News

February 8, 2013 - CNN on Diets Through History

In a featured article on CNN, ephedra has made it onto the timelime. From 1820 to today, a number of famous (some controversial) diet methods are listed. The article mentions ephedra as follows:

2004: The FDA bans the sale of diet drugs and supplements containing ephedra after it's linked to heart attacks.

A quick search on Google Trends shows that the use of ephedra-based diet supplements is still in decline. Nowadays many consumers report to use replacing thermogenic supplements, such as DMAA. However, the latter is also under attack (for reasons similar to ephedra some years ago) and its future is uncertain.

August 15, 2012 - Case of Woman who died after ephedra use discussed in NY Times

The New York Times recently published an editorial on the tragic death of a young woman, who died five years ago after taking ephedra as well as a number of other drugs in a hospital in Brooklyn. Not only is her use of ephedra debated (the woman took ephedra, as well as a 'few' beers and a herbal sleep remedy during an all-night study session), moreover people now believe she was given the wrong treatment at the hospital.

Here's an excerpt from piece:

In 2007, Ms. Seelig, 22, was working as a waitress while studying classics at Hunter College. During an all-night study session at home she took Ephedra, a stimulant diet drug that had been banned by the Food and Drug Administration, and had a few beers. She also took an herbal sleep remedy. Feeling ill, she called 911 and told the operator that she thought she may have poisoned herself.

Read the full article here: http://www.nytimes.com/2012/08/03/opinion/was-this-death-really-unavoidable.html

April 25, 2012 - Samples of traditional Chinese medicine found to contain ephedra amongst other banned or harmful products

Two recently published studies have shown that traditional Chinese medicine can be harmful and often contain ingredients that are illegal and some that can cause cancer.

Critics have long warned that some mixtures can also contain naturally occurring toxins; contaminants such as heavy metals; added substances such as steroids, which can make them appear more effective; and traces of animals that are endangered and trade-restricted.

Now, researchers in Australia have investigated the issue using modern sequencing technology. The team analyzed 15 traditional Chinese medicine samples seized by Australian officials.

In the herbal preparations that they tested, Bunce and his colleagues found members of 68 plant families, among them plants of the genera Ephedra and Asarum. Both can contain toxic substances such as aristolochic acid, banned in many countries because it causes kidney disease and upper urinary tract cancer, or UUC. Although detecting DNA from a certain species does not mean that a toxin produced by that plant is present, chemical analysis of one of the four samples containing Asarum did turn up aristolochic acid.

Read the full news article here.

January 16, 2012 - No proof that Ephedra replacement is effective

Bitter orange extract is a popular weight loss supplement, and many people used it as a replacement after ephedra was taken off the shelves. While there is no doubt that bitter orange can speed up your metabolism for a very short time, there is no solid proof that it will help lose weight.

“The data to show that it helps to lose weight is not there," said Dr. John Swartzberg, head of the editorial board at the UC Berkeley Wellness Letter. "They haven't been proven safe and they haven't been proved effective."

"People taking excessive amounts of bitter orange could develop heart disturbances, high blood pressure, really dangerous things," he said.

There's also concern that bitter orange can interfere with the proper absorption of certain medications, including antidepressants, statins and calcium channel blockers.

Read the full news article: Any proof bitter orange can help shed pounds?

March 30, 2011 - Bitter orange extract reviewed for safety

Scientists have reviewed the bitter orange (Citrus aurantium) extract containing the p-synephrine alkaloid, often used in weight loss supplements) and published their findings in Herbalgram, the quarterly journal of the American Botanical Council.

"In summary," the researchers write, "based on current research as well as the extensive ingestion of bitter orange and p-synephrine in the form of dietary supplements as well as fruits, juices, and other citrus food products, the data demonstrate that bitter orange extract is safe for human consumption. No credible adverse events have been directly attributed to bitter orange, or its primary protoalkaloid, p-synephrine, in association with oral ingestion."

This is interesting news, because Bitter Orange extract is sometimes referred to as 'The New Ephedra'. Since the ban on ephedra it is often used as natural fatburner in weight loss products.

The entire peer-reviewed safety review of bitter orange , which is published in HerbalGram 89, is available on the American Botanical Council website, www.herbalgram.org.

December 23, 2010 - General information on weight loss supplements, including ephedra and ephedrine

The website Arabnews posted an article where the main ingredient of several weight loss products are briefly reviewed. The following is said regarding ephedra:

Originally used in China in small amounts as a herbal remedy for cough and bronchial asthma. In large doses the active ingredient, ephedrine, is found to have a stimulant effect, which can increase the amount of energy lost by your body and also suppresses the appetite. It is either sold alone or in combination with a caffeine source to augment its effect. People using Ephedra lose more weight (about 1kg) per month than dieting alone, but they might also get some of these side effects: Nausea, vomiting, mood swings, high blood pressure, abnormal heart beats, heart attack or even death. Do you think it’s worth trying? The American Food and Drug Administration banned the sales of Ephedra in 2004, but it is still sold by many companies on the Internet and around the world.

Read the full article: Arabnews.com

July 14, 2010 - New website on ephedra/ephedrine launched

A new website that focuses on providing factual information about Ephedra hydrochloride and ephedra containing diet supplements recently went online. Although the makers clearly aim to sell ephedra related products, some of the information they provide is actually of decent quality. It makes a nice change in all the bogus information regarding ephedra that some supplement sources and media are spreading. See EphedrineHydrochloride.com

June 2, 2010 - Synthetic geranium substance raises ephedra-like red flags

Synthetic versions of geranium oil are being illegally formulated into weight management products. According to several sources the industry may “have another ephedra on its hands”. One source who preferred not to be named said geranium oil substitutes were being used in weight loss and body building supplements marketed mostly by fringe internet companies but also major supplements brands whose products appeared in major retail outlets.

“This whole Geranamine things has been on our radar before – about 4-5 years ago, but it never went anywhere. This time around someone got some traction with a product and now everyone is following,” he said.

“Problem is, this story is going to end badly at some point, probably with some form of FDA action.”

The ingredients typically appear on-label as geranamine or geranium oil but are in fact 1.3-dimethylpentylamine, a chemical compound.

This is different to the dimethylpentylamine compound, which can be extracted from the geranium plant, but 1.3-dimethylpentylamine is manufactured in a lab, and it does not have approval for use in the US in dietary supplemets.

“I think some of the companies here in the US are purchasing the synthetic material called “1 3-dimethylpentylamine” and labeling it as either Geranamine or Geranium Oil to make it look like it comes from geranium, when in fact it has never seen a plant,” the source said.

He said much of the material originated in China.

Mark Blumenthal, the founder and executive director of the American Botanical Council (ABC) said the ingredient that can also be derived from oil of pelargonium, had blipped on his radar, but had yet to be studied in the scientific literature.

“I think concerns about possibly another ‘ephedra-like’ may be warranted, although to date, we have not conducted a lit review on this substance and thus cannot comment on its relative safety when ingested at doses which are presumably higher than those found in geranium oil (little of which is normally ingested by humans),” he said.

Source: http://www.nutraingredients-usa.com/Industry/Synthetic-geranium-substance-raises-ephedra-like-red-flags

June 2, 2010 - Synthetic geranium substance raises ephedra-like red flags

Synthetic versions of geranium oil are being illegally formulated into weight management products, according to several sources concerned industry may, “have another ephedra on our hands”. One source who preferred not to be named said geranium oil substitutes were being used in weight loss and body building supplements marketed mostly by fringe internet companies but also major supplements brands whose products appeared in major retail outlets.

“This whole Geranamine things has been on our radar before – about 4-5 years ago, but it never went anywhere. This time around someone got some traction with a product and now everyone is following,” he said.

“Problem is, this story is going to end badly at some point, probably with some form of FDA action.”

The ingredients typically appear on-label as geranamine or geranium oil but are in fact 1.3-dimethylpentylamine, a chemical compound.

This is different to the dimethylpentylamine compound, which can be extracted from the geranium plant, but 1.3-dimethylpentylamine is manufactured in a lab, and it does not have approval for use in the US in dietary supplemets.

“I think some of the companies here in the US are purchasing the synthetic material called “1 3-dimethylpentylamine” and labeling it as either Geranamine or Geranium Oil to make it look like it comes from geranium, when in fact it has never seen a plant,” the source said.

He said much of the material originated in China.

Mark Blumenthal, the founder and executive director of the American Botanical Council (ABC) said the ingredient that can also be derived from oil of pelargonium, had blipped on his radar, but had yet to be studied in the scientific literature.

“I think concerns about possibly another ‘ephedra-like’ may be warranted, although to date, we have not conducted a lit review on this substance and thus cannot comment on its relative safety when ingested at doses which are presumably higher than those found in geranium oil (little of which is normally ingested by humans),” he said.

Source: http://www.nutraingredients-usa.com/Industry/Synthetic-geranium-substance-raises-ephedra-like-red-flags

March 8, 2010 - Biggest Loser trainer Jillian Michaels sued over diet supplements

US Biggest Loser trainer Jillian Michaels could be in big trouble. The third lawsuit against the Jillian Michaels Maximum Strength Calorie Control pill supplement was filed late Tuesday in Los Angeles County Court. According to the plaintiffs, the main reason for their lawsuits is that the pills can be potentially lethal.

The reports state that the pills contain “potentially lethal” doses of citrus aurantium. Also known as Bitter Orange or synephrine, it is the “chemical cousin” of ephedra. Ephedra came under heavy fire because a percentage of people who took it would die suddenly from a heart attack. One of the plaintiffs, Kathy Hensley, claims that Jillian’s supplements contain too much of the toxic substance. Citrus aurantium can raise blood pressure and can cause serious cardiac problems in certain people.

Read the article on MSNBC. August 28, 2009 - NFL LB suspended for ephedra use

The reason for former Chiefs OLB Vince Redd's four-game suspension was reportedly for testing positive for Ephedra. According to his agent, Joe Linta, Redd was taking Sudafed, and was unaware of the supplement containing ephedra.

"If you check the ingredients of Sudafed, it has Ephedra in it," Linta explained. "Vince said he took Sudafed around the time of a league administered test, so it was an honest mistake. I don't think he realized what was in Sudafed, which really is a cold medicine. He looks forward to continuing his career this season."

Ephedra, which is generally taken for weight loss, is a banned supplement by the NFL.

Read the full article here.

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July 10 2009 - Attack on alternative medicine

Congress is now considering Senate Bill 722, the Dietary Supplement Safety Act of 2003. The bill would amend the Federal Food, Drug and Cosmetic Act to require manufacturers of dietary supplements to submit to the Food and Drug Administration reports on adverse experiences with dietary supplements. (See “Supplements under federal scrutiny” in Newsflash, Issue 11, Chiropractic Economics or at www.chiroeco.com/news/supplement-scrutiny.html.) The underlying purpose of this bill is to move the burden of proof from the FDA to show that a supplement is not safe to the manufacturer to show that it is safe.

Ephedra. also known as Ma huang, it has been a lightning rod for controversy. This herbal weight-control supplement has been in use continuously for at least 5,000 years and is the oldest medicinal plant of which we have written records. This incredible herb promotes weight loss by producing a thermogenic and fat-metabolizing effect and acts as an appetite suppressant. It works. It is safe under normal conditions of use, has no contraindications and is inexpensive. In 2001 a carefully conducted, independent, double-blind, randomized, placebo-controlled study reported in the International Journal of Obesity found that the group taking ephedra had significantly greater reductions in waist and hip circumference than the placebo group, with no adverse effects on the subjects during the trial.

Read the full article here.

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May 8, 2009 - Weight loss pills recalled under FDA pressure

The US Food and Drug Administration (FDA) warned bodybuilders and dieters to stop using a supplement called Hydroxycut. This ephedra free supplement has been linked to a number of cases where users reported liver and heart problems after using the supplement. Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation has changed several times.

Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers. Since the ephedra ban in 2004, numerous ‘ephedra free’ products have been introduced to the weight loss market, many containing (illegal) prescription drug ingredients. It is impossible for the FDA to control and monitor ingredients in such products and therefore they rely on voluntary reports from consumers to detect problems.

More information and the list of recalled Hydroxycut products can be found here

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June 9, 2008 - While Ephedra remains illegal, FDA approves the same chemical for OTC pharmaceutical sales

(NaturalNews) The FDA has approved a new pseudoephedrine-containing product, Zyrtec D, for over-the-counter sale to people over the age of 11. "The approval of this widely used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," said Dr. Andrea Leonard-Segal, director of the agency's Division of Nonprescription Clinical Evaluation.

"This double standard in chemical safety is typical of the pro-pharma FDA," explained consumer health advocate Mike Adams. "According to the FDA, all drugs are assumed safe until proven dangerous, but all herbs are assumed dangerous unless proven safe. This approach to consumer safety is backwards," Adams said. "It is the highly-concentrated drugs that pose the real danger to consumers. The plant compounds used in Chinese Medicine are remarkably safe and have been used for literally thousands of years in the safe and effective treatment of numerous health conditions."

Zyrtec-D is indicated for the treatment of upper respiratory allergies such as watery eyes, runny nose, sneezing, nasal congestion, or itching of the eyes, nose or throat. It reduces nasal swelling and relieves sinus congestion and pressure.

Read the full article on NaturalNews

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14 april 2008 - Ephedra recall backed by industry

At the time of the Nutraceutical appeal at Supreme Court, industry group Natural Products Association also filed an amicus curiae with the Supreme Court. This asked the court to give interested parties the opportunity to prove, on merits, that the FDA overreached and exceeded the bounds of Congress' regulatory scheme.

"We filed the amicus because there is a statutory distinction between food and drugs. We think the risk-benefit standard could cause a problem with that distinction," David Seckman, president of the NPA told NutraIngredients-USA.com at the time.

Latest recall

Herbal Science International is currently recalling nine products containing ephedra as an ingredient sold labeled under the following brands:

    • Wu Yao Shun Qi San • Qing Bi Tang (Nasal Cleanser) • Zhong Fong Huo Luo Wan (Stroke Revito Formula) • Xiao Qing Long Tang (Little Green Dragon) • Ding Chuan Tang • Xiao Xu Ming Tang • Feng Shi Zhi Tong Wan (Joint Relief) • Guo Min Bi Yan Wan • Fang Feng Tong Sheng San

The company has ceased distribution of these products and is advising all consumers to immediately stop using them. It said it is working closely with FDA in the recall process.

This is an excerpt, read the full article.

Source: Nutraingredients-USA

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26 September 2007
UK: Pseudoephedrine containing drugs remain their OTC-status

The British pharmaceutical industry can take a deep breath. Flu and cold medicines that contain pseudoephedrine- and ephedrine remain available over the counter (OTC) without prescription. For now at least…

Cause there are some restrictions on the way: in the future the pack size of the medicines will be restricted to a 720mg maximum of pseudoephedrine per pack and there will be a limit of one pack per customer. Moreover the Medicines and Healthcare products Regulatory Agency (MHRA) would like to see the sale itself be carried out by pharmacists only.

The announcement of these restrictions by the MHRA, makes the reclassification of the medicines to prescription-only look unlikely. This was feared after a proposition in that direction made by the MHRA in March this year. Health authorities had pressed this to tackle the rare but concerning problem of OTC ephedrine- and pseudoephedrine-based drugs being used illicitly in the production of the Class A controlled drug Meth (methylamphetamine).

For that particular reason, the US introduced restrictions whereby the purchaser is required to show his photo ID. In the state of Oregon and Mexico pseudoephedrine medicines have already a prescription-only status.

The MHRA also announced the legal status of the products would be reclassified to prescription-only in July 2009 if the current measures to be implemented did not control the risk that the drugs could be misused.

The new controls will be phased in over the next few months.

Source: PharmaTechnologist.com

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15 march 2007 - UK to Pull Pseudoephedrine

The move could force pharmaceutical companies into a reformulation drive to produce alternative over the counter (OTC) cold and flu products that do not contain the restricted ingredients.

The MHRA has issued a public consultation letter seeking opinion on the proposed restrictions, which would see the nasal decongestants converted to prescription-only and a reduction in pack size by the end of 2007.

The move comes in response to the growing illicit use of OTC ephedrine- and pseudoephedrine-based drugs for the production of the Class A controlled drug, methylamphetamine.

The agency highlights the fact that alternative active ingredients can be used in cough/cold remedies, noting that "many manufacturers of pseudoephedrine/ephedrine containing products already have phenylephrine containing products authorised and many are currently available with similar indications."

However, experience in the US, where sales of pseudoephedrine were restricted last year, has shown some difficulties in making a straight swap from pseudoephedrine to phenylephrine, with some companies even dropping development of such products as unfeasible.

Phenylephrine has some distinct disadvantages compared to pseudoephedrine, which have hampered the growth of a market that was anticipated to expand rapidly in the US in the face of the new legislation.

Phenylephrine does not last as long in the body as pseudoephedrine, which can make it a less attractive option for consumers, and some parties have questioned its efficacy altogether.

Only last month, US firm SCOLR dropped its phenylephrine development plans, claiming that the treatment "did not justify continued internal development."

Source: MedIndia

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18 december 2006 -Bill cracks down on supplements
Times wire reports

The $22-billion-a-year U.S. dietary supplement industry will be required to report consumer side effects from its products under a bill that Congress passed and President Bush is expected to sign.


Supplement manufacturers, including Herbalife Ltd., United Natural Foods Inc., Nature's Sunshine Products Inc. and Usana Health Sciences Inc., will have 15 business days to report adverse events, including death and hospitalization, to the Food and Drug Administration.
Currently the companies are not required to inform the FDA of side effects, although many do so voluntarily.

The legislation was sponsored by Illinois Democratic Sen. Richard Durbin, who initially sought more extensive regulation, including safety testing of supplements, when two athletes died after taking the now-banned supplement ephedra.

After strong opposition from supplement makers, Durbin and his cosponsors agreed to limit the measure to the reporting requirement. 

Source

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16 oktober 2006 - Nutraceutical plans to keep fighting ephedra ban

Park City-based Nutraceutical Corp. will ask the U.S. Supreme Court to overturn the federal ban on ephedra. The action came after a federal appeals court in Denver refused Monday to reconsider its ruling upholding the prohibition. A three-judge panel of the 10th Circuit Court of Appeals ruled Aug. 17 that the U.S. Food and Drug Administration did not violate the law in banning the once-popular diet aid.

Specifically, the court said the FDA was justified in weighing the risks - the supplement has been linked to heart attacks, strokes, seizures and death - and the benefits, and determining ephedra is dangerous at any dose. Jonathan Emord, the New Jersey attorney who represents Nutraceutical, said the Denver court's decision sanctions a risk-benefit analysis never contemplated by Congress and one that creates an unacceptable inconsistency within the FDA.

The ephedra ban applies only to supplements, meaning low-dose ephedrine alkaloids if sold in a gel capsule are dangerous and illegal, but higher doses of the same substance sold in tea bags are perfectly legal. "So a dietary ingredient in food is given greater protection than one in a supplement. It's nonsensical. But it's the law the 10th Circuit has given us," Emord said. Emord acknowledged that the chance of getting the U.S. Supreme Court to consider the case is slim, which is why he plans to attack the ban in Utah's district court, arguing the FDA did not follow proper procedures in establishing the risk-benefit analysis. "This case is far, far from over," Emord said. - Linda Fantin

Bron: The Salt Lake Tribune

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13 September, 2006 - Fight the right fight

From the back of a bottle of ephedra:
Warning: Ephedra contains naturally occurring ephedrine. Do not take if you are pregnant or nursing, if you have heart disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement or seizure disorders. Stop use and call a health care professional immediately if dizziness, severe headache, rapid and/or irregular heart beat, chest pain, shortness of breath, nausea, tremor, nervousness, loss of appetite, sleeplessness, noticeable changes in behavior or loss of consciousness occur.

And so on. Sounds terrible, doesn't it? Ephedra may have been a contributing factor in the death of twenty-three year old Baltimore Orioles pitcher Steve Bechler. It may have caused dozens of deaths since somebody started taking notes back in 1997. At the same time, users have reported over nineteen thousand adverse effects' similar to those described above.

Why would anybody take a supplement that may have killed dozens of people? Ask yourself instead why anybody would ingest a pill from a class of drugs that has killed between 3500 and 16,500 people each year. That's how many people non-steroidal anti-inflammatory drugs and aspirin kill just through gastrointestinal bleeding. That figure doesn't include deaths from liver toxicity or allergic reactions. If we accept the lower estimate, that's 31,500 dead since 1997. But the Food and Drug Administration has always given aspirin and NSAIDs a pass. It has also given its stamp of approval to ephedrine, the active ingredient of ephedra. You can buy ephedrine or its less potent cousin pseudo-ephedrine at any drug store.

The FDA regulates ephedrine but thanks to the Dietary Supplement and Health and Education Act, authored by Utah's Senator Orrin Hatch and former New Mexico Congressman Bill Richardson, it's supposed to keep its long, bony fingers off supplements like ephedra. So what gives? A media firestorm, that's what. Ephedra was big news when Bechler died and with some diligent research, news outlets found other cases of deaths which may have been related to ephedra. Millions of Americans took the supplement without any ill-effects, just as millions now take aspirin without severe side-effects, but a few may have died while on ephedra.

Supplement manufacturers abandoned ephedra in droves. And the big pharmaceuticals which sell ephedrine continued to contribute to politicians' campaigns and they put pressure on the FDA. Ever eager to regulate something they should keep their mitts off, the FDA banned it in April of 2004.

Nutraceutical Corporation of Park City, Utah, and its subsidiary Solaray appealed the ban on the grounds that ephedra had been used by the Chinese for a few thousand years in the form of the herb ma huang and there still appear to be over a billion of them and that the ban shifted the burden of proving ephedra was safe/unsafe from the government to the supplement manufacturers. They won over U.S. District Court Judge Tena Campbell, no conservative, who put the kibosh on the ban in April of 2005. You can read her ruling at http://www.nutraceutical.com/courtruling.pdf.

The 10th Circuit decision violates the plain and intended meaning of the dietary supplement adulteration provision. Congress never intended FDA to use a drug adulteration standard to evaluate the marketability of dietary supplements. Congress also clearly intended that the law of adulteration not be changed and that dietary supplements be treated like foods. Under the food standard a dietary supplement is deemed lawful unless the government meets the burden of establishing the supplement unsafe and then only at dose levels proven unsafe may it be banned from the market. FDA takes the view that if it shows some evidence of a lack of safety at some dose level, it may ban dietary supplements at every dose level. That is a power grab. It violates the rule of law, and it places all dietary supplements in jeopardy, marketable only at the whim of the FDA. We will do all we can to reverse this decision on behalf of our clients.

Reversing the decision, of course, will take months or years. In the meantime, we will continue to fork over money to bloated pharmaceutical mega-corporations for essentially the same stuff. Which raises the question, what's stopping supplement manufacturers from buying politicians who can pressure the FDA to back off? Isn't that the American way?

Source: New West

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August 23, 2006 - US Court boots ephedra - once again

For now, fans of ephedra can kiss the weight-loss supplement goodbye.

An appeals court has sided with the federal government in its all-out ban on dietary supplements containing ephedra, also known as "ephedrine." The U.S. Court of Appeals in Denver Aug. 17 reserved a lower court decision that permitted sale of products with low-dose ephedra.

"The court found that the 133,000-page administrative record compiled by FDA supports the agency's findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure," agency officials said, in a news release.

The FDA banned the dietary supplements in 2004 after unearthing evidence linking the chemical to 16,000 adverse side effects, including heart attacks, strokes and deaths.

Winding through courts

In an appeal filed by supplement-maker Nutraceutical International Corp. in Park City, Utah, the lower court in Salt Lake City in 2005 allowed the sale of the low-dose products, and manufacturers began rushing to get their goods back on the shelves.

Now, Nutraceutical's lawyers vow to appeal all the way to the U .S. Supreme Court.

"The worry is that the FDA can say to anyone, 'We don't like you, you're out of here,'" says Jonathan Emord, the company's lead attorney in the case.

Michael McGuffin, president of the American Herbal Products Association, criticized the way the FDA weights the risks of a supplement against the benefits.

"The American Herbal Products Association has long had concerns about FDA's ruling on ephedrine and the outcome of this case," McGuffin says. "FDA refused, in its rule-making process, to acknowledge any benefits for ephedra, even for traditional uses. If the benefit side is judged as zero, the outcome of any risk/benefit analysis will necessarily be skewed.

"The industry will need to evaluate the implications of this as precedent."

Source: Nubella.com
See also: U.S. Food and Drug Administration

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