To: IAHF LIST
Subject: Media Pushes Full Pharmaceutical GMPs for Dietary Supplements FDA to Unleash GMP Regs from Hell in September...
From: John Hammell jham@iahf.com
Date: Sun, 04 Jun 2000 13:35:48 -0400

All Webmasters: Please post.

Everyone: Please read and take suggested action, please forward widely!

IAHF LIST: The enclosed article is from the June 2 San Francisco Chronicle- it shows the kind of propaganda being hammered out via the mainstream press to push for FDA to develop full pharmaceutical GMP standards for dietary supplements. FDA is expected to come out with GMP regs for dietary supplements in September. Under the Administrative Procedures Act, FDA is required by law to to conduct impact studies to determine how their proposed regs would impact small businesses, but will they? I predict they either won't or won't do it right, and will force people to try to sue them.

The story below about contaminated Plantain from Germany is quite interesting, especially given that it came from GERMANY... are they trying to set us up?? What do YOU think?

Go back to Rath's website and every day from now til the end of the Codex meeting on June 23 be sure to pound all delegates to the CCNFSDU Codex meeting with Dr.Rath's form letter. Go to http://www.rath.nl Just one click per day and we can bury them and make them think TWICE!

DSHEA gave FDA the right to create new GMP regs for dietary supplements. That was a HUGE weapon to hand them... illusrates once more that DSHEA was not the great and glorious victory it was alleged to be. All it really was was a way for the large sell out companies that had the most to do with drafting it to buy themselves some time to arrange their sell out deals with drug companies. This is why we're seeing no effort from CRN or NNFA to call for Codex Oversight. (Indeed- they're actively BLOCKING our efforts to get oversight.) The drug companies that are manipulating these vitamin trade associations KNOW that FDA is setting us up for "harmonization" via Codex, but they don't CARE, because it will help them WIPE OUT their competition!

Will enough vitamin consumers, health food stores, and small manufacturers wake up in time to see the BIG LIE??? They won't if you don't forward this widely and if you don't discuss it with the owner and managers of your local health food stores and urge them to help us alert the small manufacturers. Urge them to listen to the audio file of me discussing the Codex Scam in simple terms at http://www.citizensvoice.org/course/jham01.rm Listen to it yourself and tape it with a hand held tape player so you can take it to your local health food store!

http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2000/06/02/MN75760.DTL

Herb Remedies: Panacea or Problem?
Health officials look to improve safety, labeling in $14 billion industry

Kenneth Howe, Chronicle Staff Writer

Friday, June 2, 2000

When Christine Storey took her daily dose of "Chompers," a dietary supplement made by Arise and Shine of Mount Shasta, she thought she was getting a natural colonic cleanser.

But rather than experiencing a mild laxative effect, the 52-year-old Santa Monica woman suffered months of convulsions, vomiting, diarrhea, fever and exhaustion.

Federal investigators later determined that the herbal remedy, which the label said was made with plantain, a leafy herb not to be confused with the tropical bananalike plant, had become contaminated with digitalis. While digitalis, made from the purple foxglove plant, can be an effective heart medication, it can also be a lethal poison.

Investigators from the Food and Drug Administration eventually discovered that 6,000 pounds of the tainted plantain had been shipped from Germany to 150 manufacturers, distributors and retailers in 39 U.S. states, sickening an untold number of people and spawning a flurry of lawsuits and countersuits.

Storey's case was one of an alarming number of recent incidents in which herbal products offered by the $14 billion dietary supplement industry have been found to be contaminated or adulterated.

The problem, say many concerned public health officials, is that the manufacturing of dietary supplements is nearly unregulated -- few safeguards against contamination exist. Consumers cannot be certain that the ingredients on the label of an herbal product are what is actually in the bottle.

``In many cases, consumers are serving as guinea pigs because they don't really know what they are taking,'' said Bill Gurley, a pharmaceutical researcher at the University of Arkansas.

In some cases, herbal remedies have been found to be contaminated with dangerous levels of heavy metals such as lead, arsenic and mercury. In other cases, herbal products have been purposely spiked with restricted pharmaceutical drugs to boost their effects.

The most widespread problem is that when tested, herbal products -- whether St. John's wort or echinacea -- routinely do not have the potency or purity that is claimed on the label.

Some health officials have called for the United States to follow the lead of other industrialized countries where herbal remedies are widely used

--Australia, Japan and Taiwan, for example -- and establish GMPs, or good manufacturing practices, that set strict quality standards and manufacturing procedures and treat herbals like pharmaceutical drugs.

"People are taking these herbs as medicines, and some can have toxic effects," said Christine Haller, a medical toxicologist with the California Poison Control System. "Herbs have to be made to meet drug standards."

Although Congress passed the 1994 Dietary Supplement Health and Education Act authorizing the FDA to establish GMPs for herbal products, the agency has made little progress so far.

"We're pushing very hard on that," said Dr. Christine Lewis, director of the FDA's Office of Dietary Supplements Labeling and Nutritional Products. "Getting a full- blown regulatory program in place can take as long as 10 years."

Lewis said the FDA has been hampered by the complexity of the task and by a small staff. But the agency's lack of regulation worries some health officials.

"The bottom line," said Richard Ko, a food and drug scientist with the California Department of Health Services, "is to protect public health."

TROUBLING STUDIES

In recent tests of herbal remedies, researchers have found wide -- and, in some cases, disturbing --disparities between what labels on the products claim and the actual contents of the bottle.

ConsumerLab.com, which provides independent analyses on nutritional products, has run extensive tests on a number of herbal products, including: ginkgo biloba, made from the dried leaves of a tree indigenous to Asia and used to combat memory loss; saw palmetto, made from the ripe, dried fruit of a small bushy palm plant and recommended for prostate problems, and SAMe, a synthetic form of S-adenosylmethionine, a chemical produced naturally in all animals and used as an antidepressant and for joint pain.

"On average, we're seeing that one-quarter to one-third of the products do not meet the (claims on the) label, often by a wide margin," said the firm's founder, Dr. Todd Cooperman, who uses top clinical labs that conduct blind tests. "That's a lot for an American public that's grown very accustomed to having high quality products and FDA oversight."

In January, for example, ConsumerLab bought and tested 13 brands of SAMe. In nearly half of the lab's tests, the actual amount of SAMe was less than half of the amount declared on the labels. In one case, the amount of SAMe was below detectable levels.

"The more testing we do, the more concerns we have that a large number of manufacturers are either intentionally or out of ignorance not delivering what we think consumers are expecting," Cooperman said.

Recent tests performed at the University of Arkansas were even more alarming.

Pharmaceutical researcher Bill Gurley analyzed 20 herbal products containing ephedra, a heart stimulant often marketed as a natural way to lose weight or boost energy.

In an article for the American Journal of Health-System Pharmacy last month, Gurley reported that half of the products tested had discrepancies of more than 20 percent between the amount of ephedra claimed on the label and what was actually in the product. More important, he discovered that in some cases the variation between one lot of the product and another exceeded 1000 percent.

Such extreme differences can be dangerous, he said, referring to well- documented adverse effects, including death, associated with ephedra and its related compounds.

In six of the ephedra products he tested, Gurley found significant amounts of norpseudoephedrine, a controlled substance. The unlicensed sale of norpseudoephedrine is a felony, and possession is a misdemeanor.

Sometimes the adulteration of a product is not accidental.

The recent death of a Texas woman after she took an herbal energy booster led to the investigation and later indictment of a Colorado company and its chief executive officer for allegedly spiking its product with potentially dangerous pharmaceuticals not listed on the label.

Chemins Co. of Colorado Springs makes Formula One and markets it as an herbal energy booster whose prime ingredients are ma huang, an herb that contains ephedra, and kola nut, a naturally occurring source of caffeine.

To save money and increase the potency of its herbal supplement, Chemins added ephedrine hydrochloride and caffeine anhydrous, both pharmaceutical-grade drugs, a grand jury charged.

When an FDA inspector showed up at the Chemins plant, the company hid the spiking ingredients in a shed behind the factory, according to court records. The inspector asked to look in the shed but was told the key could not be located. When he returned the next day, the drugs had been moved, first to an employee's garage and then to a rental storage unit, according to those documents.

Later, a company employee sold the drugs, weighing about 2,000 pounds, to a group that used the drugs to make methamphetamine, which is a chemical cousin of ephedrine.

The company and the CEO pleaded guilty to conspiracy to evade and avoid FDA authority. Sentencing is scheduled for July 5.

IMPORTED HERBALS

Some of the biggest health worries about herbal products come from uninspected, untested natural substances imported from overseas suppliers.

Last year, a 61-year-old Sacramento woman bought a package of Chinese herbs for a tea to help ease her arthritis. The label said the tea contained clematidis, a common herb often used to treat the ailment.

However, the tea actually contained podophyllotoxin, an herb similar in appearance to clematidis but one that is used externally to treat genital warts.

The woman, a licensed acupuncturist, slipped into a coma after drinking the poisonous tea. When she awoke, she could neither walk nor use her hands. The herb paralyzed her intestinal tract as well, said Ko of the state Department of Health Services. She is currently in a nursing home unable to digest solid food.

Ko said such serious poisonings are rare, but adulterated herbal products are not.

Two years ago, he tested 260 Asian patent medicines, concentrated herbal products usually in pill form, purchased at California herbal stores. He found that nearly a third of the products were contaminated.

Thirty-one of the products contained pharmaceutical ingredients such as ephedrine, a heart stimulant, or chlorpheniramine, an antihistamine. Sixty-eight medicines contained either lead, arsenic or mercury, which are taken in China to treat various maladies, but which have not been in common use in this country since antibiotics became widely available about 60 years ago.

In some cases, Ko found the concentration of heavy metals to be thousands of times the maximum levels recommended by U.S. health officials.

Ko approached the handful of importers who handle the products and offered to test them.

"I told them that it's in their interest if we give them a free test to screen out contaminants," said Ko, whose staff is testing 100 products and expects to scrutinize 300 to 400 during the year.

CALL FOR OVERSIGHT

Ko and others say herbal product safety and quality should be addressed by creating the kind of federal guidelines that already apply to the drug industry.

"Dietary supplements just aren't being marketed to any public standard," said Dr. Roger Williams, head of the United States Pharmacopeia, the private organization that sets many of the technical standards that pharmaceutical manufacturers must meet.

The dietary supplement act passed by Congress six years ago largely exempted the industry from the stringent premarket safety and efficacy tests that the FDA requires before allowing the sale of pharmaceutical drugs.

But the law did authorize the FDA to establish good manufacturing practices that regulate how herbal products were to be made. Food and drugs each have their own set of GMPs, which set factory standards for such things as cleanliness, lighting, equipment sanitation, sampling and testing ingredients, controlling contamination and expiration dating, and a host of other processes.

In 1995, the herbal industry sent its own list of proposed manufacturing standards to the FDA, but it was not until February 1997 that the agency sent this proposal out for public comment. The FDA has yet to propose standards of its own.

The FDA's Lewis said that her unit has a staff of only four or five people to work on regulatory issues. But she said the agency expects to have a set of proposed regulations by the end of the year.

Until the dietary supplement industry gets its own GMPs, it must abide by the GMPs for the food industry. But the food industry GMPs are not very helpful when it comes to herbal products that are being taken for medicinal purposes, said Larry Sasich, a pharmaceutical analyst with Ralph Nader's Public Citizen's Health Research Group.

"The rules that apply to cornflakes aren't going to be very effective when applied to ephedra, where a variation in the dose can cause heart disturbances that can be fatal."

The rules on foods are extensive, but they deal largely with such issues as additives, factory sanitation and food cleanliness, said Sasich. By contrast, the GMPs for the drug industry also focus on lot-by-lot testing of pharmaceutical ingredients for dosage and purity and keeping precise records of these examinations.

Michael McGuffin, president of the American Herbal Products Association, thinks that with a little modification, the food industry GMPs can serve as a model for dietary supplements.

"They are absolutely applicable for dietary supplements," he said, referring to food industry GMPs that require all products be labeled accurately. "The responsible center of the (herbal) industry is dedicated to manufacturing products that are accurately labeled," he said.

McGuffin said that isolated problems in the herbal industry often stem from a lack of FDA enforcement of existing regulations. For example, he said, many of the herbal products that failed the tests of Gurley and Cooperman would be in violation of current FDA labeling rules as well as GMPs.

He also noted that the herbal industry has proposed strengthening the food industry GMPs to make them more applicable to herbal products by adding more quality control tests and requirements. In fact, many manufacturers are already abiding by these proposed GMPs, although they are less stringent than drug GMPs. But accurate testing poses a problem for the dietary supplement industry. Assays -- tests to accurately identify a particular ingredient -- have not been developed for all herbal products.

Moreover, pharmaceutical drugs often have only one active ingredient, whose presence and potency can be accurately measured and tested. But herbal products, which typically come from plants, are far more complex. Each herb may contain many active ingredients, which may interact with each other, and that combination may be key to its efficacy.

Often, no one even knows what the active ingredients are.

"That's all the more reason why these herbs should not be sold as if they were just food products," said Haller.

HERBAL QUALITY CONTROLS:

How consumers know what they're getting. The U.S. Food and Drug Administration is in the process of setting standards, called good manufacturing practices, for making dietary supplements. Currently, herbal products must meet the FDA's GMPs for food, not the stricter drug GMPs. In general, food GMPs regulate:

-- Sanitation of factories, workers and their equipment.

-- Handling of raw materials to protect against contamination.

-- Proper refrigeration and warehousing practices. Drug GMPs go beyond these issues to also deal with:

-- Sampling and testing drug components.

-- Establishing written procedures for making and handling drugs to insure they have "the identity, strength, quality, and purity they purport." Other countries have already set their own GMPs for dietary supplements. These countries treat herbals in much the same way as drugs. Among the countries with more strict herbal GMPs are:

-- Japan
-- Taiwan

-- Australia Key developments in regulating herbal products.

-- 1994: The Dietary Supplement Health and Education Act authorizes the FDA to develop GMPs for herbal products.

-- 1997: Dietary supplement industry proposes its own GMPs.

-- 2000: FDA is expected to issue its own proposed GMPs for dietary supplements.