This is the text of John McCain’s Bill in human readable form. If you use or sell dietary supplements you should be extremely concerned about this. This blog post will only take a few minutes to read, I’ve cleaned it up from the legalese format that is contained in the original bill.

111TH CONGRESS

To amend the Federal Food, Drug, and Cosmetic Act to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.

IN THE SENATE OF THE UNITED STATES

introduced the following bill; which was read twice and referred to the Committee on _____

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Dietary Supplement Safety Act of 2010’’ February 2, 2010

SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

DEFINITIONS.—Section 201 of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following:

‘‘DIETARY SUPPLEMENT FACILITY.—The term ‘dietary supplement facility’ means any business or operation engaged in manufacturing, packaging, holding, distributing, labeling, or licensing a dietary supplement for consumption in the United States.’’.

REGISTRATION OF DIETARY SUPPLEMENT FACILITIES.

ADULTERATED FOOD.—Section 402 of the Federal Food, Drug, and Cosmetic Act is amended by inserting at the end the following:

‘‘If it is a dietary supplement that is manufactured, packaged, held, distributed, labeled, or licensed by a dietary supplement facility that is not registered with the Secretary.’’.

REGISTRATION OF FOOD FACILITIES.—Section 415 of the Federal Food, Drug, and Cosmetic Act is amended in the section heading, by striking ‘‘FACILITIES’’ and inserting ‘‘AND DIETARY SUPPLEMENT FACILITIES’’; and in subsection (a) in paragraph (2) by striking ‘‘An entity’’ and inserting the following:

‘‘FOOD FACILITIES.—An entity’’; and by adding at the end the following:

‘‘DIETARY SUPPLEMENT FACILTIES‘

IN GENERAL.—A dietary supplement facility (referred to in the section as a ‘dietary supplement registrant’) shall submit a registration under paragraph to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the dietary supplement registrant conducts business. At the time of registration, the dietary supplement registrant shall also file with the Secretary a list of all dietary supplements manufactured, packaged, held, distributed, labeled, or licensed by the facility. Such list shall be prepared in such form and manner as the Secretary may prescribe, and shall be accompanied by a full list of the ingredients contained in each dietary supplement, and a copy of the labeling used by the facility for each dietary supplement.

‘‘UPDATES.—Each dietary supplement registrant shall update the registrant’s registration annually on or before the anniversary date of the registrant’s initial registration. Each dietary supplement registrant shall also update the registrant’s registration to include information regarding any new dietary supplement, or reformulation of an existing dietary supplement, on or before the date such dietary supplement is marketed for consumption in the United States.’’; and (ii) in paragraph (3), by inserting ‘‘or dietary supplement registrant’’ after ‘‘notify the registrant’’.

NEW DIETARY INGREDIENTS.

—Section 413 of 22 the Federal Food, Drug, and Cosmetic Act is amended by striking subsection (a) and inserting the following:

IN GENERAL.—A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. The Secretary shall keep confidential any information provided under this subsection for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.’’; in subsection (c), by striking ‘‘was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994’’ and inserting ‘‘is not included on the list of ‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary’’; and by adding at the end the following:

‘‘MAINTAINING SUBSTANTIATION FILE.—Any person submitting information to the Secretary under subsection (a) shall create and maintain a scientifically reasonable substantiation file relating to the claim that the dietary ingredient or dietary supplement will reasonably be expected to be safe. The substantiation file shall be prepared and maintained in such form and manner as the Secretary may prescribe and shall be available for review and inspection by the Secretary upon request.

‘‘EVIDENCE OF COMPLIANCE.—A dietary supplement facility or retailer shall, prior to manufacturing, packaging, holding, distributing, labeling, or licensing the dietary supplement, obtain adequate written evidence from the preceding responsible entity in the chain of commerce that the product is registered as required by section 415 and that the requirements of subsection (a) have been met. Such facility or retailer shall maintain such evidence of compliance for review and inspection by the Secretary upon request.’’.

CIVIL MONETARY PENALTY FOR NON-COMPLIANCE.—Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:

‘‘CIVIL MONETARY PENALTY FOR NON-COMPLANCE.—Notwithstanding the provisions of subsection (a), any person who manufacturers, packages, holds, distributes, labels, or licenses a dietary supplement in violation of section 301, 402, 413, 415, 501, 502, 505, or 761, may, in addition to other penalties imposed in this section, be fined not more than twice the gross profits or other proceeds derived from the manufacture, packaging, holding, distribution, labeling, or license of such dietary supplement.’’.

ADVERSE EVENT REPORTING FOR DIETARY SUPPLEMENTS.

—Section 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379aa–1) is amended (1) in the section heading, by striking ‘‘SERIOUS ADVERSE’’ and inserting ‘‘ADVERSE’’; in subsection (a), by adding at the end the following:

‘‘ADVERSE EVENT REPORT.—The term ‘adverse event report’ means a report of non-serious adverse events that is required to be submitted to the Secretary under subsection (b).’’; in subsection (b) by striking ‘‘The manufacturer’’ and inserting the following:

‘‘SERIOUS ADVERSE EVENTS.—The manufacturer’’; and by adding at the end the following:

‘‘NON-SERIOUS ADVERSE EVENTS.— The manufacturer, packer, holder, distributor, labeler, or licensee of a dietary supplement, whose name appears on the label of a dietary supplement marketed in the United States, shall submit to the Secretary, in such form and manner as the Secretary shall determine, a compilation report of all non-serious adverse events associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.’’; in subsection (c), by adding at the end: ‘‘The responsible person shall annually submit to the Secretary a compilation report of all non-serious adverse events received during the preceding year.’’; in subsection (e), by adding at the end: ‘‘The responsible person shall maintain records related to each annually submitted adverse event report for a period of 3 years.’’; and in subsection (f), by striking ‘‘or an adverse event report voluntarily submitted’’ and inserting ‘‘or a non-serious adverse report submitted annually’’.

RECALL AUTHORITY FOR DIETARY SUPPLEMENTS.

IN GENERAL.—Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: ‘‘SEC. 418. RECALL AUTHORITY FOR DIETARY SUPPLEMENTS.

‘‘RECALL AUTHORITY.—

‘‘CEASE DISTRIBUTION AND NOTIFICATION ORDER.  ‘IN GENERAL.—If the Secretary finds there is a reasonable probability that a dietary supplement or a product marketed or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded, the Secretary shall issue a cease distribution and notification order requiring the person named in the order to immediately ‘‘ cease distribution of such dietary supplement or a product marketed or sold as a dietary supplement;notify distributors, importers, retailers, and consumers of the order; and ‘‘instruct those distributors, importers, retailers, and consumers to cease distributing, importing, selling, and using the dietary supplement.

‘‘INFORMAL HEARING.—An order described in subparagraph (A) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of the dietary supplement or the product marketed or sold as a dietary supplement. The person subject to the order shall have 5 days to notify the Secretary of the person’s intent to challenge the order. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

‘‘RECALL. ‘‘IN GENERAL.—If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the dietary supplement or the product marketed or sold as a dietary supplement with respect to which the order was issued, the Secretary shall, except as provided in subparagraphs (B) and (C), amend the order to require a recall. The Secretary shall specify a timetable in which the dietary supplement recall will occur and shall require periodic reports to the11 Secretary describing the progress of the recall. The Secretary shall have the authority to initiate the action prescribed in this subparagraph regardless of whether or not the person subject to the order elects to exercise the right to challenge the initial order as permitted under paragraph (1).

‘‘CONTENT OF AMENDED ORDER.—An amended order under subparagraph (A) ‘‘shall not include recall of the dietary supplement or the product marketed or sold as a dietary supplement from individuals; and ‘‘shall provide for notice to individuals, at the expense of retailers and to the satisfaction of the Secretary, subject to the risks associated with the use of such dietary supplement.

‘‘NOTIFICATION.—In providing the notice required by subparagraph (B), if a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 705(b).’’.


Remember, this is going to be executed by the FDA, the same guys allowing the Chinese to ship (and other countries) millions of metric tons of cheap, uninspected food containing chemicals such as melamine in them. I stated on this blog 6 months ago that hand in hand with “gubberment” health care had to come the abolishment of supplements because once they start denying coverage’s and procedures (and they will, they have to, that’s how it works) people will turn to natural alternatives, and big pharma just cannot allow the American public to realize that there are other (and better) ways to heal the human body.

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Comments on: "Dietary Supplement Safety Act of 2010" (8)

  1. Those who support this bill would have you believe that the supplement industry is unregulated and inherently dangerous.

    Nothing could be further from the truth!

    This is a blatant attempt to stomp out competition from life giving supplements that actually promote healing in the body in favor of toxic chemicals that mask symptoms and promote disease.

    Toxic chemicals, that is, that have been “proven safe and effective” through bought and paid for “research”.

    Time to pull our heads out of the sand and get in our legislators’ faces! If we stand by and passively let them get away with this criminal injustice, we will all pay a very heavy price.

    If ever there was a community that needed to make a stand for itself, it is the Morgellons community, here and now. Without supplements to restore the integrity of our bioterrain, we really would be without hope.

    I pray for divine intervention to the source of all Hope, but we must also do our part!

  2. I couldn’t agree more John, they deny we even have a disease, I couldn’t get a script when my life depended on it, and it did, but thank God there were natural suppliements, they saved my life, but not only that, they greatly improved my life. I’ll go one step further, because of what I have learned I will be much, much, less of a burden on the American Health Care system and that should be considered a good thing, that is, unless me being healthy results in somebody making less money?

    Anyway, it’s not just our community, it’s everyone that is at serious risk here. Our food is all GMO, the prescriptions we recieve often don’t cure and make things worse, and now they want to grab control over and eventually strangle the life out of the natural supplement market.

    Please, everyone click on this post and follow the link to send your emails, it will do it automatically for you. Just scroll down the bottom …

    By the way, I have been informed that this group is kind of on the wrong side of radical in a lot of cases, if you want to go to the site and copy the text out of the email link and email it to your local representatives yourself that is fine. Feel free to do so (I just hope I don’t receive a bunch of spam or junk mail, and I wouldn’t donate to these guys). You can find your local representatives here :
    http://conservativeusa.org/mega-cong.htm or
    Senators : http://www.senate.gov/general/contact_information/senators_cfm.cfm
    Congress : http://www.webslingerz.com/jhoffman/congress-email.html

    Click here to send your letter(s) automatically. However, you might receive spam and junkmail from them. I used thier site because they made it so easy

  3. Jennifer Miracle said:

    The C.D.C. concluded their research into the causal agent of Morgellons months ago. They are sharing the results with other agency’s..
    They refuse to release the results TO THE AFFLICTED , saying they must first identify the“Stakeholders”.
    Many are sick and dying from this dreadful disease.

    MAY I ASSIST YOU C.D.C.?

    THE MAJOR STAKEHOLDERS ARE

    THOSE WHO ARE SICK AND DYING , HELLO!

    LET IT BE KNOWN,

    THE INFECTED AND THE INFECTABLE ARE THE MAJOR STAKEHOLDER’S
    IN THIS EMERGING DISEASE MORGELLONS.

    THE NEGLECT AND ABUSE OF THE SUFFERING CONTINUES UNDER THIS,
    WE ARE DOING SOMETHING ABOUT IT, BACK BURNER, RUBBER STAMP STUDY.

    C.D.C., RELEASE YOUR RESULTS! NOW!

    AN IGNORED , CONCERNED CITIZEN !!!

    IF YOU THE READER ARE IN AGREEMENT WITH THIS,
    PLEASE COPY THIS PLEA AND SUBMIT IT IN THE COMMENT SECTION IN NEWS ARTICLES EVERYWHERE

  4. McQueeg needs to be retired this year. Go J.D.Hayworth. He has done so much damage to this country, he’s no maverick, he’s a
    national disaster. This must be stopped.

  5. Hi all,
    You may have gotten the emails, but to write your congressman easily about the bill, go to http://saveoursupplements.org/

  6. Hi All,
    I just checked out Trisha’s website for the first time in a while. She has a new feature–click on the section which is specifically about Morgellons. She addresses what she is calling Hyper Toxicity Syndrome. Please check it out–her description of what’s going on and what we can do about it is very important for us all too read.
    If you haven’t been to Trisha’s site before, just click on “ESP” on the sidebar here at Mundane Approach. For those of you who don’t yet know Trish, she is indeed some kind of an angel.
    Susan

  7. Sorry, I should correct that–her site is “ESP Botanicals”–has nothing to do with extra-sensory-perception!

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