FDA May Be Getting Ready To Water-Down Your Vitamin Pills
by Bill Sardi
It's been on the docket since 2007 for the Food & Drug Administration to revamp nutrient guidelines for the American population. The FDA says it is close to issuing a new guideline that may water-down essential nutrients in foods and multivitamins.
At issue is whether the FDA will use the relied-upon RDA (Recommended Daily Allowance) that covers the nutrients needs of 98% of the population or the EAR (Estimated Average Requirement) which only addresses the nutrient level needed to meet the needs of 50% of the population.
While the proposed FDA rule is anticipated any time now (it will have to withstand a public comment period), one wonders whether the FDA will take into consideration a newly-published report showing the Estimated Average Requirement (EAR) level would leave many Americans short of meeting their need for essential vitamins and minerals.
Strikingly, the newly published report shows that dietary supplements play a stronger role in meeting the nation's nutrients needs than previously thought.
While the prevailing mantra is that an American adult can get all the essential nutrients they need out of a good diet, this is far from the truth in the real world.
According to a recently published report in the Journal of Nutrition (Aug. 26, 2011), a large percentage of the American public failed to achieve even the water-down Estimated Average Requirement (EAR) for essential vitamin and minerals even when foods were enriched, fortified or the diet amplified with dietary supplements.
Here are the percentages of Americans who failed to even achieve the EAR level of nutrient intake, even with food fortification and supplements:
Nutrient % under Est. Avg. Requirement were not taken Foods + fortification If supplements were not taken Vitamin D 70% 90% Vitamin E 60% 91% Calcium 38% 50% Vitamin A 34% 45% Vitamin C 25% 37% Magnesium 45% 55%
Only about 3% of Americans achieved Adequate Intake (AI) for potassium (4700 milligrams/day for adults) and only 35% for vitamin K (90-120 micrograms/day).
Adequate Intake (AI) is used when no RDA can be established for a particular nutrient.
Over-dosage not a significant problem
The percentage of American population that over-consumed nutrients, beyond the safe upper limit (SUL), was generally small, ranging from 1-3% for most essential vitamins and minerals. The Safe Upper Limit is about 10-fold lower than the dose required to produce observable side effects and is defined as the dose which poses no adverse risk to health. Many Americans are mistakenly led to believe by health authorities that the threat of over-dosage is considerable when taking dietary supplement, but again, in the real world, even exceeding the SUL would not be expected to produce undesirable side effects.
What will the FDA decide?
If the FDA chooses to use the EAR, then many consumers would be misled that 100% of the Daily Value would be all they need to maintain health when in fact that is only the level that would achieve adequacy in 50% of the population. Authorities in the field of nutrition advocate the RDA rather than the watered-down EAR to establish Daily Values for nutrients.
Health authorities have been criticized in recent times for establishing nutrient guidelines that are outdated and would ensure a certain level of disease to treat within the population at large. There is concern that public health authorities will capitulate to lobbyists who represent medical industrial complex in a trade to generate jobs and help get politicians off the unemployment hot seat. Disease is good for business and employment at a time when American industries are hurting.
Confusing acronyms for nutrient needs should be ignored
All of the confusing acronyms (RDAs, EARs, AIs and DRIs- dietary reference intakes) used to signify nutrient requirements generally apply to groups, not individuals, and they were developed for assumedly healthy populations, not for growing children, females during pregnancy, diabetics (~25 million Americans, smokers (~45 million), retirees (over 36 million), or those taking nutrient-depleting drugs such as aspirin, beta blockers, diuretics, statin drugs, etc (average 65-year old American takes 5 prescription drugs). So food and dietary supplement labels don't apply to most Americans.
Most Americans, reading food or supplement labels, would assume they obtain all the nutrients they need if the label reads 100% of the RDA. But this is far from the truth.
For example, the RDA for vitamin C is just 60 milligrams, not enough to even measurably raise blood levels. Since vitamin C is rapidly excreted from the body, repeated doses are needed throughout the day to maintain healthy blood concentrations. Smokers, aspirin users, females during pregnancy, the chronically ill, individuals infected with viral and bacterial infections, diabetics, the hospitalized and those under physical or emotional stress require more vitamin C.
Many Americans exhibit overt signs of vitamin C deficiency that are often ignored by modern medicine, which include chronic fatigue, anemia, irritability, bleeding gums, easy skin bruising, dark red or purple blotches on skin or in the eyes from broken capillaries in blood vessels, pinpoint cherry-red spots on the skin (petechiae), hernias, gastro-esophageal reflux (acid heartburn), aneurysm (bulge in blood vessels), varicose veins, which may not be resolved with common-dose vitamin C pills. One study shows 453% of the RDA for vitamin C is required to replenish vitamin C in smokers.
Sunlight exposure is still the primary way Americans obtain vitamin D with the diet making a small contribution. Modern Americans have been taught to be phobic over unfiltered sunlight causing skin cancer which has worsened the prevalence of vitamin D deficiency without compensating increases in the RDA for this vitamin.
As a final note, while dietary supplements do play a significant and underappreciated role in providing for the nutrient needs of the American population, it is obvious by the above numbers that many of daily multivitamins need to be updated.