It is estimated that about half of all Americans take nutritional supplements. The question is why?
The Food and Drug Administration states that “unlike drugs, supplements are not intended to treat, diagnose, prevent or cure diseases.” That means that supplements should not be advertised, as is common practice, as if they would “lower blood pressure,” “improve erectile dysfunction” or “reduce your weight.”
When we consider taking any medications or supplements, we must consider three consequences: possible toxicity and side effects; possible benefits; and cost.
The Dietary Supplement Health and Education Act of 1994 places responsibility for ensuring that the product is safe on the manufacturer, not the retailer.
The FDA is responsible for taking action against a supplement after it is marketed. It is when the supplement seems to cause a problem that the FDA will get involved.
This is radically different than the process used to approve drugs. Even before the drug is even considered for clinical trials, it must be proven to be safe in humans. Furthermore manufacturers of supplements do not have to submit or register the product with the FDA.
They just have to ensure that the product is safe and the label is not misleading. Manufacturers are supposed to report to the FDA any adverse side effects or toxicities which consumers may suffer or experience.
There are exceptions; under more recent law, manufacturers of supplements using new compounds must send evidence of their safety to the FDA before marketing.
Many companies have violated this requirement. An example is geranium extract or DMAA (dimethylamylamine) which is advertised as a “natural stimulant” and companies have marketed the product without notifying the FDA of its safety.
The FDA stated that DMAA may cause elevations of blood pressure and may lead to heart attacks. Forty-two adverse events reports have been submitted to the FDA on products containing DMAA. These ranged from mild heart conditions to death.
The FDA maintains a Dietary Supplement Alerts and Safety Information page, www.fda.gov/ForConsumers/ConsumerUpdates/ucm153239.htm, which should be consulted before a supplement is considered.
Among the most common supplements are the multi-vitamin minerals.
It is unlikely that individuals who have a healthy diet have any vitamin or mineral deficiencies. However in certain cases, when there is concern about the dietary intake, a multivitamin is a reasonable option.
We should only consider MVMs, which are within the recommended daily intake. Megadoses of vitamins have not been shown to provide any benefits. Specifically, fat-soluble vitamins (A, D, E and K), which the body stores for long periods of time, are particularly dangerous when taken in large doses.
The FDA has prepared an excellent video about vitamins and minerals; it can be found at www.fda.gov/ForConsumers/ConsumerUpdates/ucm182737.htm.
According to the FDA, certain populations could potentially benefit from the use of vitamins and minerals.
- If you’re over age 50, consume vitamin B-12 in its crystalline form, which is found in fortified foods or supplements.
- If you’re a woman of childbearing age who may become pregnant, eat foods high in heme-iron and consume iron-rich plant foods or iron-fortified foods with an iron-absorption enhancer, such as foods high in vitamin C. Prenatal vitamins with iron are a common recommended supplement.
- If you’re a woman of childbearing age who may become pregnant or is in the first trimester of pregnancy, consume adequate synthetic folic acid daily from fortified foods or supplements in addition to food forms of folate from a varied diet (400 micrograms of folic acid per day).
- If you are an older adult, have dark skin, or are exposed to insufficient ultraviolet band radiation (such as sunlight), consume extra vitamin D from vitamin D-fortified foods or supplements. Most physicians would recommend a supplement with 700 to 800 IU of vitamin D.
To establish the true benefits of a substance, careful studies have to be done including clinical trials. It is impossible or extremely costly to do these studies on supplements, which often include multiple compounds in the same capsule or pill. Besides there is no legal requirement that these products must undergo any type of effectiveness testing, as result the consumer is often left to judge supplements based on the manufacturers claims.
A common claim often exploited by manufacturers and retailers is the “natural” origin of a product. Very often the idea of a natural product conveys the image of safety.
This is the furthest thing from reality. We must bear in mind that many substances proven to be very toxic are “natural,” extracted from plants, trees or minerals widely available in nature. Curare, cyanide, strychnine, ricin and arsenic are all “natural compounds” and are also dangerous poisons.
Americans spend $23 billion annually in supplements. Most nutritional experts believe that most of this expense is completely unnecessary.
Furthermore as far as MVMs are concerned, it is far more cost-effective and healthier to consume the necessary vitamins and minerals as part of our daily diet.
Ideally, at least, the most common and dangerous supplements should go through the same toxicity and effectiveness studies that we use for drugs. However, I would not anticipate very quick changes. This is a $23 billion industry with a vigorous lobbying machine.