FW: AAHF's Response to FDA CAM Regulation Guidance

[Guest guest]

take action here:

http://ga4.org/campaign/Congress_FDA

 

 

American Association for Health Freedom and the Health Freedom Foundation are

very concerned with the FDA document 2006D-0480 - Draft Guidance for Industry on

Complementary and Alternative Medicine Products and Their Regulation by the Food

and Drug Administration (read FDA Summary). The full text of the CAM Guidance

can be read here. (Adobe Acrobat required).

 

 

 

 

A guidance like this is very confusing and there are legal issues that must be

carefully examined and responded to in writing. Therefore, as a first step, we

have officially requested the FDA extend the deadline for comment to July 31,

2007. The time the FDA has provided for comment is simply too short for

something this complex and important. We are working with Congress to ask them

to have FDA extend the comment period. Click here to read our letter to the FDA

requesting an extension.

 

 

 

CLARIFICATION

 

We wanted to clarify that much of the regulation proposed in the document has

already been claimed by the FDA. For example, making health claims as it

pertains to dietary supplements and foods is currently not permitted, and people

who do so are vigorously pursued by both the FDA and the Federal Trade

Commission.

 

 

 

MAJOR CONCERNS

 

While we have several concerns with the CAM Regulation Guidance, the two biggest

are broadening the definition of 1Chealth claim 1D and the desire to pre-empt

the states in the regulation of some health care issues.

 

 

 

Example: The document attempts to define how vegetable juice might be defined

as a drug, " 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 food in the Act and FDA

regulations...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

be subject to regulation as a drug under the Act. "

 

 

 

The FDA defines a drug as " ...(B) articles intended for the use in the

diagnosis, cure, mitigation, treatment or prevention of disease in man or other

animals; and © articles (other than food) intended to affect the structure or

any function of the body of man or other animals.

 

 

 

What the FDA is stating is that they believe that any person (or product) that

states " drink some vegetable juice to prevent [insert disease] " is actually

making a drug claim; and if vegetable juice is not recognized by the FDA as a

legally available drug in the United States, the person (or manufacturer) making

the claim is now subject to prosecution if they are not a medical professional

licensed to practice medicine.

 

 

Who is going to fund a $50,000 investigational new drug application to get

carrot juice approved as a drug, or the follow-on millions in research dollars

to conduct a study on the toxicity ($200,000) and efficacy of carrot juice ($3

million and up.) Keep in mind this would have to be done separately for any

disease process carrot juice might have an impact on.

 

 

 

WHY NOW?

 

Why did the FDA create this document? There are a couple of theories. One is

that the National Center for Complementary and Alternative Medicine (NCCAM)

asked the FDA to 1Charmonize 1D with their way of thinking. Another idea is

that importation of products (which is a major concern to the FDA) will soon be

a top issue. Functional foods could also be a target (as forewarned by the FDA

December meeting on functional foods - read about our response and

presentation). Regardless of the why, we do know that the health freedom

community was not consulted in the preparation of the document. Furthermore,

the clumping of food, products, medical devices, and therapies makes for an

awkward, confusing, and unconstitutional 1Cway of thinking 1D and does not

represent what is best for the consumer.

 

 

 

THE IMPACT

 

The draft guidance, when finalized, will represent the agency's current thinking

on the regulation of complementary and alternative medicine products by FDA.

Though it does not change the law, it does represent a potential major expansion

on how foods, therapies, and products could be regulated. Of further concern, is

that this document could be used by health freedom 1Copposition 1D and

regulators to pressure Congress to change legislation. The language in the

document gives us great concern and we cannot allow an agency such as the FDA to

finalize the document in its present form.

 

 

 

ACTION

 

The comment period expires on April 30. It has been our experience that citizen

letters to the FDA during the comment period rarely have an impact on the FDA

19s decision-making process. This is important to know, since the appropriate

response to this situation is not to just be busy (as in writing letters to the

FDA) but to be effective. What the FDA has told us is that they want to hear

from practitioner groups and trade associations. Remember, that the FDA

officials are not elected and generally the wishes of the public fall on deaf

ears.

 

 

 

The two things that are most likely to influence the FDA 19s actions as it

pertains to the issues outlined in this document are:

 

Members of Congress who have a variety of mechanisms for shaping the authority

of the FDA.

State Attorneys General who can threaten legal action if the agency tries to

usurp the authority of the states in regulating health care activities within

their states.

 

In consideration of the above, we are taking these actions:

 

We are alerting our Congressional friends about this issue, and asking them to

take appropriate action. We will notify you when it is time to write to these

elected officials and make your wishes known.

We have commissioned an extensive, legal response to the guidance that has the

kind of technical detail the FDA bureaucracy wants (or actually DOESN 19T want)

to see as they strive to give this document the force of law.

We are planning to communicate with the proper officials in each state to notify

them of the potential for federal interference in state regulatory activities.

If you do write the FDA, please send a copy of your concerns to your

representatives in Congress. These elected officials DO care about your opinion

and your voice matters. CLICK HERE to contact Congress.

http://ga4.org/campaign/Congress_FDA

 

 

 

SUMMARY

 

We believe the CAM Regulation Guidance would set the tone of the FDA in regards

to functional foods; alternative medicine therapy, devices, and products; as

well as dietary supplements and could help set the stage for future legislation

that would restrict access. While public comments to the FDA by individuals are

a course of action, we want you to be aware that fighting FDA 19s 1Cway of

thinking 1D will need a stronger course of action and we are prepared to follow

though. We have fought the FDA before and have been successful.

 

 

 

There are numerous issues facing the health freedom community that need

attention where your action can make a big different: a draft bill to restrict

access to individualized/compounding medicine, the right of the practitioner to

practice being threatened by individual states, and Rep. Dingall wanting to

1Ckill 1D dietary supplements because they are a 1Csnake 1D to be killed.

 

 

 

http://www.healthfreedom.net/index.php?option=com_content & task=view & id=185 & Itemi\

d=230

 

 

 

Please know that we are working diligently on the important issues facing the

health freedom community. It takes both time and money and your financial

support is greatly appreciated.

 

 

 

http://www.healthfreedom.net/index.php?option=com_content & task=view & id=60 & Itemid\

=97

 

 

 

SUBMIT COMMENTS

 

If you would like to submit your written comments to the FDA, please use one of

the following methods

 

 

 

MAIL:

 

Division of Dockets Management (HFA-305)

 

Food and Drug Administration

 

5630 Fishers Lane, Room 1061

 

Rockville, MD 20853

 

 

EMAIL:

 

Click here or copy & paste this link:

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DO\

CUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA

 

 

 

NOTE: No matter which method, be sure to refer to Docket No. 2006D-0480

 

 

Brenna Hill

Executive Director

Health Freedom Foundation and American Association for Health Freedom

4620 Lee Highway, Suite 210

Arlington, VA 22207

1.800.230.2762

Fax: 703.294.6380

www.healthfreedom.net

P.S. Don 19t forget to JOIN, DONATE, TAKE ACTION, and TELL-A-FRIEND!

 

 

--

 

Visit the web address below to tell your friends about this.

Tell-a-friend!

 

 

If you received this message from a friend, you can sign up for

Healthfreedom.net.