- New Clients
by Tammera J. Karr, PhD
On July 1, 2011, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols required by the Dietary Supplement Health and Education Act (DSHEA). This action will turn a notification system into an approval system – JUST LIKE DRUGS.
The current bills “Free Speech About Science Act (H.R. 1364)” and S.1310, have the potential to be devastating to your health freedom rights. Not only will the passing of these bills prevent the dissemination of legitement health information regarding natural foods like walnuts, pomegranates, blueberries and cherries, but it also requires American Owned nutritional companies to stop manufacturing of any products developed prior to 1990.
Both the Durbin bill and the dangerous FDA’s proposed NDI guidance seek to give the FDA broad new authority to disapprove supplements or supplement ingredients on totally arbitrary grounds, with no rules or standards. If allowed to stand, over time this will drastically reduce the number of supplements and supplement potencies, raise prices substantially, injure our ability to take care of our health, raise healthcare costs, stifle supplement innovation, nutrition research and cost millions of jobs.
S.1310 – The proposed law trusts the FDA and the Institute of Medicine (IOM) to decide what levels and combinations of dietary ingredients are considered safe. Given the FDA’s profound bias against supplements, and the skewed, anti-science recommendations of the IOM’s recent vitamin D report, these are hardly trustworthy sources of guidance.
These guidelines coordinated closely with a similar clampdown happening in Europe. The guidelines bear an uncanny likeness to the European Union’s Novel Food Regulation. The justification given for the new guidelines is – consumer safety. “But where are the dead bodies?” It’s actually a pertinent question, one rarely taken seriously by the FDA or other regulators.
An examination of the last two years of US National Poison Data System (NPDS) reveals, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% and 81% of fatalities, respectively. The majority of these were from unintentional poisoning. The NPDS data, combined with data from the Centers for Disease Control and Prevention (CDC), shows emphatically that botanicals and dietary supplements are the safest products we can use for our health.
In the most recent 2009 NPDS dataset, one death is reported, it was concurrent with an “unknown dietary supplement or homeopathic agent.” So they have no idea of what the cause of death was, only that the individual was also taking a homeopath or supplement. Maybe they ate walnuts for their heart and choked or had an allergic reaction?
If the bill is passed, both the FDA nor the IOM can make it all up as they go. Their judgments can be completely arbitrary.
The Dietary Supplement Labeling Act needs to be defeated. S.1310 has been referred to the Senate Health, Education, Labor, and Pensions Committee for further deliberation.
H.R. 1364 – On April 5, 2011, a bipartisan bill was introduced into the House of Representatives called the Free Speech About Science Act (H.R. 1364). This landmark legislation protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.
The Free Speech About Science bill has the potential to transform medical practice by educating the public about the real science behind natural health and healthy food choices – In essence putting the control of your health back into your hands through information.
For this very reason, the bill will be opposed by the FDA and drug companies, since it restricts their ability to censor the dissemination of published scientific data. Drug companies fearing competition from natural health approaches based on diet, dietary supplements, and lifestyle.
By the way DeFazio responded to my letter with – “I support allowing food and supplement producers to print reasonable nutrition and health information, but am concerned that H.R. 1364 poses too great of a risk for false or unsubstantiated claims. Unfortunately, however, H.R. 1364 is not the way to get there.” This is from a representative who said “we pass bills all the time that are unconstitutional; it’s up to the courts to sort it out.”
Passage of the Free Speech About Science Act will stop federal agencies like the FDA from squandering tax dollars on censoring information about health-promoting, practices, foods and nutrients.
Please take the time to voice your opinion, they view each e-mail and letter as representative of 1,000 voices – we can make a difference. Do not delay, the Durbin S.1310 bill is a critical bill to stop. Time is of the essence.
To Your Good Health and Freedom.
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