Archive for the ‘Action Alerts’ Category
It is being confirmed that Senator McCain is withdrawing support from the Dietary Supplement Safety Bill that he introduced in February. Due to a push-push-back from so many – including the POP Campaign – and especially due to the outstanding education and ongoing discussions with Senators by the POP Campaign lobbyist, Beth Clay, Senator McCain now will be collaborating with Senator Orrin Hatch, R-Utah, on revised legislation.
There apparently will still be an effort to seek transparency and safety but without the intense new regulatory layers proposed in S 3002. In a March 4 letter, Senator Hatch thanks Senator McCain for shifting his position.
We will keep you posted on the outcome of the amendments as the crafting continues.
Thank you to everyone who called or sent in letters or participated in getting the word out. Thank you for the donations because these are keeping us alive to stay on the pulse and make a difference with you – keep the support coming as we need to continue showing up in a huge and effective way.
“Being Italian, (as you can tell from my surname Leonardi) I do not want McCain’s Bill or the FDA to take away my garlic …or other healthy supplements for that matter – this bill really stinks. Take Action Now!” ~ Rudi Leonardi
It is important to highlight a few key dangerous points and considerations that support the POP perspective pertaining to Senator McClain’s S 3002 Bill, “The Dietary Supplement Act of 2010”. It is ESSENTIAL to act NOW and to show the strength of our pushback so other Senators and members of Congress do not support or co-sponsor this bill.
DSHEA, historically, is based on an intent and established framework that supports the concept that dietary supplements are generally safe….We know that there are dangerous ingredients that could be placed in supplements by unscrupulous and money-grubbing companies and individuals. There already are guidelines in place to protect us. We know that there are many ingredients that have to be tracked – a huge job, but it can be done – we are fortunate to have great resources to help us find the truth. For example, Dr. Brian Clement’s latest book “Supplements Exposed” is an excellent resource. (See popcampaign.org for the full article.)
DSHEA legislation already allows the FDA to evaluate each ingredient in a supplement to determine if it presents an unreasonable risk of injury or illness. It already has an approval process in place and is alerted to major problems. Key here is that, if a “signal” is sent and detected that a product needs to be reviewed, then the FDA can decide the next step, coordinate with existing other agencies, conduct its own research, gather its “sensible facts”, and act…. DSHEA allows the FDA the discretionary power to do what is necessary to protect us. (See reporting requirements in articles on popcampaign.org)
The “signal”: “Serious” vs “Non-Serious” Adverse – Could mean Anything?
On page 7, lines 16 & 17, the McCain bill states: “…striking ‘‘SERIOUS ADVERSE’’ and inserting ‘‘ADVERSE’’. The signal changes dramatically and dangerously. DSHEA currently states “SERIOUS” adverse effects trigger enforcement.
“Serious” is defined as:
… any experience resulting in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes previously listed (in accordance with 21 C.F.R. § 600.80 [2002] and 21 C.F.R. § 314.80 [2002]).
Without “serious” in the text, the FDA signal to act is instructed as “adverse,” which can be ANYTHING that happens ANYWHWERE in the world. It could be interpreted that supplements that interfere with prescription drugs are powerful enough to interfere with the stability of the human condition, could be equally dangerous and cause an “adverse” problem. This means that if someone in China gets sick (yes even 1 person of the 2 billion plus) because he/she suffered a stomachache because of an over abundant supplement of soy in the food, this would be an “adverse” signal. If a European connoisseur of wine and cheese got ill because of a supplement of valerian to help sleep off a happy hangover, this would be considered an “adverse” signal. If someone in Africa reportedly got dizzy after taking yohimbe, this would be an “adverse signal”. An “adverse: signal could be the effects of ginseng, garlic…WHAT? Being Italian, (as you can tell from my surname Leonardi) I do not want McCain’s Bill or the FDA to take away my garlic …or other healthy supplements for that matter – this bill really stinks!
Yes, this is a grey area and could happen with the proposed amendments, the S 3002 bill allows the FDA to yank a product for the simplest reason or smallest event while reinforcing it’s modulated criteria and selective rationale with such articles as listed below be relied upon fully as evidence for banning supplements, with or without consideration of all elements:
Other dietary supplements shown to potentiate or interfere with prescription drugs include garlic, glucosamine, ginseng (Panax), saw palmetto, soy, valerian, and yohimbe.14 (((De Smet PA. Herbal remedies. New England Journal of Medicine. 2002;347(25):2046-2056.))
If amended, the FDA could also use any incident, report, finding, research, etc. from another country to yang a product from a shelf and set policy in the United States. This would be consistent with the some of the WTO Codex efforts to control supplements in other countries. We do not want this here in the US. We must protect ourselves.
There is snapshot in Europe of what we Americans might look forward to if this bill passes – “…EFSA, the European Food Safety Authority, has sharply reduced the list of available supplements and is in process of reducing potencies to ridiculous levels, such as less beta carotene than can be found in half of a large carrot.” (European Legal Director Gretchen DuBeau working with ANHI).
Yes, there are money issues involved, reductions in government spending, and the perception (and facts) that the FDA is friendlier towards drug companies and less favorable to supplement businesses. Also, in his press release, Senator McCain references for his bill changes a GAO (Government Accounting Office) recommendations that came out in January 2007, from the previous Bush administration – these recommendations are believed by many to be biased and slanted to the industry drug giants. Many of these points will be discussed further as we continue our efforts to educate on this bill.
We still need to take action immediately.
Lastly – Athletes and Drugs
In his press release and citing his supporters of the NFL and Major League Baseball, Senator McCain highlights suspended Athletes – their situations being adverse signals”. Sports figures are used to signals from the quarterback, the center, and the backs, to the catchers, pitchers, managers and umpires. Should we be sensitive that these athletes got their signals mixed up and that implementing this Bill will help these men on the field become more clear and allow them to make better health choices? There clearly is more to this. Does it not make sense that the athletes who were suspended purchased “illegal drugs”? Calling the Athletes confused and what they took as mislabeled supplements is really a backing away from the real issues of enforcement, illegal sales and use of steroids. Is the Sports industry trying to shift blame from the “US Anti-Doping Agency” (USADA) to the supplement industry, asking the FDA to get involved? Who is using whom to get what?
This is a crucial time. What we do now will dictate our future. As we return from the Thanksgiving holiday, we remain grateful for what we really DO have – our gift of life, freedom of choice and the pure organic foods we eat and share. Congratulations on some victories. We have a ways to go.
As you know, the POP Campaign has cultivated a full-blown effort to strengthen our collective voice to keep this freedom and to ensure that our organic food remains pure. CODEX becomes fully employed on December 31, 2009 in 182 countries, including the US – through the WTO. We intend to be heard and make a difference!
Thanks to all of you who took a few minutes to call and fax Senators in November… we got some successes, and we take these victories! CONGRATULATIONS on the push.
We appreciate the leadership of Chairman Harkin and the Senate HELP Committee for their commitment to Food Safety and work on S 510. We especially thank Senators Merkley, Franken, Bennet, Fergunson,Brown, and Sanders for their work in protecting organics. This is good news! Food safety is an important issue; however, the Senate Members have not brought these issues to the place of the most solid protection levels to Preserve Organic Power in our standards.
New sections were added to S 510, the Food Safety Bill, which mimicked the language of the proposals we submitted and conversations we had with Senate offices. The bill passed unanimously out of committee and is “ordered to be reported” to the full Senate – we don’t know exactly when because of the Health Insurance debate……..
What Our Voices Accomplished
- The Senate Health Committee added language that requires that FDA guidelines not include any requirements that conflict with the Organic Foods Production Act of 1990 – a big save.
- The FDA also must coordinate with the Department of Agriculture.
- New wording was added ensuring the protection of conservation and environmental practices.
- The FDA is required to report back to Congress on the impact of its requirements on “certified organic farms and facilities,” including being instructed to “provide flexibility” in its guidelines for those “engaged in the production and harvesting of raw agricultural commodities, including small businesses…that sell directly to consumers….” Some excellent accountability.
- New language states that “nothing in the amendments…shall apply to any dietary supplement that is in compliance with…the Federal Food, Drug, and Cosmetic Act…..”
The Loophole
There still appears to be an alarming loophole in this bill in spite of the newly inserted “protective” language that connects it to the Organic Food Act. Specifically, irradiation and pasteurization can still be used on organic produce, fruits, nuts, and herbs as these processes can be considered “organic” methods because the processes use forms of light energy (Co, C’s or electron beams or eV) and heat and/or water. Tricky!
In the Organic Food Act Section 2113 [7 U.S.C. 6512], it is stated that if a practice is not prohibited, then it is permitted. The FDA still provides a framework for irradiation without disclosure, therefore, we want clear language inserted that protects us.
We are proposing two more powerful amendments for the floor of the Senate and if needed, the Conference Committee. These are called “The POP Amendment” and “The CODEX Amendment”. Let’s step up NOW.
The POP Amendment
“In the case of farming, production, processing and sale of organic (produce, fruit, nuts, herbs), for consumption exclusively within the U.S. local marketplace, no form of irradiation or pasteurization shall be required or used.”
Secondly, clear language exists in S 510 to “harmonize with CODEX” and be consistent with the World Trade Organization policies. Nothing grown, produced, and consumed within the “good old US of A” boundaries should be subject to anything trade, CODEX or WTO related. These are ONLY trade related regulatory bodies and rules. It is essential that these external trade policies be contained and stay this way. US laws stand alone, without being trumped by the international CODEX food rules or the WTO agendas pertaining to organics.
Further, consistent with the pureness of organic standards and rights, we are requesting that First Nations be exempt from CODEX so as to support the cultural integrity of indigeneous food.
The CODEX Amendment
“Organic produce, fruits, herbs, and nuts, grown and consumed within the United States, including all First Nations, shall be exempt from CODEX harmonization.“
Take Action NOW – Here’s How
S-510 is getting close for a floor vote, so we need you to contact Senators (yours and others) ASAP. We are in discussions with certain members of Congress to sponsor these amendments.
1) Call 1-866-544-7537 – This will take you to the Capital swithchboard toll-free. Ask for your Senators’ office or tell them what state you are from and they will connect you to your Senator. *There is also a list of Senate phone and fax numbers here.
2) What to Say:
“Hello, I am______________, a constituent (if you are) of Senator________ and I am calling to ask him/her to support the following proposed amendments to S 510 offered by the POP Campaign: “The POP Amendment” saying NO to irradiation and pasteurization of organics and “The CODEX Amendment” on excluding organic food and First Nations from harmonization with CODEX. Thank you.
3) Fax a letter: You may copy and paste the following letter and fill in the blanks with your own information.
To: Senator ___________
From: Your Name_________
Re: S 510 – FOOD SAFETY BILL
Dear Senator _______
I am a constituent of Senator________ and am faxing to ask you to support the following proposed amendments to S 510 offered by the POP Campaign: “The POP Amendment” saying no to irradiation and pasteurization of organics and “The CODEX Amendment” on excluding organic food and First Nations from harmonization with CODEX. Thank you.
Your Signature___________________
4) Forward this email to your networks – Encourage them to ACT TODAY!
5) Tell us how it went: info@popcampaign.org
Thank you – Keep up the momentum – We have a strong voice together.
Rudi Leonardi and Mikaele Holzer, Green Your SPIRIT
Brian Clement, Hippocrates Health Institute
Preserve Organic Power!
Photo above lovingly taken at San Francisco Green Festivals by Michael Buchanan.
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