FDA to ban over the counter vitamins & supplements

[Kandra]

Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

This new regulation will restrict vitamins and supplements by prescription only. It will mean we won't have the choices of all the supplements that we have today and we will only get what our doctors (who aren't trained in this area) tell us we can take.

The FDA is trying to fast track this so they are only taking public comments until April 30th. Please tell your friends and family to post a comment or better yet, to call your Senators and Representatives (generally their phone numbers are in the front of your phone book under Federal Government).

Here's an article with more info and it has the link to the FDA website where you can post your comments Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

[Nelson]

This new regulation will restrict vitamins and supplements by prescription only. It will mean we won't have the choices of all the supplements that we have today and we will only get what our doctors (who aren't trained in this area) tell us we can take.


Don't panic yet. This has the earmarks of an urban legend, like the one that went around a few years ago claiming the government was going to make email illegal because the Post Office was losing money. The link isn't working for me, but I will remain skeptical until I can see some corroboration in the mainstream press.

[Zuleikaa]

Try this:

http://www.fda.gov/bbs/topics/news/2004/NEW01130.html

http://72.14.205.104/search?q=cache:7WOUCSgx2OEJ:www.fda.gov/cber/gdlns/altmed.pdf+Draft+Guidance+for+Industry+on+Complementary+and+Alternative+Medicine+Products+and+Their+Regulation+by+the+Food+and+Drug+Administration.&hl=en&ct=clnk&cd=1&gl=us

[Zuleikaa]

Interesting:

http://www.camlawblog.com/dietary-supplements-677-dietary-supplement-recommendation-as-unlawful-practice-of-medicine.html

[Zuleikaa]

http://72.14.205.104/search?q=cache:fol31dBxoKkJ:www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.pdf+Draft+Guidance+for+Industry+on+Complementary+and+Alternative+Medicine+Products+and+Their+Regulation+by+the+Food+and+Drug+Administration+%222007%22&hl=en&ct=clnk&cd=1&gl=us

[Nelson]

Thanks. Those links did work. However, I still didn't see anything that suggested the FDA was seeking to "ban over the counter vitamins & supplements." It is a long article, however, and I might have missed it.

I certainly welcome a move by the FDA to ensure "giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling," which is the stated goal, but that is a long way from requiring a prescription for every bottle of Vitamin C or amino acids, which could be inferred from the original post. A more likely outcome is that the supplement packagers will become even more coy and mealy-mouthed about what their supplements are supposed to do for you.

I personally am persuaded that ephedra is dangerous and banning it was defensible (although I am inclined to err on the "buyer beware" side of these issues), but I saw nothing at the FDA site that makes me fear that Whole Foods, etc., are about to be told to put all their supplements under lock and key and demand Drs. prescriptions for probiotics, digestive enzymes, vitamins, minerals, herbs, etc., at the checkout stand, if for no other reason than that Big Pharma wouldn't stand for it!! They make billions on prescription drugs, sure, but they also make billions on OTC supplements, and as the population ages, they're only going to make more. There would be definitely drop off in sales if people had to see their dr. everytime they wanted to started taking One-A-Day or Caltrate.

[Nelson]

I realizing this debunking page is old, but I still suspect that something similar is afoot today.


http://www.snopes.com/politics/medical/vitamins.asp

[kebaldwin]

The FDA (front men for big pharma) tried to out law them in the 1990s and congress passed a law saying they could not. I know that the FDA would love to outlaw anything healthy.

[Nelson]

If the FDA would put more effort into making sure that food and drug labels are true and accurate and less into "saving me from myself" I'd be a bigger fan. In my opinion, the proper role of government in this area is prosecuting people who tell you that their supplement contains "100 pure extract of XYZ," when it really is about 30% XYZ and 70% inert filler and junk. That happens way too often, even among big-name drug companies.

Then, if I have all the facts available to me, I'll decide what to put in my body and what not to.

[Kandra]

Hi. Since I didn't give any details in my original post, I'm putting in a cut and past from ReginaW because she has the facts about what's going on. I'm also giving you a link to something someone said elsewhere on the forum who knows what's going on, too. If you take supplements, or just believe in health freedom, you'll want to read these.
http://forum.lowcarber.org/showthread.php?t=331003http://forum.lowcarber.org/showthread.php?t=331003 (http://forum.lowcarber.org/showthread.php?t=331003)

Also here's a cut and past of what ReginaW said on another post:

Ah, yes...and all have been through various levels of testing prior to being allowed on the market (except for drugs on the market pre-1962, like aspirin, when the Drug Efficacy Study Implementation (DESI) went into effect that mandated all drugs be shown effective and safe before approval to be sold in the US).

In the US there is a two-tiered system for regulation of "theraputic goods" classed as drugs - by prescription only and OTC. If a substance is classed a drug, it is assigned a schedule level based "potential for risk" for abuse under the Controlled Substances Act (CSA)....the CSA is the legal basis by which the manufacture, importation, possession, and distribution of drugs are regulated by the federal government. Any substance classed a drug is subject to the CSA - including enforcement by the DEA and the ATF for those in violation of the regulations, which include the manufacture and possession of controlled substances.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) already gives the FDA authority to regulate dietary supplements and even remove a supplement from the market if they're shown (or suspected of) causing harm, and the law already specifically states a dietary supplement product CANNOT legally make claims of cure, treatment or prevention of a specific disease. Any product making such claims on their labels is misbranding and mislabeling an unapproved drug as the law already stands.

Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., "glucosamine helps support healthy joints"). The FDA must be notified of these claims within 30 days of their first use, and there is a requirement that these claims be substantiated.

Other claims that required approval from FDA include health claims and qualified health claims. Health claims are permitted to be made if they meet the requirements for the claims found in the applicable regulations. Qualified health claims can be made through a petition process, including scientific information, if FDA has not approved a prior petition.

As I noted previously, the wording of the guidance document is troubling - it medicalizes the terminology and thus makes, with the terms, supplements, vitamins, herbs, etc. DRUGS because it specifically contradicts the DSHEA terminology which now states:

The DSHEA established a formal definition of "dietary supplement" using several criteria. A dietary supplement: is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients; is intended for ingestion in pill, capsule, tablet, or liquid form; is not represented for use as a conventional food or as the sole item of a meal or diet; is labeled as a "dietary supplement; and includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

Contrast that with the new guidance document - "This guidance makes two fundamental points:

First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device or food (including food additives and dietary supplements) under the Act or the PHS Act. For example, the PHS Act defines "biological product," and the Act defines (among other things):
Cosmetic
Device
Dietary Supplement
Drug, as well as "new drug" and "new animal drug"
Food
Food Additive
These statutory definitions cover some CAM products.

Second, neither the Act nor the PHS Act exempts CAM products from regulation. This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for foods in the Act and FDA regulations, including hazard analysis and critical control point (HACCP) system requirements for juices in 21 CFR part 120. If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act." [emphasis mine]

I emphasized "disease treatment" because alternative medicine does not treat per se, but this document establishes that all CAM is medicine and treatment is part and parcel to CAM...instead of therapy with different modalities. It effectively places all CAM products - vitamins, supplements, foods, etc. - under the Act because it defines it medical their use by practitioners "treating," which then quietly takes them to the state level for regulation which requires a license to practice medicine to diagnose or treat disease.

BTW - it's a PITA connecting this dots....anyway....

While they point to the Act and PSH as not exempting dietary supplements, they quietly ignore the DSHEA in which the terminology already establishes what they are and how they are regulated.

This guidance document would effectively render the DSHEA null and void and place all supplements, devices, herbs, tinctures, and even common foods under a new way to view them and determine whether "regulation" applies or not....are they potential drugs or medical devices? Are they tested? Are they legal? The DSHEA, as it is now, protects these products from such abuse - abuse which could potentially make water a drug since it most definitely "cures, mitigates and prevents" dehydration! - all claims which, if stated, make water a drug under this document.....right now, as long as product labels are within the law and the practitioners of CAM are not making claims that are illegal....with the way this document is worded, that changes and everything is suddenly viewed from the perspective of potential use as a drug or medical treatment.

[Kandra]

If the FDA would put more effort into making sure that food and drug labels are true and accurate and less into "saving me from myself" I'd be a bigger fan. In my opinion, the proper role of government in this area is prosecuting people who tell you that their supplement contains "100 pure extract of XYZ," when it really is about 30% XYZ and 70% inert filler and junk. That happens way too often, even among big-name drug companies.

Then, if I have all the facts available to me, I'll decide what to put in my body and what not to.


EXACTLY That's what DSHEA says that the FDA is suppose to be doing NOW. But, instead of taking care of the consumer the way DSHEA says they are suppose to be doing, they are trying to classifly the natural stuff as drugs.

[kebaldwin]

Al Sears, MD
12794 Forest Hill Blvd., Suite 16
Wellington, FL 33414

April 16, 2007

Dear Reader,

It’s hard to believe but your government is considering a bill that if passed would in many cases give you no option but drugs. The big drug companies and the FDA are planning to cut off your choice of medications. Even the choices your own doctor makes…

The latest bill going to congress, the “Safe Drug Compounding Act of 2007” would make many natural compounds and medications from a compounding pharmacist illegal.

A compounding pharmacist is a specialist who can mix, blend and prepare customized medications and dosages according to your doctors instructions. That may not sound important to you, but it could have a profound impact on your life.

There’s not a single day that goes by in my practice that I don’t use compounding pharmacists. Why? Because it’s better medicine than relying on Big Pharma’s one size fits all rip offs. Here’s an example: A patient needs a small dose of a blood pressure drug – let’s say 6 mg. But the smallest dose offered by a drug company is 25mg. In that case, I’ll have a compounding pharmacist custom prepare a 6 mg dose of that drug.

It’s simple, effective and very economical. Prices are much lower when you can buy directly from the pharmacist. But that’s the real issue. If it’s not a prepackaged patented dose, it means drug companies and the Feds in cahoots at the FDA are losing money.

You see the drug companies pay the FDA to approve their drugs. It sounds unbelievable, but it’s completely legal. And when doctors use compounding pharmacists, theirs no money for the FDA drug company cronies.
But the problem with the FDA’s attempt to drive compounding pharmacists out of business cuts even deeper…

If you’re a regular reader of Doctor’s House Call, you’ve heard me talk about the remarkable power of Bio-Identical Hormone Replacement. It’s the safer and more effective alternative to dangerous “hormone replacement therapy” (HRT) drugs sold by the big pharmaceutical companies.

But what you read about as HRT aren’t real hormones but drugs. They cause a number of health risks and side effects, including an increased risk of cancer, heart disease and stroke.

Prempro and Premarin are two popular examples of these so-called “hormone replacement” drugs. You’re not really “replacing” anything. These drugs were never in your body. To introduce that hormone-mimicking drug to your body is an experiment with unpredicatable results. Not so with the bio-identical version…

I use customized doses of bio-identical hormones for my patients. They’re so effective, some of my patients travel thousands of miles just to see me at my clinic in south Florida.

Being able to create just the right formula to meet their individual needs makes all the difference. These customized doses prescribed by doctors are prepared by compounding pharmacists.

For women, bio-identical hormones can help boost progesterone. At the onset of menopause, a woman’s progesterone production falls to almost zero. Many women I measure have progesterone below the lowest detectable limit of the blood test.

Progesterone maintains healthy features critical for a woman’s well being, like elevating mood, boosting sex drive, using fat better and keeping blood sugar normal.

It's no wonder when a woman’s progesterone falls they gain weight, feel depressed, and lose interest in sex. But prescribing the right amount of bio-identical progesterone can reverse these troubling symptoms almost overnight.

Bio-identical hormones are critical for men too. Testosterone levels start to drop when men are as young as 30. The symptoms are devastating, and many men experience:

Loss of drive, energy and ambition
Inability to achieve and maintain an erection
Loss of memory and clouded thinking
Loss of muscle and bone density
Long-term depression and anxiety

Over the years, thousands of my male patients have turned their lives around by supplementing with bio-identical testosterone. Not only does it slow the aging process, it keeps them feeling strong, masculine and optimistic.
But back to the current problem…

A few US Senators from the biggest drug producing states have introduced a bill that would wipe out your ability to choose bio-identical hormones.
If this legislation passes, federal regulators – NOT your doctor – will decide what medicines you can take. And there will be severe restrictions on what a compounding pharmacist will be able to prepare even if a doctor asks for it for a patient.

The bill would give the Food and Drug Administration (FDA) the power to:
Broadly eliminate the availability of many critical, commonly compounded medications that many patients rely on, such as bio-identical hormones for women, hospice care treatments for the terminally ill and customized medicines for children.

Determine when compounded medicines are needed – a decision that has always been and should always be made by doctors.

Restrict the compounded medications your doctor can prescribe even if he or she determines you need them.

According to the Washington, D.C. political magazine Congressional Quarterly, the big drug makers are in “high lobby mode” in support of this legislation. But this shouldn’t surprise you… They want doctors and pharmacists to become compliant dispensers of their variety only of potentially toxic patent drugs.
But you don’t have to stand by while the government tries to take away your rights.

Just go to
http://www.healthfreedom.org
and click “Stop new bill to restrict access to individualized medicine” on the bottom left of their home page. Then click “What You Can Do” on the right-hand side. You can then fill out one of their forms that go straight to your congressman or senator.

To Your Good Health,

Al Sears, MD

[kebaldwin]

Dear Reader,

This might be the most important e-Alert I'll ever send you.

Your healthcare freedom is constantly under attack. And as we've just discovered, that freedom has suddenly come under fire as never before.

--------------------------------------------
Always something
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Most HSI members won't be surprised to learn that the FDA has launched a plan to impose new regulations on alternative healthcare - regulations that are far more severe than existing regs.

Attempts like this aren't new, of course. Over the years we've diligently monitored such actions so that we can keep you informed through the e-Alert, the HSI Members Alert, and our web site.

Just last month I told you about a new senate bill called the Safe Drug Compounding Act that would limit the freedom of women to choose a safe alternative to synthetic hormone replacement therapy. So far, there's no further news about the progress of that completely unnecessary act, but now a much larger threat looms.

This past December, the FDA quietly put a document on its web site titled "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration." This document is open to public comments until April 30, 2007 - just a few days from now.

After that, FDA officials will evaluate the comments and decide if they dare proceed with a regulation that might actually make it a crime to take vitamin C for a cold without a prescription.

Sound extreme? Absolutely! This is the most extreme attempt to control the sale and use of dietary supplements I've ever seen.

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The cards are stacked
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The FDA document is 14 pages long, but here's what it boils down to: If you use an herbal or dietary supplement to stay healthy or to help prevent an ailment, that's fine. But if any supplement is used to treat a symptom, then it's a medicine and will be regulated by the FDA, just like any prescription drug.

And there's a qualifying statement to that second part: The supplement will be exempted if it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."

In other words, the freedom to use a supplement to treat a condition will be at the discretion of FDA experts. And given the track record of FDA experts, this is really bad news.

With this spacious latitude, there's no telling just how far the FDA might go to restrict access to supplements. For instance, they could take a widely used supplement off the market if the label states a benefit; such as using lutein to reduce the damage from age-related macular degeneration, or using chondroitin and glucosamine to reduce joint pain, or using probiotics to address digestive problems - the list goes on and on.

As HSI Panelist Jon Barron points out on his web site (jonbarron.org), under the proposed FDA guidelines even bottled water might be considered a drug if used to alleviate severe dehydration, which is an emergency medical condition.

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Time to act!
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Just think of all the e-Alerts I've sent you with details about supplements that address health problems. All of those supplements might become so tightly regulated that you would have to get a doctor's prescription to use them.

Of all the times to raise our voices, none is more important than this time.

You can find the full text of the FDA document at this link:

http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

And you can use this link to submit your comments:

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA

In addition, we also need to let our representatives in Washington know that we strongly resist this attack on our healthcare freedom. You can find the names and e-mail addresses for your congressmen at this web site: congress.org.

And finally, I hope you'll forward this e-Alert to other people you know who value our right to make our own healthcare choices.

To Your Good Health,

Jenny Thompson

[kebaldwin]

FDA's attempts to slip its CAM Guidelines under the radar fail; deadline for public comment extended to May 29

http://www.newstarget.com/021810.html