Panel Wants Tougher Supplement Standards

[Zing Zing Zingbah]

"WASHINGTON - With nearly one-fifth of Americans taking dietary supplements, the Institute of Medicine (news - web sites) on Wednesday called for tougher regulations to make sure the products are safe and do what they claim. The institute expressed concern about the quality of dietary supplements, saying "there is little product reliability."

This makes it difficult for health professionals to guide patients in use of supplements, the report said. The panel urged that Congress take steps to require improved quality control of supplements and to provide incentives to study the efficacy of the products. "


http://story.news.yahoo.com/news?tmpl=story&cid=541&ncid=541&e=1&u=/ap/alternative_medicine

I think this is a good thing. I hope we get tougher standards for supplements.

[Ian David]

1. It's about time!

Let me start by saying that NOT all nutritional supplements are bad. NOT all
nutritional supplements are worthless.

With that out of the way...

The free reign nutritional supplements have is a Republican plot that many on
both the right (and especially) the left have fallen for.

They have used a Roveian trick on us: Republican style de-regulation has been
spun into "medical freedom" and "medical choice."

The chief architects of this fiasco called "The Dietary Supplement Health and
Education Act (DSHEA) were Senator Orin Hatch (R-UT) and Senator Tom Harkin
(D-Iowa).

THIS IS THE SAME Orin Hatch that people (especially the left) cite when they
claim Nutrasweet is dangerous!
Senator Orin Hatch (R-Utah) for using his influence to kill a bill introduced
by Howard Metzenbaum (D-Ohio) to fund a non partial study on the effects of
aspartame by NIH
http://www.aspartame.com/indicted/

Also:
However one year later under the new Reagan administration, Searle resubmitted
their app with "new" evidence and it was accepted by the FDA and held from
congressional scrutiny by Orin Hatch and other Reagan Republicans - who also
fostered it's expanded use into children's vitamins and soft drinks less than
two years later.

Between 79 and 82 four FDA officials who took part in the aspartame approval
process left for jobs in the industrial nutrasweet community - Senators Hatch,
Heflin and Byrd reportedly received numerous campaign contributions thereafter
from Searle
---

Personally, I'm skeptical of the whole "Nutrasweet is bad for you" campaign.

But the point I am trying to make is this: Why do the same people who believe
Orin Hatch lied to us about Nutrasweet believe he acted honorably in
de-regulating nutritional supplements?

---

Also:
From The National Council Against Health Fraud:

Orrin Hatch takes two media hits. Senator Orrin Hatch (R-UT), whose 1994 Dietary
Supplement Health and Education Act has greatly weakened the FDA's ability to
protect consumers, has been rebuked for suggesting that the FDA has not done
enough to protect the public from ephedra's dangers. Calling Hatch's remarks "a
dazzling display of hypocrisy," Time senior science writer Leon Jaroff said,
"The time has come for drastic revision of DSHEA, the re-empowerment of the FDA
and the rejection of cynical proposals by legislators like Orrin Hatch." L. It's time to rethink ephedra regulation. March 5, 2003] Meanwhile, the Los
Angeles Times noted:

* From 1998 to 2001, while Hatch's son Scott worked for a lobbying firm with
close ties to his father, supplement industry clients paid the company more than
$1.96 million, more than $1 million of it from clients involved with ephedra.
* In 2002, Scott Hatch opened his own lobbying firm in partnership with two
of his father's close associates. So far, the firm has received at least
$30,000 in retainers from the National Nutritional Foods Association and a
major manufacturer of ephedra (Twinlab) , both of whom were clients of the
previous firm.
* During the past decade, Orrin Hatch has received nearly $137,000 in
campaign contributions from the supplements industry. Senator, his son get boosts from makers of ephedra. Los Angeles Times, March 5,
2003]
http://www.ncahf.org/digest03/03-10.html


For more good information:

Why the FDA Does Not Approve Supplements
David A Kessler, M.D, J.D.
This article is a slightly condensed version of a talk given at the Good
Housekeeping Institute Consumer Safety Symposium on Dietary Supplements and
Herbal Remedies, held in New York City on March 3, 1998. Dr. Kessler was FDA
Commissioner from 1990 through 1997 and currently is dean of Yale University
School of Medicine.
http://www.quackwatch.org/02ConsumerProtection/kessler.html



How the Dietary Supplement
Health and Education Act of 1994
Weakened the FDA
Stephen Barrett, M.D.

Most people think that dietary supplements and herbs are closely regulated to
ensure that they are safe, effective, and truthfully advertised. Nothing could
be further from the truth. Although some aspects of marketing are regulated,
the United States Congress has concluded that "informed" consumers need little
government protection. This conclusion was embodied in the Dietary Supplement
Health and Education Act of 1994 -- commonly referred to as "DSHEA" -- which
severely limits the FDA's ability to regulate these products.
Background History

In the early 1990s, Congress began considering two bills to greatly strengthen
the ability of federal agencies to combat health frauds. One would have
increased the FDA's enforcement powers as well as the penalties for violating
the Food, Drug, and Cosmetic Act <1>. The other would have amended the Federal
Trade Commission Act to make it illegal to advertise nutritional or therapeutic
claims that would not be permissible on supplement labels <2>. During the same
period, the FDA was considering tighter regulations for these labels.

Alarmed by these developments, the health-food industry and its allies urged
Congress to "preserve the consumer's freedom to choose dietary supplements." To
whip up their troops, industry leaders warned retailers that they would be put
out of business. Consumers were told that unless they took action, the FDA
would take away their right to buy vitamins. These claims, although bogus,
generated an avalanche of communications to Congress <3>.

The end result was passage of DSHEA, which defined "dietary supplements" as a
separate regulatory category and liberalized what information could be
distributed by their sellers. DSHEA also created an NIH Office of Dietary
Supplements and directed the President to appoint a Commission on Dietary
Supplement Labels to recommend ways to implement the act <4>. The Commission's
final recommendations were released on November 24, 1997 <5,6>.

The Food, Drug, and Cosmetic Act defines "drug" as any article (except devices)
"intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease" and "articles (other than food) intended to affect the structure or
function of the body." These words permit the FDA to stop the marketing of
products with unsubstantiated "drug" claims on their labels.

To evade the law's intent, the supplement industry is organized to ensure that
the public learns of "medicinal" uses that are not stated on product labels.
This is done mainly by promoting the ingredients of the products through books,
magazines, newsletters, booklets, lectures, radio and television broadcasts,
oral claims made by retailers, and the Internet.

DSHEA worsened this situation by increasing the amount of misinformation that
can be directly transmitted to prospective customers. It also expanded the
types of products that could be marketed as "supplements." The most logical
definition of "dietary supplement" would be something that supplies one or more
essential nutrients missing from the diet. DSHEA went far beyond this to include
vitamins; minerals; herbs or other botanicals; amino acids; other dietary
substances to supplement the diet by increasing dietary intake; and any
concentrate, metabolite, constituent, extract, or combination of any such
ingredients. Although many such products (particularly herbs) are marketed for
their alleged preventive or therapeutic effects, the 1994 law has made it
difficult or impossible for the FDA to regulate them as drugs. Since its
passage, even hormones, such as DHEA and melatonin, are being hawked as
supplements.

The rest at:
http://www.quackwatch.org/02ConsumerProtection/dshea.html


Also:
United States Senate Special Committee on Aging
Hearing on Swindlers, Hucksters and Snake Oil Salesmen:
The Hype and Hope of Marketing Anti-Aging Products to Seniors
September 10, 2001
http://www.quackwatch.org/01QuackeryRelatedTopics/Hearing/gorski2.html

Also:
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
December 1, 1995
DIETARY SUPPLEMENT
HEALTH AND EDUCATION ACT OF 1994
http://vm.cfsan.fda.gov/~dms/dietsupp.html

[HuckleB]

2. More than supplements are under the microscope of this report.

Report Calls for Tougher Oversight of Alternative Medicine

http://www.ajc.com/health/content/shared-auto/healthnews/altm/523380.html

WEDNESDAY, Jan. 12 (HealthDayNews) -- More than one-third of U.S. adults use alternative or complementary medicine, and an Institute of Medicine report released Wednesday calls for these treatments to be held to the same standards as conventional medicine.

In particular, the 327-page report recommends tougher oversight of dietary supplements. Among other actions, it asks Congress and others involved to amend the Dietary Supplement and Health Education Act of 1994, which classifies dietary supplements as foods instead of drugs, and doesn't require that manufacturers conduct efficacy or safety tests on their products.

For some advocates of alternative medicine, their own personal good experience is enough proof that it works, said Dr. Stuart Bondurant, executive dean at Georgetown University Medical Center, and chairman of the committee that wrote the report. For others, no amount of evidence is enough, he added.

[Trillo]

4. A committee (syndicate) decides what is best for consumers.

This reminds me of Florida's Tomato Committee in the news today.

[HuckleB]

5. I have my suspicion about some of the motivation.

Still, I don't think that legitimate practices have anything to fear. I think studies of acupuncture and other genuine, long-time practices will be positive, and that the studies will make it more difficult for insurance to deny consumers coverage for these practices.

[DARE to HOPE]

7. I have my own suspicions, too...

Do you all not know about the EU moves against supplements in Britain? Do you not know about the FDA moves against alternative practitioners in this country?

There have been two big democratic movements against the FDA's moves to take away supplements in the last six years. They know how many of us depend on natural solutions.

HOW CAN YOU TRUST THIS FDA--after the Vioxx, Celebrex, Aleve, and Prozac scandals?!! I mean, there are smoking memos!

There are people in this country who are now in jail because they tried to educate and help others with technologies and therapies that were known in the early part of the 20th c, before the drug companies and "food" companies got their postwar hegemony. I for one would rather take oregano oil and vitamin C against cancer, rampant everywhere these days. And don't even ask about electrotherapies. But they WORK.

[jman0]

3. maybe not a good thing

It's the pharmaceutical industry that stands to gain from regulation of any over-the-counter stuff.
I've read that they also sponsor research to "prove" things like herbal remedies are not good for you.

Edit: adding:

"The news media has disseminated several articles over the last few months implying that dietary supplements are useless and dangerous. The basis for these articles are press releases from mainstream supported groups such as the American Heart Association and American Cancer Society. These organizations receive financial grants from the pharmaceutical industry, and have openly expressed their bias against dietary supplements in court briefs filed in support of FDA regulatory restriction"

http://www.lef.org/featured-articles/may2000_vitamin_c_01.html

[TahitiNut]

6. Well, safety is one thing and efficacy is another.

I think standards in each area should be separable.

[jcappy]

8. consumer reports do exist

http://www.consumerlab.com/

subscription necessary, but sample info given

[Ian David]

9. ConsumerLab is a FRAUD!!

FTC Urged to Investigate Purported Consumer Watchdog

Trade Association Petitions Agency to Stop ConsumerLab.com's
Deceptive Business Practices

WASHINGTON, Jan. 13 /PRNewswire/ -- The Council for Responsible Nutrition
(CRN) has asked the Federal Trade Commission (FTC) to investigate deceptive
business practices by ConsumerLab.com and take appropriate action.
The CRN complaint states that ConsumerLab.com -- which represents itself
as a consumer watchdog testing dietary supplements -- is in reality a for-
profit company that solicits money from the makers of products it plans to
have tested. Those that pay have positive results highlighted and negative
results quashed; those that don't pay have negative results highlighted and
positive results obscured.
"Until now, nobody has looked behind the curtain and exposed
ConsumerLab.com's tactics," said CRN President Annette Dickinson, Ph.D. "It
is a business, not a watchdog -- one that intimidates manufacturers to pay for
its services. We ask the FTC to lift the veil this company uses to disguise
its true nature."
ConsumerLab.com promotes itself as "a leading provider of consumer
information and independent evaluations of products that affect health and
nutrition." Contrary to the image it projects of an actual testing facility,
ConsumerLab.com essentially is a three-person operation, and its business
address is a UPS drop box in White Plains, N.Y. It farms out product testing,
but does not make public the identity of the laboratories it uses.
Here is how it works: ConsumerLab.com approaches dietary supplement makers
requesting that they enroll in its "voluntary" testing program -- for a fee.
Those that pay are guaranteed that products failing the subsequent testing
will not be identified publicly. Companies that do not pay risk having their
products tested anyway and, if they fail, being publicized on
ConsumerLab.com's Web site and in the media.
Meeting ConsumerLab.com's standards is no guarantee that a manufacturer
will be treated fairly. Only products from companies that pay up and pass are
mentioned on the free portion of ConsumerLab.com's Web site. Products that
pass but are made by companies that don't pay are listed only on the private
portion of the site. These products are absent from the public site, giving
the impression to non-subscribers that they must have failed because they
aren't listed. And even the 20,000 Web subscribers, who pay $24 a year for
"full access" to product tests, aren't told that ConsumerLab.com has agreed to
suppress failing results for companies that paid up.
CRN and its member companies recognize the value and importance of
legitimate third-party testing programs -- such as those run by U.S.
Pharmacopeia and NSF International -- that operate in an honest and aboveboard
manner and help consumers select high-quality products. The ConsumerLab.com
business model, by contrast, is unfair and deceptive.
CRN is asking the FTC to make ConsumerLab.com: 1) make public all future
test results regardless of whether companies have paid money to
ConsumerLab.com; 2) release testing criteria and methodologies in advance; 3)
identify the contract laboratories that actually do its testing; and 4) change
its name to one that does not falsely imply that it does its own testing.
"ConsumerLab.com's entire business model is based upon threat and
deception," Dr. Dickinson said. "Forcing it to come clean will take away its
ability to mislead the media and the public."

Founded in 1973, CRN is a Washington, D.C.-based trade association
representing dietary supplement industry ingredient suppliers and
manufacturers. CRN members adhere to a strong code of ethics, comply with
dosage limits and manufacture dietary supplements to high quality standards
under good manufacturing practices. For more information on CRN, visit
http://www.crnusa.org.



SOURCE Council for Responsible Nutrition
Web Site: http://www.crnusa.org

[HuckleB]

12. Not a good example.

Consumerlab's been found to be quite sleazy. It makes the FDA look good by comparison.

[Ratty]

10. DSHEA went way way too far

Can't we all agree at least that a supplement should have what it says it has on its label? Can we agree it should have it in the same amounts it claims on the label? Just those two simple things would go a long way to improving the situation right now.

I for one think it would be nice for the US Government to test for contaminants such as estrogen, pesticides, fuel, mercury, lead, etc. Some of the supplements on the shelves now, particularly those imported from China, have really scary amounts of those things.

I personally have no problem with health claims on the labels not being supported by FDA-approved studies or whatever (if people want to throw their money away...) and I understand that kind of government heavy-handedness was what lead to DSHEA in the first place.

[Ezlivin]

11. Who listens to the IOM anymore? They said marijuana was okay

After the passage of the medical marijuana legislation proposition 215 in California the American "drug czar" and retired General Barry McCaffrey declared that there was "not one shred of evidence" that marijuana had medical uses and denounced it as "Cheech and Chong medicine", after a marijuana-using team of comedians.

General McCaffrey then made the fatal mistake of ordering a study from the Institute of Medicine (IOM) of the Academy of Sciences. For about $900,000 it was to determine the facts by review existing literature and talking to patients and doctors to determine what is known about marijuana as a medicine. The study was finally released on March 17, 1999. It confirmed that:

• it does not lead to harder drugs (gateway or stepping stone theory)


• its addiction potential is not very serious and


• its side effects are within the range tolerated for other legal medicines.

This study has basically destroyed any justification for classifying marijuana with other drugs that are addictive or without established medical use. See http://www.mpp.org/science.html for some quotes for details.

[HuckleB]

13. LOL!

:)

[napi21]

14. I worked for one of the largest supplement mfg's for 14 years.

We were closely monitored by the FDA. We had to perform lab tests on each batch the same as the pharmaceutical mfg's must do. We had surprise inspections by the FDA all the time.

I can't answer for the mfgs that are outside the US, but for the 2 major mfgs in the US, they must follow rules and restrictions almost as strict as the ones that make prescription drugs.

During the 14 years I worked there, we did encounter several investigations because of some people being harmed, some seriously, by a product we made. In EVERY case, the problem was not the product, but the consumer who abused it. People tend to think, if a product is good, more of it is better! That's never true.

[Ian David]

15. I stand corrected re: ConsumerLab

Sorry, I pulled a Dan Rather.

This information was just handed to me....

From:
Tod Cooperman, M.D.
President, ConsumerLab.com

To:
Annette Dickenson, Ph.D.
President
Council for Responsible Nutrition
1828 L Street, NW Suite 900
Washington, DC 20036-5114

January 13, 2005

Dear Dr. Dickenson,

I am dismayed and disappointed by your request
that the FTC investigate your trade groupís
allegations that ConsumerLab.com "deceptively
portrays itself."

ConsumerLab.com has been at the forefront of
exposing problems in the supplement industry and
helping consumers identify better quality
products. We have earned the respect of consumers
and health professionals not by deception but
with rigorous science and transparency. Your
request and related press release are full of
mistruths and misinformation. By way of this
letter, I wish to bring to your attention
examples of false, misleading and, in our
opinion, defamatory statements.


This tactic of "shooting the messenger" by
casting doubt on our research or attempting to
undermine our credibility has been tried in the
past by some members of your industry when we
have identified problems with their products such
as lead in a children's vitamin or a vitamin low
in ingredients. More responsible companies admit
to problems and taken corrective action.

Your claim that ConsumerLab requires supplement
manufacturers to pay a fee to avoid unfavorable
publicity for negative test results is both false
and absurd. We publish our findings for all the
products that we choose to test, whether they
pass or fail. These reviews are conducted at
ConsumerLab.com's sole cost and expense. We also
publish the names of products that pass our
voluntary certification program, which products
are clearly marked as having participated in that
program. These two programs allow us to test a
greater number of products and provide more
information to consumers. We demand payment
from no one.


You claim that CRN recognizes the importance of
legitimate third-party testing programs that
operate in an honest and aboveboard manner. Yet,
you fail to disclose that CRN only recognizes
testing programs that are members of your trade
association, never disclose information to
consumers about products that fail, and rarely
publish details of their testing methods. Our
testing methods have always been freely
accessible, and our reports are available to
readers of our book and to those who subscribe
for a modest fee to our website

We use outside, expert laboratories for good
reason. First, we are involved in a wide range
of testing and strive to use the most advanced,
reliable, and accurate methods. This is best
achieved by using outside experts. Using outside
laboratories, we are also able to blind the
product identities whenever possible to avoid
potential bias by the researchers. Third, before
we publish a failing test result, our protocol
requires us to confirm the results in a second
independent laboratory. Our research staff,
overseen by William Obermeyer, Ph.D., a highly
respected pharmacognocist, reviews all test
results. Prior to helping start ConsumerLab.com
in 1999, Dr. Obermeyer oversaw natural products
testing at the FDA. All laboratories that we use
are well-established commercial or academic
laboratories. The reason that we do not publicly
disclose the names of these labs is because
members of your industry have threatened several
with loss of business.

How ironic that your organization suggest that we
change our name to better reflect the true nature
of our business.î Our name, ConsumerLab.com, is
highly indicative of our unique work in providing
results of expert laboratory analyses to
consumers. How many would guess from the name of
your group, the Council for Responsible
Nutrition,î that you are a trade association of
supplement ingredient suppliers and manufacturers.

What ConsumerLab.com is and what it does is
clearly explained on our website and in our book
and we do not violate any FTC regulations. I am
extremely proud of ConsumerLab.comís work,
thrilled with the improvements in many products
that have resulted, and uplifted daily by praise
we receive from consumers and others. Many of
your own members benefit, at no cost, by our
informing our readers and subscribers that
certain of their products are of high quality.
Your trade group, too, has a history of using
ConsumerLab.com information when it has been to
your benefit.


I suppose that if you loved us, we wouldn't be
doing our job right. But you need not create and
spread lies about ConsumerLab.com. We trust that
you take immediate corrective action.


Sincerely,



Tod Cooperman, M.D.
President
ConsumerLab.com, LLC

[Ian David]

16. Also, here is a source on alt.medicine that I trust greatly

Mission Statement
Stephen Barrett, M.D.
http://www.quackwatch.org/00AboutQuackwatch/mission.html

Quackwatch, Inc., which was a member of Consumer Federation of America from 1973 through 2003, is a nonprofit corporation whose purpose is to combat health-related frauds, myths, fads, and fallacies. Its primary focus is on quackery-related information that is difficult or impossible to get elsewhere. Founded by Dr. Stephen Barrett in 1969 as the Lehigh Valley Committee Against Health Fraud, it was incorporated in 1970. In 1997, it assumed its current name and began developing a worldwide network of volunteers and expert advisors. Our activities include:

* Investigating questionable claims
* Answering inquiries about products and services
* Advising quackery victims
* Distributing reliable publications
* Reporting illegal marketing
* Assisting or generating consumer-protection lawsuits
* Improving the quality of health information on the Internet
* Attacking misleading advertising on the Internet

Stephen Barrett, M.D.
Board Chairman, Quackwatch, Inc.
NCAHF Vice President and Director of Internet Operations
P.O. Box 1747, Allentown, PA 18105
Telephone: [phone]

http://www.quackwatch.org (health fraud and quackery)
http://www.autism-watch.org (guide to autism)
http://www.casewatch.org (legal archive)
http://www.chelationwatch.org (under construction)
http://www.chirobase.org (guide to chiropractic)
http://www.dentalwatch.org (guide to dental care)
http://www.dietscam.org (under construction)
http://www.devicewatch.org (under construction)
http://www.homeowatch.org (guide to homeopathy)
http://www.ihealthpilot.org (under construction)
http://www.infomercialwatch.org (guide to infomercials)
http://www.mentalhealthwatch.org (under construction)
http://www.mlmwatch.org (multi-level marketing)
http://www.naturowatch.org (naturopathy)
http://www.nutriwatch.org (nutrition facts and fallacies)
http://www.ncahf.org (National Council Against Health Fraud)
http://www.chsourcebook.com (consumer health sourcebook)

Editor, Consumer Health Digest
http://www.quackwatch.org/00AboutQuackwatch/chd.html

[DARE to HOPE]

19. Well, I DO NOT!!

(trust Quackwatch AT ALL!)--quack, quack, quack!!

[amazona]

17. why is this a good thing ?

This is insane. We have real problems in this country. So let's spend our law enforcement dollar chasing not just marijuana and ephedra users but let's make even more harmless herbs illegal?

What happened to freedom? What happened to "my body, my choice?"

The conservation movement is a breeding ground of communists
and other subversives. We intend to clean them out,
even if it means rounding up every birdwatcher in the country.
--John Mitchell, US Attorney General 1969-72

[Ian David]

20. You should be able to put whatever you want into your body

But the people selling it to you shouldn't be allowed to lie about what it is or what it does.

[bemildred]

18. This is self-serving drool. nt