Regulation of the Vitamin Industry By The FDA
“What do vitamins do for you? Well, I don’t know about you, but they built my home, put my kids through college, bought me nice cars...” President of a Major Vitamin Manufacturing Firm
In 1973, legislation was introduced to make it mandatory to obtain a physician’s prescription for any level of nutrients beyond 100 percent of the USRDA. The health food industry responded by soliciting support from its millions of customers across the country. The avalanche of mail that arrived in Washington showed that the people of this country wanted the right of free choice in the nutrition supplement market. Legislators listened and have since abandoned the idea of serious restrictions on the vitamin industry.
There are a few laws that the vitamin industry must heed, however:
- Levels of folacin supplements cannot exceed 400 micrograms per day for adults, and 800 micrograms per day for pregnant women. More than this requires a physician’s prescription. Folacin and vitamin B 12 work closely together in the body. A deficiency of one can often be mistaken for a deficiency of the other. If a person were seriously low in B12 and were taking high doses of folacin, the folacin could conceivably mask the symptoms of pernicious anemia (B12 deficiency) and lead to permanent nerve damage.
- No claims can be made by a vitamin manufacturer as to health benefits to be derived by taking its products. For instance, a vitamin bottle cannot say, “Cures or prevents heart disease.” Get a healthier heart doing this.
- Coated tablets should dissolve in sixty minutes and uncoated tablets in thirty minutes in the stomach of a healthy individual.
- A nutritional product can contain no more than 2 percent impurities (excipients).
- All products must contain what the manufacturer’s label states. They must have the same amount of nutrients after a two-year shelf life.
- Due to problems encountered by kidney patients, potassium levels cannot exceed 95 milligrams per day without a prescription.
Two-thirds of All Households Buy Vitamin Supplements
An attempt was made by the FDA to limit vitamin A levels to 10,000 I.U. per day and vitamin D to 400 I.U. in nutrition supplements. Given the high level of these nutrients found in foods, however, this has been a difficult concept to enforce. This is why you need Vitamin D
Two-thirds of all households buy vitamin supplements, while one-third of all people take them. But do the people get what they need? In many cases, we don’t think so, because of flaws in the governmental regulation of the vitamin industry.
“Bioavailability” refers to how much you absorb of a nutrient. Bioavailability is known to vary considerably among foods.1 The same probably is true for nutrients from pills. Yet few or no studies are done on this issue when a pill is made. You may be absorbing far less than what the label states, depending on the form of the vitamin or mineral used and the way it was processed. Time release capsules have been found in the feces and large intestines. Time release vitamin C is less efficiently absorbed than regular C. Time release tablets may even accumulate in the stomachs of patients with gastrointestinal problems.
Labels Should Compare the Nutrient Content to the USRDA.
In an attempt to make their products look more potent, some manufacturers will compare their products to the minimum daily requirements (MDR), which are substantially lower than the USRDA. Other manufacturers will express the units in abnormal ways. For instance, thiamin is usually expressed in milligrams, with 5 being the USRDA. A manufacturer may claim 200 micro grams of thiamin, an impressive number, but equivalent to only 1.2 milligrams.
Many vitamin formulas seem to have no biochemical rationale.
Nutrients that Americans are commonly low in, such as selenium and chromium, are often omitted.
Many nutrients are included in negligible quantities, merely so that the manufacturer can list them on the label. Fifty milligrams of potassium is about I percent of an active adult’s daily needs, yet it appeals to the consumer who sees this nutrient included.
Many vitamin C products claim to be made with rose hips or acerola cherries, for which the consumer pays nearly triple the price of synthetic C.
“Chelated minerals” is another sales pitch. Each of these claims may have some nutritional merit, yet there is no minimum requirement for these substances. A manufacturer can claim chelated minerals or rose hips C and have only one percent of these items in the product.
Acerola and rose hips C are bulky and expensive. Even a generous manufacturer would give no more than 10 percent of the C in this form. Since there are no federal guidelines for minimum levels, the consumer has no idea of what percentage of the product is chelated or rose hips. Magnesium is a vitally important nutrient for your body
“Natural” and “organic” have no legal meaning. Chemically, they refer to carbon compounds. All vitamins, whether synthetically or naturally derived, are technically organic. All vitamins, natural and synthetic, have the same action in the body. There may be accessory factors found in natural foods that aid in the absorption or action of certain vitamins and minerals, but whether these are found in “natural” vitamins is anybody’s gness. Con sumers pay more for the “natural” label with no assurance that the product is different or better.
Many people go to health food stores in desperation because of poor health. Once there, they are subjected to the sincere but misleading claims of a sales clerk telling them which nutrients will help what condition. If a registered dietitian made the same statements, he or she could be indicted and possibly jailed for practicing medicine without a license. With people’s health on the line, there should be certification for “nutritionists,” with penalties for fakers.
Impurities in Vitamins Versus Drugs
The 2 percent allowable standard for impurities in vitamins is far higher than the standards set for the drug industry. Since nutrients are being used by trained professionals for therapeutic purposes, vitamin manufacturers should have equally stringent purity codes. The partial nerve paralysis caused by excessive doses of vitamin B6 does not occur in pharmacological grade B6. This indicates that the impurities cause the problem, not the vitamin.
Some vitamin manufacturers omit the nutrient that they claim on the label. Drug manufacturers are federally licensed and more likely to be truthful about including all claimed ingredients in their vitamin products, since their licenses are more expensive and inspection by the FDA is more frequent.
But for many of the “Orand X” vitamin manufacturers, the license is cheap and the inspections are few, if any. These vitamin pills, especially those that seem remarkably cheap, may not contain what it claims. This is illegal. Yet the FDA’s manpower is insufficient to police the industry. Also, the FDA feels that the less vitamins present, the less the possibility of harming the consumer. We can only say caveat emptor-let the buyer beware. If the vitamin product seems too inexpensive to be possible, think again about buying it.