Wednesday, February 27, 2008

02/27/08 - 2008 Supplement Tends

Vitamin Lawyer Update Memo: February 27, 2008

This issue:
“Quackwatch” Exposed
Supplement Trends for 2008
Metabolic Syndrome
C&D Letters
FDA Gets Tough on Health Claims
Natural Solutions Panama ARC Project
Tim Bolen has exposed the “quackwatch” methodology used to attack CAM practitioners, nutrient and natural remedy purveyors. Please read my blog on this important issue.


[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]

Hartman outlines supplement trends for 2008 - By Lorraine Heller
nutraingredients-usa .com/news/ng.asp?n=83162&m=1NIU211&c=jegwylrviswtnqa

Feb-11-2008 - Healthy aging, balanced energy and inflammation are the three core health concerns that consumers try to address with dietary supplements,
according to a new report. The Hartman Group's Tinderbox on Trends 2008 draws its conclusions through ethnographic research, which includes consumer
interviews and observation in the home and in retail outlets. According to the research group, when a health concern presents itself, most consumers will first examine their diet. When food does not remedy the situation, they look to supplements, preferably from whole foods, to correct and balance their condition.

Supplements most popular with "leading-edge" or "core" consumers were those that addressed aging, energy and inflammation, said Hartman.

Although most supplement users are diligent when it comes to taking multi-vitamins, Hartman said that they tend to vary in their choice of supplements addressing
these three issues, either as they learn of new products, or as they shift focus from the one issue to another.

The group said consumers are "constantly searching for the latest supplement that may ease their condition or outperform a current supplement which is filling
nutritional holes missing from their diet".

Supplement use

Hartman divides supplement usage into three main categories: frequent, occasional and sporadic.

Frequent usage refers to those supplements that are taken on a daily basis in order to complement nutritional needs that are lacking from the diet. Ideally, consumers prefer 'daily' supplements to be sourced from whole foods sources.

These supplements are considered mainstays are taken daily and year-round as a preventative, said the group. Occasionally used supplements are those that are used to boost or alleviate a chronic condition or as a substitute for a prescription drug.

"Typically these supplements are taken from a few days to a week or until the bottle is finished. This demonstrates the core consumer's proactive approach to their
health," said Hartman.

Supplements that are sporadically used are those taken to alleviate an immediate health condition, or those that are tried for the first time. They are typically not taken in the long-term because consumers are unsure about their long-term use or possible side-effects.

Healthy mind and body

According to the report, consumers place a lot of emphasis on the balance between a healthy mind and body. Linked into this is the increasing search for natural methods to reduce low energy, sleep disturbances and anxiety. "Getting enough sleep, having sustained energy throughout the day and managing emotional ups and downs requires being present and truly paying attention to what their body and soul needs from day to day. When one element is out of balance, such as sleep or feeling blue, the whole person eventually needs tuning," said the report. "The core consumer looks to whole foods and the latest vitamin, mineral and herbal supplements in their quest for balancing mood, energy and sleep."


nytimes .com/2008/02/05/health/nutrition/05symp.html?_r=1&oref=slogin

"Researchers have found a correlation between drinking diet soda and metabolic syndrome — the collection of risk factors for cardiovascular disease and diabetes
that include abdominal obesity, high cholesterol and blood glucose levels, and elevated blood pressure... But the one-third who ate the most fried food increased their
risk by 25 percent compared with the one-third who ate the least, and surprisingly, the risk of developing metabolic syndrome was 34 percent higher among those
who drank one can of diet soda a day compared with those who drank none."


nutraingredients-usa .com/news/ng.asp?n=83202&m=1NIU212&c=jegwylrviswtnqa
How to respond to a Cease & Desist Letter
By James F. Ewing, Michelle A. Flores, and Michel Morency

Feb - 12 -2008 - Legal experts form Foley & Lardner suggest a strategy to help nutraceuticals companies respond to an accusation of infringing patent rights.
The nutraceuticals market is dynamic and competitive. As such, your nutraceuticals company may be subject to enforcement of another's patent rights. Receiving a
Cease & Desist letter ('the Letter') accusing you of infringing the patent rights of another is an unwelcome notice that can create a sense of urgency akin to having
been just set ablaze.

Being subject to enforcement of another's patent rights, however, is not an uncommon occurrence for successful businesses in competitive markets such as the
nutraceuticals market. Such letters usually identify the granted Patent(s) by its number(s), assert ownership to the Intellectual Property, and detail your alleged infringing activities as well as conditions and deadlines that are to be met.

To avoid being burned in such circumstances, you may consider implementing a STOP, DROP and ROLL approach. STOP and objectively consider the claims.

Implementing the STOP, DROP and ROLL approach does not mean that you need to immediately stop your business activities upon receiving a Cease & Desist
letter. However, whether the Letter demands that you cease making, using, or selling a particular product or service, or merely suggests that you might be interested in licensing certain patent(s), you should stop to carefully consider the allegation, and refer it to knowledgeable Counsel.

Being placed "on notice" of another's patent rights, is a legally significant event where you have a duty to act. Proactively addressing the concerns or demands of a
patent owner serves to protect your company and mitigate exposure to possible damages and fees for alleged willful conduct.

'DROP a Line' to experienced patent counsel Your response to the Letter should be timely, well-considered, and strategic.

Before responding you need to engage the services of knowledgeable patent counsel. This may involve one or more individuals with expertise in patent prosecution
and enforcement matters who can render an opinion regarding whether your commercial product or activities may infringe the patent claims asserted against you
and/or assess the validity of these claims, and develop an appropriate response strategy.

Enforcement issues can be highly complex and a skilled patent counsel will provide essential guidance to address the issues and assess the risks and potential
commercial impact against your company. Be prepared to 'ROLL with the Punches'...

Simply ignoring a Cease & Desist letter will not make the issue go away and may result in increased costs and liability for the accused patent infringer. The STOP,
DROP and ROLL approach provides a strategy to minimize potential adverse impacts in these situations.

James F. Ewing, Michelle A. Flores, and Michel Morency are attorneys with Foley & Lardner LLP.

[Yes, The Vitamin Lawyer does have C&D formats for your use....]
FDA gets tough on rogue health claims
By Alex McNally

25-Feb-2008 -

Two companies have signed an agreement that prohibits them from claiming any of their products can cure, treat, mitigate or prevent diseases after making
unauthorized health claims. The Food and Drug Administration said both Cherry Capital Services and Brownwood Acres Foods have a history of promoting unapproved claims, such as "chemicals found in cherries may help fight diabetes." The terms of the consent decree mean the firms have to remove drug and unauthorized health claims from their labels, brochures and websites....

Margaret Glavin, associate commissioner for regulatory affairs, said: "The FDA will not tolerate unsubstantiated health claims that may mislead consumers. The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."

...The US version of health claims was introduced a few years ago. Initially the legislation was beset by delays. Despite pledging that a response would be given to all claims submitted within 365 days, the FDA has exceeded this timeframe on a number of occasions. In one case the FDA was more than 300 days over an original
deadline for approval.


If you've been trying to reach me, you know I just got back from a quick trip to Panama. Awesome! Read on...

Natural Solutions Foundation in Panama was set up to research, educate and demonstrate natural solutions. Our shared vision is of an intentional community that links home sites (on a wonderful hillside with great views) with a natural wellness center/spa and organic+ farm and school, all on a 300 hectare (700+ acre) site that has never been farmed with chemicals. Currently, about ten acres are planted with organic coffee.

Our Panamanian legal entity is very flexible, combining the best aspects of a non-profit and a “private interest” entity that is allowed to form its own commercial enterprises. In keeping with the Songhai Principals, we see three “profit centers” for the project: the Wellness Center, the Organic+ Farm and School and what I call the Infrastructure Company, which provides transportation, communications, off-grid power, etc. to the center and farm school as well as the home sites. The Foundation will hold majority interest in the commercial entities, but there will be private investment opportunities.

The area is in the far north, by the Costa Rica border, against the 17,000 acre Amistad National Forest. Elevations vary from 3,000 to 5,000 feet above sea level. It is in the township of Santa Clara (Sacred Light) and is reached by modern road about an hour from the Vulcan eco-tourist area. The climate is year-round temperate (the woods look much like the woods of the US Northeast: similar evergreen, birch and other deciduous trees, deer and rabbits, but with coffee, banyan trees, plantains and howler monkeys too).

Gen. Stubblebine and Dr. Laibow have explored the area in recent months and I went there last week with a Natural Solutions supporter, guided by Kenneth Taylor, our Panamanian builder with experience in the area.

I am most impressed by Panama as a country where people have great hopes for the future... Panama City and the Canal area, where half of the 3 million population resides, is a very modern, thriving area with a huge building boom, very well developed banking and commercial sectors (the Singapore of the New World).

The Santa Clara area, to the far north, is pristine, flower filled and well connected to civilized amenities (international cuisine, locovore restaurants). It is becoming an eco-tourist center mostly because of the Vulcan Baru. The area is filled with ExPats from the US and Europe (20% of one town is American).

Land values are quite reasonable right now, but will not stay that way for long, as Americans and Europeans looking for more freedom than they can find at home, join the Panamanians in appreciating this land. Two hours away, in Boquete, land is bumping $100,000 per hectare (2.45 acres) – about 8 times our cost. Land taxes are very low and there is a 20 year tax holiday for new construction.

Because the land owners, who farm organically themselves, appreciate our vision, they are giving us a highly favorable financial arrangement and going far out of their way to work with us in a positive and helpful way. One of their sons, who lives on the land, would be ideal as a land manager for us. He is most amenable to that idea.

We are currently making arrangements to have the land surveyed, the soil and water tested and will be setting up preliminary meetings with architects to determine the number of building lots and areas. A generous donor has made that possible with a first gift for Panama.

We are now open for donations which, while fully tax deductible in the US, will allow the Natural Solutions Foundation to proceed with the development of our better than organic, advanced farming technology project complete with farm school for farmers from around the world -- teaching how to farm and feed communities while resisting the pressures of Big Agribiz is a central commitment of the Panama Project.

So is providing a free, beautiful, healthful and sustainable community for visionaries like ...YOU! Leasehold and ownership interests will be available.

If you are interested, just send an email to Ralph Fucetola - - with "Panama" in the subject line or call 973-300-4594 to learn more about your place in the Panama Project! Before I became “The Vitamin Lawyer” I grew up on family construction projects and practiced construction law for fifteen years, being involved in housing, hotel, mall and commercial developments (including historical renovations) in northeast NJ.

I believe this site is ideal to develop and demonstrate natural solutions. It is the right country (friendly to Americans, natural health and organics) and the right natural area. We've looked for years for the best place to demonstrate natural solutions. In my humble opinion, this is the place!

You are invited to join our Panama Yahoo!Group forum where you will find many photos, copies of the organizing documents, skills database and much more:

Natural Solutions Foundation is more than just talk: we are willing to walk our talk… and a beautiful walk up the mountain it will be!

Ralph Fucetola JD
vitaminlawyer .com

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