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NOW JOHN MCCAIN TRYING TO KILL NUTRITIONALS!
NEW NUTRITIONAL SAFETY BILL STARTS OUT
WANTING YOU TO REGISTER YOUR NUTRIONAL BUSINESS
Require the registration of “dietary supplement facilities,” which are defined as “any business or operation engaged in manufacturing, packaging, holding, distributing, labeling, or licensing of a dietary supplement for consumption in the United States.”

READ LETTER FROM DRA LEGAL ADVISOR




The McCain Bill







LETTER TIME!  SEND A LETTER ASAP!
FDA TRYING TO KILL OFF MLM LIQUID NUTRITIONALS!
Beverages Are FOOD, NOT TO Be Marketed as Supplements
(see below Section 3 from FDA)


Submit written comments to:

The Division of Dockets Management (HFA-305)
Food and Drug Administration,
5630 Fishers Lane,  rm. 1061,
rm. 1061,
Rockville, MD 20852.

For questions regarding this document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-2375.

NOT POSSIBLE AT THIS TIME: Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.


FDA TRYING TO KILL OFF MLM LIQUID NUTRITIONALS!
Beverages Are FOOD, NOT TO Be Marketed as Supplements
(see below Section 3 from FDA)

On Dec 5th 2006 the Distributor Rights Association (DRA) represented MLM Distributors in an FDA hearing on liquid nutritionals.  We were represented by the Law Office of Johnathan Emord who is a leading opponent of oppression by the FDA. That meeting was benign and the FDA representatives said they were on a fact finding mission.  The majority of the input to them was to leave liquid nutritionals alone, they are fine being classified as a nutritional under DSHEA.  So the meeting ended with no action.  It turns out this was a ruse to an end play political manipulation.  Now, once again, we find that the FDA is pulling sneaky back door tactics to try to get liquid nutritionals bashed or banned - NO DOUBT AFTER THAT ALL NUTRITIONALS!

UR Editor: Here is the FDA presentation >>            HERE IS FDA PRESENTATION >
at the meeting see if you see anything
about liquids at all = benign

In your Editors not so humble opinion: The mild dog and pony show above were orchestrated by the FDA under the cover of a Petition by left wing extremists the Center for Science In The Public Interest who don't like DSHEA. WHY?

1. I have found reports the Food - Nutritional part of the FDA has been reduced by 11 percent since 1978.  Why?  Because BIG PHARMA drug companies pay the FDA for working on Drug Approvals.  To grab the money and buff up the FDA budget... No doubt the FDA moved bodies to the Drug side of their house!  So my opinion is this was a poorly disguised manpower grab.  Hey there are good folks at the FDA some just get myopic!

                                                                                   


This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction
FDA is issuing this guidance to assist dietary supplement and beverage manufacturers and distributors in reaching a determination as to whether a liquid product may be labeled and marketed as a dietary supplement.  The guidance describes factors that can be used to identify liquid products that are excluded from being dietary supplements because they are represented as conventional foods.  Further, this guidance reminds manufacturers and distributors of beverages and other conventional foods, particularly those that contain novel ingredients, about the requirements of the Federal Food, Drug, and Cosmetic Act (the FFDCA) regarding ingredients and labeling.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required . (this is first step d disarm your critics!)

II. Background
The Food and Drug Administration (FDA) has observed and become concerned about two trends in the marketing of beverages.  First, we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods.  Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement in section 201(ff) of the FFDCA (21 U.S.C. 321(ff)) and must meet the regulatory requirements that apply to conventional foods.

Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.  Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods.  This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use.  Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.

III. Discussion

A. Beverages Are Conventional Foods That May Not Be Marketed as Dietary Supplements

CONTINUE: NEXT PAGE - FDA ATTACK ON MLM LIQUID SUPPLEMENTS
FULL DETAILS



Watchdog the FDA quotes this case to bust your chops:   Nutrilab v. Schweiker, 713 F.2d 335  (7th Cir. 1983).   I have reason to believe there is an Appellate Court decision that is almost opposite of the District Court Case site above the FDA is hiding or hidden.  HELP!! I need that case! BAD!

HELP CLICK HERE! SEND A LINK TO A PDF (OR COPY) OF  THE CASE ABOVE SEEMS BIG BROTHER HAS WIPED IT OFF THE INTERNET
The WatchDog Only Has A Partial Quote!


.After the benign meeting above on 5 Dec. 2006 fuel was added to the fire at the FDA when they got their hands on the lawsuit Amway filed against Monavie for violations of the Dietary Supplementry Health Education Act of 1994.  A question is more about the evidence in the Amway - Quixtar Vs. Monvie? Did it get into get into FDA hands if so how? Public document but was it expedited....to the FDA? Investigation ongoing!
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FDA_Hearing_5_Dec_2006_-PUBLIC_hearing_no_liquidsAttacked.pdf
FDA_Hearing_5_Dec_2006_-PUBLIC_hearing_no_liquidsAttacked.pdf
Amway-Quixtar_Vs_Monavie.pdf
Amway-Quixtar_Vs_Monavie.pdf
Part II FDA
TRYING TO KILL NUTRITIONAL
BEVERAGES
2010-2-9_-_Memorandum_on_McCain_s_DSSA.pdf
2010-2-9_-_Memorandum_on_McCain_s_DSSA.pdf
Dietary_Supplement_Safety_Bill.pdf
Dietary_Supplement_Safety_Bill.pdf