The Dietary Supplement Health and Education Act
The DSHEA was signed by President Clinton on October 15, 1994. For the first time dietary supplements were given their own set of rules by which to abide. The DSHEA included definitions of dietary supplementand new dietary ingredientand provided for the creation of a commission to advise on the regulation of these substances.
Early Regulation of Dietary Supplements
During the late 1800s and early 1900s, concerns about the safety and purity of the American food supply were mounting. Farmers, millers, trade associations, and drug producers agreed that a government intervention was warranted, but each group was unwilling to compromise its own agenda in the interest of an agreement. In addition to concern about the quality of food that was being sent to American troops fighting in the Spanish-American War, people had qualms about poisonous preservatives and dyes in food and were skeptical about the various health claims for worthless and potentially dangerous patent medicines. Widespread trepidation also came as a result of Upton Sinclair’s The Jungle, which portrayed the graphic and gory details of Chicago’s meat-packing industry.
In 1906 the Pure Food and Drug Act was passed by Congress and signed by President Theodore Roosevelt. The act was created to protect consumers and to provide them with education and choice of products. Essentially, the Pure Food and Drug Act prohibited interstate commerce in misbranded or adulterated foods, beverages, and drugs.
Adulteration included removal of valuable components, reduction of overall quality by substituting other ingredients, addition of harmful ingredients, and use of spoiled animal or vegetable products. The act also defined specific labeling requirements; foods and drugs could not be labeled with misleading or false statements, and doing so constituted misbranding. Although the concept of dietary supplements did not yet exist, the Act regulated as foods products that are now known as dietary supplements. Since this first Act, a number of laws have affected the regulation of dietary supplements.
The 1938 Federal Food, Drug, and Cosmetic Act contained many overriding changes to the 1906 Act, including placing the burden of scientific proof of drug safety and efficacy on the manufacturer, no longer requiring proof of fraud before stopping false claims on drugs, performing food and drug factory inspections, and establishing food standards to “promote honesty and fair dealing in the interest of consumers.” During the next several decades, the availability ofproducts we now classify as dietary supplements grew exponentially, as did their use.
The Regulation of Dietary Supplements
One hundred years ago, the dietary supplement industry was very different from today. Production and processing were not standardized, sanitation was questionable (manufacturers had little understanding of bacterial/microbial control and refrigeration was primitive), and distribution was unregulated. The twentieth century brought many changes in how dietary supplements were handled and transported, and several laws sought to improve supplement manufacturing practices.
The U.S. government has long concerned itself with regulation of the substances Americans consume. In the early 1900s, what we now consider to be dietary supplements were regulated as foods. While they are still technically considered foods today, dietary supplements are now regulated by the Dietary Supplement Health and Education Act (DSHEA) under the FDA.
Do Dietary Supplements Provide a Benefit?
While characteristics such as age and geographic location are related to dietary supplement use, the most striking characteristic about dietary supplement users is that they make health and nutrition a top priority. Therefore, it is important to consider whether people who take dietary supplements benefit from them and whether those people who might benefit from dietary supplements take them.
To consider these questions, I created two diets for a hypothetical 50-year-old woman who is 5 feet 6 inches tall, weighs 150 pounds (body mass index of 24.2; a body mass index of 25 is overweight and 30 is obese), is moderately active, and has a daily energy expenditure of approximately 2110 calories. Diets 1 and 2 are similar from the standpoint of total calories, and both diets comprise one snack and three meals, including dinner at a restaurant. Although I do not recommend evaluating a person’s nutrient intake based on one day’s diet (and people who occasionally consume poor-quality diets may compensate with variety over time), I am doing this for the purpose of illustration.
Both diets are compared with regard to the percent daily value (%DV) and the tolerable upper limit (UL). The %DV is calculated using the nutrient per serving of food compared with the reference daily intake for that nutrient established by the Food and Drug Administration.
The UL is the highest level of a nutrient consumed in one day that is likely to pose no risk of adverse effects. Whether intake of vitamins and minerals above 100 percent of the %DV provides additional benefit is questionable, but exceeding the UL may cause harm. There are no equivalent levels set for other substances such as those found in herbal and botanical dietary supplements. Due to inadequate research and scientific consensus, I cannot comment on their contribution to these diets.
Both diets 1 and 2 meet or exceed established goals for calories, protein, and fat, and both are low in calcium. Diet 1 is low in many nutrients, including fat-soluble vitamins (vitamins A, E, K, and likely D); the B vitamins (thiamine, riboflavin, folate, and vitamins B6 and B12); several antioxidants (vitamin C and selenium); and minerals (potassium, iron, magnesium, zinc, and copper). A person consuming this diet would therefore be a good candidate for daily supplementation with a multivitamin and/or specialized supplements such as calcium with vitamin D, B-complex vitamins, and antioxidants. However, a person who relies heavily on convenience and prepared foods (as in diet 1) is less oriented to healthful eating and may therefore be less likely to consume these supplements.
Diet 2 exceeds nutrient recommendations for vitamins A, C, and K, the B vitamins, iron, magnesium, zinc, and selenium, and consumption of several nutrients is above the UL. Most worrisome is vitamin A, a fat-soluble vitamin that is stored in the body rather than excreted when consumed in excess, which may be associated with adverse effects. If an individual consuming this diet were to take a dietary supplement (for example, multivitamin or single-nutrient supplements), other nutrient levels could easily exceed potentially harmful levels. A person consuming diet 2, which is composed of whole grains (some fortified), colorful fruits and vegetables, and sources of mono- and polyunsaturated fats (nuts, olive oil, and salmon), makes healthful food choices and is therefore more likely to use dietary supplements.
Many people who take dietary supplements are not lacking nutrients, according to U.S. government recommendations, and little scientific evidence suggests that consuming more than the recommended amounts of some nutrients improves health.
Taking dietary supplements to fill a dietary gap, however, is beneficial. Several populations may need dietary supplementation to meet their nutrient goals. The elderly, who require fewer calories as they age, still need to consume high levels of nutrients. One Boston study found that many elderly people did not meet their nutrient needs from diet alone, and a study of the older-old in Georgia found that dietary supplement users and nonusers did not get enough of some nutrients from diet alone. Recent data also suggest that most Americans, especially women and teenage girls, are not consuming adequate amounts of vitamin D.
Experts say a varied, healthful diet is the best way to meet nutritional needs, and consumption of dietary supplements cannot make up for a poor diet. When taken by people who need them, however, dietary supplements can improve nutritional status.
Consumer Knowledge of Dietary Supplements
Although most consumers believe they have adequate knowledge about dietary supplements, a significant number would like more information about health benefits and think additional information would help them avoid potentially harmful adverse reactions. Other knowledge gaps pertain to specific nutrients, relationships between dietary supplements and disease, and outcomes of taking dietary supplements. In one survey, almost 60 percent of consumers incorrectly answered that it is more important for postmenopausal women to consume the recommended amount of calcium than for people of other ages. (In fact, after age 9, both males and females should consume approximately 1300mg of calcium daily.) More than 40 percent incorrectly answered that iron supplements provide more energy (only 13 percent of consumers surveyed understood the role of iron, that is, as the oxygen-carrying component of hemoglobin). Twenty-one percent of consumers thought that noticeable effects of dietary supplements can be appreciated after one week, while 12 percent said they did not know how long it would take to see the effects.
According to the 2001 “Dietary Supplement Barometer Survey,” 91 percent of consumers said it was important to comply with recommended dosages for prescription drugs, whereas only 71 percent shared this view on dietary supplements. Those surveyed also had surprising opinions about the comparison between dietary supplements and conventional prescription and over-the-counter drugs. About half believed that some supplements are superior to drugs, and about half believed dietary supplements were equivalent to conventional drugs but threatened fewer adverse effects. All of those beliefs are false.
Information from the Natural Marketing Institute showed that more than 70 percent of consumers believed dietary supplements can prevent and treat certain health conditions. While most consumers still choose prescription drugs before dietary supplements to treat a disease or condition, about 40 percent said they would use a combination of prescription drugs, over-the-counter therapies, and dietary supplements as their first choice. About 30 percent of consumers said they would first use only dietary supplements.
A 2002 Harris Poll found that 59 percent thought that dietary supplements must be approved by a government agency before they can be sold to the public. Sixty-eight percent believed that the government required warning labels on supplements with potential adverse effects or dangers, and 55 percent believed that supplement manufacturers cannot make safety claims without solid scientific support. None of these statements is true.
Only half of dietary supplement users tell their doctors about the supplements they are taking. It is unclear whether this is because doctors don’t ask or because patients don’t tell. What is clear, however, is that this lack of communication prevents doctors and patients from making informed decisions about which dietary supplements, drugs, and behaviors are appropriate and safe.
Dietary Supplement Use for Treatment
The other group of dietary supplement users takes them to treat or manage a current disease. For instance, chondroitin sulfate is used to treat osteoarthritis; saw palmetto is used to treat an enlarged prostate (benign prostatic hypertrophy); and fish oil is used to treat high blood pressure. Despite extensive medical research, many conditions and diseases still have no cure or limited treatment options; other conditions have inadequate treatments and/or treatments that cause adverse effects. Many consumers believe dietary supplements offer an alternative to conventional medicine. Long clinical trials and protracted drug approval processes, which seem to keep valuable information and treatments from people in
need, may engender consumer skepticism of traditional medicine, as do fears about drug dependence, adverse effects, and interactions.
Individuals may feel empowered by the choice and ability to take dietary supplements. For them, dietary supplements represent hope when conventional approaches have failed. To be able to take something to promote healthfulness without the written permission of a doctor or pharmacist can provide a sense of autonomy. In addition, dietary supplements have a “natural” connotation, which elicits less fear than a prescription drug synthesized in a factory (although dietary supplements are also manufactured this way).
Dietary Supplement Use for Prevention
Many people who take dietary supplements are in good health. Sometimes characterized as “the worried well,” this population tends to consume healthful diets and dietary supplements and to lead healthy, active lives. While there is no evidence that people in this group rely on dietary supplements as a substitute for good dietary habits, they do believe dietary supplements provide something that may be missing from their diets or that could help them to lead longer, healthier lives.
Among people who use dietary supplements for prevention, some have a more specific agenda. Some take dietary supplements to prevent a specific disease or condition, such as a disease that runs in the family or any disease or condition that has caused the individual concern. If a woman’s mother and father died of heart disease, for example, she may use dietary supplements touted to prevent heart disease. However, many health conditions have gained popular attention through the media, and American consumers have responded with heightened awareness. A study by the American Institute for Cancer Research found that 39 percent of people surveyed said they had made changes to their diets to reduce cancer risk, and 68 percent of those reported using dietary supplements. Of the 61 percent of people who had not made changes to their diets, only 36 percent reported using dietary supplements.
Health professionals comprise another large group of dietary supplement users. Doctors, nurses, dietitians, and pharmacists tend to use dietary supplements more frequently than the general public, and they choose dietary supplements according to specific health concerns. One survey of about 4500 female physicians found that half took a multivitamin; those who were at high risk for heart disease were more likely to use antioxidants, and those with a family history of osteoporosis were nearly three times more likely to regularly use a calcium supplement. Among almost 200 cardiologists surveyed in the late 1990s, 44 percent routinely took antioxidants. Within this group, 90 percent took vitamin E, 75 percent took vitamin C, and less than half took beta-carotene. (Unfortunately, this population has not been surveyed since several widely publicized studies linked high intakes of vitamin E and beta-carotene with serious adverse events.)
Health-Related Beliefs
Whether they are in good health, trying to prevent family medical history from repeating itself, or managing a known illness, people want to feel in control of their health. According to the 2001 “Dietary Supplement Barometer Survey,” the top three reasons consumers take dietary supplements are to feel better, prevent sickness, and treat sickness. Dietary supplement users can be further divided into two groups: those who take them for insurance, which includes people who take dietary supplements for prevention and those who take them to treat an existing condition.
Health-Related Behaviors
People who take dietary supplements are likely to be concerned with health-related issues. They eat more fruits and vegetables, exercise more regularly, and smoke and drink alcohol less often than their counterparts who do not take dietary supplements. The 1992 “National Health Interview Survey” found that the diets of dietary supplement users are lower in fat, higher in fiber, and higher in some vitamins and minerals than the diets of nonusers. A 2005 study published in the Journal of the American Dietetic Association found that people who take a multivitamin, single-nutrient supplement, and at least one herbal supplement consume more fruits and vegetables than people who only take a multivitamin.
By contrast, a study of people entering the military (mostly young men) showed that the use of ergogenic aids, supplements such as steroid hormones and creatine that are used to increase muscle mass and strength, is associated with high-risk behaviors. People in this group are more likely to drink alcohol and to drink heavily, to ride in a car with a drunk driver or to drive drunk themselves, and to be in a physical altercation.
Across all age groups, most people who take a dietary supplement only consume one product, which is usually a multivitamin. The “National Health and Nutrition Examination Survey III” found that 90 percent of children and 75 percent of teenagers who take dietary supplements only use one product. The 2001 “Dietary Supplement Barometer Survey” showed that about half of people who regularly take dietary supplements take multivitamins. Another one-third takes single-nutrient dietary supplements, the most popular of which are vitamin C, vitamin E, and calcium. Fewer, but a significant number, take herbal supplements or specialty dietary supplements for specific health or mental health conditions, such as depression. Recent data indicate that use of herbal dietary supplements has reached a plateau or decreased, while the use of condition-specific or specialty dietary supplements has increased.
Among people with known health conditions, dietary supplement use may differ from that of the general population. A study of more than 600 colon cancer survivors enrolled in a cancer-prevention trial found that 55 percent of them took at least one supplement; among those, 66 percent took more than one product, 13 percent took five or more products, 5 percent took fiber supplements, and about 5 percent took botanical and specialty supplements.
How often users take dietary supplements is somewhat unclear, and estimates vary across surveys. The 1992 “National Health Interview Survey” asked people about daily supplement use, whereas the 1986 survey asked people about dietary supplement use during the prior 2 weeks. The figures from the 1986 survey were substantially larger because they captured both daily and occasional users. The “Slone Survey” found that 40 percent of adults had used vitamin or mineral supplements during the prior week, and a 2001 Council for Responsible Nutrition survey found that 71 percent of people use dietary supplements at least occasionally: 42 percent are regular users, 22 percent are occasional users, and 7 percent are seasonal users.
According to the Nutrition Business Journal,while as much as 70 percent of the American population uses supplements, only about 40 percent uses them regularly. About 5 percent of adults are heavy users of dietary supplements, which equates with 10 million people who spend roughly $40 per month; 35 percent are regular users (75 million people who spend about $10 per month); 22 percent are occasional users (50 million people who spend about $4 per month); and 10 percent are rare users (20 million people who spend less than $2 per month on one or two purchases per year).
People are most likely to buy dietary supplements in supermarkets, drug stores, discount department stores, and health food stores (66 percent of total purchases). Others purchase dietary supplements from multilevel marketers (20 percent), through the mail (6 percent) or World Wide Web (2 percent), or from healthcare professionals (6 percent).