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FDA approval. It essentially put the burden <strong>of</strong> pro<strong>of</strong> on<br />

the FDA. The actual language <strong>of</strong> the Act makes “amazing<br />

reading. The Act is a watershed event for the health food<br />

industry in the USA. “If the <strong>soy</strong>bean is<strong>of</strong>l avones are h<strong>and</strong>led<br />

correctly (<strong>and</strong> I am not divulging exactly what that means),<br />

the regulatory <strong>and</strong> safety issues will be greatly minimized.<br />

It becomes feasible to make <strong>and</strong> market the product. A<br />

company’s risk is diminished, for example, by appropriate<br />

use <strong>of</strong> warning statements.<br />

Audax is fully booked at this point. He has more orders<br />

than he can h<strong>and</strong>le. Up to this time, he has been making only<br />

pilot plant quantities. If all goes well, Audax will be making<br />

commercial quantities within the next 4 months. At that time<br />

he will be looking for new customers. Their fi rst product<br />

will be Genistone, which is a <strong>soy</strong> extract; approximately<br />

50% <strong>of</strong> the content <strong>of</strong> the product is <strong>soy</strong> is<strong>of</strong>l avones. Of<br />

those is<strong>of</strong>l avones, approximately 80% contain genistin. It<br />

will be sold as a dry powder <strong>and</strong> sell for about $2,000 per<br />

kg <strong>of</strong> is<strong>of</strong>l avone content. At his price, the 25 mg <strong>of</strong> total<br />

is<strong>of</strong>l avones in a typical serving <strong>of</strong> t<strong>of</strong>u would be worth about<br />

$0.05 (5 cents). He feels that this price can drop quite a bit if<br />

he is processing hundreds <strong>of</strong> tons a day <strong>of</strong> defatted <strong>soy</strong>bean<br />

meal. He thinks he will have the capacity to do that, because<br />

he is now working with a large, local <strong>soy</strong>bean crusher.<br />

His main plan for marketing the product is to sell it to<br />

food processors who would add it to food products (such<br />

as <strong>soy</strong> <strong>yogurt</strong> or t<strong>of</strong>u) at levels with valuable biological<br />

benefi ts; he does not plan to sell it as a supplement to avoid<br />

the risks <strong>of</strong> people overdosing. One problem with adding <strong>soy</strong><br />

is<strong>of</strong>l avones to <strong>other</strong> products is that they have a bitter fl avor.<br />

However since very small amounts will be added to foods,<br />

they may not be noticeable in the fi nal product.<br />

He is using defatted <strong>soy</strong>bean meal as his starting<br />

material from which to extract the <strong>soy</strong> is<strong>of</strong>l avones. Thus he is<br />

using the protein fraction <strong>of</strong> the <strong>soy</strong>bean rather than the lipid<br />

fraction (incl. <strong>soy</strong> molasses). Is<strong>of</strong>l avones are closely bound<br />

with proteins. The reason he is not using the lipid fraction<br />

or <strong>soy</strong> molasses is proprietary. He has noticed that his byproduct<br />

(defatted <strong>soy</strong>bean fl our containing no is<strong>of</strong>l avones)<br />

has a better taste than most <strong>soy</strong> fl our (<strong>and</strong> maybe better<br />

stability) <strong>and</strong> he is looking for ways to sell it as a valueadded<br />

product. He is currently adding it to chicken feed.<br />

If you look at all the is<strong>of</strong>l avones in the whole <strong>soy</strong>bean,<br />

50-60% is daidzin. But genistein has the greatest biological<br />

activity. So he set out to make a product that is rich in<br />

genistin. However his product, Genistone, contains genistin<br />

as its largest constituent. This is because genistin is<br />

hydrolyzed in the gut to genistein, which is then absorbed<br />

into the bloodstream.<br />

Charles believes that genistein, at a high enough<br />

dose, can stop the growth <strong>of</strong> cancer in humans. There is<br />

scientifi c evidence that genistein has cytotoxic activity at<br />

a high enough dose; all the major anti-cancer medicines<br />

(chem<strong>other</strong>apeutic agents) these days are cytotoxins. Put in<br />

HISTORY OF SOY YOGURT & CULTURED SOYMILK 418<br />

© Copyright Soyinfo <strong>Center</strong> 2012<br />

the right place, they kill both cancer- <strong>and</strong> non-cancer cells.<br />

Genistein has some <strong>other</strong> properties that make it attractive<br />

therapeutically; at a very low dose, it may stop the growth <strong>of</strong><br />

cancer without killing the cancer cells. This dose is roughly<br />

that obtained by eating 6 servings <strong>of</strong> t<strong>of</strong>u per day. There is<br />

also some evidence <strong>of</strong> anti-metastatic activity, i.e. it may<br />

prevent the cancer from metastasizing, or spreading to <strong>other</strong><br />

parts <strong>of</strong> the body–at much lower doses than the cytotoxic<br />

activity.<br />

Soy is<strong>of</strong>l avones have some very potent biological<br />

activities. They are an inhibitor <strong>of</strong> a group <strong>of</strong> cell<br />

transduction proteins called the protein tyrosine kinases,<br />

which modify cell division, cell signalling mechanisms,<br />

etc. At a high dose (e.g. ten times the desirable dose) there<br />

could be some problems. Look at the market for estrogen<br />

replacement therapy. Estrogens are great; they do everything<br />

that genistein does except they cause cancer instead <strong>of</strong><br />

preventing it. Genistein does all the things that estrogens<br />

do <strong>and</strong> it prevents cancer. About 6 months ago Merck<br />

introduced a drug named Fosamax that prevents osteoporosis<br />

<strong>and</strong> increases bone density. They billed it as one <strong>of</strong> their big<br />

blockbuster drugs for the future, with sales projected at $1.5<br />

billion a year. It was selling very well, but just last week<br />

Merck sent out a “Dear doctor” letter to 150,000 physicians<br />

notifying them that one serious side effect was extreme<br />

abdominal pain. 36 women have been hospitalized. Sales<br />

have started to drop.<br />

What will prevent companies like ADM, Merck, or<br />

S<strong>and</strong>oz/Novartis from competing with Audax? Nothing.<br />

Talk with Steve Buchheim, marketing manager for<br />

<strong>soy</strong> applications at ADM. 1998. March 6. Steve thinks that<br />

Audax never brought their product to market because they<br />

were unable to get the <strong>soy</strong> solids they needed. It was NOT<br />

because <strong>of</strong> any problems or potential problems related to the<br />

FDA or regulation. Address: Director <strong>of</strong> Research, Audax,<br />

Inc., 1385 Bear Creek Road, Leitchfi eld, Kentucky 42754.<br />

Phone: 502-242-3791.<br />

1097. Montanaro, Pamela. 1996. Attending the First National<br />

Soybean Workshop in Cuba (Interview). SoyaScan Notes.<br />

April 15. Conducted by William Shurtleff <strong>of</strong> Soyfoods<br />

<strong>Center</strong>.<br />

• Summary: Pam Montanaro, Coordinator <strong>of</strong> the Cuba<br />

Campaign Department <strong>of</strong> Global Exchange, just returned<br />

from 2 weeks in Cuba. She led an alternative medicine<br />

group during the fi rst week. While there, she attended the<br />

First National Soybean Workshop (Primer Taller Nacional<br />

Soya), 2-day meeting held on 11-12 April 1996 at the Food<br />

Research Institute outside Havana. It was attended by<br />

about 200 Cubans, <strong>and</strong> many important Cubans were there,<br />

including Jesu Montané Oropesa, a top advisor to Fidel<br />

Castro, <strong>and</strong> Vilma Espín, head <strong>of</strong> the Federation <strong>of</strong> Cuban<br />

Women (Federation de Mujeres Cubanos, FMC). One <strong>of</strong><br />

the founders <strong>of</strong> the Cuban revolution in the 1950s, she is

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