Richters HerbLetter

Date: 97/07/03
1. Ottawa Delays New Regulations for Herbal, Homeopathic Remedies
2. A Daily Dose of Garlic Helps to Keep Your Ticker Ticking
3. Down-home to Exotic, Food Choices Broadening in Future
4. Vietnamese Herbal Treatement for Drug Addiction to Undergo Trials
5. Herb Business News

1. Ottawa Delays New Regulations for Herbal, Homeopathic Remedies
By Laura Eggerton

OTTAWA, June 28, [Toronto] Globe and Mail -- The federal government has softened its crackdown on the regulation of herbal remedies and homeopathic products amid accusations from consumer and health groups that it is protecting the interests of pharmaceutical companies.

Health Minister Allan Rock said in a news release yesterday he will delay until Jan. 1 new rules that would require manufacturers, distributors and importers of herbal remedies and health products to be licensed.

The licencing regulations and a cost-recovery program that would have required businesses to pay 1.5 per cent of their sales to have products safety-tested, were to take effect July 1.

If the businesses passed along their costs to consumers, the changes would drive up the price of the natural remedies to which a growing number of Canadians are turning for nutritional supplements and relief from illness.

"It’s a money grab by the Health Protection Branch and it’s a hidden tax," said Bruce Johnstone, a member of Freedom of Choice for Health Care. "I firmly believe that the pharmaceutical [companies] and the pharmacies are out to put the natural health-products business out [of the market] and take it over."

During the six-month delay Mr. Rock will consider amending the regulations, said his spokewoman, Jennifer Lang. They specify a 12-month phase-in period for compliance.

The government’s tough stand on herbal products includes classifying products ranging from vitamins to some weight-loss powders as drugs instead of food, and sending inspectors to traditional herb stores to insist that some substances be pulled off shelves.

Melatonin, for example, a popular remedy for sleeplessness in the United States, is not allowed on the market in Canada, although people can legally import it from south of the border.

Health Canada officials say they are acting to protect consumers’ safety, noting that some products they have ordered removed from sale contain banned ingredients or have never been approved.

The change in licencing policy has generated petitions, protests and a general outcry from consumers and small businesses, many of them in communities in Vancouver and Toronto where traditional Chinese medicines are popular.

As Health Canada was readying the announcement of a relaxation in its plans, one consumer group was filing a motion in the Ontario Court’s provincial division to try to stop the planned policy change from proceeding.

Freedom of Choice for Health Care applied fro an injunction against the cost-recovery and licensing program. Lawyers for the group and for the government were to have been in court Wednesday to argue the case.

And an expert advisory committee that met last week for the first time to study the fee requirements, called for the moratorium to which Mr. Rock has now agreed.

"There’s been a real expression of concern by those who use and sell herbal remedies and the minister wants to take into account the views of those in the drug industry, stakeholders and the advisory panel before fees or licenses are finalized," Ms. Lang acknowledged in an interview.

The planned changes are part of a move by the Health Protection Branch to declare most herbs, vitamins and mineral supplements drugs instead of foods. They would be subject to the same type of licencing and testing requirements as prescription drugs.

That would allow Health Canada to collect money for product testing, as they do from the multinational drug companies that have to licence patentable drugs for humans and animals.

Mr. Johnstone of Freedom of Choice said 125,000 people have signed a petition asking Mr. Rock and the government to halt the crackdown.

In 1995, 3.3 million Canadians sought treatments outside mainstream medicine. They spent more than $1-billion on services not covered by provincial health plans, and sales of vitamins and food supplements are growing by about 20 per cent a year.

Small-business operators such as Rick [DeSylva], who owns Herb Works in Guelph, Ont., say they will be forced out of business because of the licencing costs if the regulations are implemented.

Dal Anderson of Added Dimension, a herbal business in Calgary, is a member of the advisory committee that recommended the moratorium.

"I think it’s a step forward. For the first time in four years I think they’re not only listening but they’re hearing some of us," Mr. Anderson said.

2. A Daily Dose of Garlic Helps to Keep Your Ticker Ticking
By Wallace Immen

MONTREAL, July 2, [Toronto] Globe and Mail -- Garlic can do more than just ward off vampires, it can help keep your heart healthy, according to results of a long-term study reported at a cardiology conference here yesterday.

A German clinical trial found that people who take daily garlic supplements have more flexibility in their major blood vessels and a lower incidence of heart disease than those who don’t take garlic or use it in cooking.

"The effect is very striking," said Dr. Gustav Belz, cardiologist and director of the Institute for Cardiac and Vascular research at the University of Mainz in Germany.

Stiffening of the vessel walls, a condition called arteriosclerosis, makes blood flow less freely and puts a greater load on the heart. Stiffening occurs naturally with age, but Dr. Belz said people who take garlic can slow the hardening process by 20 per cent.

"The effect is like delaying by years the stiffening that comes with aging."

Equipment was used to measure how long it takes the pressure from a heart beat to move through the arteries that lead to the groin and neck. In a stiff artery, the pulse travels quickly but in a flexible artery, blood moves smoothly and more slowly.

"Elasticity is a good thing; a stiff aorta is bad news for the heart," Dr. Belz noted.

He said this is the first study to look at garlic’s effect on the arteries. Previous research has shown garlic can lower cholesterol and blood pressure and this could explain part of the result. More important, he believes is garlic’s ability to reduce the rate of blood clotting, which is a factor in the buildup of blockages on the inside of blood vessels.

The 202 Germans in the study were between the ages of 50 and 80. Half took daily supplements in the form of garlic powder tablet and their results were compared with the other half who had similar diets but didn’t take garlic. Many of the subjects in the study have been taking garlic supplements for as long as five years.

"It was simple finding controls [people who don’t use garlic] because people in Germany don’t like garlic in their food," Dr. Belz said in Montreal at the Fourth International Conference on Preventive Cardiology.

The garlic users taking 600 to 900 mg a day had an average reduction in serum cholesterol of 12 per cent. This was estimated to have lowered their overall risk of heart attack by an equal percentage.

The garlic was given in the form of standardized tablets sold over the counter in Canada as Kwai. Dr. Belz said the pills contain more allicin, the active ingredient in garlic, than most people would get in a diet that liberally uses garlic. Raw garlic has been shown to have a cholesterol- lowering effect in some studies, but recent research has questioned the findings. Dr. Belz believes the confusion may be because garlic varies widely.

"Fresh garlic contains amounts of allicin that can vary by a factor of 100," Dr. Belz said. The most potent form is Chinese garlic the type used in freeze-dried form to make the garlic pills. The least potent types of garlic come from the Middle East.

No matter where it is grown, though, raw garlic has a major drawback.

"The odour problem," Dr. Belz explained, comes about because the membranes in the mouth absorb it. Pills can help get around the problem because they take the substance directly in the stomach. "If pills are taken at bedtime, the odour problem is very minor," he said.

3. Down-home to Exotic, Food Choices Broadening in Future
By Patricia Commins

CHICAGO, June 29, Reuter -- The answer to the age-old question -- "What’s for dinner?" -- is going to get a lot more complicated.

Mid-life Baby Boomers will be demanding more variety in their diets in the future, from exotic Asian and African cuisines to down-home staples like mashed potatoes and meatloaf.

"There’s a fascinating yin-and-yang of it. We want to revisit our childhoods through macaroni-and-cheese and we want to visit Asia through ... (its) foods," said Faith Popcorn, chairman of New York-based BrainReserve Inc., which predicts consumer trends.

Ethnic foods will continue to be hot -- literally and figuratively -- with growing popularity of spicy fare from far-flung parts of the globe. Beyond the popular staples of Indian, Italian and Mexican cuisine, consumers will be trying a wider variety of foreign foods.

"Many of us already know what Ethiopian food is. Many of us know what Szechuan Chinese food is," said Mark McLellan, chairman of Cornell’s Department of Food Science and Techology.

McLellan, director of Cornell University’s Institute of Food Science, said many of the foodservice entrepreneurs he encounters are looking to bring ethnic foods to a wider consumer audience.

Beyond that, food scientists and trend-watchers said consumers will be turning more to food for better health, eating foods that contain certain potentially beneficial substances to prevent disease.

Conversely, they will be treating themselves to an indulgence like a prime-cut of beef at a top-line steakhouse.

Consumers will also become increasingly conscious of food-safety issues and will look to labels to tell them how and where the food was raised.

"The whole field of nutrition and dietetics is in the most interesting time since I’ve been in the field, and one of the most challenging times," said Jenny Taylor Bond, professor of nutrition in the Department of Food Science and Human Nutrition at Michigan State University and a 23-year veteran.

One trend Bond expects to grow is the use of food as medicine, with an emphasis on herbs to promote health and prevent diseases such as arthritis.

4. Vietnamese Herbal Treatement for Drug Addiction to Undergo Trials
WASHINGTON, (June 23) IPS - Almost 25 years after withdrawing its defeated troops from Vietnam, the United States is welcoming Vietnamese scientists to its shores hoping they can help Washington win its $16 billion a year war against drugs.

Nine Vietnamese scientists are visiting here this week as part of a major international study to determine whether an herbal compound developed by traditional healers in Vietnam can actually cure drug addiction.

The medication, Heantos, has apparently produced sensational results in Vietnam where it has been tested on some 4,000 drug addicts. It will now undergo rigorous trials that meet top international standards in a collaboration between Vietnam’s National Center for Natural Science and Technology (NCNST) Johns Hopkins University in Baltimore, one of the top U.S. institutes dealing with drug addiction, and the National Institute of Drug Abuse (NIDA) here.

Funded with more than $400,000 from the U.N. Development Program (UNDP), the unprecedented international program could mark a historic breakthrough in fighting addiction, according to Dr. Roy Morey, UNDP’s Washington director.

"We hope to God this thing is at least half as effective as we think it is," he told reporters at a press conference here today.

"We think it will save this country and the Western world billions of billions of dollars," said former U.S. Congressman Bill Alexander. The former Arkansas lawmaker and long-time friend of President Bill Clinton became interested in Heantos on a visit to Vietnam in 1991.

With almost three million hard-core heroin and cocaine addicts, the United States spends as much as $80 billion a year to cover the direct and indirect costs of drug abuse. Rising drug use and addiction rates in other countries, especially in some poor nations, have made the scourge one of the costliest challenges facing governments today.

Officially, almost 200,000 Vietnamese suffer addiction, primarily to opium-based drugs, including heroin, morphine, and opium itself. But cocaine addiction is also on the rise, and independent analysts say the actual overall addiction rate in Vietnam runs much higher.

The addicted population is divided into three major groups: traditional users of opium; people who were treated with morphine for severe wounds incurred during the war or from accidents; and younger Vietnamese who have become addicted for social reasons, similar to those which motivate young addicts in western societies.

Dr. Tran Khuong Dan, Heantos’ inventor, said he hails from a family of traditional herbalists which goes back many generations. After witnessing his elder brother die of a drug overdose and the sharp rise in drug addiction rates in Ho Chi Minh City in the early 1980s, he decided to seek a cure based on the principles and accumulated wisdom of 2,500 years of traditional Asian medicine.

He began by collecting herbs in all parts of Vietnam, including the traditional opium-growing areas of the Montagnard tribes people in the western highlands of the country. He also studied and worked for six years in a laboratory refining a compound made from 13 common, indigenous herbs. Much of his work was based on the recipes of Chinese physicians and remedies used by the indigenous groups themselves when their opium crop failed.

By 1989, Tran, who used Heantos to cure his own drug addiction, launched the compound through the Ministry of Health. Tests involving almost 4,000 opium, heroin, morphine, and cocaine addicts from about three dozen hospitals, clinics, treatment centers in both northern and southern Vietnam, followed. More than 3,000 patients have reportedly been treated successfully.

Heantos is administered in two different stages. In the first, the patient is given the compound in liquid form over three to five days to overcome withdrawal symptoms. The second stage, during which the patient is given the compound in capsule form, can last between one and six months, depending on the subject’s physical condition. It is designed to eliminate the craving for drugs altogether.

Unlike methadone, a popular but costly heroin substitute for addicts in much of the West, Heantos is not addictive. "Heantos is not a drug substitute," according to Tran. "(Addicts) can stop taking it" after they complete the second phase.

The total treatment costs about $70 in Vietnam. By contrast, annual methadone costs per patient can run as high as $3,000 in the United States.

Heantos’ most spectacular results were achieved with war veterans who became addicted to opium after treatment for their wounds. Of more than 100 veterans who were treated with Heantos, only 30 percent returned for their opium dosage after one year.

One of the many unique aspects of the proposed collaboration, according to Dr. Lutz Baehr, who heads the project for the U.N. Office for Project Services, is the "intercultural" exchange that will take place between western scientists and eastern herbalists.

"We have the best people in place for studying this at Johns Hopkins," said Baehr, "and there is no better herbalist in Vietnam than Tran.

Heading up the U.S. side at Johns Hopkins is Dr. Donald Jasinski, chief of the Department for Clinical Pharmacology and Chemical Dependence. "The Vietnamese want to introduce this to the West in such a way as to evaluate the compound in accordance with scientific standards," he told IPS.

"We looked at the data...and we asked, ‘Is it in the public interest to evaluate this?’ The answer is yes," he said. "There is enough to justify doing a study." Jasinski noted that many of the most effective medicines used in the West today derived originally from folk preparations.

The initial $400,000 provided by UNDP will fund the collaboration through the end of the year, according to Morey. If the initial trials go well, he said, further work could cost up to $4 million over the following two-and-a-half years. That money could be raised from bilateral donors, private foundations, or private sector industries. He described UNDP’s role as that of "a kind of venture capitalist."

"As this drug treatment becomes better known, there may be considerable interest on the part of the private sector," he noted, adding that the Vietnamese government turned to UNDP "because they want a neutral institution to help them establish contact with counterparts in other countries. We served as a honest broker in this," he added.

Alexander praised the U.N. role in facilitating the collaboration, and especially in overcoming what he called the "enormous bias in western medicine" against traditional remedies. "The U.N. has been enormously effective compared to the U.S. government in dealing with a problem of this type," he said.

5. Deepak Chopra Settles Libel Suit
WASHINGTON, June 23, AP -- Best-selling author Deepak Chopra and The Weekly Standard have reached an out-of-court settlement of his libel lawsuit, the magazine said Monday.

In a July 1, 1996, article, the conservative weekly accused the self-help guru of plagiarism and of hiring on three occasions a prostitute who claimed he paid her with a credit card.

"While we operated in good faith in publishing the article, we are now convinced that certain allegations reported in that story were false," the Standard said in a "correction and an apology." It added that the tone of its original article was unfair to Chopra.

The magazine said it now believed someone else used a credit card with Chopra’s name and forged his signature.

It also retracted the allegation that Chopra plagiarized another published work.

And the magazine said, "We also would no longer state that his company’s herbal remedies have high levels of bug parts and rodent hairs, or levels higher than other such organic products."

Chopra had sought $35 million in the lawsuit. The Washington Post said sources familiar with the case told it the settlement included payment of his legal fees but no additional cash.

"The dispute between Dr. Deepak Chopra and The Weekly Standard has been resolved to the mutual satisfaction of the parties," the Standard said in one-sentence statement about the settlement’s terms.

6. Herb Business News
Herbalife: Exclusive Suppliers May Not Renew Contracts

LOS ANGELES, June 27, BUSINESS WIRE -- Herbalife International Inc. (NASDAQ/NM:HERB) Friday announced that it has informed its exclusive suppliers of weight-management and food and dietary supplement products, D&F Industries, Dynamic Products Inc. and Raven Industries Inc., that the company will not exercise its right to automatically renew its existing supply agreements for a five-year period beginning in January 1998.

Herbalife continues to negotiate with its suppliers for replacement contracts for the non-renewed agreements. Herbalife indicated that it has had a long and mutually beneficial relationship with its suppliers and remains open to entering into replacement contracts with them, if mutually agreeable terms can be achieved.

The company also indicated that it is continuing to implement contingency plans to assure a smooth transition to new suppliers, if necessary. In particular, the company is continuing to evaluate several alternative manufacturers and expects that if agreements with its current suppliers are not executed, the company will enter into alternative supply arrangements in a timely manner.

The company expects no disruption in supply or to its worldwide distribution network as a result of effectuating its contingency plans.

Herbalife International markets weight-management products, nutritional, food and dietary supplements and personal care products in 36 countries worldwide. Herbalife products are available only through a network of independent distributors who purchase the products directly from the company.

Herbalife: Declares Dividend

LOS ANGELES--(BUSINESS WIRE)--June 25, 1997--Herbalife International Inc. (NASDAQ/NM:HERB) Wednesday announced that its board of directors has approved payment of the company’s regular quarterly cash dividend of 15 cents per share.

The dividend is payable Aug. 1, 1997, to shareholders of record on July 25, 1997.

PharmaPrint: Past Fiscal Year Results

IRVINE, Calif.--(BUSINESS WIRE)--June 26, 1997--PharmaPrint Inc. (NASDAQ:PPRT) Thursday reported that financial results for the fiscal year ended March 31, 1997, were in line with development stage plans described in the company’s August 1996 initial public offering and that plans are on track to produce significant revenues in the current fiscal year.

In related news, PharmaPrint’s Chairman and Chief Executive Officer Elliot P. Friedman said: "PharmaPrint expects to make its first Investigational New Drug (IND) filing in July to address the symptoms associated with benign prostate enlargement with a pharmaceutical version of the saw palmetto berry. If this IND is allowed as filed, we expect to begin Phase II clinical trials in the United States later this summer."

Friedman also said the company expects to announce new strategic relationships with large, multi-national pharmaceutical companies during the coming months to help bring to market pharmaceutical versions of several other herbal medicines.

For the three months ended March 31, 1997, the company reported no revenues and a loss of $1,884,000, or 17 cents per share, excluding non-recurring (non-cash) stock compensation expense charges of $309,000, or 3 cents per share. Including these charges, the company’s net loss was $2,193,000, or 19 cents per share. For the comparable quarter in 1996, the company reported no revenues and a loss of $505,000, or 6 cents per share.

For the year ended March 31, 1997, the company reported no revenues and a loss of $5.9 million, or 58 cents per share, excluding non-recurring (non-cash) stock compensation expense charges of $5,333,000, or 52 cents per share. Including these charges, the company’s net loss was $11,233,000, or $1.10 per share. For the fiscal year ended 1996, the company reported no revenues and a loss of $1,344,000, or 16 cents per share.

At March 31, 1997, the company reported no long-term debt and cash equivalents of $8,170,000 vs. $890,000 at March 31, 1996.

PharmaPrint is the only developer and manufacturer of patented pharmaceutical versions of herbal medicines. Management expects to introduce a succession of new pharmaceuticals originating from widely demanded, but previously scientifically untested and unregulated herbal products. The PharmaPrint process was developed over the course of 20 years at the University of Southern California, which still owns an interest in the company.

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