Fw: PRIORITY - Summer of Decisions - Vitamin Lawyer Update eMemo . . .

[Guest guest]

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Ralph Fucetola JD

Ralph Fucetola

Wednesday, June 06, 2007 10:01 PM

PRIORITY - Summer of Decisions - Vitamin Lawyer Update eMemo . . .

 

 

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1. Summer of Decision “Not Unreasonable…â€

2. Entire Web: Define Your Target Market

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1. A Summer of Decision: Suggested Amendments to FDA " Revitalization " bill -

" Not Unreasonable " and Commentary by the Vitamin Lawyer

 

Take Action: Natural Solutions:

http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.\

jsp?campaign_KEY=11344

 

Wellness Resources:

http://capwiz.com/wellnessresources/issues/alert/?alertid=9773656 & PROCESS=Take+A\

ction

 

 

This is a summer of significant decisions in the Dietary Supplement and

Natural Products marketplace.

 

From Wellness Resources: " The Senate has recently passed bill S.1082,

commonly

known as the FDA Revitalization Act. ...the legislation, as currently

written,

opens the door for considerable regulatory confusion enabling the FDA to use

this legislation to undermine my access to safe and effective dietary

supplements. There must be no confusing the safety of drugs and the safety

of

food and food ingredients – which are governed by different laws. ...members

of Congress are not intending to create such concern among the 150 million

Americans who rely on dietary supplements to assist their health, and this

matter is easily corrected with the following amendment, which will not in

any

way stop the FDA from identifying truly contaminated food that poses a risk

to

human health.

 

" Changes in Existing Law. The following provides a print of the existing

statute or part or section thereof to be amended or replaced so as to delete

the words “or unreasonable†(existing law proposed to be omitted is

enclosed in black brackets, existing law in which no change is proposed is

shown in roman):

 

" CHAPTER IV – FOOD - SEC. 402 (f) – (1) If it is a dietary supplement or

contains a dietary ingredient that – (A) presents a significant [or

unreasonable] risk of illness or injury under — (i) conditions of use

recommended or suggested in labeling, or (ii) if no conditions of use are

suggested or recommended in the labeling, under ordinary conditions of use:

 

" Changes in Proposed Bills Proposed amendment to S.1082 and HR.1561:

 

" The bills are hereby amended to prohibit the Foundation or Institute from

evaluating the health benefit or efficacy of foods, dietary ingredients, and

dietary supplements and to limit review of foods, dietary ingredients and

dietary supplements to a determination of whether they are safe. In

assessing

whether dietary ingredients and dietary supplements are safe, the Foundation

or Institute shall not compare product risks with health benefits or

efficacy.

Instead, the Foundation or Institute shall determine whether the product

presents a significant risk of illness or injury under conditions of use

recommended or suggested in labeling, or if no conditions of use are

recommended or suggested in labeling, under ordinary conditions of use... "

 

My comment: it may seem small, but the words " not unreasonable " do have a

big

impact... and it is in the small space made by such words (or their

deletion!)

that Health Freedom has room to grow. This amendment, together with the

wording of Dr. Paul's HR.2117, would go a long way toward protecting our

access to truthful information about the health benefits of foods. Please

note

that S.1082 does not explicitly mention Dietary Supplements (except for the

DSHEA Exemption Amendment adopted 94 to 0) so the suggested Emord Amendment

would change existing law to be more protective of Dietary Supplements by

attaching the change to the pending pro-FDA bill, the same parliamentary

procedure that has been suggested with Dr. Paul’s bill.

 

One concern I do have with this amendment is that the recent Supreme Court

Ephedra decision, not to review the appeals court upholding the Ephedra ban,

effectively means that nearly any risk of illness may be considered

" significant " and therefore, the amendment may not be strong enough.

However,

it may be possible to get it adopted… one step at a time!

 

This is an especially exciting time to be in the Dietary Supplement /

Natural

Products market. While stricter regulations seem on the way, scientific

advances and ongoing clinical studies point the way to better and more

effective products. The problem is not in the science or the production; the

problem is in the politics. These products are generally recognized as safe

when used as directed, like any food. We therefore need to reject the big

government notion that tells us we will only be safe if bureaucrats have

more

control over us. That nostrum is provably wrong, as we see from the failure

of government, with plenary power over approving drugs (as to efficacy and

safety) to protect the public from what some estimate to be hundreds of

thousands of unnecessary deaths each year from lawfully utilized

prescription

drugs.

 

The next few weeks, as the FDA “revitalization†bill is amended or not,

and adopted, or not, will tell us a lot about the future of this market.

Other

important regulatory events are happening this summer as well: the FDA

anti-CAM guidance may be finalized; the new Dietary Supplement “Good

Manufacturing Practices†have been finalized and should be issued. And, as

always, the FDA’s announced intent to “HARMonize†our freedoms to

international rules (even where that decreases our access to safe products),

operating through the North American Union, Codex and the new US/EU

cooperation agreement, remains an ever present threat.

 

This will be a summer of rapid events; stay up to date, even between VLUeM

Memos, by checking my Vitamin Lawyer Health Freedom Blog at:

http://tinyurl.com/yo5t4t - updated every couple days; also

http://www.globalhealthfreedom.org . . .

 

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