distributors
agree with this definition. I respect differing views. At the time of
this writing, I am unaware of any regulatory agency in the United
States or Canada who defines an M/L/M company substantially
differently from what I have just stated. It is the compensation
feature described in C2 above that brings the company under the
microscope of regulatory scrutiny. A “participant” in the legal
sense has the right to introduce another “participant.” If your
rights stop at finding, introducing, locating, or selling to
“customers,” you are not a “participant” in the legal sense,
rather you are operating in the C1 portion of this analysis. Whether
or not there are “participants” is very critical. The fact that
you may receive a 1099 on the rewards of your efforts does not make
you a “participant,” unless you also have the right to introduce
others who also have the same 1099 potential. No amount of e-commerce
manipulation or affiliate program wording can change this. Only
legislatures can change laws, and they are notoriously slow to act.
Personal consumption by representatives is much discussed. A lot of
it is good for the company’s bottom line, but too much of it is bad.
How much is too much? One hundred percent personal consumption creates
a presumption in the law and in the analysis of the business by
regulators (in my view) that the only persons willing to buy the
products or services are income opportunity seekers, and the amounts
being paid are no more than disguised headhunting fees. Such payments
are pyramidal and illegal.
“What percentage of sales to non-representatives do I need to be
legal?” You do not want to ask the question, and you do not want it
answered for you by government agencies. There are companies with very
high percentages of “personal consumption” by their
representatives that pose no risk of abuses, such as deceptive
recruiting, inventory loading, or the “running out of people”
pyramid risk. Also, an argument can be made that people who become
representatives solely to buy products or services at wholesale,
rather than retail, and who do not also buy for resale and do not
sponsor, are customers, rather than income opportunity seekers. For
the purpose of defending high amounts of personal consumption, an
argument can be made that one does not become a “participant” in
the legal sense until one introduces another participant, since only
then can rewards flow based on the second participant’s sales
volume. If all of the elements of the analysis above are present, the
percentage of personal consumption by representatives should not
matter. If the question is even raised, it usually means A1, A2, or C1
is missing or flawed. But I will not duck the question. My answer is
this: Twenty percent of total sales to non-representatives should be
sufficient to rebut any presumption. Of course, other pyramid tests
would still apply. One reason I say this is because companies with
very high personal consumption percentages have been going strong for
ten years or more and pose no pyramid risk.
A1, A2, or C1 in the above analysis cannot be missing or flawed. C2
alone, without A1, A2, and C1, is deemed an endless chain and an
illegal pyramid. If in the design or in the implementation of an M/L/M
program all that is visible—all that the regulators see, all that is
really happening—is income opportunity seekers who find more income
opportunity seekers who find more income opportunity seekers, etc.
(legally, “participants”), the regulatory end is near, sooner or
later. The regulators, with or without specifically drafted laws,
state their position simply—you run out of people.
So, since retailing is so essential, let’s examine it in more
detail. What does “retailable” mean? It simply means “Will
people buy my product or service?” The question appears almost too
simple, so we need to be more specific about “people.” The
“people” need to be people in a “customer” sense, rather than
in an “income opportunity seeker” sense. There are hundreds of
reasons why people will not buy products or services: They already
have one; the cost is too high; they have no need or desire to own
one; what is being sold is of poor quality; etc. The test here does
not need to find a specific reason. If no one but income opportunity
seekers buys the product or service, the presumption is raised that
the product or service is not retailable, and A1 in the analysis is
flawed. Look at traditional companies by comparison. If no one buys
what they offer for sale, they are out of business. If the M/L/M
company continues in business anyway, regulators presume the company
is selling the right to sponsor yet more people. Federal and state
laws prohibit selling the right to sponsor.
Once the retailability of the product or service is questioned, the
risk of the MLM element of the compensation plan (C2 above) being
attacked as illegal greatly increases. An argument can be made that
people who become representatives solely to buy products or services
at wholesale, rather than retail, and who do not also buy for resale
and do not sponsor or refer, are customers, rather than income
opportunity seekers.
Examining A2 in more detail, it differs from A1 primarily in the
focus placed on retailing by both the company and its distributors. If
the product or service is not retailable, we do not even get this far.
If the product or service is retailable, but little corporate or field
focus is placed on retailing, A2 is flawed, possibly not in the
design, but surely in the implementation. Some things to look for:
Does information exist in paper or electronic form specifically
designed to assist the retailing effort? Does training exist to assist
the field in its retailing efforts? Is retailing discussed in
opportunity meetings or on web pages if the company is primarily
e-commerce driven? Once the lack of actual retailing activity is
identified, the risk of C2 being deemed illegal greatly increases.
C1 and C2 are separated on purpose. It is a critical separation for
legal positioning. The existence of a viable income opportunity,
without the necessity of recruiting more income opportunity seekers,
is absolutely essential. Simply stated, one test for the legality of a
multilevel income opportunity is a single-level analysis. Can money be
made by the income opportunity seeker without sponsoring? The form of
the single-level income opportunity is not as important as the
substance. Traditionally, the representative’s first way to make
money is to keep the difference between what he/she pays for the
product and what is received for the product when he/she resells it.
This “two passages of title” method of distribution has been
replaced to a great extent by the representative being a “customer
finder” and the company performing direct fulfillment. The
e-commerce revolution may totally obsolete the “two passages of
title” method of distribution. Some companies add to the first
profit opportunity an additional profit opportunity in the form of
bonuses, rebates, or commissions. The key to the C1 analysis is that
sponsoring of another “participant” must be optional. There must
be a place in the compensation plan for the non-sponsoring income
opportunity seeker. If the ONLY way an income opportunity seeker can
make money is to bring to the company more income opportunity seekers,
the plan is fatally flawed. It is an endless chain. The argument that
it “really is not” an endless chain, when you carefully examine
the design and read all the fine print, will not hold up if the field
force presents it only as a sponsoring opportunity. The fine print
does not save the day. How a plan is implemented carries much more
weight than how a plan is designed.
Some specific points need to be made about C2. No reward can be paid
to the first representative for the act of introducing the second
representative to the company. Such payments or rewards are called
“headhunting fees” and are barred by law. No charge or required
product purchase can be imposed on the second representative by the
company or the sponsor as an entry fee. (A required purchase of an
at-cost, non-commissionable sales or starter kit is permitted.) Simply
put, neither the company nor the sponsor can profit from the sole act
of recruiting. Profit to the company and profit to the representatives
must come from the sale of products and services to customers, and
only from the sale of products and services to customers.
If, from the start, all of the points made above are addressed in
the initial design and are monitored in the implementation, regulatory
scrutiny is unlikely. When inadequate or no attention has been paid to
A1, A2, and C1, the states with proactive consumer protection agencies
are likely to start an investigation rather quickly. I advocate
correct initial design and company-monitored, correct implementation.
However, some companies getting off on the wrong foot can recover.
Fixing a flawed plan can be as easy as changing language in
corporate literature, or as difficult as rolling out totally new and
substantially restructured products, services, and methods of
compensation, accompanied by massive nationwide retraining. Some
companies have made these transitions, and others have died in the
process. When the alternative is a cease and desist order in a key
state, with more states to follow, hard choices must be made. The
bottom line will be affected. Fickle representatives will jump ship.
Some representatives seek out and work flawed plans for the quick
monetary gain and are prepared to move on to the next one at a
moment’s notice.
Patching up C1 and C2 is inadequate, without a corporate resolve to
address A1 and A2. It starts with the company’s product or service.
Long before M/L/M, around the turn of the century, someone said,
“Build a better mousetrap, and the world will beat a path to your
door.” The “making legitimate,” or “legalizing,” of an M/L/M
plan under regulatory scrutiny can only be accomplished by going to
the core. The core is the product or service being brought to the
general public marketplace by the company, and, of course, how it is
brought to the marketplace. The core is not the bells and whistles of
the compensation plan.
If a flawed M/L/M plan is under attack, it must be taken most
seriously. State and federal regulators are too savvy to accept
wordsmithing patches without substantive changes to the way business
is done. Often, distributor “leaders” want the simple formula of
“get two who get two, et cetera, and cash those commission
checks.” If, in the analysis above, A1, A2, and C1 are flawed,
either in the design or the implementation, significant changes to the
way business is done must be made. If few or no one will buy the
company’s products or services, except to play the game, then the
M/L/M plan will be attacked as an endless chain money game. The state
or federal agencies will eventually hound the company out of business.
What is often required to close or settle an investigation is a
corporate marketing shift to a retailing focus, followed by field
retraining. Corporate monitoring and verification that the changes are
being implemented in the field are often required.
Since retailing is the legal answer to M/L/M longevity, finding the
right products or services is critically important. But I am
digressing from the legal perspective. To wrap up, I have looked for
other paths through the jungle of laws and regulations regarding
M/L/M. E-commerce increases the many variations of selling, but does
not bring with it exemptions from anti-pyramid statutes. If another
path exists that does not include or require these legal ABCs, I have
not found it.
--------------------------------------------------------------------------------
-------------------------------
Gerald P. Nehra is a private practice Attorney at Law. He is one of
only a few attorneys nationwide whose practice is devoted exclusively
to direct selling and multilevel marketing legal issues. He began his
legal career in 1970, and from 1982 to 1991 he was the Director of the
Amway Corporation Legal Division. He can be reached at Nehra & Waak,
Attorneys at Law, 1710 Beach Street, Muskegon, Michigan 49441,
231-755-3800. His e-mail address is GNehra@mlmatty.com
GNehra@mlmatty.com>
. You are invited to visit his web site at www.mlmatty.com
<http://www.mlmatty.com/>
. Permission to reproduce, with this attribution included, is
granted.
0. Blog & News – EU Health Claims Decisions /New Vitamin Lawyer Video
1. FDA Finalizes AER Guidelines
2. FTC Testimonial Advertising Changes are Coming…
3. Vitamin Lawyer Webinars
------------------------------------------------------
- Blog & News –
For
your EU exports: “The European Food Safety Authority (EFSA) and
European Commission have acknowledged for the first time that the July
31 deadline for publication of the first batch of health claim opinions
will not be met. EFSA will now publish the first batch of 1024 claim
opinions “by September” although
a spokesperson was not able to confirm the exact date nor what effect
this would have on the ultimate nutrition and health claims deadline of
January 31, 2010.”
www. nutraingredients. com/Regulation/EFSA-First-article-13.1-health-claim-opinions-delayed-until-September-2009/
NEW VITAMIN LAWYER VIDEO
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$14.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter.com/healthfreedomus
Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
Dr. Laibow deconstructs Codex’s pretensions
www. youtube. com/watch?v=Hyo_VjJSVFo
[Please
note: all URLs in this memo are "broken" with spaces inserted after the
www. to avoid the memo being treated as "spam" by certain email service
providers.]
-----------------------------------------------
1. FDA Finalizes AER Guidelines (July 13, 2009)
The Natural Products Association issued the following statement –
“The
final version is almost identical to the draft guidance on this topic
(not to be confused with the labeling guidance, which still has areas of
contention).
“The
final guidance clarifies the agency’s expectations of the information
the FDA expects to receive on a serious adverse event report (SAER). It
also indirectly highlights the importance of having the appropriately
trained personnel with some sort of medical expertise to receive and
procure additional information around the submission and background of
SAERs to the agency. This is becoming more and more significant, as
adverse event records are being requested by the agency on inspection.
“The
guidance addresses the major provisions of the AER act , specifically
providing detail on reporting responsibilities, and elaborates and
offers some clarification on the use of agreements between retailers and
manufacturers to transfer the responsibility for submitting adverse
event reports for the product to the manufacturer.”
Please
note: “as adverse event records are being requested by the agency on
inspection.” This is a clear warning that you need to be able to show
that you’ve prepared in your Standard Operating Procedures for any
Adverse Event reported to you about one of your products, even if no
such report is ever made.
The final guidance is at: http:// edocket.access.gpo .gov/2009/pdf/E9-16702.pdf
-----------------------------------------------
2. FTC Testimonial Advertising Changes are Coming…
Here
is the current status: with the new Administration, proposed FTC
changes are not moving forward as rapidly as some feared last year.
However, it is expected that the changes discussed below will become
effective this year. FTC extended the comment period on testimonial
rules changes earlier this year, stating:
"The
Commission has extended the current public comment period related to
proposed revisions of its Guides Concerning the Use of Endorsements and
Testimonials in Advertising (Endorsement Guides)... In a Federal
Register notice published on November 28, 2008, the Commission requested
public comments... on proposed revisions to the Guide provisions
addressing, among other things, consumer endorsements and disclosure of
material connections between advertisers and endorsers."
Here is a summary of the proposed changes:
www2.ftc .gov/os/2008/11/P034520endorsementguides.pdf [this is an 86 page document]
These changes include several items relevant to testimonial advertising:
Primary
rule remains the sanme: "endorsements must reflect the honest opinions
or experience of the endorser, and may not convey any [express or
implied] representation that would be deceptive if made directly by the
advertiser"
"The
Commission proposes one significant revision to this section of the
Guides, the addition of a new Section 255.1(d) explicitly recognizing
two principles that the Commission’s law enforcement activities have
already made clear. The first is that advertisers are subject to
liability for false or unsubstantiated statements made through
endorsements, or for failing to disclose material connections between
themselves and their endorsers. The second is that endorsers may also be
subject to liability for their statements. The Commission has brought
law enforcement actions against both expert endorsers and well-known
personalities (i.e., celebrities) who have acted as endorsers..."
And:
"A third new example illustrates the potential liability of advertisers
who use bloggers to promote their products and of the bloggers
themselves."
"The
Commission’s proposed new Section 255.2(a) would state that an
advertisement employing endorsements by one or more consumers about the
performance of an advertised product or service will be interpreted as a
representation that the product or service is effective for the purpose
represented in the endorsement. Consumer endorsements convey not only
that the advertised product or service worked for the consumers depicted
in the advertisement, but also that it will work for others. This is
the natural implication of an advertiser’s use of a consumer
endorsement, and this view is supported by the consumer research
conducted for the Commission."
"New
Section 255.2(a) also states that an advertiser who uses consumer
endorsements must possess and rely upon adequate substantiation to
support efficacy claims made through endorsements, just as the
advertiser would be required to do if it had made the representation
directly. It also notes that consumer endorsements themselves do not
constitute competent and reliable scientific evidence; anecdotal
evidence about the individual experience of consumers is not sufficient
to substantiate claims requiring scientific evidence."
"...renumbered
Section 255.2(b), presently provides that an advertisement employing an
endorsement reflecting the experience of an individual or a group of
consumers on a central or key attribute of the product or service will
be interpreted as representing that the endorser’s experience is
representative of what consumers will generally achieve with the
advertised product in actual, albeit variable, conditions of use."
The
above section will be modified slightly to "... qualify the currently
unequivocal language of renumbered Section 255.2(b) to state that “an
advertisement employing an endorsement reflecting the experience of an
individual or a group of consumers on a central or key attribute of the
product or service will likely be interpreted as representing that the
endorser’s experience is representative of what consumers will generally
achieve with the advertised product in actual, albeit variable,
conditions of use”"
The
Commission is considering "requiring that atypical testimonials include
disclosure of typical results..." [This would abolish the "results not
typical" safe-harbor.]
Commenters
"stressed the importance of “aspirational” testimonials in weight-loss
advertising, consumers understand that the weight loss achieved by the
testimonialist does not necessarily reflect the experience they will
have using the product or program." Commission thought this could be
allowable if carefully stated.
"As
with all advertising, the fundamental question to be answered is
whether, taken in its entirety, an advertisement that uses testimonials
is likely to convey to reasonable consumers a message that is false or
for which the advertiser does not have substantiation. The
substantiation requirements for advertisements that convey performance
claims are the same, whether the claim is made with or without the use
of testimonials. Advertisers cannot use testimonials to convey claims
they could not make through other means."
"...the
Commission notes that such a change in the Guides would not mean that
advertising using testimonials would be subject to stricter legal
standards than other advertising – to the contrary, it would merely
eliminate a safe harbor that has allowed advertisers to avoid the
general requirement that they be able to substantiate all material
claims conveyed by their advertising to reasonable consumers."
"The
Commission does recognize that a revision of renumbered Section
255.2(b) calling for non-typical testimonials to be accompanied by
disclosure of the results consumers generally achieve with the
advertised product would increase costs for those advertisers who have
not previously tracked consumers’ experiences with their products, and
could present an impediment to the use of such testimonials by certain
advertisers..."
"For
example, an advertiser may use testimonials from a defined subset of
users for which it can determine the typical results.” Or, “…given the
Commission’s proposal to revise the Guides so that they no longer
provide unequivocally that testimonials will convey typicality claims,
the advertiser could write its ad in such a way that consumers would not
take away the message that they can expect to achieve the same results
as the testimonialist."
"Moreover,
the Commission does not assume that the use of testimonials necessarily
gives rise to typicality messages, and thus to a need for disclosures,
regardless of the nature of the product. Advertisements that use
testimonials to promote products for which consumers’ reactions are
inherently subjective and their endorsements thus merely statements of
personal opinion (e.g., restaurants or games) are less likely to convey
typicality messages than ads using testimonials to make objective,
quantifiable claims (e.g., pounds lost, money saved)."
"..the
Commission now proposes to revise the renumbered Section 255.2(b) not
only to provide that testimonials reflecting consumer experience on a
key attribute of the product will likely be interpreted as representing
that the endorser’s experience is representative of what consumers will
generally achieve with the advertised product in actual, albeit
variable, conditions of use, but also to provide that when testimonials
do so convey, and the advertiser does not possess adequate
substantiation for this representation, the advertiser should clearly
and conspicuously disclose the generally expected performance in the
depicted circumstances."
"Specifically,
the new example clarifies that whether the person making the statement
is speaking from a script, or giving the endorsement in his or her
words, is irrelevant..."
[Side
issue: under the new rules, an expert who gets a royalty may have to
disclose that: "the Commission now proposes to revise the renumbered
Section 255.2(b) not only to provide that testimonials reflecting
consumer experience on a key attribute of the product will likely be
interpreted as representing that the endorser’s experience is
representative of what consumers will generally achieve with the
advertised product in actual, albeit variable, conditions of use, but
also to provide that when testimonials do so convey, and the advertiser
does not possess adequate substantiation for this representation, the
advertiser should clearly and conspicuously disclose the generally
expected performance in the depicted circumstances."]
The existing Guide covers compensation to testimonial givers:
"However,
when the endorser is neither represented in the advertisement as an
expert nor is known to a significant portion of the viewing public, then
the advertiser should clearly and conspicuously disclose either the
payment or promise of compensation prior to and in exchange for the
endorsement or the fact that the endorser knew or had reasons to know or
to believe that if the endorsement favors the advertised product some
benefit, such as an appearance on TV, would be extended to the
endorser."
http://www.ftc.gov/bcp/guides/endorse.htm
-----------------------------------------------
3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A
PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. $49.95 - Includes eBook
with forms.
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
www. healthfreedomusa. org/?page_id=2002
(this page links to VitalConnnectionUniversity.com).
Once at Vital University, at the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past and the new webinar as well.
Other Webinar Archives [follow instructions above to reach these]
A. CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook with forms.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
C. Sustainable IRA
Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)
Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time!
The Foundation Trustees lead you through an interesting slide
presentation that will help you make important decisions about where you
want to be in the event conditions in the US continue to deteriorate.
Free Webinar ($25 donation suggested). With eBook.
Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95
Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
0. Blog & News - Self-Shielding is going viral…
1. Confusion reigns in cosmeceutical name game
2. New Webinar - July 9, 2009 – The Ministry and Alt Practices
3. Webinar Archives
------------------------------------------------------
0. Blog & News –
Follow me on Twitter - www. twitter.com/healthfreedomus
Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
Gen Bert on Freedom for Independence Day
vitaminlawyerhealthfreedom.blogspot. com/2009/07/gen-stubblebine-on-freedom-for.html
[Please
note: all URLs in this memo are "broken" with spaces inserted after the
www. to avoid the memo being treated as "spam" by certain email service
providers.]
-----------------------------------------------
1. Confusion reigns in cosmeceutical name game
The
article below highlights some of the changes facing the natural
products industry, as more creative products "cross the lines" created
by bureaucracy.
In
a normally functioning market, the market would set product categories
based on consumer desires, and thereby greater social utility would
evolve, as independent actors in the market competed for consumer
loyalty.
However,
in a bureaucratized market, the "soft fascism" that Dr. Ron Paul so
eloquently warns us against, whether, for example, your product is
"ingested" or taken into the body some other way (sublingually,
transdermally...) will determine whether it is a dietary supplement,
even though in reality, the nutrient benefits the normal structure and
function of the body no matter how it is delivered. Similarly, whether a
substance is a nutrient, a cosmetic or a drug, will depend on how you
sell it and what your "intent" is, not what the market wants. Such
interventions tend to reduce consumer satisfaction and reduce overall
social utility, thereby reducing all our prosperity.
So what do you sell?
www.
nutraingredients.
com/Industry/Confusion-reigns-in-cosmeceutical-name-game/?c=gbrnO2ewSG1xi7WszuqLDQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
29-Jun-2009
– “The term cosmeceutical has always been controversial, but the
blurring boundaries between the worlds of nutrition and cosmetics are
highlighting divisions that neither industry can ignore. Ingestible
products with cosmetic benefits are an emerging product category for
both the nutritional and the cosmetics industries.
“Beauty
yoghurts, anti-wrinkle drinks, and skin care supplements are all part
of a market expected to be worth $2.5bn by 2012, according to market
research company Kline.
“However,
the industries don’t seem to agree on what to call this emerging
product category. For the healthy foods and supplements industry these
products fall under the term cosmeceuticals, which for the cosmetics
industry means something quite different.
“As
these industries begin to work together to take advantage of this
growing market, there is a dire need for some clear definitions.
“Click
here to read full comment from our sister publications for the
cosmetics industry, www. cosmeticsdesign. com/ and
http://www.cosmeticsdesign-europe.com/ .”
-----------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
New Webinar: Thursday July 9, 2009 - 6 PM MT (4 PM EDT): Your Ministry, the Law and Alternative Practices -
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. Includes eBook
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
www. healthfreedomusa. org/?page_id=2002
(this page links to VitalConnnectionUniversity.com).
Once at Vital University, at the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past and the new webinar as well.
3. Webinar Archives [follow instructions above to reach these]
A. CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)
What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"Your papers must be in order."
Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?
Your papers need to be in order before the FDA inspection!
C. Sustainable IRA
Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)
Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time!
The Foundation Trustees lead you through an interesting slide
presentation that will help you make important decisions about where you
want to be in the event conditions in the US continue to deteriorate.
Free Webinar ($25 donation suggested). With eBook.
Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95
Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources). The new webinar system will also
include Vital Connection forums specific to the participants in the
webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
