pamoisondelune
Frequent Contributor (1K+ posts)
Member # 11846
posted
Subject: S T O P _ T H E _ F D A � from banning your supplements
From: Dr. Robert J. Rowen
Sent: Wednesday, November 9, 2011 9:02 AM
Subject: Stop the FDA from banning your supplements
After 17 years with a near-perfect safety record (ephedra being one of the only exceptions), the FDA has announced a new set of guidelines for supplements. These new guidelines will roll back the availability of supplements to those that were sold in 1994, and in the forms they were sold at during that time. In other words, these guidelines will roll back a decade of innovation, discovery, and improvements. We have discovered incredible combinations of supplements, better delivery methods, improved methods of extraction, etc. But your rulers say they know better than science and you. They plan to remove the majority of supplements that you well know, including fish oil, high-potency vitamin C products, new bioflavonoids (such as resveratrol), and combination products.
In order to get these non-patentable formulations to you, the supplement companies will have to comply with costs and regulations that will drive them out of business.
It's no wonder this is happening. Big Pharma's in big trouble. Its products not only don't work, but they also kill and maim people. Profitable drugs are going off patent, which will incur bazillions in lost revenue. Pharma's products simply cover symptoms with chemicals, resulting in yet more symptoms, needing yet more treatment. This is great for the drug companies. But it's horrific for you and your wallet.
Big Pharma knows it's selling snake oil. And it knows the public is getting wise to its ponzi scheme. So if you can't beat the competition with a superior product, as a true free market system should provide, then buy the government and destroy your competition with regulations. Big Pharma has the billions of dollars it takes to buy and control government. The FDA says it's doing all this to protect you. But the reality is the FDA is doing this to protect Big Pharma.
It's not just the government and FDA that Pharma own and runs. It's also the medical journals that are supposed to publish information that can help save your life. In light of the FDA's move to wipe out supplements, I'd like to give a nod to cardiologist Stephen Sinatra, MD. Two recent articles in mainstream medicine admitted that conventional medicine has NOTHING to offer for a serious and growing heart problem � diastolic dysfunction. Dr. Sinatra wrote the Archives of Internal Medicine a letter (in his capacity as a cardiologist) to the editor in response to the two reports pointing out his effective approach using the "awesome foursome" for heart: D-ribose, CoQ10, magnesium, and L-carnitine, the very supplements I recommend here.
You'd think that the journal would snap up a treatment for a major disorder. This disorder affects millions worldwide, has no drug treatment, and can lead to serious heart failure. Add to this that it's a disorder often caused by statins! But, no, he quickly got a form letter of rejection. Sinatra noted that previous medical research found that the more pharmaceutical advertising a journal publishes, the less reporting on supplements it does. And, what these journals report is generally negative.
Now please consider that there is NO drug that cures any disease (except perhaps antibiotics for infection). Consider that nutrition insufficiency is 100% proven as a major cause of disease. It's also 100% proven to help or cure certain conditions, like the above heart condition. So, is there any wonder who owns the FDA and who has every interest in controlling the disease maintenance system of America?
Here's what you need to do today:
Complaining to the FDA will likely do little. Leopards don't change their spots. Neither will those who are working actively FOR Pharma. Please contact your U.S. elected officials. You can find their contact information at: www.usa.gov/Contact/Elected.shtml.
Please call their offices AND write letters demanding that they rein in the FDA to protect your rights to the supplements you choose (not supplements based on the knowledge of two decades ago). There is already enough protection written into law for the FDA to move on anything found unsafe. We don't need to wipe out an entire industry at this time of economic hardship. We don't need to wipe out your means to maintain and regain your health, at a time when "symptom suppression" costs are skyrocketing. We need to empower people to keep well. My publisher Garret Wood has a far more detailed story that you can read here.
Please read it thoroughly and join me in my continuing efforts to totally wrest our medical freedoms from draconian government interventions. Please act NOW to prevent the 200-year-old warnings of Thomas Jefferson and Benjamin Rush from happening.
"Was the government to prescribe to us our medicine and diet, our bodies would be in such keeping as our souls are now." � Thomas Jefferson "The Constitution of this Republic should make special provision for medical freedom. To restrict the art of healing to one class will constitute the Bastille of medical science. All such laws are un-American and despotic.
�.Unless we put medical freedom into the constitution the time will come when medicine will organize into an undercover dictatorship and force people who wish doctors and treatment of their own choice to submit to only what the dictating outfit offers." � Benjamin Rush (famous colonial physician, Founding Father and signer of the Declaration of Independence, 1787).
Yours for better health and medical freedom,
Robert J. Rowen, MD
Soundview Communication, Inc.
Posts: 1226 | From USA | Registered: May 2007
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pamoisondelune
Frequent Contributor (1K+ posts)
Member # 11846
posted
Here's another quote, i forget who wrote this: QUOTE QUOTE QUOTE:
FDA set to ban supplements in December!
If the FDA has its way, your favorite supplements will begin to disappear in a few weeks. The FDA has proposed new guidelines for supplements that may pull all but the weakest, least-effective supplements off the market as early as this December.
According to these guidelines, the FDA will have to put its stamp of approval on almost every supplement on the market. Supplement companies will have to spend millions of dollars to submit applications to the FDA for approval. And, as you'll soon see, there's no guarantee the FDA will ever approve any of the applications.
The FDA is telling the public that these new regulations apply only to "new" nutrients. However, there aren't any "new" nutrients. Remember, the nutrients in supplements are substances that occur in nature. This is what differentiates them from drugs. They aren't man-made chemicals. And people have used these products for generations. The only thing new about supplements is the scientific methods of extraction, the dosages, and the combinations. As our science improves, our ability to leverage nature improves. And the effectiveness of our supplements improves.
So the FDA isn't really attacking "new" substances. It's simply attacking the scientific advancements we've made in the area of natural health. This is as ridiculous as saying the earth is flat and putting a stamp of approval on it!
If these proposed guidelines become permanent regulations, the FDA will have the tools it needs to ban almost all of your favorite products. This would include products like probiotics, resveratrol, PectaSol, and Alginol. It also would include new forms of certain nutrients, such as Ubiquinol (CoQ10), tocotrienols, and lipoceuticals.
Why? Simply because science has found a better way to deliver these nutrients. Advanced Memory Formula, for example, has a fruit extract with European studies on safety and efficacy going back two decades. Remember, this is fruit we're talking about here. Not a manmade chemical. But because we just recently introduced it into the U.S., Advanced Bionutritionals will have to submit an application to the FDA for approval. And the FDA may never give its approval, forcing this incredibly effective memory-enhancer off the market forever.
As if that weren't bad enough, the FDA would have to approve other common nutrients. You would think minerals like magnesium, boron, copper, and others would already have the FDA's approval. Technically, they have approved their basic form. But the highly absorbable and far superior amino acid chelate forms of these minerals, like those in Healthy Resolve and Bone Support, are "new" and, therefore, subject to approval.
The guidelines also force any supplement sold in what the FDA considers "high doses" to go through the approval process. Remember, the FDA considers anything over the RDA to be "high doses," so most supplements would require approval.
It gets worse. The guidelines also could apply to any change in dosage that's occurred in the last 17 years. So if a product raised its dosage of vitamin C from 500 mg to 1,000 mg, that product will likely have to go through the approval process as well. So now we see the real scope of these guidelines. They could force almost every supplement off the market. The only ones you'll be able to find are those with the antiquated RDAs. Amazingly, any synthetic supplement, such as those sold by the drug companies, are exempt from these guidelines.
The FDA is saying these guidelines won't force any supplements off the market. But that's not true. Any supplement a company submits for approval must be removed from the market for 75 days or until the FDA grants approval - whichever is longer. Once the FDA has the application, the guidelines don't force the FDA to approve the supplement on any schedule. So the product could remain off the market indefinitely!
The truth is we can't trust the FDA. These guidelines are a direct contradiction to the mandate given the FDA by Congress. The FDA has proven it is a rogue agency obsessed with banning supplements one way or another.
Friend, this is a serious threat to your health! You already know how great supplements are for your health. Our bodies need as many nutrients as we can give them. And supplements are the safest way to get ample amounts. While supplements should never replace a healthy diet, this fact remains: supplements are safer than food. We hear about food-related deaths regularly. But supplement-related deaths are almost non-existent.
In 2008, the Poison Control Centers confirmed this. The government organization reported zero supplement-related deaths. In other words, while drugs were killing over 106,000 people that year, not one single person died because of a supplement. In 2009, only one person died from a supplement-related problem. And the Poison Control Center doesn't tell us what that supplement was - so it may have been someone abusing ephedra, which the FDA has already banned.
Rep. Dan Burton of Indiana said it best: "It is more likely that you will be struck by lightning and die in this country than it is you will die from using a dietary supplement."
And yet, the FDA wants to destroy your ability to take these completely safe life-enhancing nutrients.
Fortunately, the FDA guidelines are only in draft form right now. They have given us until December 1, 2011 to comment. At that point, they will decide whether to make the guidelines permanent or not. If they do, you will likely lose access to any supplement that can actually keep you healthy.
That's why it's absolutely vital you contact your elected officials immediately and tell them to pressure the FDA to abandon these draconian guidelines and leave the supplement market alone. You can find the contact information for your congressional representatives at http://www.usa.gov/Contact/Elected.shtml.
Write your representatives and tell them about your experience with supplements. Tell them exactly what you take, how long you've taken them, and that you've experience zero negative side effects from any of your supplements. The more they hear about the safety of supplements, the more likely they are to pressure the FDA to back off these new regulations.
Please, please, please don't think the FDA won't take your supplements. Europe has already banned supplements and put thousands of people in the supplement industry out of work. It will happen here in the U.S. if we don't take a stand now.
So please take action now! There's a limited time to make your voice heard. If you don't take action today, you may not have access to any of your health-giving supplements tomorrow.
Your insider for great health, --------------------------------------------------
Posts: 1226 | From USA | Registered: May 2007
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�.Unless we put medical freedom into the constitution the time will come when medicine will organize into an undercover dictatorship and force people who wish doctors and treatment of their own choice to submit to only what the dictating outfit offers." � Benjamin Rush (famous colonial physician, Founding Father and signer of the Declaration of Independence, 1787).
- Our founding fathers and their friends were very wise, but I wish they had put this in the Constitution way back when.
-------------------- --Lymetutu-- Opinions, not medical advice! Posts: 96222 | From Texas | Registered: Feb 2001
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pamoisondelune
Frequent Contributor (1K+ posts)
Member # 11846
posted
I'm terrified of losing my supplements!
My Strontium, my Vit K2-7, my fancy calcium pills, would be lost---- my bones would break!
My Broccoli sprout pills, my Indole-3-carbinol pills, my DIM, etc---- i'd get breast cancer!
And my antioxidants, my lyme herbs, my Babesia herbs, my memory herbs.... all would be lost!
Please write and phone your congress-people!
Posts: 1226 | From USA | Registered: May 2007
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MichaelTampa
Frequent Contributor (1K+ posts)
Member # 24868
posted
Just made calls to my reps, will also fax and mail them something.
FYI, the link above did not work for me, but the league of women voters website (easy to google and find) provides easy access to who your elected officials are and their contact info, glad they're around!
Posts: 1927 | From se usa | Registered: Mar 2010
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posted
I suggest also contacting your healthfood/supplements stores and letting them know, if they don't already know. Ask them to get involved and help spread the word through their networks.
Posts: 13116 | From San Francisco | Registered: May 2006
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posted
I wrote to my Congressman already about this. Today I saww this GAO Report about Adverse event reporting for supplements: It doesn't say anything about pulling supps off the market:
pamoisondelune
Frequent Contributor (1K+ posts)
Member # 11846
posted
I've emailed my reps. They say emails aren't good enough, we also need to phone, fax, and write. ------------------------------------
Here's a quote: QUOTE QUOTE Unless you (and I) act quickly, loudly -- and with the force of the "Occupy" movement, the FDA might declare them illegal and snatch them right off the shelves.
Oh yes, Chicken Little...the sky is really falling this time.
--------------------------------------------------------------------- Rigging the rules ---------------------------------------------------------------------
You see, your right to choose whatever supplements you want is protected by the 1994 Dietary Supplement Health and Education Act (DSHEA).
But, in an end-around that would make any NFL playcaller green with envy, the FDA recently proposed revised guidelines for new dietary ingredients (NDI). That may not sound like much, but it's huge.
Under the current guidelines, once an NDI is introduced by one company, that ingredient can be used by any company. That's a workable system, and everyone -- especially consumers -- benefit.
But the new guidelines would require a separate NDI disclosure every time an ingredient is used that wasn't on the market in 1994. And that can mean any time someone uses a different extraction method, standardization formula or form (powder vs. oil, for example).
And just to be clear, literally everything new since 1994 could be under attack.
That would include ingredients we use every single day, like resveratrol, since it was introduced after 1994. Even though resveratrol has been used safely and effectively for YEARS, any time it's reintroduced in a new supplement, the maker will have to submit a disclosure letter to prove that resveratrol is safe.
It's absurd! And it's nothing less than official harassment by an agency that feels impotent against the public demand for access to supplements.
I'll hold resveratrol up against ANY approved drug, and I have no doubt the drug will have far greater dangers than resveratrol.
And yet, supplement companies may be required to conduct expensive and time-consuming safety trials before bringing a resveratrol product to market. And if they make a change to a product that already contains resveratrol, they'll have to start from scratch with new safety trials.
Not only will this stifle much-needed innovation in the supplement industry, it will simply put tons of supplement makers out of business.
And then what supplement companies will be left? The ones with really deep pockets. And in many if not MOST cases, that means supplement companies owned and operated by...you guessed it -- drug companies.
And now you see why this new "guidance" is just one more attempt by the FDA to genuflect to its Big Pharma buddies.
Every time Congress has threatened our supplements, we have stood strong -- and loud and said "Hands Off!" And every time, they have backed down. But the FDA is trying to do this without going through Congress, so we need to be stronger, louder and angrier.
Take a few minutes now. Stop whatever you're doing and tell FDA officials to keep their "guidance" away from our supplements.
There are three things we all need to do right now...
1) Most importantly, use this link to post a comment on the FDA website. The deadline for comments is coming up quickly: 12/2/11.
2) Send a message by e-mail, letter or phone to your Congressional representatives. Even though this is not a congressional matter, it's important to let them know where we stand, and we expect them to support the law. (For names and addresses of your representatives, go to opencongress.org)
3) Rally the troops! Tell your friends, family, neighbors, dog trainer...everyone you know to demand that the FDA leave our access to the supplements we have been safely taking for a decade and a half alone.
For more information about this proposed FDA action, you can visit the website for the Alliance for National Health (anh-usa.org).
DSHEA states: "The Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers."
We've got to let the FDA know that we will not tolerate regulators who don't follow the rule of law! ------------------------------------
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pamoisondelune
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Member # 11846
posted
Here's a link:
They give you a form letter you can email. They do say that a personalized letter is more effective.
-----Polly Polygonum
Posts: 1226 | From USA | Registered: May 2007
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randibear
Honored Contributor (10K+ posts)
Member # 11290
posted
which supplements? are they talking about my calcium, multivitamin, milk thistle, resveratrol, garlic, adn probiotics??
-------------------- do not look back when the only course is forward Posts: 12262 | From texas | Registered: Mar 2007
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pamoisondelune
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posted
Everything since 1994, which includes resveratrol. The others, i don't know---- it depends on if there is anything new about the way they are formulated or processed.
Posts: 1226 | From USA | Registered: May 2007
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pamoisondelune
Frequent Contributor (1K+ posts)
Member # 11846
posted
Write, call, fax, send form email, send personalized email.... There's not much time left!!
So if the FDA declares these impossible, company-breaking rules, then the supplement companies all go out of business the same day, and next day they are all bought up by the Big Pharma companies?
It sounds like a government scheme for transferring ownership, like in Russia 1992!
----Polly Polygonum
Posts: 1226 | From USA | Registered: May 2007
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pamoisondelune
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Member # 11846
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Here's more explanation: QUOTE QUOTE QUOTE I apologize for the barrage of e-mails I've been sending you lately. But this is so important that I wanted to be absolutely certain that you knew about it.
You see, the FDA has issued new rules that, if enacted, will enable them to ban many of the supplements you are now taking.
Think I'm exaggerating? Then please listen to the full story ...
Back in the early 1990s, the FDA tried to make many supplements illegal. Consumers were so alarmed by the FDA's bullying that they staged a massive revolt. The result was that Congress passed the Dietary Supplement Health and Education Act (DSHEA). That law protected supplements from the FDA unless the FDA could prove a supplement wasn't safe.
There was, however, a loophole in the 1994 law. The FDA was given the authority to regulate new ingredients introduced after October 15, 1994.
So what happened? Nothing at first. For 17 years, the FDA took no action, gave no guidance, and launched no enforcement of these "New Dietary Ingredients."
And that's been a good thing. Because for 17 years, the dietary supplement industry has enjoyed tremendous innovation. These innovations have allowed us to extract and concentrate the most effective natural ingredients. As a result, millions of consumers have benefitted. They've protected their hearts and arteries ... found relief from their joint pain ... boosted their memory ... and more.
And during this time, supplements have enjoyed a remarkable safety record. Statistics show that supplements are safer than prescription drugs, cosmetics, medical devices, and even food!
According to the Poison Control Centers, there were zero deaths due to supplements in 2008. In 2009, there was one.
Meanwhile, pathogens like e. coli in food kill at least 2,000 people each year. Acetaminophen in drugs like Tylenol kills 450 people every year. And more powerful prescription drugs kill many more. Even the FDA now says Vioxx likely killed over 26,000 people before they finally took it off the market!
Supplements the FDA Wants to Ban
But now the FDA wants to act like the last 17 years never happened. The agency has drafted a proposal to regulate what it calls New Dietary Ingredients. If this proposal is implemented, some of the most effective nutrients you take will be pulled from the market. Nutrients like resveratrol ... ubiquinol CoQ10 ... bacopa ... strontium ... and more.
But that's not all. Under these guidelines, the FDA can define almost anything as a "new" dietary ingredient. For example: If a supplement includes more of an ingredient than was used 17 years ago � even something like vitamin C � it's "new."
If an ingredient uses a different extraction process � like baking or fermentation � it's "new."
If a supplement uses an ingredient at a different "life stage" � such as using ripe rather than non-ripe apples � it's "new."
If a supplement duplicates an ingredient in a laboratory rather than extracting it from the food � even though it's chemically identical � it's "new."
And if a probiotic formula includes a strain of bacteria that wasn't found in yogurt 17 years ago, it's "new."
So what would happen to all these "new" ingredients? The manufacturers would have to take them off the market until they could prove the ingredients are safe � even if those ingredients have been safely used for 17 years!
Why It's Nearly Impossible to Comply
What kind of proof is the FDA demanding? According to the guidelines, many companies would have to conduct animal studies using a dosage that's 1,000 times the typical dose.
I'm not kidding you. It's right there in black and white on the FDA's website. The FDA wants vitamin makers to do studies for a full year, at 1,000 times the typical dose.
So a fish-oil manufacturer would have to conduct a one-year study where animals are force-fed the human equivalent of 240,000 milligrams of fish oil each and every day! This outlandish dose would injure the animals and give the FDA an excuse to outlaw the product.
But wait, it gets even better. If one fish-oil manufacturer performs such a study and it passes, it doesn't mean the other fish-oil makers can use the same data. No sir. They are still required to go out and do their own studies before they're allowed to sell their product.
And these studies are very expensive. A study like the one above typically costs about $100,000-$200,000 to perform. Multiply that by several ingredients in several products, and you get an idea of the cost.
Say a company carries 6 products containing 6 ingredients each. It would cost between $3.6 and $7.2 million in studies before that company could even offer the products for sale. For a larger company offering 50 products or more, the costs would be astronomical.
Few supplement makers will be able to afford these studies, and many will be put out of business. And the ones that remain would still be at the mercy of the FDA's whim. That's because there are no requirements for the FDA to approve anything. They can approve or reject anything they want. And in the past, they have rejected the majority of ingredients submitted to them.
That means most of the nutrients you buy today will be pulled from the market and never return. Those that do return will be a lot more expensive � or may only be available as prescription drugs!
A Blatant Abuse of Power
This is a blatant abuse of power. What the FDA is doing here is performing an end-run around the existing law. According to the law, the FDA has to prove a dietary supplement is unsafe for it to be taken off the market. These new guidelines turn that on its head. They are clearly not what Congress intended.
Fortunately, these FDA guidelines have not yet been finalized. All federal agencies are required to give the public an opportunity to comment on a draft before it is made final. In this case, the FDA has given interested parties until December 1st to comment on the draft. That means there's a small window of opportunity for you to voice your disapproval.
Frankly, I wouldn't bother commenting to the FDA. The process is cumbersome, and those unelected bureaucrats don't care what you think anyway.
What You Can Do
The best way to defeat these new rules is to talk to the people you do elect � your congressman and your two U.S. senators. They have the power to reign in the FDA � and they have done so in the past when enough voters complained.
Back in the 1970s, the FDA tried to require "warning labels" on vitamins. Angry voters called and wrote letters, and Congress responded with the Proxmire Amendments which limited the FDA's power.
Then in the 1990s, the FDA went on the warpath again. When voters complained, Congress passed the Dietary Health Supplement Education Act, which once again limited the FDA's power.
But like a monster killed in a horror movie, the FDA keeps coming back. And so once again, it's time for us to step up and call the folks who rely on our votes.
Here's what you need to do:
Go to http://www.usa.gov/Contact/Elected.shtml and look up the phone numbers of your U.S. Senators and your Representative (congressman). Then give them a call.
Don't be shy and don't worry. No one is going to bite you, no one is going to argue with you, and no one is going to quiz you to see how well you know the issues. The job of the staffers who answer is to listen politely and to relay what you say to their boss. So please do call. And please be polite and respectful of the staffers' time.
Here are some talking points to use when you call:
Hello, my name is [name] and I am a constituent of [name of Senator or Representative].
I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.
[Feel free to tell them about the supplements you take and/or the benefits you get from those supplements. Then feel free to make as many of the following points as you like:]
Supplements have an unrivaled safety record. Statistics show they're safer than drugs, safer than medical devices, safer than cosmetics, and even safer than food.
The FDA cannot define New Dietary Ingredients so broadly. According to these guidelines, almost everything is a New Dietary Ingredient. This will strangle innovation and deprive consumers of the supplements they depend on for their health.
The FDA did nothing about new dietary ingredients for 17 years. Now they want to wipe out 17 years' worth of innovation and 17 years' worth of benefits to the consumer.
When the Dietary Health Supplement Education Act was passed, Congress intended a simple notification process for new dietary ingredients. The FDA is turning this into a pre-approval scheme, which goes against the intent of the law.
The FDA already has ample regulatory authority to take action against a product if it's unsafe. They don't need to have this pre-approval power, too.
These could be disastrous to public health. At a time when preventative measures are even more important to health care costs, the FDA is limiting access to preventative health care.
The cost of complying with these guidelines would be astronomical. Experts estimate that the studies required would cost between $100,000 and $200,000 per ingredient notification. That adds up to millions of dollars per supplement company. Smaller companies would not be able to afford this and would go out of business.
The economy is already hurting and we have high unemployment. Experts estimate that this could cost the economy tens of billions of dollars and result in the loss of tens of thousands of jobs.
The government's resources are already stretched. We have record budget deficits and record debt. Why enact more regulations when there are no safety issues here?
I request that Congress direct the FDA to carefully review their draft guidance. If they do not amend the guidance to reflect my concerns, I request that Congress call hearings at the end of the review process. I also call on Congress to write legislation that would "grandfather" all supplements currently on the market.
Thank you for your time.
After the phone call, send a letter to your senators and reps, making the same points. Make sure the letter is in your own words (form letters tend not to work as well). You can find the e-mail and physical addresses at the same website, http://www.usa.gov/Contact/Elected.shtml.
Then send the same letter to President Obama. (His address and phone number are on the website, too.)
Please, please, please don't make the mistake of thinking that the FDA won't take your supplements away. Similar regulations were passed in other countries, and the result was disastrous. Many supplements were taken off the market forever. In some instances, the entire supplement industry was decimated. Don't let that happen here.
posted
I think everyone should be contacting your healthfood/supplement stores and asking them to get involved, or at least check it out!!
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