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Our expertise is in FATS, the # 1 consumer nutrition issue & probably the nutrient with the greatest impact on health. |
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Under
development
HIPAA
Understanding
HIPAA. Problems, solutions.
essentialfats.com\hipaa\hipaa.htm
Legal
Procedure and Strategies: prototype documents
Caviat:
not legal advice. Documents require substantial modification by a lawyer to
adapt to your case
Requests
for Documents
Requests
for Admissions
Interrogatories
Motions
to Compel production of List of privileged documents
Motions
to compel production of documents
Proving
damages
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Contact us. Serious inquiries only, please. |
We invented the blood tests that found that
abnormalities and deficiencies of essential fats are highly prevalent in
western society. Before our research, deficiency of EFAs was considered
practically non-existent. We did studies on the prevalence of abnormal levels
of w3 and w6s in the US population.
We created new ways to identify the effects
of diets rich in essential fats, and how to measure body changes in response to
diets high in essential fats. We have written about
fish oils (use, etc.), diagnosis and treatment of EFA abnormalities, role of
low fat diets, dangers of low fat diets, designing foods with EFAs or PUFAs,
and more.
We identified mixtures of fatty acids
associated with health and disease, based on our proprietary studies of body
fatty acid composition, health, and disease.
We have invented sophisticated blood tests to
measure EFA status, fatty acid abnormalities, and the impact of foods on
cholesterol, HDL, and triglycerides.
We combined new developments in nutrition
research and food composition to create new options for medical treatment and
for increasing life span. Our approach identifies key nutrients that can delay
the onset of aging and disease.
We assist companies to write health claims,
structure and function claims, label design, etc. We can provide the studies
needed to support your statements and comply with FTC rules. Dr. Siguel has
performed and published many relevant studies, including analyses of blood
samples of the Framingham Heart Study. See references below. We evaluate new findings impacting nutritional foods from meetings on
functional foods, nutraceuticals, FDA rules, and suggestions on marketing foods
rich in PUFAs.
We can help you design a better product
and/or avoid mistakes that could hurt your future sales.
Designing & marketing foods rich in Essential
Fats
This report discusses the different types of commercially available fatty acids, and examines how to incorporate these fatty acids in foods or supplements. We review companies that make different types of fatty acids and investigate current products rich in essential fats. We survey marketing problems (past and present), potential markets, new marketing strategies. We discuss making a food, a supplement, or a medical food: pros and cons; health claims vs structure/function claims; FDA, FTC issues.
The information is derived from public documents, web sites, presentations at scientific meetings, our personal conversations with leading industry and academic leaders, and the opinions and interpretations by Dr. Siguel [who organized major courses on this topics for the world's leading nutrition and professional societies (ASPEN, AOCS, etc.) and published key articles in leading professional journals on marketing issues and requirements for essential fats].
Topics include:
Types of fatty acids, sources of fatty acids.
Definition of a "medical food," a
"food," and a "supplement." Similarities and differences.
FDA regulations. Where to find the regulations.
Claims of nutrient content for PUFAs. What
you can and cannot say about PUFAs on the label. For example, because no RDAs
are established for PUFAs, labels cannot state that the food/supplement is
"rich in PUFAs" or "high in PUFAs". But you can make other
nutrient content claims.
Health Claims for foods. Which health claims
require FDA prior approval and which ones do not. These claims apply both to
foods and to nutritional supplements.
Structure/function claims which apply only to
nutritional supplements, not to foods. Medical foods can make health claims; no
regulations exist. Pros and cons.
When a food or supplement becomes a drug
depends on whether it diagnosis or treats a disease. Definition of
"disease" by the FDA.
Products made by Martek, OmegaTech, Zapata,
and other corporations. Similarities and differences.
Infant formulas, supplements for pregnant
women, infants, children.
Supplements for patients with various health
conditions.
Fish oils: benefits and problems. Potential
for losses, profits.
Eggs rich in essential fats. Pilgrim's Pride,
other companies. Similarities and differences between products.
Why products fail. How to avoid common
pitfalls. Nutrition does not provide immediate results like a pain reliever; it
takes years to work.
Emerging markets: we identify needs that you
can fill.
Learn which information sources are the most
credible.
How to design and implement an effective
clinical trial. How to get the greatest return on investment from your clinical
trial.
Future outlook.
See summary of report, discussion of some issues.
Siguel, E. Issues and Problems in the Design of Foods Rich in Essential
Fatty Acids. Lipid Technology, 8(4):81-86, 1996 (July). (send $10 check
to cover S&H)
Siguel, E. The Essential Fat Revolution: Part I, Nutrition and Essential Fatty
Acids. Decision Resources, Waltham, MA. December 12, 1997: 81-1 - 81-12.
Siguel, E. The Essential Fat Revolution Part II, Implications for Food Design
and Marketing. Decision Resources, Waltham, MA. December 12, 1997:82-1 -
82-10.
Healthy
Foods
Do you need new foods to revitalize sales? Do you want to redirect your company’s focus towards functional or medical foods?
Would you like to know which of your new products are likely to offer substantial medical benefits and which ones work like placebos?
Have you been discouraged by sales of new "healthy" products you developed?
If you are trying to provide a useful product, contact us.
Product Examples
We proposed a new diet for hens and chicken, resulting in eggs richer in w3s and EFAs. Pilgrim’s Pride is selling a new type of egg based on our ideas. Check stock price and data from public sources and from Pilgrim's Pride literature/ web site.
We have been recommending oils rich in EFAs since the 1970s. We published articles linking low fat diets to EFA deficiency, and recommended oils rich in EFAs in scientific articles, conferences, and lectures aimed to health professionals. Health writers picked up our material and wrote numerous articles on the dangers of low fat diets and the benefits of EFA-rich oils. Sales of PUFA-rich oils (flaxseed oil, etc.) have zoomed.
In the 1980s, we discouraged several companies
from marketing fish oil capsules through aggressive newsmedia campaigns such as
ads in magazines, newspapers and TV. After spending millions of dollars in
clever advertising, the market for fish oil sales collapsed.
Today there is renewed interest in fish oils. Clever advertising ties fish oils
to w3s and makes people believe that failure to eat fish oils will lead to
brain dysfunction, heart disease, depression, and perhaps the collapse of the
stock market, TV shows, and civilization (as many know it from the perspective
of changing TV channels). The advertising promises that salvation is only a few
dollars away-- eating fish oil capsules will make people smarter, and save you
from dementia, depression, heart disease, etc.
The ads do not mention bad breath, because fish oils do not cure bad breath (if
you do not believe me, take a few oil capsules and try kissing somebody,
preferably someone you want to get rid of… assuming you did not sign an
agreement refusing to participate in chemical warfare).
In our experience, advertisements in news media are not effective to sell fish
oils. These advertisements may increase sales temporarily, but sales will
decline at a later time when customers shift brands or stop taking the oils.
The reasons are many (and we can discuss them for our consulting fee). We
believe there are effective ways to market fish oils.
One needs be aware of the likely toxic effects of fish oils. Fish oils are rich
in highly polyunsaturated fatty acids. They oxidize quickly both outside and
inside the body. High intakes appear to reduce longevity! The trick is to know
who needs fish oils and how much. Marketing to the people who benefit the most
assures satisfied customers. Marketing fish oils to the wrong people can
decrease their life expectancy and kill your customers. Even the mafia knows it
is bad business to kill customers; their relatives may tell their friends and
soon you will have a room full of the aroma of surplus fish oils.
Are you wasting money designing
scientifically outdated products?
A company has been trying to develop foods for patients with diabetes, to be
delivered at home. We considered such a program practically useless. Food
composition was based on nutrition research which we found severely outdated.
Not only did we think the foods were not medically useful, but we considered
them counterproductive. According to our research, the foods proposed were more
likely to cause than to prevent disease.
The company would have saved considerable money if they had followed our
suggestions. We now read that the company abandoned this product line and
returned to their conventional products. Had they listened to us they would
have saved millions!
In the 1980s, when many companies were losing money trying to sell fish oil capsules, we wrote several reviews of fish oils and fish oil marketing. We explained to several large companies why their strategies were faulty (some reasons are outlined in our published papers). Had these companies listened to us, they would have saved considerable money. After a few years, many companies terminated their marketing of fish oils, with considerable losses. We can help you target your marketing campaign because we know who benefits from fish oils, and how they benefit. We can explain the benefits of EPA vs. DHA. We can discuss which types of fish are the best to use, and the best way to encapsulate.
We can answer questions like: Do pregnant women need fish oils? Do infants need fish oils? Do children need fish oils, or would they be better eating flax seeds or soybean oil? What is the optimal balance of w3:w6 in foods? What conditions would benefit from fish oils? What factors influence the optimal ratio of w3:w6: age, sex, health status, climate, environment, pre-existing diseases, genes, ancestry, etc?
We assisted Pilgrim's Pride to develop EggsPlus™. We started with them in 1994, when Dr. Siguel met with Mr. Pilgrim, the CEO of Pilgrim's Pride. You can check their stock prices in 1994 and today (up > 100%).
If you are designing foods based
on current USDA, AHA or NIH guidelines, BEWARE!
At recent meetings of the American Dietetic and Heart Associations, we found many companies developing foods and educational programs based on the USDA Food Pyramid and USDA nutrition guidelines. We have written some of the reasons why we consider USDA nutritional guidelines counterproductive and how they can contribute to cardiovascular disease in many people. We also explained why we consider current American Heart Association and National Institutes of Health guidelines to treat cardiovascular disease less effective than alternative approaches.
You may find that, by the time your product reaches the market, public health organizations and research articles will publicize new findings (many already known) that dramatically change the way we use fat in foods. Are you designing your new foods based on outdated nutrition principles? Read:
Siguel E, Lerman RH. The Role of Essential Fatty
Acids: Dangers in the USDA Dietary Recommendations ("Pyramid") and in
Low Fat Diets. Am. J. Clin. Nutrition, 1994; 60:973-9.
Siguel E, Lerman, RH. The Role of Essential Fatty Acids: Reply to the USDA. Am.
J. Clin. Nutrition, 1995; 63:973-9.
Siguel E, Lerman RH. The Effects of Low-Fat Diet on Lipid Levels. JAMA, 1996;
275:759.
Siguel E, Lerman RH, MacBeath, B. Very Low-Fat Diets for Coronary Heart
Disease: Perhaps, But Which One? JAMA, 1996:275: 1402-1403.
Educational
Programs
We organized the symposium "How Low to Go on Fat" (desirable levels of fats and types of fats in foods) for technical staff from food corporations around the world. The symposium was very well attended at the Am. Oil Chemistry Society Annual Meeting, 1997.
We organized lectures for Archer Daniels Midland, Pilgrim’s Pride, Natural Health Expos East and West, National Nutritional Food Association, and many other companies, medical centers, hospitals, scientific associations, etc.
We organized and taught a Post Graduate course on fats at the American Society of Parenteral and Enteral Nutrition (ASPEN) in San Diego, Feb, 1999. ASPEN is the leading clinical nutrition society. It groups doctors, pharmacists and dietitians at most medical centers in the US (hospitals, universities, etc.). The course had great attendance (participants from all over the world).
We presented papers at ASPEN, 1999, on designing eggs rich in essential fats and their effect on people (blood levels of w3s, etc.) and lipids.
We presented papers at the American Oil Chemistry Society annual meeting, 1999, Orlando, FL on designing foods rich in essential fats, functional foods, etc.
If you have a research project
involving fatty acids, contact us for collaborative or contract work.
We are looking for
collaborators and funding for the following studies, which
help to prove the usefulness of certain products:
Using soybean products and soybean oil to treat cardiovascular disease,
abnormal lipids, and gastrointestinal disease.
Status
Research completed. Guidelines available to better use soy products.
Further work
Funds needed to write education brochures and to educate health providers and consumers. We will produce several sets of prototype packages of materials on soy and EFAs suitable for use by consumers, health providers, nutritionists, or lecturers. The material will be prepared in English and Spanish. Different sets will be created for physicians, nutritionists, dietitians, and instructors. These materials will be distributed at or below cost to instructors and health practitioners in hospitals, schools, universities, medical practices, libraries, etc. across the country.
Although there are many materials on soy products and EFAs, none incorporate recent research describing what makes soy a superior provider of EFAs. Unfortunately, most medical and nutritional textbooks contain either trivial amounts of information or erroneous material pertaining to the role of EFAs and to soy foods as EFA sources. Under this project, accurate and up-to-date materials will be made available for educational purposes.
Recent research by Dr. Siguel, explaining why soy is an excellent source of EFAs, has yet to be published. Some material has recently been published in scientific journals, but these new findings will take about 5 years to reach the general public. For example, Dr. Siguel has explained the benefits of soy products for patients with hyperlipidemia, hypertension, and chronic gastrointestinal disease.
The result of this project will be a better understanding of the role of EFAs, the need for EFAs, and the unique contribution of soy products as a major source of a balanced source of w3 and w6 EFAs.
Ref: These articles explain, in part, the use of soy foods.
Siguel EN, Lerman, RH. Altered Fatty Acid
Metabolism in Patients With Angiographically Documented Coronary Artery Disease.
Metabolism 1994; 43:982-993.
Siguel E, Lerman, RH. Prevalence of Essential Fatty Acid Deficiency in Patients
with Chronic Gastrointestinal Disorders. Metabolism. 1996; 45(1):12-23.
(Jan)
Siguel, E. A New Relationship between Total/HDL Cholesterol and Polyunsaturated
Fatty Acids. Lipids, 1996; 31, S51-S56.
Siguel E. Dietary Sources of Long-Chain n-3 Polyunsaturated Fatty Acids. JAMA,
1996; 275:836.
Experiments to test the value of soybean products and soybean oil (or
other foods rich in PUFAs)
We will measure changes in EFA status after subjects eat a soy-rich diet (or a diet rich in PUFAs) for 2 to 4 months. This diet will likely produce very small changes in body EFA composition, because most people have huge reserves of fat compared with the amount of EFAs in soy foods. Therefore, being able to measure small changes in EFA status is critical to make health and food label claims pertaining to EFA status.
Technology developed by Dr. Siguel allows the measurement of small changes in EFA status. Dr. Siguel’s measurements of EFA status are about 10 times more sensitive than previously available methods. Before, changes in EFA status were often not detected, because the methods available to measure EFAs were not sensitive enough.
Recent research has shown that Americans are becoming EFA deficient because they eat too many foods low in fat and deprived of EFAs. When these research findings become better known in the health community, we anticipate that consumers and health providers will recommend that Americans eat more EFA-rich foods. Recent studies (Lipids, March, 1996; Metabolism, Jan 1996, J. Am. Medical Assoc, March 13, March 20, 1996, May, 1996) explain the need for EFAs and the reasons why people are becoming EFA deficient.
The proposed research opens the door to increasing sales of soy (and other foods rich in PUFAs) by educating consumers about health benefits, and by encouraging food manufacturers to develop EFA-rich foods using soy products. This project also standardizes the methods used by researchers to evaluate the health benefits of soy, thereby saving considerable time and money to individual researchers and food manufacturers.
These claims will significantly change the marketing approach to soy foods, because most Americans need to eat EFA-rich foods (such as soy products) to correct or prevent existing EFA deficiencies.
Using figs to prevent diarrhea
We are evaluating the use of figs to prevent cardiovascular and gastrointestinal disease. We would like to develop medical foods that incorporate figs and a few other key ingredients that could be used as supplements for patients with various conditions.
Status
Waiting for funds to purchase figs, pay for blood tests, design and test foods.
Further reading (read other publications)
Siguel, E. Issues and Problems in the Design of
Foods Rich in Essential Fatty Acids. Lipid Technology, 8(4):81-86, 1996
(July). ). (send $10 check to cover S&H)
Siguel, E. Symposium on Measuring EFAs in Biological Tissue. Abstracts & Proceedings
Am. Oil. Chemistry Society Annual Meeting 1996.
Siguel E. Comments on Low- and High-fat, Peptide-Based Diets in Adolescents
with Active Crohn's Disease. J Parenteral Enteral Nutr 1997;21(5):304.
Siguel E. Essential fatty acid status in patients [letter; comment]. J
Parenteral Enteral Nutr 1997 Jul-Aug;21(4):243.
Siguel, E. Dietary Fat: How Low Can or Should You Go? Abstracts, Am. Oil.
Chemistry Society Annual Meeting 1997; INFORM, 1997:8, No7:714-717.
Siguel, E. The Essential Fat Revolution: Part I, Nutrition and Essential Fatty
Acids. Decision Resources, Waltham, MA. December 12, 1997: 81-1 - 81-12.
Siguel, E. The Essential Fat Revolution Part II, Implications for Food Design
and Marketing. Decision Resources, Waltham, MA. December 12, 1997:82-1 -
82-10.
Siguel, E. Comments on Dietary Modulation of w3/w6 Polyunsaturated Fatty Acid Ratios in
Patients with Breast Cancer. J National Cancer Institut,
1998;90(8):629-31.
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For further information, Contact us. Serious inquiries only |
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reading this web site, you agree to read & comply with the following
instructions: You agree to pay us $300 for each unsolicited communication to sell us unsolicited products/services (by e-mail, mail, phone, etc.). Read details. |
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© 1998 Edward N. Siguel. All rights
reserved |
modified 1/15/00 |