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We specialize in real ephedra! Look out for new products that will be added! If your order is returned to us by the mail carrier due to wrong/missing/incomplete shipping information, we will refund you the order price minus the shipping charges incurred to us. All orders are processed the following day or when the funds clear your financial institution to prevent fraudulent purchases. WHERE DO YOU SHIP FROM? Products are shipped from within the US. Your merchandise should get to you from 1 to 6 business days of payment including Saturdays. Signature is required upon receipt of merchandise so make sure there is somebody present at the shipping location. If you don't receive your item within 7 days, then give it an extra day or two as the delivery services sometimes are not so reliable. If not received after 7 days then look for a failed delivery attempt notice left at your mail box or contact us via our live chat system or leave us an email at sales@thatswholesale.com We will then send you the tracking information again.  Make sure you provided a valid email account in your order form.  Otherwise you will not be able to get the tracking or information from us.  You can also request NO SIGNATURE in the notes section of the checkout page.  We cannot be responsible for lost packages if you make this request. WHY DIDN'T I GET MY PACKAGE YET? Make sure that the shipping address you provided is complete and correct or the merchandise will be returned to us. In such a case, we will refund your purchase price minus the shipping charges incurred to us.  We will first contact you via email for a valid address to resend to.  Verify with the order invoice we sent you via email that your entire address, including apartment or suite number is present. If delivered to a large commercial facility, then provide also the company name, floor or building designations.  If after purchase you did not get any email confirmations, then please check your bulk or spam box.  If you still don't find any confirmations then you have provided a bad email address.  Common mistakes made are the accidental omission or addition of a letter.  E.G: customer@yaho.com, instead of the correct customer@yahoo.com We are not responsible for delayed mail due to lack of important delivery information that is needed for a timely delivery. Even with the correct address but  wrong zip code will result in the package getting delayed or returned to us. WHY AM I NOT GETTING A REPLY? We receive tons of emails a day and reply in the order they are received. Don't worry if we don't reply on time. Sometimes the spam filter will delete it. If you don't receive a response from us within 24hrs, then don't hesitate to send another one. We have been receiving too many emails lately and cannot respond to all of them in time. For faster response, please use the live chat system on our site. Be patient, your order will arrive soon and we hardly lose a package. The postal service slows down due to natural events such as hurricanes, flooding, forest fires etc. HOW MUCH IS SHIPPING? With quantity purchases, we offer free priority shipping. Only $3 is charged for handling on all orders and the shipping is free within the US!!! With us, what you see is what you pay. There are no surprises when shopping with us. We deal directly with the source for the lowest prices. HOW DISCREET IS MY ORDER? Don't worry about the description on your credit card statement. All packages and descriptions are very discreet. Nobody will even know a package arrived from us. We are also very successful in sending our products to Canada, United Kingdom and the rest of Europe. We make it so that you don't have to pay customs either. PO BOXES, APO, FPO and other military locations are not a problem for us and we constantly strive to maintain a very high level of customer satisfaction. All transactions are kept in strict confidentiality and packages are sent unmarked. Your credit card statement will show as T.W.S. for the purchase. IS EPHEDRA LEGAL? Let me answer that question by saying that ephedrine has never been illegal.  It is legal to purchase ephedrine both natural and synthetic (Ephedrine HCL made by Vasopro) for it's intended use which is as a decongestant and bronchodilator. It will also provide energy, appetite suppression and increase your metabolism which leads to weight loss. It will also increase your blood pressure so do not take it with any blood pressure medication, antidepressants or if you have a history of heart disease. Read all warnings before using and consult with your physician before use. WHY DON'T YOU TAKE PHONE ORDERS? Placing your order online via our hacker safe and encrypted system provides higher protection than placing an order over the phone.  Here are the reasons why.  By placing your order over the phone, you are giving your personal information that can be intercepted via another line in your office or residence.  A person taking your order could be a reseller, drop shipper or an affiliate making a commission.  They can record your information for future malicious purposes should the employee leave the company.  By placing an order online with us, all the transaction data is entered by you into Cartmanager, our third party shopping cart software (verified hacker safe and with a strong encrypted system). The encrypted information (your data is broken down into computer language) is then passed directly to our credit card processor to verify the information you entered with your bank.  If all checks out, then the total for the order is placed on hold at your bank.  We do not receive your payment into our account until we process all the orders at the end of the day.  For this reason we are primarily a web based business which has served our worldwide clientele for over 5 years.  We do not keep our customer's personal or financial records locally and all orders are kept in strict confidentiality by our electronic secured payment systems and processors.  Click here to learn a bit more about our reputation online.  All purchases are 1 time only and we never bill and ship orders you never placed. MY ORDER FAILED BUT I HAVE A CHARGE IN MY ACCOUNT. Upon placing your online order, your bank places the transaction amount on hold believing that the money is supposed to be used for a purchase.  This hold is a way your bank locks up the amount that is supposed to be paid to us and to make sure that there are sufficient funds in the first place.  It is what's called an AUTHORIZATION.  At this point, no money has moved anywhere and is still in your possession.  Our credit card processing company then verifies the information you entered with the one on file with your credit card company or bank.  If everything matches then the transaction becomes successful.  Then the AUTHORIZATION turns into a CAPTURE of your funds.  If it fails, then the transaction amount stays in AUTHORIZATION status and will later be removed (3 to 6 days depending on your bank guidelines).  So don't worry if you see money "taken out" of your account.  It is just an AUTHORIZATION done by your bank that is  later released since there was no CAPTURE by our credit card processing company.  An AUTHORIZATION is placed every time an order fails but only the funds from the successful transaction gets taken out of your account.  The entire process is done by your bank and our bank via their secure system.  So please do not believe that we "took" more money than we deserve when you see multiple charges to your account.  They are not charges but merely AUTHORIZATIONS. WHY ARE YOUR PRICES SO LOW? The advantages of automation coupled with low overhead expenses in online shopping, allows us to offer wholesale prices directly to the public. Our goal is for all our customers to have a superb online shopping experience. Our core values are primarily honesty and integrity. All merchandise is thoroughly supervised and inspected before shipping. All personal requests are welcomed and can be fulfilled to your exact details. If you are interested in certain items that you would like featured in my shop, let us know and we will do our best. We respond to all our email inquiries within 24hrs. from Monday to Friday in the order they are received. Sincerely, Thatswholesale Team. Send all inquiries and custom orders to: sales@thatswholesale.com Take our webpoll below and see what others think.

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[misleading ephedra news]

Associated Press:
"Ephedra: Also called ma huang, epitonin and sida cordifolia, it contains stimulants known chemically as ephedrine. The Food and Drug Administration has 900 reports of side effects, including heart palpitations and psychosis, heart attacks and strokes. Several states have banned ephedrine-containing supplements. Federal limitations are pending."

Comment:
As with any nutrient, including water and oxygen, herbs can produce side effects if taken in excess or at the wrong times. I do not dispute that. Critics of Ephedra, however, focus only on the isolated chemical components and fail to see the whole picture. In the hands of an experienced herbalist, nutritionist, naturopath or doctor, the side effects with the proper use of Ephedra are rare. Drinking coffee or tea is far more likely to cause insomnia, dizziness, increased blood pressure and death than any whole Ephedra product. The same can be said for cigarettes and nicotine-containing chewing gum, both sold without prescription despite being proven to be lethal substances.

Yes, if you isolate ephedrine or pseudoephedrine from the whole herb, side effects are much more pronounced or even dangerous. It must be remembered that herbs were never meant to be used in this fashion. Only pharmaceutical manufacturers use herbs in this way and, as a result, get toxic effects - over 1000 deaths occurring each year as a direct result of over-the-counter cough and cold remedies.

Pseudoephedrine is the chemical responsible for the side effects frequently whined about by the critics of herbal medicine. It does not have the same properties as ma huang. Any claim to the contrary is false and is being used as a smokescreen to remove Ephedra, a perceived competitor to drug company pseudoephedrine products, from the market. Drug companies are guilty of doing just that in over 30 prescription and over-the-counter drugs that contain pseudoephedrine (e.g. Actifed¨, Novahistex¨, Sudafed¨, etc.). Many over-the-counter drugs for colds, allergies, asthma and obesity contain these herbal extract mimics and are big business for the multinational drug companies. Their effects, however, are clinically much different from those of the whole herb. Alarming people about their dangers without taking these facts into consideration is a grave disservice to the public.

It is said that people with high blood pressure, heart problems and prostate problems should not take ma huang. Nonsense. Coffee and tea are more likely to cause such people problems than ma huang. For those with heart or blood pressure problems, ma huang should be taken starting with low doses and gradually increased as tolerated. For those with prostate problems, ma huang can be combined with saw palmetto or seronoa repens extract (from saw palmetto) and flower pollen. This will prevent problems with the urinary flow and help shrink a swollen or enlarged prostate. In large doses, ma huang can prevent weight gain and, for this reason, it is not recommended during pregnancy. Weight loss is not what one wants for a healthy baby. Once the baby is weaned, the mother can go back to using ma huang to help lose the weight accumulated during pregnancy.

 

[FDA about to confiscate viatamins]

The FDA Is About To Confiscate Your Vitamins
By Dave Gibson (04/27/07)
Read more here.

The FDA under President Bush, is planning to take all dietary supplements, exercise equipment, and even therapeutic massages out of our control and make it necessary to receive a doctor's approval before we can use these items. The proposal for the new regulation is known as Docket # 2006D-0480 Draft Guidance for Industry and Alternative Medicine Products . The FDA is taking public comments on the matter until April 30th.

[alcohol, tobacco among worst drugs]

Alcohol, tobacco among worst drugs

Mar 23, 2007
LONDON, England (AP) -- Alcohol and tobacco are more dangerous than illegal drugs like marijuana or ecstasy, according to a new British study.

In research published Friday in The Lancet magazine, Professor David Nutt of Britain's Bristol University and colleagues proposed a new framework for the classification of harmful substances, based on the actual risks posed to society.

Their ranking listed alcohol and tobacco among the top 10 most dangerous substances.

Read the original article or here.

Alcohol is ranked much more harmful than the Class A drug ecstasy in a controversial new classification system proposed by a team of leading scientists.

The table, published today in The Lancet medical journal, was drawn up by a team of highly respected experts led by Professor David Nutt, from the University of Bristol, and Professor Colin Blakemore, chief executive of the Medical Research Council.

The authors proposes that drugs should be classified by the amount of harm that they do, rather than the sharp A, B, and C divisions in the UK Misuse of Drugs Act.

They say the basis of the Act is ill-defined, opaque, and seemingly arbitrary and overestimates the risks of ecstasy, which kills around ten people annually of the half a million people who use it every weekend, while neglecting those of alcohol, a legal substance which kills more than 300 annually by acute poisoning, and many tens of thousands by road traffic accidents, cirrhosis, gut and heart disease.

In the paper, the team argues that it would make much more sense for drugs to be reclassified on a rational basis that can be updated as new evidence emerges, and more easily than the current rigid category system now in use.

Prof Blakemore added that policies of the past four decades “clearly have not worked”, given the ubiquity and low price of illegal drugs, and that fresh thinking is now required.

Today’s call to overhaul the UK drug classification system, which will be examined by the forthcoming UK Drug Policy Commission, is likely to receive popular public support, according to research into attitudes to drugs by the Academy of Medical Sciences’ DrugsFutures project.

Harmful drugs are currently regulated according to classification systems that purport to relate to the harms and risks of each drug.

However, “these are generally neither specified nor transparent, which reduces confidence in their accuracy and undermines health education messages,” said Prof Blakemore.

“The most striking observation is that there is no statistical correlation between this ranking of harm of drugs and the ABC classification.”

In the new system legal drugs, such as alcohol and nicotine, are ranked alongside illegal drugs.

The new ranking places alcohol and tobacco in the upper half of the league table. These socially accepted drugs were judged more harmful than cannabis, and substantially more dangerous than the Class A drugs LSD, 4-methylthioamphetamine and ecstasy.

“Alcohol is not far behind demonised terrors of the street such as heroin and cocaine,” said Prof Blakemore.

But the conclusions are likely to be ignored, according to coauthor Prof David Nutt from the University of Bristol, who has worked with the Advisory Council for the Misuse of Drugs.

Because some individuals with a particularly genetic make-up are at greater risk, as has been seen with rare deaths connected with ecstasy, ministers have been reluctant to change classifications despite the relative safety for the rest of the population.

Several millennia of human experience with alcohol, its pervasiveness in industrialised cultures, and the US experience with alcohol prohibition (1920–32) make it unlikely that any industrialised society will criminalise alcohol use, he said.

But that still leaves taxation and regulation as methods of control. “Alcohol is a drug we should take very seriously.”

The team identified three main factors that together determine the harm associated with any drug of potential abuse: the physical harm to the individual user caused by the drug; the tendency of the drug to induce dependence and addiction; the effect of drug use on families, communities, and society

Within each of these categories, they recognized three components, leading to a comprehensive “matrix of harm”.

Expert panels gave scores, from zero to three, for each category of harm for 20 different drugs.

All the scores for each drug were combined to produce an overall estimate of its harm. In order to provide familiar benchmarks, for comparison with illicit drugs, five legal drugs of potential misuse (alcohol, khat, solvents, alkyl nitrites, and tobacco) and one that has since been classified (ketamine) were included in the assessment. The process proved simple, and yielded roughly similar scores for drug harm when used by two separate groups of experts, one of consultant psychiatrists who were on the Royal College of Psychiatrists’ register as specialists in addiction and the second including a range of expertise, from police chief constables to scientists. “The two show very good agreement,” said Prof Nutt.

Cannabis, the subject of much recent debate, was ranked below tobacco, despite the evidence for a link with psychotic episodes in about 7% of schizophrenics. Since the expert panels were asked to assess the harm of drugs in the form that they are currently used, this ranking took account of the widespread use of skunk, which is about twice as potent than traditional cannabis resin.

Other experts still doubt there is a cause and effect relationship between cannabis and psychosis, while a study that claimed genes place some people at particular risk requires confirmation.

Prof Nutt said that young people believe that the establishment lies and distorts the dangers posed by drugs and the only way to restore their confidence is to rely on hard evidence, not arbitrary classifications.

“It is a landmark paper, a real step towards evidence based classification,” commented Prof Leslie Iversen of the University of Oxford, a member of a working group of the Academy of Medical Sciences, though he added that there is still more to be done to take on board new understanding of addiction arising from neuroscience.

The Academy has been asked by the Government to undertake an independent review of the issues raised in the Foresight report ‘DrugsFutures 2025?’ The review will take on board the opinions of many hundreds of people from across the UK who have taken part in face to face discussions and an online debate at www.drugsfutures.org.uk, which is open until end of this month.

Participants are clear that the current classification of drugs is “confusing and inconsistent”. A majority of participants support a health-based approach to drug use and treatment, rather than a law enforcement approach. Many also point out that alcohol is one of the most harmful drugs in common use, to both individuals and wider society.

There appears to be little support for decriminalising drugs however. Professor Sir Gabriel Horn, Chair of the Academy of Medical Sciences group considering the findings of the DrugsFutures project said “The UK Government have asked us to explore the likely future impact of recent developments in science on addiction, drug use and treatments for mental health. We have heard views from both members of the scientific community and of the public which indicate that the current classification system is in need of review.

“Such a review must be underpinned by evidence on the harms of drug use to the individual user, to families and to society, and be considered in the light of the latest evidence from the brain sciences.”

Drug misuse is one of the major social, legal, and public-health challenges in the modern world.

In the UK, the total burden of drug misuse, in terms of health, social, and crime-related costs, has been estimated to be between £10 billion and £16 billion per year.

[ephedra ruling]

NEWS FLASH - FOR IMMEDIATE RELEASE
02/26/2006

Hi-Tech Pharmaceuticals      
6015-B Unity Drive
Norcross, GA 30071
 

                On February 24^th the Food and Drug Administration (FDA) and U.S. Marshals seized approximately $3,000,000 worth of ephedra-containing dietary supplements from our firm. They also filed a Complaint for Forfeiture against Lipodrene® and Stimerex-ES®- supplements that are manufactured, marketed, and distributed by Hi-Tech Pharmaceuticals, Inc. This action was in response to a lawsuit filed by Hi-Tech on August 10^th, 2005- 1:05-CV-2083.

            We believe this was a result of a series of unsuccessful attempts by the FDA regional offices to prevent Hi-Tech from legitimately selling our ephedra-based Lipodrene® and Stimerex-ES® to health food stores, gyms, drug stores, and various other retailers. Initially, on August 3^rd, 2005, the FDA requested that Hi-Tech cease and desist sales of our ephedra-containing dietary supplements. The FDA, however, refused to provide Hi-Tech with any written documentation from the FDA’s national office stating that selling Lipodrene® or Stimerex-ES® was illegal. The FDA also chose not to exercise its right to seize a dietary supplement that is being introduced into interstate commerce in violation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) or the Food Drug and Cosmetic Act (FD&C). Because of the failure on the part of the FDA to justify any legal basis for their request that Hi-Tech not sell Lipodrene® or Stimerex-ES®, Hi-Tech informed the FDA that we would not stop selling our ephedra-containing dietary supplements.

            On February 21^st, 2006, Hi-Tech Pharmaceuticals, Inc. responded to the United States Government’s and the FDA’s motion to dismiss our lawsuit pending in the United States District Court of the Northern District of Georgia, before the Honorable Judge Ernest Tidwell. They alleged they had taken no action against Hi-Tech, therefore, the lawsuit was without merit. Hi-Tech responded with allegations that the government was “venue shopping.”

            In a desperate attempt to “not lose at any cost,” and prevent Hi-Tech from selling our ephedra-containing inventory, on that following day, the FDA asked the U.S. Attorney's office to file a civil complaint against the Lipodrene® and Stimerex-ES® inventory, requesting that the U.S. Marshall's Office exercise its authority to “arrest” the Lipodrene® and Stimerex-ES® bottles. Note that this is not a criminal action, nor even a civil action against Hi-Tech, but a civil action against the actual Lipodrene® and Stimerex-ES® inventory so that it could be “arrested” and taken into custody.

To prevent the continued development of this type of arbitrary and capricious behavior on the part of the FDA in complete contravention to the federal court decision in April 2005 in which the Honorable Judge Tena Campbell reversed the FDA's ban on ephedra, Hi-Tech filed a challenge against the FDA's ability to regulate ephedra-containing dietary supplements on August 10, 2005.

The case, Hi-Tech Pharmaceuticals, Inc. v. Lester M. Crawford, et al., No. 1:05-cv-2083 (Northern District of Georgia), will now likely be before the Court within a few days due to this recent seizure by the FDA in Georgia. Although this action may on the surface appear to be a blow to the rights of consumers to continue to obtain the benefits of Lipodrene® and Stimerex-ES®, the reality is that Hi-Tech Pharmaceuticals is actually pleased that the action in Georgia was taken, because it provides Hi-Tech with the mechanism to move our case more quickly before the Court to ensure that this type of FDA misconduct, both directly and through its “pawn” regulatory agencies at the state and local level, does not happen again with our ephedra-containing products. Hi-Tech will be filing a Preliminary Injunction motion on February 27^th, 2006.

It is quite noteworthy that the FDA had not taken any action directly against Hi-Tech Pharmaceuticals in regard to the manufacturing and selling of our Lipodrene® and Stimerex-ES®, even though the FDA routinely visits our facility in Norcross, Georgia, consistent with its purview authority of all dietary supplement companies. This lack of action squarely dismisses their own allegations that ephedra is dangerous! 

Hi-Tech will continue to sell, manufacture, and distribute Lipodrene® and Stimerex-ES® and many other dietary supplements containing ephedrine alkaloids. All retailers should understand that the Honorable Judge Tena Campbell's ruling in Utah made the following determinations:

1) The 2004 Final Rule issued by the Food and Drug Administration (“FDA”), which declared dietary supplements containing ephedrine alkaloids illegal, has been ruled invalid. This means dietary supplements containing ephedra are currently legal again.
           
2) The matter has been remanded back to the FDA for further rule-making consistent with the court's opinion.

              Hi-Tech has always maintained that dietary supplements containing ephedrine alkaloids are safe and effective when used as directed on our labels. Lipodrene® and Stimerex-ES® contain 25mg ephedrine group alkaloids per tablet. We recommend taking two tablets daily - not to exceed four tablets within a 24-hour period, or 100mg per day, which is consistent with the FDA's own safety parameters for the consumption of ephedrine.

              In addition, this ruling has been significant for the dietary supplement industry, in general. The Court's Order makes clear that the FDA must comply with the current law, as explicitly written in DSHEA. If the inappropriate standard that the FDA had applied in regard to ephedra-containing dietary supplements (supplements are defined as “food” under DSHEA) had been upheld, other foods, such as potato chips, could potentially have been banned.

            We will remain steadfast in our position and continue to fight the David vs. Goliath battle. This is an excellent example of the FDA trying to intimidate a small, dietary supplement company, like Hi-Tech, from legally selling dietary supplements containing ephedrine alkaloids, irrespective of the Federal Court’s ruling in Utah to the contrary. We stand behind the safety and efficacy of our products, and we look forward to our day in court.

 

See the ruling here in PDF format.

District Judge Orders FDA to Reopen Ephedra Rulemaking

SALT LAKE CITY—A U.S. District Court judge declared the Food and Drug Administration’s (FDA) ephedra ban unlawful and ordered the agency to reopen its ephedra rulemaking. The April 13 decision from Judge Tena Campbell, U.S. District Court, District of Utah, Central Division, stems from a lawsuit filed in May 2004 by Nutraceutical Corp. against the agency.

Nutraceutical Corp. is the parent company of Solaray, which manufactures an ephedra dietary supplement (EDS) with no more than 10 mg of naturally occurring ephedrine alkaloids per serving. In its original complaint, Nutraceutical alleged FDA failed to prove ephedra presented a significant or unreasonable risk of illness or injury at every dose level, and that the agency’s use of a risk-benefit ratio in determining whether ephedra posed an unreasonable risk was in violation of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

In her decision, Campbell examined the process FDA took in releasing the final April 2004 ban on EDS, which dates back to the early 1990s. In making the final rule, FDA considered evidence on the pharmacology of ephedrine alkaloids, peer reviewed scientific literature, adverse event reports (AERs) and expert reviews of the scientific evidence. In issuing its ban, FDA concluded the benefits did not outweigh the risks of EDS and could not determine a safe intake level; therefore, all EDS were found to pose an unreasonable risk.

However, Campbell found the agency erred in using a risk-benefit analysis, noting “dietary supplements are not classified on the basis of a risk-benefit analysis ... [and] FDA’s requirement that EDS demonstrate a benefit is contrary to the clear intent of Congress.” In addition, after a review of the scientific evidence, Campbell concluded it did not support the conclusion that a dose of 10 mg per day of EDS presented a significant or unreasonable risk. “A negative inference is different from the affirmative proof required,” she wrote. “The statue requires an affirmative demonstration of ‘significant or unreasonable’ risk at a particular dose level to support a finding of adulteration.”

Campbell ordered FDA to reopen its ephedra rulemaking and adopt a dose-dependent toxicity analysis, and enjoined FDA from taking any enforcement action against Solaray’s sale of its EDS containing 10 mg or less of ephedrine alkaloids.

Jonathan Emord, the lead attorney for Nutraceutical, said the company was “delighted” with the judge’s decision and believes it was the correct legal analysis. Emord noted the judge’s ruling that FDA cannot take enforcement action against the Solaray EDS is company-specific, but other companies supplying EDS with similar or lower levels of ephedrine alkaloids could argue that their products are equivalent.

The National Nutritional Foods Association (NNFA) issued a member alert, noting that while the decision appears to permit sales of low-dose EDS, the issue is far from over. “It is important to remember this decision does not undo state laws, nor does it alter the ban established by FDA in the federal rule against dosages in excess of 10 mg,” said David Seckman, NNFA’s executive director and chief executive officer. “However, an important effect of this decision is that it does challenge FDA’s risk/benefit safety analysis test, which most industry members agreed was inappropriate under DSHEA.”

The American Herbal Products Association (AHPA) responded to the ruling by advising its members against reintroducing ephedra products to the market. In a press release, AHPA’s executive committee cautioned against broad interpretations of the ruling and suggested the industry not act until FDA clarifies its intentions in response to the ruling.

The Council for Responsible Nutrition (CRN) echoed the sentiment that the court ruling is a mere first step, and it is too soon to tell how FDA will proceed. “This ruling applies only to a specific segment of the ephedra dietary supplement market and should not be misinterpreted as a complete overturn of the ephedra ban, nor should anyone leap to inappropriate conclusions about what this means for DSHEA,” said Steven Mister, president of CRN.

Kim Rawlings, a spokeswoman for FDA, told INSIDER the agency is currently evaluating the court’s decision. FDA does have the option to appeal to the 10th Circuit Court of Appeals.

 

....dietary supplements are regulated as a subset of foods unless the supplement producers make disease claims that bring the supplements within the definition of a drug....Accordingly, dietary supplement manufacturers are not required to produce evidence of product safety and efficacy before marketing their products. Additionally, the DSHEA [the governing law] does not require dietary supplement manufacturers to comply with the post-market product safety monitoring or reporting requirements that the FDCA [Food, Drug, and Cosmetic Act] requires for drugs. The FDA relies on voluntary studies, voluntarily reported adverse event reports ("AERs"), and other data to identify potential safety problems associated with dietary supplements.
 

[defend DSHEA]

From www.drrathresearch.org DEFEND DSHEA! Dr. Rath has dedicated his life to ensuring that his scientific discoveries are available to people around the world. He has assumed a leadership role in the battle for natural health freedom by courageously exposing the profit motives of the pharmaceutical industry in suppressing this information. Dr. Rath invites his fellow natural health advocates to join him in the battle for vitamin freedom! Your hard-won natural health freedoms as guaranteed by the Dietary Supplement Health and Education Act (DSHEA) of 1994 have come under attack by the political allies of pharmaceutical interest groups! As a result of the negative media attention surrounding the herbal supplement ephedra, a new Senate bill, the “Dietary Supplement Safety Act,” has been introduced. If passed, this bill would amend DSHEA so that the FDA could arbitrarily ban your access to dietary supplements! In addition, the bill would subject safe and effective natural therapies to approval standards more stringent than those for pharmaceutical drugs. We are alerting you about the existence of this unconstitutional bill so you can take immediate action by voicing your protest to the government leaders voting on it. THE EPHEDRA BAN: THE FIRST WINNING BLOW AGAINST DSHEA On December 30, 2003, under the guise of consumer protectionism, U.S. Secretary of Health and Human Services Tommy Thompson announced a national ban on the dietary supplement ephedra. Secretary Thompson, with the backing of the FDA, declared ephedra a health hazard. This ban is a direct attack on your health food store! The ephedra ban could serve as a catalyst to passage of Senate Bill 722, the Dietary Supplement Safety Act of 2003. If passed, this bill would give the FDA power to potentially remove thousands of herbs and other dietary supplements from the marketplace and effectively revoke the vitamin freedom ensured by DSHEA. Senate Bill 722 has been referred to the U.S. Senate Committee on Health, Education, Labor, and Pensions, where it awaits review. Contact your congressional representatives today and let them know you oppose this unconstitutional bill! Your vitamin freedom is at stake! The time to act is now!