Chapter 1
Supplementing 101
Given the current information on food intakes in this country, it’s safe to say that most people could stand some improvements to their diets—especially in the fruit and vegetable area. Supplementing with over-the-counter options could be a good way to
get everything your body needs. However, do your homework first!
The Truth Behind Supplement Benefit Claims
Have you ever wondered if these supplement label claims are true, or if anyone in the government is regulating these claims? If so, you’re not alone.
Structure/Function Claims
The U.S. Food and Drug Administration (FDA) is the federal agency responsible for regulating the safety of—and claims made in the labeling of—dietary supplements (including vitamins, minerals, herbs, amino acids, and other dietary substances). The FDA regulates dietary supplements under the guidelines set in the Dietary Supplement Health and Education Act (DSHEA) of 1994. The DSHEA was an amendment to the FFDCA (Federal Food, Drug, and Cosmetic Act), which created a new regulatory category, safety standards, and other rules for supplements.
Under DSHEA, dietary supplements may display what they call “structure/function claims” without prior FDA review. Structure/function claims describe how a supplement will affect a structure (such as the skeletal system) or function (such as the nervous system) or an individual’s well-being, but do not claim to treat, prevent, or reduce the risk of a disease. An example of a structure/function claim is “supports the immune system” or “helps support joint and cartilage function.”
Under FFDCA, structure/function claims cannot be misleading or false. However, the law does not define the source or quantity of evidence needed to support these claims. Moreover, the FDA has not instructed the industry on what constitutes appropriate documentation—one study or dozens of studies?
Health Claims
Unlike “structure/function” claims, labels cannot, however, bear a “health claim” without FDA review. What’s the difference? Health claims state that a supplement may reduce the risk of a specific disease such as cancer or heart disease. For example, after FDA review, a folic acid supplement label can have a health claim stating that a certain amount of folic acid may reduce the risk of brain and spinal cord birth defects.
Before a health claim can be made for a supplement, it must go through a rigorous FDA review of the scientific evidence supporting the claim. To date, only four health claims—for soy (may reduce the risk of heart disease), calcium (helps maintain healthy bones and may reduce risk of osteoporosis), folic acid (may reduce the risk of brain and spinal cord birth defects), and psyllium husk (may reduce the risk of heart disease)—have been approved for use on dietary supplements.
NOTE: The first step to take before actually purchasing supplements is to see your doctor. Never begin taking a supplement without speaking with your doctor about it first.
Although the FDA is required to review health claims before authorizing their use on product labels, the same is not true for structure/function claims. Companies must notify the FDA of their supplement’s structure/function claim within 30 days after marketing the product. The FDA then reviews these notifications to determine whether the claim is a true structure/function claim as opposed to a claim to prevent, treat, or reduce the risk of a disease.
If the FDA decides the claim is actually a health claim, a letter is sent to the company objecting to the claim. In other words, if a company made a claim that product X “reduced the risk of diabetes,” they would get a letter from FDA saying they had made a health claim rather than a structure/function claim. The FDA would not, however, go a step further and ask them if they had the scientific evidence to show that product X reduced the risk for diabetes. This has raised concerns that because of the limited amount of research and FDA review, many claims on supplements may not be supported by scientific data. This has led many in the supplement industry to push the FDA to take enforcement actions against unsupported claims.
While the FDA regulates supplement labels, the Federal Trade Commission (FTC) regulates advertising on television, radio, the Internet, and print media. Unfortunately, these two agencies operate under different rules for regulating claims on product labels and advertising. This has enabled some claims that were denied by the FDA for supplement labels (the body of data may not be large enough to meet FDA requirements) to be permitted by FTC for use in advertising—provided the claim is truthful and not misleading, and supported by scientific data.
So what’s the consumer to do? Research. Talk to your doctor, pharmacist, or registered dietitian.
How to Read a Supplement Label
All dietary supplements, including vitamins, minerals, and herbs, must have a “Supplement Facts” panel on the label. This panel lists ingredients by weight and gives the percent Daily Value (DV) for those nutrients with an established Dietary Reference Intake (DRI). Following are some terms you’ll need to be familiar with in order to understand supplement labels and compare products:
• Disease claim. A statement that links the supplement to a disease or health condition, such as calcium and osteoporosis. These are rarely found on labels, since the FDA only allows a few supplements to carry these claims.
• Directions. Guidelines for when and how to take the supplement, and how much to take.
• Expiration date. The date when the supplement may start to lose its potency. Though not required by law, it’s common practice to list an expiration date so consumers have an idea of how “fresh” the supplement is and how long it will last.
• High potency. This term may be used to describe a single nutrient when it is present at 100 percent or more of the Daily Value. For multi-ingredient or combination products, two-thirds of the nutrients for which the DV is known must be present at 100 percent or more of the DV, and these nutrients must be specifically named on the label.
• Ingredients. Everything that’s contained in the supplement will be listed in order of decreasing weight. However, if an ingredient is cited in the “Supplement Facts” panel, it does not have to be included in the ingredients list.
• Lot number. A number or combination of letters and numbers that appears on the label or is stamped into the container of some supplements. Reputable manufacturers always include a lot number on their products because it allows the manufacturer to trace the product on its journey through production to sale. It’s useful for checking product quality or for product recalls.
• Miscellaneous certification insignia. There are a few patented certification insignia owned by specific manufacturers that may appear on labels. These insignia generally indicate that the products have passed tests for consistency between batches and pills.
• Serving size. The manufacturer’s suggested serving expressed in terms of the supplement’s form, such as “1 tablet.” All numerical values listed on the “Supplement Facts” panel are for that specified serving size.
• Statement of identity. A description of the type of supplement; it must include the words “dietary supplement” or “supplement,” such as “iron supplement.”
• Storage advice. A proper storage place for most supplements is a cool, dry location—not in the bathroom (too hot and damp) or the refrigerator (too cold and damp). Any unusual directions for storage will be stated on the label.
• Structure/function claim. This statement indicates the benefit of taking the product and relates it to the body or general health status, such as “aids digestion” or “helps maintain flexible joints.” Such claims must also be accompanied on the label by a disclaimer that says that the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.
• USP. The acronym for the United States Pharmacopeia, an independent body of experts that sets the standards for purity and potency for drugs, supplements, and some herbs. A product that says “USP” on the label indicates that the manufacturer has voluntarily tested the product and found it to comply with USP standards for purity, strength, disintegration, and dissolution. (Dissolution is the portion of an ingredient, usually expressed as a percentage, that dissolves in the digestive tract.) The product will also have an expiration date. Products without the “USP” designation are not necessarily inferior—there may be no standards for that supplement, or the manufacturer may choose not to do the required testing for the designation. Keep in mind that no one checks to make sure that manufacturers who do use the “USP” designation actually meet the standards. However, the chance that the standards have been met are greater if a well known brand carries the “USP” designation.
Guidelines for Using Supplements
You’ve consulted with your doctor and purchased your supplements; now you need a few pointers about using supplements safely and effectively.
1. Don’t exceed the recommended dosage: Taking less of a supplement is always wiser than taking more in hopes that it will work better. In general, start with the lowest effective dosage and work up from there if necessary.
2. Check your reaction to the supplement: Some supplements may disagree with you or cause an adverse or allergic reaction. Be aware of how you feel, taking note of any symptoms that might be related to the supplement you’re taking. If an adverse reaction occurs, stop taking the supplement immediately and contact your doctor.
3. Evaluate your progress: If you’ve taken the supplement for the recommended amount of time and you haven’t noticed improvement of your symptoms or health problem, stop taking it and consult your doctor.
Children and Vitamins
According to the American Academy of Pediatrics, a healthy child who eats a balanced diet based on the Food Guide Pyramid should meet all requirements for essential vitamins and minerals. Periods of rapid growth, such as infancy and adolescence, usually require a little more food but don’t necessitate supplements. For most kids—even those who seem to eat unbalanced meals or little food at all—vitamin and mineral supplements are seldom necessary.
Sometimes parents give children a daily multivitamin as a form of nutritional “insurance.” Generally, a multivitamin supplement that provides no more than 100 percent of the RDA for nutrients for the child’s age is considered safe. It’s important to realize, however, that if a child’s diet isn’t healthy to begin with, supplements won’t make it right—they can’t make up for too much sugar, too little fiber, or too much fat.
Never give a child any supplement (even a regular multivitamin) designed for adults—they contain too much of certain nutrients that can be dangerous for children. To be safe, check with the child’s pediatrician before giving a child any type of vitamin or mineral supplement. If your child can’t chew the vitamin, crush it into smaller pieces to avoid choking. Finally, keep all supplements out of the reach of children—preferably in a locked cabinet.
Chapter 2
Vitamins A, C, D, E, and K
What essential vitamins may you need to take supplements of in order to meet your RDAs? This chapter will discuss five important vitamins you may need to supplement.
Vitamin A
Vitamin A, the first fat-soluble vitamin to be discovered (in 1913), is the general name given to a family of compounds called retinoids (i.e., retinol, retinal, and retinoic acid). We obtain the vitamin A we need primarily through the diet. However, the body can also convert some carotenoids—yellow, orange, and red pigments in foods—into vitamin A. There are more than 600 different carotenoids in nature, but not all are provitamins—carotenoids that turn into vitamin A in the body. Approximately 90 percent of the vitamin A in the body is stored in the liver.
Vitamin A is believed to be one of the most versatile fat-soluble vitamins because of its role in a number of important body processes. It is important for growth, reproduction, proper bone development, healthy skin, and the immune system. It’s also necessary for healthy mucous membranes (the smooth linings of the mouth, stomach, intestines, lungs, etc.). Too little vitamin A, for instance, can lead to a lack of mucus in the eye, causing drying and hardening of the cornea, which can result in blindness.
Vitamin A and Vision
Although many of us know that vitamin A is important for vision, most people don’t know why. Vitamin A makes up the visual pigments in the eye. One of the earliest signs of vitamin A deficiency is night blindness—or the slow recovery of vision after flashes of bright lights at night. This occurs because there is an insufficient amount of retinal (vitamin A) available to regenerate the pigments bleached by the light.
Vitamin A and Skin
Vitamin A also plays a role in healthy skin. Both natural and synthetic forms of the vitamin, such as isotretinoin (trade name Accutane), are regularly used in the treatment of skin disorders including acne and psoriasis. Individuals undergoing retinoid, or vitamin A, therapy are monitored closely to avoid side effects of vitamin A toxicity such as abnormal blood lipid levels, liver toxicity, and birth defects.
When to Supplement with Vitamin A
Most Americans get enough vitamin A from the diet. The USDA Continuing Survey of Food Intakes by Individuals in 1994–96 showed an average intake of 1,133 micrograms RE (Retinol Equivalent) of vitamin A for males aged 20 and older, and 982 micrograms RE for females aged 20 and older. The recommended intake for vitamin A for adult males is 900 micrograms per day, and 700 micrograms for adult females.
Vitamin A deficiency is not a common problem in the United States. For that reason, vitamin A is not recommended for children in the U.S. However, children, especially those in undeveloped countries, are at an increased risk because they have not yet built up their stores of vitamin A in the liver.
One of the earliest signs of too little vitamin A is night blindness—because of its role in vision. It is estimated that of the 500,000 children worldwide who become blind each year, as many as 70 percent do so because of a vitamin A deficiency. Symptoms of severe vitamin A deficiency can result in abnormal appearance and function of skin, lung, and intestinal tissues.
Although too little vitamin A can pose a problem, too much can be just as devastating. Symptoms of extremely high doses of vitamin A (greater than 200,000 micrograms RE in adults) can include nausea, vomiting, dizziness, blurred vision, muscular uncoordination, a...