what is cefadroxil 500 mg levitra at walmart olanzapine other drugs in same class took 800 mg ibuprofen error isotretinoin best time take viagra prices at cvs pharmacy occupational specialist in education spironolactone brands india side effects of grifulvin v 500 mg can you buy viagra at pharmacy in usa donde comprar viagra generico contrareembolso trazodone in dogs dosage allegra hcl 180 mg clonidine hcl 0.1 mg tablet price what is zetia 10 mg ic bupropion hcl sr 150 mg tablet micardis cost comparisons nexium cut in half zithromax 250 mg 4 capsules innemen azithromycin tablets 500 mg untuk jerawat side effect of simvastatin 20 mg necesito receta para comprar cytotec en argentina dialysis in metformin overdose can i take prilosec 20 mg twice a day is synthroid over the counter drug tadalafil liquid not for human consumption viagra 50 mg kaç para nizoral 2 shampoo price in india benadryl for dogs where to buy amoxil and doxycycline for sale no prescription in usa how to calculate time in therapeutic range for warfarin buy diovan esomeprazole 40 mg capsule mexico topamax 100 mg yan etkileri sildenafil 100 mg precio mexico cialis edmonton online how to buy viagra in hanoi what does cvs generic viagra look like metoprolol succinate extended release tablets 12.5 mg is zofran safe in renal dialysis patients metformin solubility in acetonitrile clopidogrel made in west virginia alendronate sodium 70 mg treatment is it safe to take prilosec with zoloft sildenafil generico del viagra atorvastatine paypal robaxin used in dogs inexistencia de los actos procesales simvastatin 40 mg pdf linezolid kaufen nexium 10 mg sachet for babies dosage benadryl use in labor propecia liquida buy clomid hereisthebestin orlistat 120 mg ? bom para que sirve la pastilla celebrex de 200 mg sharai adalat in mumbai where in leeds to buy viagra buying cialis online with next day air prix viagra 50 en pharmacie clonidine with prozac in dogs dove comprare cialis generico online forum flagyl dosage for in wounds buy fluconazole for systemic candidiasis is levothyroxine sodium a generic drug seroquel market size atorvastatin tablets ip 5 mg cetirizine hydrochloride safe dose revista de indias papers soledad gonzalez diaz motilium 10 mg tabletten cialis 10 e 20 mg cuanto sale el viagra en chile montelukast 10 mg for cough irbesartan jubilant 75 mg orlistat 60 mg emea pfizer brand viagra online prescription generic for diltiazem cd name of generic clomid how does clomid cost how to buy protonix quetiapine 100 mg tab lasting of effects amoxicillin 250 mg dogs te cialis is made in 25mg buy tadalafil dubai pharmacy montelukast 10 mg with zyrtec buy xenical weight loss pills usd betamethasone injection cost losartan 50 mg tablet price in india viagra pharmacy costco do we get orlistat in india hyderabad para que sirve lamisil 250 mg where to buy liquid benadryl reciprocal accountability in education permethrin in singapore does seroquel show up in blood test buspar online order azithromycin powder reviews zithromax same day delivery vancouver availability estradiol patches in pakistan topamax generic pricing metformin 1000 mg prospect linezolid australia spironolactone guercmorteo online indocin howdotofound discount xenical uk sale ciprofloxacina 750 mg argentina zovirax ointment 15 mg help me with a sore on my rectum kamagra gel como se usa provera 10 mg para q sirve levitra in dubai. viagra from canadian online pharmacies viagra from london best moisturizers to use with tretinoin is it safe to take viagra and coversyl erythromycin 500 mg obat apa chloromycetin for sale price for cabergoline prozac 40 vs 60 mg blueberry 100 does it really work forum viagra bactrim 30mg no rx review of low doses of cialis can i be in the sun while taking bactrim much does flonase generic cost phenytoin in stroke como usar cytotec abortar viagra launch uk stopping cymbalta safely generic name of atarax buy permethrin cream 5 for scabies generic atorvastatin release date social anxiety disorder and zoloft biochemistry of isotretinoin safe take panadol during pregnancy ofloxacin market india london uk buy generic viagra cytotec in labor and delivery pantoprazole iv 40 mg buy flagyl fast shipping cheapest fluconazole tablets in india accutane 120 mg a day generic abilify fda singulair tab 10mg uk price side effects amoxicillin in cats compare cost propecia and generic finasteride lipitor prices walmart retina specialists of alabama in montgomery brand name for flagyl generic cardizem cd 240 mg reviews for buspar for anxiety cheapest neurontin motrin 400 mgs norvasc 5 mg and pravastatin side effects fluconazole 100 mg oral tablet ciprofloxacin in horses quien puede comprar viagra is it safe to take propecia and fluconazole piroxicam tablets 20 mg cialis in usa best rite aid viagra singulair prix france cialis 5 mg ervaringen the cost of propecia with prescription mobicash shops in peshawar like viagra over counter clomiphene citrate 100 for sale strattera 60 prix para que se usa el seroquel atarax 25 mg purpose vardenafil 3 mg canada cialis fast shipping canada wellbutrin xl onde comprar orlistat 80 mg safety lamictal pregnancy doxycycline for acne online uk liquid albuterol sulfate buy liquidex arimidex is it safe to take ibuprofen with glucosamine mexico viagra prices prix viagra en pharmacie tunisie 40 mg prednisone for 5 days comprar xenical en espa?a sin receta can ranitidine 300 mg be cut in half indian manufacturers raloxifene how to taper off cymbalta safely celexa starting dose 10 mg requip xl 8mg price xenical at walmart side effects of 40 mg of cialis propranolol in ciroza generic meds for atarax is 5 mg of abilify a lot prometrium 400 mg amenorrhea cialis 10 mg filmcoated tablets spironolactone hctz reviews 30 day cialis prices buying viagra the second time in boots generic singulair rash average cost of coumadin prednisolone sodium phosphate manufacturer in india ranitidine 150 mg for babies specialist degree in education regalia escitalopram best ssri over the counter antibotic for the medicine bactrim nifedipine uses in pregnancy risperdal avis santé canada color bupropion sr 150 mg compazine over the counter how safe is generic viagra from india prix viagra générique en france aciclovir dosage uk enthusia viagra tablates details with price in india cheap viagra furthermore wellbutrin ordering online derealizzazione zyprexa side effects of tegretol 400 mg does cialis come in more than 20 mg cephalexin 500 mg dogs what is the cost of celebrex at walmart buy diflucan from canada buying research chemicals in canada clomid gabapentin actavis 300 mg flashback cash price for generic lexapro coreg marketing ho preso il clomid in gravidanza albendazole special access canada buy viagra in edinburgh doxycycline dose in leptospirosis buy levitra insurance do boots sell generic zovirax in uk viagra kaufen apotheke wien buy generic viagra through paypal bupropion tqeovertoz australia vardenafil 20 mg from india can you buy cialis in amsterdam cytotec in south africa can i take 1000 mg ibuprofen singulair patent expiry uk is metronidazole 200g is safe in pregnancy ibuprofen günstig bestellen 40 mg provera daily can nexium be dissolved in water roaccutane in south africa pharmacy prices for cialis generic lexapro experiences safe to drink alcohol on amoxicillin lamisil cost generic can i order viagra with paypal cheap levitra online next day delivery cymbalta rem behavior disorder can i buy metronidazole zovirax 400 mg hinta clotrimazole for yeast infection in baby which country buy cialis over the counter sertraline 100 mg withdrawal 25 mg metoprolol compared to 100 mg labetalol is candian cialis real purchase levitra 10 pills cheapest cialis walgreens walmart how much does clomid cost in india viagra in uk online no prescription cost clomid walgreens viagra pill discounts yellow generic viagra vgr 100 difference between brand viagra viagra motilium best price cvs cialis costs viagra performance anxiety in bed buy original viagra online cheap teva amoxicillin and alchol usage price of viagra per tablet side effects of nortriptyline 10 mg seroquel used in treating horizontal synonyms levothyroxine generic and brand name overnight zithromax delivery azithromycin 500 mg in combinatie met ibuprofen buy 150 mg viagra lisinopril hctz 10 12.5 mg side effects dry cough questions raised prozac in pregnancy 0.5 mg of propecia cost of branded lipitor viagra rosa in farmacia viagra stuck at canadian border is ibuprofen 600 mg a fever reducer gabapentin for dogs buy viagra price australia viagra price australia is clotrimazole a corticosteroid sildenafil citrate in saudi para que sirve la glipizide 2.5 mg 300 mg de 906 quetiapine prednisolone sandoz 20 mg notice over the counter naproxen brands cialis kaufen in den usa cheapest sildenafil in the world comprar viagra femenino en chile viagra difference in mg naproxen vicodin safe take together clomid 150 mg ervaringen can i take 10mg of levitra 2 days in a row revista selecciones en espanol usa actos realizados fuera del objeto social esomeprazole cost in uk viagra 50 mg vaikutusaika metformin brand in slovakia orlistat buy in australia without prescription differnce in symptomsb on clomid when pregnant vs not seroquel 200 mg bivirkninger metronidazole in obstetrics and gynaecology spironolactone price in philippines colchicine plants sale 12.5 mg of atenolol how fast does liquid zantac work amoxicillin generic over the counter quante volte si puo usare il viagra levothyroxine whartisthebestin australia 600 mg motrin while breastfeeding furosemide over the counter in canada depakote er 500 cost xenical is it covered buy a plan amoxicillin online quick is human benadryl safe for dogs low dose doxycycline mgd parlodel 2.5 mg comprimidos vitamin k dosage in warfarin toxicity effect of allopurinol in chronic kidney disease is fluoxetine legal in dubai cialis 5mg price no prescription how to buy propecia uk socialist realist painting date of first publication buy lexapro escitalopram oxalate 10mg no prescription cialis 5 mg presentacion pill indomethacin 50 mg selegiline hydrochloride 5 mg tablets viagra no insurance cost walmart generic lexapro zithromax 600 mg tablets what does accutane cost warfarin toxicity in rats does cleocin have sulfa in it why is the cost of doxycycline so high order clomid next day delivery zyprexa reviews bipolar disorder price of valacyclovir hcl going in sun on accutane how much does a valtrex prescription cost how much is generic viagra in mexico 25 mg atomoxetine hcl medroxyprogesterone acetate drug bank tadalafil tablets best buy estrace eciwlcodkedefe online is botox safe while on accutane cialis oral jelly tantra in india is 20 mg of celexa a lot warfarin 6 mg side effects is cipro safe to take for 10 days where to buy clomiphene in south africa seroquel dosage 1200 mg estradiol mic in faza foliculara ciprofloxacin 500 mg en francais discounts on micardis hct generic viagra in us male impotence flagyl metronidazole reviews guna salep voltaren atenolol hereisthebestin uses randy price tricor suprax from canada xenical in japan is 5oo mg of azithromycin safe for an 8 year old propecia whole sale what is the active ingredient in omeprazole decadron elixir como usar sildenafil citrate 50mg india comprar viagra en barcelona milanuncios amoxicillin dosierung 1000 mg metformin canada brand name flagyl side effects in cats yellow amoxicillin capsules india difficulty with nexium generic mobic in early pregnancy trazodone 60 mg snort gabapentin 400 mg where buy kamagra shops sydney use of coumadin in afib does augmentin have sulfa in it cefixime 200 price india plavix 75 mg nota tacrolimus market size walmart pharmacy price check doxycycline can you cut wellbutrin xl 300 mg in half are there side effects with generic cialis walmart prozac generic amantadine bipolar disorder risperidone attention deficit disorder the generic name for cipro is when is cymbalta going generic kegunaan tablet ranitidine 150 mg how much does cialis cost nz best time to administer sucralfate metoprolol 25 mg tabl keflex 1000 mg dose terbinafine online purchase tamoxifen rowcmoadreders discount voltaren gel over the counter canada buspirone 10 mg reviews weight loss tadalafil in saudi arabia cefuroxime in chronic kidney disease ondansetron dose in neonates prevacid for infants generic over the counter antivert for vertigo pcos clomid success rate in 201 statistics in nigeria what is the cost of celexa venlafaxine generic side effects compare xenical prices generic cialis difference brand black generic brand for albenza cialis and levitra in south africa what is olanzapine details in hindi lipitor generic brand recall anafranil quanto costa labetalol in pregnancy side effects levitra buying drinks with viagra in it viagra in delhi 25 mg cn i buy azithromycin 250mg tablet in nigeria comprar cialis salvador glaucoma is viagra safe doxycycline in siadh flagyl 400mg tablets cost ivermectina venta online generic singulair dry mouth chiness viagra in glasgow naltrexone india prices zoloft buy cialis 25 mg usa ventolin in sports why does viagra cost so much no price regulation using ivermectin to treat ear mites in cats comprar revista ciclismo a fondo en new york procardia mgso4 can you buy fluconazole over counter is amoxicillin safe if trying to get pregnant cheapest place to buy cetirizine augmentin 1000 mg sivilce zovirax over the counter cvs atenolol pain in feet generic anacin cat costa aciclovir crema ciprofloxacin in respiratory tract infections seroquel prolong 50 mg efectos secundarios safe dose for lisinopril preço do viagra 50 mg viagra spray for men purchase how often should you take 800 mg of ibuprofen 1000 mg azithromycin for ngu api clopidogrel bisulfate price can zoloft 50 mg be cut in half comprar cialis original espa?a naprosyn 375 mg medication brand name hydroxyzine pamoate voltaren tabletki 100 mg cena how long is lasix in your system prednisolone vs dexamethasone in croup how to spot real viagra colchicine buy canada actos recall in europe prednisone tmj disorder 75 mg seroquel xr propranolol dose in thyroid storm best?lla viagra olagligt migraine specialists in wisconsin tadalafil uk suppliers costo de celebrex 200 mg lipitor price hike mirtazapine for insomnia in the elderly metformin order zoloft generic or brand is trazodone safer than ambien gabapentin 700 mg prozac generic costs brand name for irbesartan hydrochlorothiazide 40 mg prednisone for 7 days viagra 25 mg from digoxin in peds gabapentin 300mg cost getting viagra cialis in korea lexapro brandi glanville buy propecia rx metronidazole benzoate powder price cats can naproxen sodium cause blood in urine buy sibutramine and orlistat wellbutrin smoking cessation reviews how much does olanzapine cost at walmart finasteride in prostate cancer amitriptyline best dosage for sleep wellbutrin available in canada omeprazole tablets 20 mg delayed release levaquin in pediatrics zoloft withdrawal from 25 mg viagra average prices ciprofloxacin side effects in neonates where to buy amoxicillin in the us where to buy azithromycin tablets 250mg

To: IAHF List
Subject: Article By Dr.Gaby: Safe Upper Limits for Nutritional Supplements: One Giant Step BACKWARD
Date: 27 Jan 2004 21:57:13 -0000

IAHF List: Alan Gaby, MD just sent me his article (see below) which was just published in the Special Issue of the Journal of Orthomolecular Medicine on the Safety and Efficacy of Vitamins. The footnotes are not included, if you require the footnotes, please order a copy of the original from JOM at http://www.orthomed.org/jom/jom.htm

I just sent this article to Dr.Antoinette Booyzen, South African Codex Delegate who as things currently stand, appears to be convinced that CRN's views on "Safe Upper Limits" are "scientific". This article refutes any such conclusion. Please forward it to your countries delegate to the UN Codex Alimentarius Commission's Committee on Nutrition and Food for Special Dietary Uses.

There is a very real danger that unless enough vitamin consumers world wide lobby against it, a grossly unscientific vitamin standard could be rushed through to completion at the next Codex meeting in November in Bonn, Germany.

I am especially concerned that pharma dominated controlled opposition groups CRN and IADSA have announced their intention to hold a political summit meeting two days before the next Codex meeting. Unless enough consumers world wide get behind ANH's legal and lobbying efforts, we won't be able to stop the pharmaceutical takeover of the natural products industry. (The CRN meeting is October 24- 27th, the CRN/IADSA Political Summit to screw the dietary supplement industry is being held October 28-29th, and the Codex meeting is the following monday, 2 days later, starting November 1st......)

Want more help in connecting the dots? Read the Cover story interview Greg Ciola did with me in the Dec/Jan issue of The Health Crusader Magazine at http://www.thehealthcrusader.com/pgs/article-0104-ban.shtml Please forward this like wildfire throughout your up and downlines if you are a network marketing distributor for any CRN member company: Mannatech, Shaklee, Herbalife, GNLD, NuSkin.

These companies have been lied to by CRN in a press release on CRN's website which proclaims that a "victory" has been won at Codex due to RDA's being scrapped in favor of so called "Safe Upper Levels" (allegedly based on "science") but Gaby's article (see below) EXPLODES that contention....

I am blown away by the naivete of such people as Sam Caster at Mannatech who has been flattered by CRN's making him a Board Member so he thinks John Hathcock at CRN is "his friend". Sam better wake up, because Hathcock used to work at FDA and might as well STILL be working at FDA, and he's NOT our friend, Gaby's article EXPLODES any contention that we can trust Hathcock's so called "scientific" risk assessment methodology, which was misextrapolated from toxicological risk assessment methodology originally intended for the evaluation of toxic pharmaceutical DRUGS and which they're MISAPPLYING to safe vitamins.

Never forget that CRN is dominated by Wyeth, Monsanto, Bayer, BASF, and Pfizer....

"Safe Upper Limits" for nutritional supplements: one giant step backward

by Alan R. Gaby, M.D.

In May, 2003, the "Expert Group on Vitamins and Minerals" (EVM), an advisory group originally commissioned in 1988 by the then Ministry of Agriculture Fisheries and Food, and subsequently reporting to the Food Standards Agency in England, published a report that set "Safe Upper Limits" (SULs) for the doses of most vitamin and mineral supplements. The establishment of SULs was based on a review of clinical and epidemiological evidence, as well as animal research and in vitro studies. For those nutrients for which the available evidence was judged insufficient to set an SUL, the EVM instead established "Guidance Levels", which were to be considered less reliable than SULs.

This writer's analysis of the EVM report reveals that the dose limits were set inappropriately low for many vitamins and minerals; well below doses which have been used by the public for decades with apparent safety. While the release of this 360-page document would be of little import, were it to be used solely as a manifesto for the pathologically risk-averse, preliminary indications are that it could be used very actively to support the arguments of those who are seeking to ban the over-the-counter sale of many currently available nutritional supplements. If the report is used that way, then the public health could be jeopardized.

On May 30, 2002, the European Union adopted Directive 2002/46/EC, which established a framework for setting maximum limits for vitamins and minerals in food supplements. The EVM report is seen by the UK government as the basis for its negotiating position in the process of setting these pan-European limits.

The apparent anti-nutritional-supplement, anti-self-care bias that permeated the process of setting safety limits is evident both in the way in which the SUL was defined and in the fact that the benefits of nutritional supplements were purposely ignored. The SUL was defined as the maximum dose of a particular nutrient "that potentially susceptible individuals could take daily on a life-long basis, without medical supervision in reasonable safety." In other words, it is the highest dose that is unlikely to cause anyone any harm, ever, under any circumstance. Furthermore, the EVM was specifically instructed not to consider the benefits of any of the nutrients, and not to engage in risk/benefit analysis.

There is little or no precedent in free societies for restricting access to products or activities to levels that are completely risk-free. Aspirin causes intestinal bleeding, water makes people drown, driving a car causes accidents, and free speech may offend the exquisitely offendable. Politicians and bureaucrats do not seek to ban aspirin or water or driving or free speech, because their benefits outweigh their risks. For vitamins and minerals, however, some authorities seem to believe that unique safety criteria are needed.

Moreover, the government's instructions to disregard the many documented benefits of nutritional supplements introduced a serious bias into the evaluation process. As the EVM acknowledged, determining safety limits involves an enormous degree of uncertainty and a fairly wide range of possible outcomes. The committee might have established higher safety limits than it did, had it been told to weigh benefits against risks. The government's instructions appeared to be an implicit directive to err on the side of excluding doses that are being used to prevent or treat disease. And that is what the EVM did, often by making questionable interpretations of the data, and doing so in what appears to have been an arbitrary and inconsistent manner.

Riboflavin Guidance Level

A typical example of the EVM's dubious approach to establishing safety limits is its evaluation of riboflavin. The committee acknowledged that no toxic effects have been reported in animals given an acute oral dose of 10,000 mg/kg of body weight, or after long-term ingestion of 25 mg/kg/day (equivalent to 1,750 mg/day for a 70-kg human). Moreover, in a study of 28 patients taking riboflavin for migraine prophylaxis, a dose of 400 mg/day for 3 months did not cause any adverse effects. Despite a complete absence of side effects at any dose in either humans or animals, the EVM set the Guidance Level for riboflavin at 40 mg/day. That level was established by dividing the 400 mg/day used in the migraine study by an "uncertainty factor" of 10, to allow for variability in the susceptibility of human beings to adverse effects.

A more appropriate conclusion regarding riboflavin would have been that no adverse effects have been observed at any dose, and that there is no basis at this time for establishing an upper limit. If the EVM's recommendation is used to limit the potency of riboflavin tablets to 40 mg, then migraine sufferers will have to take 10 pills per day, in order to prevent migraine recurrences.

Vitamin B6 Safe Upper Limit

Similar reasoning led to an SUL of 10 mg/day for vitamin B6, even though this vitamin has been used with apparent safety, usually in doses of 50 to 200 mg/day, to treat carpal tunnel syndrome, premenstrual syndrome, asthma, and other common problems. The SUL for vitamin B6 was derived from an animal study, in which a dose of 50 mg/kg of body weight/day (equivalent to 3,000 mg/day for a 60-kg person) resulted in neurotoxicity. The EVM reduced that dose progressively by invoking three separate "uncertainty factors:" 1) by a factor of 3, to extrapolate from the lowest-observed-adverse-effect-level (LOAEL) to a no-observed-adverse-effect-level (NOAEL); 2) by an additional factor of 10, to account for presumed inter-species differences; and 3) by a further factor of 10 to account for inter-individual variation in humans. Thus, the neurotoxic dose in animals was reduced by a factor of 300, to a level that excludes the widely used 50- and 100-mg tablets.

The decision to base the SUL for vitamin B6 on animal data (modified by a massive "uncertainty factor") was arbitrary, considering that toxicology data are available for humans. A sensory neuropathy has been reported in some individuals taking large doses of vitamin B6. Most people who suffered this adverse effect were taking 2,000 mg/day or more of pyridoxine, although some were taking only 500 mg/day. There is a single case report of a neuropathy occurring in a person taking 200 mg/day of pyridoxine, but the reliability of that case report is unclear. The individual in question was never examined, but was merely interviewed by telephone after responding to a local television report that publicized pyridoxine-induced neuropathy.

Because pyridoxine neurotoxicity has been known to the medical profession for 20 years, and because vitamin B6 is being taken by millions of people, it is reasonable to assume that neurotoxicity at doses below 200 mg/day would have been reported by now, if it does occur at those doses. The fact that no such reports have appeared strongly suggests that vitamin B6 does not damage the nervous system when taken at doses below 200 mg/day. As the EVM did with other nutrients for which a LOAEL is known for humans, it could have divided the vitamin B6 LOAEL (200 mg/day) by 3 to obtain an SUL of 66.7 mg/day. Had the committee been allowed to evaluate both the benefits and risks of vitamin B6, it probably would have established the SUL at that level, rather than the 10 mg/day it arrived at through serial decimation of the animal data.

Manganese Guidance Level

Chronic inhalation of high concentrations of airborne manganese, as might be encountered in mines or steel mills, has been reported to cause a neuropsychiatric syndrome that resembles Parkinson's disease. In contrast, manganese is considered one of the least toxic trace minerals when ingested orally, and reports of human toxicity from oral ingestion are "essentially nonexistent." The neurotoxicity that occurs in miners and industrial workers may result from a combination of high concentrations of manganese in the air and, possibly, direct entry of nasally inhaled manganese into the brain (bypassing the blood-brain barrier).

In establishing a Guidance Level for manganese, the EVM cited a study by Kondakis et al, in which people exposed to high concentrations of manganese in their drinking water (1.8-2.3 mg/L) had more signs and symptoms of subtle neurological dysfunction than did a control group whose drinking water contained less manganese. The committee acknowledged that another epidemiological study by Vieregge et al showed no adverse effects among individuals whose drinking water contained up to 2.1 mg/L of manganese. The EVM hypothesized that these studies may not really be contradictory, since the subjects in the Kondakis study were, on average, 10 years older than were those in the Vieregge study, and increasing age might theoretically render people more susceptible to manganese toxicity. Based on the results of these two studies, the EVM established a Guidance Level for supplemental manganese of 4 mg/day for the general population and 0.5 mg/day for elderly individuals.

There are serious problems with the EVM's analysis of the manganese research. First, the committee overlooked that fact that in the Kondakis study the people in the high-manganese group were older than were those in the control group (mean age, 67.6 vs. 65.6 years). Many of the neurological symptoms that were investigated in this study are nonspecific and presumably age related, including fatigue, muscle pain, irritability, insomnia, sleepiness, decreased libido, depression, slowness in rising from a chair, and memory disturbances. The fact that the older people had more symptoms than did the younger people is not surprising, and may have been totally unrelated to the manganese content of their drinking water.

Second, the EVM broke its own rules regarding the use of uncertainty factors, presumably to avoid being faced with an embarrassingly low Guidance Level for the general population. In setting the level at 4 mg/day, the committee stated: "No uncertainty factor is required as the NOAEL [obtained from the Vieregge study] is based on a large epidemiological study." As a point of information, the Nurses' Health Study was a large epidemiological study, enrolling more than 85,000 participants. The Beaver Dam Eye Study was a medium-sized epidemiological study, enrolling more than 3,000 participants. In contrast, in the Vieregge study, there were only 41 subjects in the high-manganese group, making it a very small epidemiological study. In its evaluation of the biotin, riboflavin, and pantothenic acid research, the EVM reduced the NOAEL by an uncertainty factor of 10, in part because only small numbers of subjects had been studied. Considering that more subjects were evaluated in the pantothenic acid research (n = 94) than in the Vieregge study (n = 41), it would seem appropriate also to use an uncertainty factor the for manganese data. Applying an uncertainty factor of 10 to the Vieregge study would have produced an absurdly low Guidance Level of 0.4 mg/day for supplemental manganese, which is well below the amount present in a typical diet (approximately 4 mg/day) and which can be obtained by drinking several sips of tea. Parenthetically, in a study of 47,351 male health professionals, drinking large amounts of tea (a major dietary source of manganese) was associated with a reduced risk of Parkinson's disease, not an increased risk. In changing its methodology to avoid reaching an indefensible conclusion, the EVM revealed the arbitrary and inconsistent nature of its evaluation process.

Niacin (nicotinic acid) Guidance Level

Large doses of niacin (such as 3,000 mg/day) can cause hepatotoxicity and other significant side effects. The EVM focused its evaluation, however, on the niacin-induced skin flush, which occurs at much lower doses. The niacin flush is a sensation of warmth on the skin, often associated with itching, burning, or irritation that occurs after the ingestion of niacin and disappears relatively quickly. It appears to be mediated in part by the release of prostaglandins. The niacin flush is not considered a toxic effect per se, and there is no evidence that it causes any harm. People who do not like the flush are free not to take niacin supplements or products that contain niacin. For those who are unaware that niacin causes a flush, an appropriate warning label on the bottle would provide adequate protection.

Granting, for the sake of argument, that the niacin flush is an adverse effect from which the public should be protected, the EVM's Guidance Level still is illogical. The committee noted that flushing is consistently observed at a dose 50 mg/day, which it established as the LOAEL. That dose was reduced by an uncertainty factor of 3, in order to extrapolate the LOAEL to a NOAEL. Thus, the Guidance Level was set at 17 mg/day, which approximates the RDA for the vitamin. The EVM also noted, however, that flushing has been reported at doses as low as 10 mg, so the true LOAEL is 10 mg/day. Applying the same uncertainty factor of 3 to the true LOAEL would have yielded a Guidance Level of a paltry 3.3 mg/day, which probably is not enough to prevent an anorexic person from developing pellagra. As with manganese, the EVM applied its methodology in an arbitrary and inconsistent manner, so as to avoid being faced with an embarrassing result.

Vitamin C Guidance Level

The EVM concluded that vitamin C does not cause significant adverse effects, although gastrointestinal (GI) side effects may occur with high doses. The committee therefore set a Guidance Level based on a NOAEL for GI side effects. It is true that taking too much vitamin C, just like eating too many apples, may cause abdominal pain or diarrhea. The dose at which vitamin C causes GI side effects varies widely from person to person, but can easily be determined by each individual. Moreover, these side effects can be eliminated by reducing the dose. Most people who take vitamin C supplements know how much they can tolerate; for those who do not, a simple warning on bottles of vitamin C would appear to provide the public all the protection it needs. Considering the many health benefits of vitamin C, attempting to dumb down the dose to a level that will prevent the last stomachache in Europe is not a worthwhile goal. However, as mentioned previously, the EVM was instructed to ignore the benefits of vitamin C.

Granting, for the sake of argument, that there is value in setting a Guidance Level for GI side effects, the EVM did a rather poor job of setting that level. The committee established the LOAEL at 3,000 mg/day, based on a study of a small number of normal volunteers. An uncertainty factor of 3 was used to extrapolate from the LOAEL to a NOAEL, resulting in a Guidance Level of 1,000 mg/day. However, anyone practicing nutritional medicine knows that some patients experience abdominal pain or diarrhea at vitamin C doses of 1,000 mg/day or less, and the EVM did acknowledge that GI side effects have been reported at doses of 1,000 mg. It is disingenuous to set a NOAEL and then to concede that effects do occur at the no-effect level. To be consistent with the methodology it used for other nutrients, the committee should have set the LOAEL at 1,000 mg/day, and reduced it by a factor of 3 to arrive at a NOAEL of 333 mg/day. The EVM was no doubt aware of the credibility problems it would have faced, had it suggested that half the world is currently overdosing on vitamin C. To resolve its dilemma, the committee used a scientifically unjustifiable route to arrive at a seemingly politically expedient outcome.


These and other examples from the report demonstrate that the EVM applied its methodology in an arbitrary and inconsistent manner, in arriving at "safety" recommendations that are excessively and inappropriately restrictive. While the directive to evaluate only the risks, and to ignore the benefits, of nutritional supplements created a rigged game, the members of the EVM appeared to be willing participants in that game.

If the EVM report is used to relegate currently available nutritional supplements to prescription-only status, then millions of people would be harmed, and very few would benefit. It would be of little consolation that the higher doses of vitamins and minerals could still be obtained with a doctor's prescription, because most doctors know less about nutrition than many of their patients do. Moreover, the overburdened health-care system is in no position to take on the job of gatekeeper of the vitamin cabinet; nor is there any need for it to do so.

Ironically, as flawed as the EVM report is, its recommendations may ultimately prove to be "as good as it gets" in Europe. Other European countries are recommending that maximum permitted levels be directly linked to multiples of the RDA, which could result in limits for some nutrients being set substantially lower than those suggested in the EVM report.

While some nutritional supplements can cause adverse effects in certain clinical situations or at certain doses, appropriate warning labels on vitamin and mineral products would provide ample protection against most of those risks.

Note: Reprinted with permission from the Journal of Orthomolecular Medicine (in press), as part of a special issue devoted to clearing up the confusion about the toxicity of vitamins.

For Health Freedom,
John C. Hammell, President
International Advocates for Health Freedom
556 Boundary Bay Road
Point Roberts, WA 98281-8702 USA
800-333-2553 N.America
360-945-0352 World