13 replies to this topic

[Laura]

Hello all,

I'm sure many of you are aware of the FDA's recent ban on the dietary supplement ephedra. What you may not know is there is an attempt being made, quietly and sneakily, to give the FDA blanket authority to ban ALL supplelements, even before proving that they are harmful. If this bill passes, you could lose the right to purchase safe, effective natural remedies, even those with NO PROVEN ill-effects and proven benefits.

Here's a copy of the article:

Pending Bills in Congress Could Take Away Your Health Care Rights to Buy Vitamins and Herbs
NUTRITIONAL HEALTH ALLIANCE ACTIVATED AGAIN TO PROTECT DSHEA

TELL THE FDA: HANDS OFF MY DIETARY SUPPLEMENTS!

Did you know that the federal Food and Drug Administration has just issued a rule that will enable it to ban dietary supplements arbitrarily? Don’t you want Congress to reverse that rule before the supplements you depend on are taken off the market?

Responsible members of the dietary supplement industry were all too glad to see ephedra taken off the market. However, the FDA in its ephedra ruling established a new legal standard that gives it unlimited authority to swoop down and ban any products that it chooses, without proving that the product is harmful.

As you know, dietary supplements, derived from entirely natural sources, are not drugs. The federal Dietary Supplements Health and Education Act of 1994 (DSHEA) reflected the consensus of industry experts, policymakers and consumers that supplements should not be forced to endure prohibitively expensive and time-consuming trials before being approved for sale to consumers.

With its new ephedra rule, the FDA violated that agreement. Supplement manufacturers can now be required to “prove” that the benefits associated with a particular supplement outweigh its alleged risks. In other words, the FDA has found a back-door approach to treating supplements as if they were drugs.

Congress should act to restore the sane regulatory environment that consumers have benefited from for the last ten years, while retaining the ban on ephedra. Congress should also authorize increased federal research on dietary supplements, thereby increasing the likelihood that future regulatory measures have a scientific basis.

DSHEA passes for one simple reason: the people wanted it. Congressional offices received an unprecedented flood of constituent mail and telephone calls demanding passage of the bill. Upon signing DSHEA into law, the president said, “The passage of this legislation…speaks to the diligence with which an unofficial army of nutritionally conscious people worked democratically to change the laws in an area important to them.”

Today, consumers must once again put the federal government on notice. Tell your Congressman or Congresswoman that you want him/her to take whatever action is necessary to maintain the regulatory regime established 10 years ago under DSHEA, while taking ephedra off the market. Consumers are encouraged to visit The Nutritional Health Alliance website at www.nha2004.com regularly for up-to-the-minute news and information on the campaign to protect your right to purchase safe and beneficial dietary supplements. Don’t let the FDA take your vitamins away! Write, e-mail or fax representative in Congress today! Visit www.nha2004.com today for the name and address of your congressman, along with helpful tools and sample letters for your convenience.

Together we can ensure that consumers have access to the dietary supplements they have grown to depend on!

(end of article, my two cents follow....)

It's bad enough that prescription drugs are too expensive for many people to afford, and now our president is attempting to make it illegal for Americans to get less expensive meds from Canada. Now, they want to take away our right to purchase safe, natural alternatives. Things like protein powder, herbs, vitamins, even Wreck Wench's Flax seed, could be arbitrarily banned under this new ruling.

I believe in a complementary approach to health. I use a combination of traditional western medicine, Chinese herbs and good quality nutritional supplements to maintain my health. I don't like the idea of the FDA taking away MY power to decide what I will put in MY body.
If you agree with me, visit www.nha2004.com and WRITE to your legislators!!!

Okay, I'll step off my soapbox now. Have a pleasant and HEALTHY weekend everyone
Laura

[No Pressure]

The issue with dietary supplements, incl herbs, vitamins, botanicals, and others, is that with no FDA oversight, there was no quality control. There have been reports of liver damage/ failure with Kava kava; heart transplant rejection with St John's Wort, ureter and kidney cancer with weight loss compounds, and bleeding with Gingko biloba. Ephedra is ephedrine, a precursor to methamphetamine. It caused massive increases in blood pressure, cardiac arrest, heart attacks, and death in over 50 people (including healthy college students), and a resurgence of meth labs in the country.
That being said, it is not the herbal compound that is evil. It is the contaminants in the preparation, or the lack of standardization of dose that was hurting people. 1/3 of products tested in California had dangerous contaminants in them, incl arsenic, lead, and others. Most of these were made in China.
Now, US pharmaceutical manufacturers have gotten on the herbal band wagon and are making these compounds. Centrum boasts 10 compounds they think are safe enough to make and put their name on. Many of them have definitive physiologic efects, are cheaper than prescription drugs, and work. I take some dietary supplements myself, and I think that those made by reputable sources are OK. The trouble is in finding out the potential drug/ drug/ herb interactions, since these were never studied. When complications develop in America, the standard reaction is to swing the pendulum to the far side, and wait it out.
I agree to contact your legislature and protest the banning of these compounds. We should have a right to effective (but safe) pharmaceutical therapy at reasonable prices.

[Diverbrian]

I hate to sound like I disagree, because I don't completely disagree. But,

A point of fact is that Thaliomide was not approved by the FDA, it was approved in Europe. Look what happened!

I work for a cGMP regulated (FDA regs) facility that makes tubing for IV's and pacemakers. They (the FDA) ARE concerned that people get what the manufacturers say that they are getting. There was a case a few years ago of a company that accidently mislabeled a shipment. The FDA managed to get the CEO convicted of roughly 5,000 counts of mail fraud (one for each label in the shipment) because action wasn't take fast enough to recall it.

If all the people that packaged these herbal supplements were up-front about proving the concentrations and purity of the herbs in them, it would be a different story. As NP, says most of the reputable manufacturers are very up-front about it. But many of them like to slip through the facts that they are basically unregulated on this.

My view is make the companies be factual on the concentrations and purity of the herbal supplements. The side effects are published fact. Make those be listed.

However, as much of Eastern medicine is basically passed down generation to generation and difficult to prove scientifically, don't put them in a position to have to do complicated studies to prove "benefits" of herbal supplements. If the companies can prove where the doses are at that generally cause side effects that is good enough in my mind. While largely unproven by science, the fact is that Eastern medicinal practices can be highly effective. Let the people continue to do what they do with the confidence that they are not violating one of the first rules of medicine which is "First, Do no harm!"

[Laura]

Thanks for the input, gentleman.

I'm off to drink my whey protein shake now, while it's still legal!!

Have a good day
Laura

[bigblueplanet]

There are certainly companies out there that are less than ethical and do not test or use good quality control procedures in their manufacturing processes. There are companies out there that do treat suppliment manufacture as if it were drug manufacturing. They go through formal quality control processes and use true scientific testing to check the efficacy of their products. A good deal of the industry of suppliments is snake oil. They promise the world and develop the lowest possible quality for the highest possible profit.

The swing side is that it is nearly impossible to get all of the essentials that you need from just your diet. Even the AMA recommends supplimenting now. The profiloration of industrial farming and chemical fertilizers has robbed most of the food we eat nutritionally vacant. Supplimantation us some hope of actually boosting our micronutrient levels to a level that might actually protect us from free radical damage as well as a suite of other bad things in the enviroment.

It is buyer beware, but if you find a good product it is well worth the health benefits. Especially in the antioxident areas. As divers we do face a level of frre radical damage that the average person does not see. Compounded even more if we breath nitrox and oxygen for decopressor. This can be even more profound with closed circuit diving. Add to this the activity, sun and all the other harsh interactions we go through as divers.

The average American scores very low on anti oxident protection. I assume that most divers would score even lower. It is not a bad health practice for divers to suppliment with a good product. I recommend it to all students. If not regularlym at least when diving.

We are not getting what we need from even the most balanced diet.

My two cents.

G2

[Coo's Toe]

Most farming today is supported by fertilizers, as the soils in most areas are pretty nuked nowdays. The fertilizers used are primarily N-P-K, which will support plant growth, but do nothing to replace the trace elements that are lacking in the soil. Eating your veggies does not in fact give you what you need in terms of proper nutrition.

Then there's the factory farming techniques used to raise our meat. Chickens eating chickens, and the host of hormones to keep crowded populations from succombing to disease...

Who knows what we're eating exactly?

Yes... suppliment. But do some checking about what you're using, and don't jump on every new fad. Snake oil sales haven't declined much in the last hundred years.

[jextract]

I agree with all of you about truth in labeling. But let's not forget a very important issue ... drug companies lobby the FDA every single day to set up or maintain barriers to entry and monopoly pricing structure. I'm not saying in the least that drug companies aren't entitled to a return on their intellectual capital, however the fact that the government has gone along with banning drug reimportation from Canada for instance is ridiculous.

That said, the libertarian in me says that whatever I put into my own body is none of the governemt's business. I used Xenadrine (ephedra-based) for years, used it responsibly according to the label, and NEVER had a side effect. The fact that one idiot overweight baseball pitcher takes three times the allowable dose, wraps himself up in sweats and exercises himself silly in the hot Florida sun until he passes out ... well, chalk that up to natural selection. More people die every year from aspirin than die from ephedra.

What the hell ever happened to the Ninth and Tenth Amendments?!?

Don't even get me goin' on this whole thing..... GRRRRRRRRRRRRR!

[Laura]

I thought of something really ironic. If the FDA is really THAT concerned with our health, then why haven't they banned cigarettes? Obviously there's enough scientific evidence that they cause health problems. So why are cigarettes still legal, but they want the ability to arbitrarily ban supplements? DUH! It's all about money.

It's legal to buy cigarettes, alchohol, sugar-laden foods, etc but GOD FORBID we should buy some protein powders, or vitamens!! GIVE ME A BREAK!

(jumping off my soapbox now)

Have a great day everyone!
Laura

Edited by Laura, 14 May 2004 - 07:07 AM.

[Coo's Toe]

Yes, but where do we draw the line? Alcohol and cigarettes are legal, but cocaine, heroin, cannabis and many others are not. Jumping out of an airplane is legal, but riding a motorcycle without a helmet is not. Twinkies and super-sized french fries are legal. If we regulate any of it, it opens the door to backroom politics regulating ALL of it. We may not be happy with the results, but if we maintain that certain things SHOULD be regulated by law, then we really can't complain too much when they start encroaching on things that we personally feel should be left alone.

What ever happened to personal responsibility?

Personally I feel none of it should be regulated, but since my taxes ( whether government imposed, or increased prices in the marketplace to cover the cost of the non-payers ) pay for the mistakes and irresponsibility of others, I have to admit that NO regulation would be a losing proposition.

Yeah, Jex, don't get me started. GRRRRRRRRRRRRRR

[Laura]

Coos Toe,

(thanks for the post)

I didn't mean to imply that it should all be regulated. Quite the contrary, in fact.

I was just pointing out how ironic it is that they should try to covertly ban supplements and openly allow cigarettes, etc.

I am a really big fan of individual rights, as long as those rights don't impede on the rights of others.

Have a great weekend!
Laura

[jextract]

Thought this might interest all:

Some Supplements Can Damage Eyes

http://story.news.ya...lements_eyes_dc

[WreckWench]

2 excellent comments are made in this article:

1. Most people do not tell their doctors what supplements they are taking which is dangerous since almost 40% of our meds are made from or based upon elements and components occuring in nature. In other words...herbs are the original medications. (Since companies can not patent something that occurs in nature, many drugs are naturally occuring components whereby a molecule or two are changed so that it is now patentable. Often times these simple changes can wreck havoc on the body as we are now finding out.)

2. Natural is better however taking herbs without understand the consequences of their effects is not wise. It would be the same as mixing a bunch of pills and then taking them randomly...you have no idea what the interactions will be nor all the impact of what you are taking.

And although not expressely stated, many people die from drug interactions with over the counter meds, other prescription meds they have forgotten that they take or with herbs and natural remedies they take. All must be relayed to your medical professionals however seeking out natural or less invasive courses of action for remedies is not bad. It allows for possible healing from least to most invasive measures rather then always trying to fix something with the 'big guns'.

[Laura]

Also note, it said the supplements caused damage when taken in LARGE DOSES. And it said echinacea could cause problems when used topically. I've never seen echinacea sold as a topical formula, only was a pill or tincture.

Still, it's worth noting, so thanks for the info, JEX

[WreckWench]

And the flip side to this is the huge number of people who die every year due to drug reactions to prescription medications. It is considered a common, normal, and acceptable percentage of loss.