MUCH ADO ABOUT NOTHING-Let's Get the FDA/CAM Issue Put to Rest

[Guest guest]

NATIONAL HEALTH FEDERATION

A NOT-FOR-PROFIT HEALTH-FREEDOM ORGANIZATION

 

 

MUCH ADO ABOUT NOTHING

Let's Get the FDA/CAM Issue Put to Rest

http://www.thenhf.com/press_releases/pr_27_apr_2007.html

April 27, 2007

 

 

The greatest threat to a totalitarian movement, once it gains power, is

factuality. Hannah Arendt: Prophet for our Time

 

 

Refined Guidance Response

By Lee Bechtel, NHF Lobbyist

 

The National Health Federation is hearing from folks and is aware of what

other groups are saying about the FDA Guidance for Complementary and Alternative

Medicine Products issued by the FDA on February 27, 2007.

 

As the NHF lobbyist, my style is to work from the facts. In dealing with

Members of Congress, their staff, and FDA personnel, credibility is the only

stock in trade. And, things do get around to people involved in FDA issues in

both places.

 

Currently, several groups - other than the NHF - are circulating news about

the " end " of dietary supplements and ability of medical professionals,

State-regulated or not, to practice Complementary and Alternative medical (CAM)

professions, as we currently know it to be the case.

 

What is being consistently lost in the issue translation in these messages is

what the proposed Guidance really means, to CAM providers and consumers, the

intent of the Guidance, and the federal and State medical regulatory processes

in place that will not mean the " end of the world " as we know it.

 

The Guidance as drafted does not prevent access to CAM providers. It does

not prevent the use of supplements/herbs etc. by medical professionals in their

practice, with limitation, nor does or would it directly impact

consumers/patients. It would not prevent the use of healthy foods in a diet

recommended by a

doctor.

 

What the Guidance does do is present current FDA thinking on how CAM fits

within the current context of FDA food and drug regulation. Again, Guidance is

not a regulation, nor is it a law. It confers no legal impact on the FDA or the

public. Guidance specifically relates to FDA thinking on the design,

production, labeling, promotion, and manufacturing of regulated products. In

this

case, products related to CAM medical practice. This includes FDA-regulated

drugs,

supplements, and potentially foods, with severe restrictions.

 

Some groups have raised the concern that the Guidance would cause problems

with a CAM practitioner treating patients, in the confines of their office, with

a food, and recommending a food (in this case orange juice used as an

example) that would be translated into a drug. Specifically, that a CAM

practitioner

" prescribing " a natural food to treat a medical condition could lead to FDA

action. The same logic is being applied to dietary supplements.

 

A few facts.

 

First, a CAM practitioner cannot " prescribe " a food in any event under State

or federal laws, because natural foods are not regulated as drugs. Foods

appear nowhere in the classifications of drugs, regulated by the FDA and the

various States. Dietary supplements are also foods. A CAM Medical Doctor could

be

employing " off-label " uses of FDA approved drugs for patient treatment, which

includes a combination of supplement and natural foods. Prescribing, within the

office, only applies to the drug. There have been attempts, and will be

attempts, to blur the line between supplements claiming a curative or

preventative

outcome and their classification as a drug by the FDA. Recommending foods and

supplements is not, under federal law and most State Medical Practice Acts,

" prescribing. "

 

A question has come up and relates to why CAM practitioners should not be

allowed to " practice off-label uses for dietary supplements " ? This is a

completely implausible situation, for the time being. The FDA and its

counterpart State

agencies - unless and until Senators Durbin and Congressman Waxman get their

way - regulate supplements as foods. Yes, there are State FDA agencies not

officially affiliated with the FDA. But there are no federal or State " on label "

curative uses for foods. There is FDA regulation of food-labeling claims, such

as that a cereal helps the consumer reduce cholesterol levels or lose weight.

Without specific FDA approval of " on label " requirements for specific

preventative, mitigative, or curative disease or conditions for specific foods,

however, there are no " off label " matters for the FDA to regulate.

 

On the fear that the FDA will go after MDs practicing CAM - keep in mind,

that physician/patient medical records and communications are protected by the

federal HIPPA law. If the FDA wanted to go after a CAM practitioner, based on

evidence of using a CAM treatment regime, they could not get evidence, without

violating this law. The FDA would have to get a patient's written consent to

release records.

 

A person could file a malpractice complaint with a State licensing board, if

the CAM profession is State regulated, and then the FDA could get this public

information.

 

This is the case unless a CAM medical treatment goes beyond an office setting

and is advertised for whatever purpose to the general public as a

treatment/cure for a condition. In the eyes of the FDA, it becomes marketed as a

" drug, "

even if there is, in fact, only one drug involved, either on-label or

off-label use, used in the combination comprising the CAM therapy.

 

This point is important and has been around since the creation of the

National Center for Complementary and Alternative Medicine (NCCAM) in 1998. This

creation is, in my view, the basic reason for the Guidance.

 

Could there be Guidance transference to States and their regulation of CAM

practitioners? Sure, but the Guidance and the federal Administrative Procedure

Act (APA), Code of Federal Regulations, provides legal protection.

 

On this point, the Guidance does raise the issue of how far the FDA can or

would go to preempt State medical-practice laws for licensed CAM professionals.

However, FDA Guidance is not federal regulation, as is stated in the APA.

However, State Medical Boards going after physicians who practice CAM is an

ongoing issue, with exception for several States. This is because there are no

clarifications/exemptions specified for CAM practitioners who are MDs and DOs.

Naturopathic Doctors (NDs) are licensed in 12-13 States, but, for the most part,

are not granted drug prescriptive authority.

 

Federal preemption is a concern, but the Congress has not allowed this in the

past. Clearly, these are State issues and not directly related to anything

the FDA could do, unilaterally on it own. So, this is simply another fear

based on speculation and not on the facts. The FDA does not, and cannot,

regulate

the practice of medicine/healing arts at the State level of government, within

the confines of a CAM provider/patient relationship. This is not my

interpretation. It is spelled out in the Food, Drug, and Cosmetic Act (FDCA).

This

applies unless or until a person, a company, a partnership of both, or anyone

else goes public with a CAM treatment that infers that the combination therapy

would prevent, mitigate, or cure a medical condition.

 

Remember, the FDA Guidance only reflects FDA thinking. And, that their

bureaucrats and the law and regulations are so out of date with the current

practice

of medicine that we are where we are when it comes to the Guidance issue.

 

Process Lost in Translation

 

Some groups have taken the position to specifically file comments on the

interpretation of CAM used in the draft Guidance document. Others are asking

members to send letters to the FDA requesting an extension in the filing

deadline,

and suggesting that Members of Congress should be lobbied to write letters to

the FDA to grant a deadline extension.

 

There are, in fact, two levels of FDA Guidance. In the current case, this is

a Level 1 Guidance. This means that that document sets forth its initial

interpretations of statutory or regulatory requirements to guide FDA

bureaucrats,

and the public, when a complementary and alternative medical treatment is

claimed, in the public domain, to prevent, mitigate, or cure a type of disease

or

condition - in other words, when making a drug claim without FDA approval.

 

Unfortunately, none of these messages have placed the issue in the context of

the real world of public policy, and federal and State regulatory process. To

be clear, this outlines the current federal Administrative Procedure Act,

applying to the FDA and its " Good Guidance Practices. " The CFR/APA citation is

Title 21, Section 10.115. People may read this section for themselves, if they

want.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115 & \

SearchTerm=good%20guidance%20practices

 

The FDA is not required to review any comments sent in before issuing a Level

1 Guidance. There is a reason. They have to publish notice and they can

request comments, but are not required to respond. If they do, this helps with

the

bureaucratic learning curve. Asking Members of Congress to ask the FDA to

extend the deadline is an idea, but I seriously doubt there will be any takers.

There is a reason, see below.

 

The FDA is required by the APA to review comments and suggestions for

revisions on any Guidance document issued by the agency, at any time, for either

Level 1 or Level 2 Guidances issued by the Agency, from any groups/people. So,

the

draft Guidance is not, even if published in its proposed form, the end of CAM

or the use of supplements, as we now know them to be.

 

Finally, after a Guidance is finalized, the FDA can issue a Compliance

document. This provides more specificity on what the FDA meant when it issued a

Guidance. And, this would also be open for public comment, and so forth.

 

As the NHF lobbyist, I suggest that all of the players in the health-freedom

community need to keep an eye of what the FDA is really doing.

 

Spreading fear and misinterpreting the facts, in virtually complete ignorance

of FDA processes and without having done the simplest of basic legal research

does not inform people, nor does it do anyone in the health-freedom community

any good.

 

This is not about protecting the FDA. It is not about an FDA conspiracy. It

is about reliable information and experienced analysis to be more informed

about what Congress and the FDA are doing that really impact health freedom of

choice

 

I would also counsel that people should ask themselves WHERE these other

groups were when the NHF was actively lobbying Congress against passage of the

AER

bill last December. The answer - Nowhere to be found. Lost in action!

 

I would also suggest that the players in the health-freedom community be more

concerned about when the FDA issues a Guidance when implementing the AER law.

 

 

This applies to consumers and supplement manufacturers as well as CAM medical

professionals. This event will be serious and will deserve grassroots

participation from all parties involved. This will happen at some point because

it is

written into the law. Stay tuned to the true facts and situation. Don't be a

lemming and jump off the deep end just because some misinformed people point

the way off the cliff. Let this be a lesson to avoid listening to them in the

future.

 

This Guidance and clarification actually dates back to the FDA's Strategic

Plan in 2000/2004, but it has taken them until 2007 to produce this draft

Guidance.

 

 

 

**********************************************************

 

 

Supporting this position, veteran food-and-drug lawyer Todd Harrison of the

Washington, D.C. law firm Venable, says " the FDA's CAM Guidance document does

not contain anything new. Indeed, FDA has long taken the position that if these

products are marketed to cure, treat, mitigate, diagnose, or cure disease,

then the products are subject to FDA's regulatory authority as a drug, biologic,

or medical device. The document stops short of stating that FDA has the

authority to prohibit a practitioner from using a lawfully marketed food,

dietary

supplement, cosmetic, or device to treat or prevent a disease. "

 

 

 

About the National Health Federation

 

Established in 1955, the National Health Federation is a consumer-education,

health-freedom organization working to protect individuals' rights to choose

to consume healthy food, take supplements and use alternative therapies without

government restrictions. With consumer members all over the world, and a

Board of Governors and Advisory Board containing representatives from 6

different

countries, the Federation is unique is being the only consumer health freedom

organization in the world to enjoy official observer status with the Codex

Alimentarius Commission.

 

 

 

 

 

 

 

 

 

[Guest guest]

Well, respectfully as possible . I disagree. .

 

the FDA in my opinion has demonstrated a remarkable callousness toward common

sense regularly.

EVERYTHING the FDA does requires diligent scrutiny and caution.

 

YES the mentioned " Natural Health " group May Possibly be using people,but more

so reminding to have alarm at a powerful organization which is an ideological

arm of the AMA and large Pharmaceuticals .

 

It is not chicken little scenario because obviously and ALWAYS the FDA is

AGAINST truthful labeling . dilute organic etc. .. AGAINST HEALTH and

individual responsibility and accountability ..

 

Since it has shown virtually NO conscience regarding its allowable and banned

substances

 

EVERYTHING is does must remain ALWAYS suspect. It has an agenda to bolster its

sister organizations. .. . AMA and Drug Companies

to even remotely think anything different is worse than being an Ostridge with

its head in the sand.

 

WATCH THEM ALWAYS

 

SUSPECT THEM ALWAYS

 

Not because we are paranoid, but because they have already shown their colors

 

is it Paranoid if they REALLY ARE after you?!

 

Their actions have already spoken . .. and done so MUCH LOUDER than their

words or yours

 

To say do not be worried is one thing. . .to say DO NOT ACT

tells me you may just be hired to diffuse their opposition.

 

~~Michael Phoenix Rising

 

 

 

 

 

 

 

It's not always what you look at that matters. It's what you see.

Henry David Thoreau

 

In recognition that matter is energy and that

many higher levels of energy exist in reality.

KNOW that By changing energy, miracles occur ! !

Clearing Dark and Detrimental Energies, Entities, Vibrations etc of all types.

.. .Glad to Help!

 

Michael Phoenix Rising

�…�ï¿ï½ …..\\ | //

ï¿½ï¿½ï¿ ï¦ â€¦â€¦( o o )

~~~~~~~~~ ~o00o~(___)~o00o~~~~~~~~~~

 

 

 

 

 

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[Guest guest]

Michael

If you want to run around and sign fake petitions; go right ahead. But

there are many many people whom are ill and do not have the excess energy to

run around like that. For them it is what is MOST important that has to matter -

they need to focus on what is 'real'. I posted an article yesterday called

" The Spoon Theory " that explains this better then I can.

This was not the first time that The Natural Solutions Foundation has

tried to DISTRACT people from the real threat. They also tried this last year.

They have become more sophisticated and better at it though this year. Do

you think they don't know that sick people have limited energy and ability to

focus? They are not stupid whatever else they are.

Shan

 

 

MUCH ADO ABOUT NOTHING-Let's Get the FDA/CAM Issue Put to Rest

 

Posted by: " Michael PhoenixRising " gandolph_4u   gandolph_4u

 

Mon Apr 30, 2007 2:12 am (PST)

 

Well, respectfully as possible . I disagree. .

 

the FDA in my opinion has demonstrated a remarkable callousness toward common

sense regularly.

EVERYTHING the FDA does requires diligent scrutiny and caution.

 

YES the mentioned " Natural Health " group May Possibly be using people,but

more so reminding to have alarm at a powerful organization which is an

ideological arm of the AMA and large Pharmaceuticals .

 

It is not chicken little scenario because obviously and ALWAYS the FDA is

AGAINST truthful labeling . dilute organic etc. .. AGAINST HEALTH and individual

responsibility and accountability ..

 

Since it has shown virtually NO conscience regarding its allowable and banned

substances

 

EVERYTHING is does must remain ALWAYS suspect. It has an agenda to bolster

its sister organizations. .. . AMA and Drug Companies

to even remotely think anything different is worse than being an Ostridge

with its head in the sand.

 

WATCH THEM ALWAYS

 

SUSPECT THEM ALWAYS

 

Not because we are paranoid, but because they have already shown their colors

 

is it Paranoid if they REALLY ARE after you?!

 

Their actions have already spoken . .. and done so MUCH LOUDER than their

words or yours

 

To say do not be worried is one thing. . .to say DO NOT ACT

tells me you may just be hired to diffuse their opposition.

 

~~Michael Phoenix Rising