April 2016 Archives

Safety - Nutra vs. Pharma

| No Comments | No TrackBacks
This is where the medicinal world divides into two: nutraceuticals and pharmaceuticals. They are both regulated and watched over by the Food and Drug Administration, the FDA.

The FDA came into being due to the necessity of regulating pharmaceutical drugs. This was especially important because of the nature of the product. One can easily understand the FDA's responsibility for these products, "pharma" is a Greek word that means "poison" and "ceutical" means "medicine". These are chemically altered ingredients from natural products or even a newly inspired arrangement of molecules into something not seen in Nature.

The pharma products require strict guidelines for testing and reporting. That is because they represent something new in the world of medicine. Even so, many products gain approval only to be forbidden for sale after actual use and performance  proves them to be dangerous or life threatening to the public.

In most cases pharmaceuticals have added bad effects that are listed as "side effects" with warnings stating to immediately stop the drug and seek medical advice. The FDA monitors this activity and determines the availability and safety of the drug. It's major goal is to protect people from these dangers and also, to protect the pharmaceutical industries' role in providing new medicines.

Into this world is cast the natural remedies that have been used for centuries by medical practitioners, along with the nutritional derivatives of the natural diet that have been found to be necessary for life called vitamins and other nutritional medicines, along with minerals, amino acids, and enzymes.

These substances from food have been discovered because without them a deficiency disease occurs. Their discoveries result in great advances in medicine and health and their researchers receive Nobel prizes for their discoveries.

Can you imagine the difficulty of having two distinct worlds of medicinal aids regulated by the same regulatory agency?

Pharmaceutical is a patent oriented, high profit producing enormously wealthy segment  that also maintains deep ties to the government regulators of the industry. (For example, one product alone for lowering cholesterol produces more incomes than the entire nutraceutical industry)

Whereas, the nutraceuticals are usually in competition without patent protection, easily available on the open market, does not require a doctor's prescription, extremely safe, low priced and growing rapidly.

Here is an agency, the FDA, whose goal is to protect pharmaceuticals and looks at everything from the viewpoint that there must be something wrong with the drug since all have "side effects". And I'm not joking here. The number of deaths annually reported by medical records due to pharmaceuticals makes it the fourth major cause of death in the USA. The number of hospitalized severe reactions to pharmaceutical drugs is in the low millions. This makes pharmaceuticals one of the major causes of seeing a doctor, buying a prescription, and being hospitalized which in turn produces the most expensive cause of high medical costs and funeral expenses.

The FDA is protecting this system and even goes to court to stop anything else that competes with a pharmaceutical.

There was a simple eye drop formula with Vitamin A that produces excellent, inexpensive medicinal relief to eye problems which was attacked by the FDA which prefers to protect a new pharmaceutical eye drop appearing in the marketplace. The attack results in high legal costs causing the business to fail. Meanwhile, the pharmaceutical derivative that is more expensive, requires a prescription and doctor's visit, and is less effective remains.

The eye product was taken off the market the first time because it used Vita A in its name, which is a description of its contents. However, the FDA said it was prescriptive because vitamin A is good for the eyes and as an eye drop could not be called Vita A eye drops. When the company struggled onward and changed their name they were then hit with other regulatory issues that could have been resolved with the FDA's help but were not.

So you can easily see the difficulty of having a government agency meant for drug control overseeing the Nutraceutical world. For your information the safety differences are so great that one need only read this quote:

(OMNS Jan 16, 2015) There was not one death caused by any dietary supplement in 2013, according to the most recent information collected by the U.S. National Poison Data System. The new 251-page annual report of the American Association of Poison Control Centers, published in the journal Clinical Toxicology (1), shows no deaths whatsoever from any dietary supplement.         ( Mowry JB, Spyker DA, Cantilena LR Jr, McMillan N, Ford M. 2013 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 31st Annual Report. Clinical Toxicology (2014), 52, p 1032-1283. ISSN: 1556-3650 print / 1556-9519 online. DOI: 10.3109/15563650.2014.987397)

This is part one of several articles to come that look at the differences of pharmaceuticals vs. nutraceuticals.

The 2008 California Health Emergency - a Historical View

| No Comments | No TrackBacks

On August 1st, 2008, the California Department of Food and Agriculture will begin spraying the San Francisco Bat Area by air with a pheromone pesticide called Checkmate OLF-R.  The spraying will be continuous every 30 to 90 days for the next two to ten years.

The spray has never been independently tested. The spray has no environmental studies done. The spray is time-released microcapsules containing known carcinogens and endocrine disruptors. The label on the product states it is harmful if absorbed through the skin. Harmful if inhaled. Contamination requires rinsing with water and calling poison control.

The US Department of Agriculture announced emergency funding (where have we heard that before) to combat the Light Brown Apple Moth (LBAM) infestation bypassing normal safety and environmental studies!

The Manufacturer is Dupont. Signs and symptoms effects of acute overexposure: High oral doses can cause apathy (lack of feeling or emotion). Spraying has led to major respiratory problems.

Whenever anything is an emergency and bypasses safety precautions it should be a flag that some individuals are pushing this through the normally slow governmental machinery of change.

This long term commitment of spraying is costing us great sums of money. It is endangering our health, especially that of our children.

These are the important questions:

  • How much does it cost?
  • Who is receiving the money?
  • Is there any collusion taking place between the government and the contractors?
  • Are alternatives that don't put us at risk being used as practiced in New Zealand? There the moth has been established for more than 100 years and controlled using sticky traps to monitor the LBAM.
  • Is this an intelligence test of the Bay Area? If so, we have passed it because the multitude of studies and observations by citizens of Santa Cruz, California recently documented the dangers of spraying and for it to continue represents a heinous act by the government of the people without the people's consent. The spraying in the SF Bay Area is opposed.

So, to get the message out there to fellow citizens who work for the government- it is necessary to sign petitions, write letters and go to this website: http://www.lbamspray.com/index.htm

Another Major TEST of intelligence

The National Health Federation, who is the most trusted source of health-freedom information, has released an important press release, linked below.  California's Office of Environmental Health Hazard Assessment is proposing language to add to proposition 65 that "would essentially classify all vitamin-and-mineral dietary supplements with above-RDA potencies as cancer-causing agents unless proven otherwise."

Please forward this link to everyone interested in health-freedom. There is an online petition to act on as well as a public hearing in Sacramento on April 18. http://www.thenhf.com/press_releases/pr_23_mar_2008.html

The NHF is the only health-freedom organization with recognized observer-delegate status at Codex meetings.

California - ever known for its luscious beauty, endless energy, and general wackiness - is on the verge of stepping off the edge of the cliff yet again.  A trial balloon is being floated by California's Office of Environmental Health Hazard Assessment (OEHHA) to limit the potency of vitamin-and-mineral supplements under California's Proposition 65 as cancer-causing agents.

Proposition 65's history is well-known within the State.  In November 1986, voters in the State of California approved Proposition 65, in the belief that its passage would help protect them from toxic chemicals in the environment.  Officially known as the "Safe Drinking Water and Toxic Enforcement Act of 1986," almost everyone these days just calls it Prop 65.  Prop 65 requires the State to publish a list of those chemicals "known" to cause cancer or birth defects or other reproductive harm.  This list is updated at least annually and has ballooned to include some 775 chemicals.  Although Prop 65 uses the term "known," in the real world substances on the list are not necessarily known to cause cancer but are only those thatcould, under certain circumstances, pose a risk of cancer based upon the interpretation of existing scientific data, such as animal studies.

Prop 65 also requires businesses with 10 or more employees to notify Californians about the presence of listed chemicals in their products, in consumers' and employees' homes or workplaces, or that are released into the environment.  The law further prohibits California businesses from knowingly discharging significant amounts of listed chemicals into drinking-water sources.  OEHHA administers this program.

Scott Tips, the President and General Counsel of the National Health Federation, notes that, "Without the warnings on listed products, private legal bounty hunters can sue those companies in violation of Prop 65, even though no harm from the products is ever demonstrated, and exact enormous legal and other costs. While some (not much) good has resulted from Prop 65, like all government programs the good intentions quickly lead to enormously bad consequences that far outstrip any possible good.  One easy example of this is the Prop 65 listing of natural progesterone as a cancer-causing agent when in fact it helps counteract the carcinogenic effects of estrogen.  Natural, bioidentical progesterone is an important hormone-replacement therapy for women, many of whom have been unfortunately scared away from its health benefits by the Prop 65 warnings that are mandated on the product."

"Without such warnings," Mr. Tips continues, "the products and their manufacturers and distributors are sitting ducks.  In fact, one growth industry spawned by Prop 65 consists of numerous private law firms dedicated to shooting first and asking questions later in a "no prisoners taken" attempt to earn huge legal fees while doing a bare-minimum of public good.  The State and County governments may also bring legal action, but often it is these vulture firms that are first out of the gate to win the jackpot.  After all, BMWs and exotic vacations must be paid for somehow."

OEHHA, it says, is proposing regulatory language - in concept only and not as a formal regulatory proposal, mind you - that would essentially classify all vitamin-and-mineral dietary supplements with above-RDA potencies (note they still use the old Recommended Daily Allowance term instead of the correct RDI, or Recommended Dietary Intake) as cancer-causing agents unless proven otherwise.  Because California's Prop 65 has nationwide impact due to the size of the market, consumers can easily imagine the harm this will do with substances that have a long history of being incredibly safe and effective.

Here is what OEHHA wrote in a typical, late-Friday release (March 21, 2008):

"Certain chemicals or compounds such as vitamins and minerals are necessary to promote human health or to ensure the healthy growth of food crops. Excessive exposures to these same chemicals or compounds can cause cancer or adverse reproductive effects.  OEHHA is seeking a way to balance the need for these nutrients with the necessity for providing Proposition 65 warnings for exposures to listed chemicals in foods. OEHHA has developed draft regulatory language that addresses this issue, which can be found below." (emphasis added)

OEHHA has then proposed the following regulatory "concept" (conveniently worded already by the Agency's legal department):

"Section 1250X. Exposure to Beneficial Nutrients in a Food

(a) Human consumption of a food shall not constitute an "exposure" for purposes of Section 25249.6 of the Act to a listed chemical in a food if the person causing the exposure to the chemical can show that the chemical is a nutrient that is beneficial to human health and that the total amount of the chemical consumed in a food, whether naturally occurring, intentionally added to the food, or otherwise present, does not exceed the level established in subsection (c).
(b) For purposes of this section, a chemical is beneficial to human health if a daily value or allowance has been established for the chemical or compound by the Food and Nutrition Board of the Institute of Medicine, National Academies.
(c) This section applies only to exposures that do not exceed the Recommended Daily Allowance (RDA) established in the Dietary Reference Intake Tables of the Food and Nutrition Board of the Institute of Medicine, National Academies, current edition, if one is established. If no RDA is established, this section applies only to exposures that do not exceed 20 percent (20%) of the Tolerable Upper Intake Level established in the Dietary Reference Intake Tables of the Food and Nutrition Board of the Institute of Medicine, National Academies, current edition." (emphasis added)

In its Notice, OEHHA has set two key dates for public input: (1) A public meeting on April 18, 2008, to be held from 10:00 a.m. to 12:00 noon in the Sierra Hearing Room at the California Environmental Protection Agency Headquarters Building located at 1001 I Street, Sacramento, California, where OEHHA will hold a public workshop for the ostensible purpose of gathering input from interested parties concerning the issues raised by these regulatory "concepts"; and (2) Written submissions to be received from all interested parties no later than 5:00 p.m. on Friday, May 2, 2008, directed to the attention of Fran Kammerer, Staff Counsel, Office of Environmental Health Hazard Assessment, 1001 I Street, Sacramento, California 95812; or by e-mail to fkammerer@oehha.ca.gov.

The National Health Federation has already consulted with outside legal counsel specialized in this area of law for the express purpose of stopping this idea from proceeding beyond its conceptual stage.  NHF will be in attendance at the April 18th meeting and will be submitting cogent written comments, assisted by scientific and legal experts, opposing this regulatory "concept."  The Federation is also exploring legal action against the Agency should it proceed in any way with implementing its concept.  This is critical and will affect individuals, supplement manufacturers, and vitamin retailers.  This is not just a California issue.  Anyone who depends on supplements for their health or livelihood must voice their opposition.

In the meantime, the NHF asks all interested parties to sign our on-line petition opposing this ridiculous concept, which the Federation will then personally submit to OEHHA.  (Go to http://thenhf.com/press_releases/prop65_petition.htm.)  The NHF also asks all interested parties to provide us with any scientific and legal data that they might have supporting our position that vitamins and minerals are not carcinogenic and therefore do not belong on the Proposition 65 list, so that all pertinent information may be included into the Federation's comments and possible lawsuit.

March 21, 2008 OEHHA Notice http://www.oehha.ca.gov/prop65/law/regs032108.html

(Click Here For The Online Petition)

Inform others to sign our on-line petition-send this link to the press release

April 18, 2008 Public Hearing
10:00 a.m. to 12:00 noon
Sierra Hearing Room
California Environmental Protection Agency Headquarters Building located
1001 I Street
Sacramento, California
Please attend and voice your opposition.

Written opposition submissions:
Directed to the attention of Fran Kammerer, Staff Counsel
Office of Environmental Health Hazard Assessment
1001 I Street
Sacramento, California  95812
Comments due by May 2, 2008