Regulation of Dietary Supplements
When the news media examines the dietary supplement industry, it usually asks three questions:
Are they regulated?
Are they safe?
Do they work?
To help members and others better respond to these questions about dietary supplements whether from the media or their customers, NPA has compiled the following information:
Both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have regulatory authority over dietary supplements and can and do take action when necessary to police the market place. The Dietary Supplement Health and Education Act of 1994 (DSHEA) gave the FDA the power to ensure dietary supplements are safe, properly labeled and that the claims they make are substantiated.
Dietary Supplement Health and Education Act of 1994
With the passage of DSHEA, Congress recognized the role supplements can play in promoting health. DSHEA ensures access to safe products, made to quality standards. It also promotes the dissemination of information about the benefits of supplements, so that consumers can make informed decisions about their health.
This comprehensive piece of legislation defines dietary supplements, creates a mechanism for dealing with safety issues, regulates health claims and labeling of dietary supplements, provides for good manufacturing practices, and encourages research on dietary supplements.
Key Provisions of DSHEA
The following provisions of DSHEA ensure that millions of Americans have access to safe, affordable dietary supplements:
DSHEA defines a dietary supplement as any product that contains one or more dietary ingredients, such as vitamins, minerals, herbs or other botanicals, amino acids or other ingredients used to supplement the diet. Dietary supplement ingredients may not be regulated as food additives or drugs.
The legislation maintains the FDA’s authority to safeguard the public against any unsafe product. A dietary supplement can immediately be removed from the market if the FDA believes that it presents a public health hazard.
Before marketing a new dietary ingredient, a manufacturer must supply the FDA with adequate safety information at least 75 days before marketing. A “new dietary ingredient” is one that is first marketed after October 15, 1994.
Under DSHEA’s provisions, dietary supplement makers may include on product labels truthful and non-misleading claims that describe the role of a nutrient in supporting wellness. Examples of truthful claims include: calcium builds strong bones; antioxidants protect against cell damage. These claims are referred to as structure/function claims or nutritional support claims. Manufacturers must have proof for these claims and notify the FDA within 30 days of first marketing the supplement.
Articles from scientific journals or other publications may be distributed by dietary supplement sellers as long as they are not false or misleading, do not promote a specific brand, present a balanced view of the scientific evidence and are displayed separately from dietary supplements.
A dietary supplement label must list the name and quantity of each active ingredient; identify the product as a dietary supplement; and for herbal supplements, identify the part of the plant from which it is taken. Nutrition labeling must be presented in a format appropriate to the product.
Good Manufacturing Practices (GMPs)
Under DSHEA, supplements must comply with current good manufacturing practices. The FDA is authorized to issue special regulations on GMPs for dietary supplements, modeled after food GMPs.
Office of Dietary Supplements
DSHEA’s passage established an office within the National Institutes of Health to coordinate research on dietary supplements and disease prevention, develop a database of supplement research, and advise the Secretary of Health and Human Services on supplement regulation, safety and health claims.
Dietary supplements have an excellent safety record, especially compared with other consumer goods, such as drugs and even other foods. Below are a few statistics that support this claim.
The truth is that dietary supplements are far safer than most common foods and drugs that consumers use without a second thought. For instance, it may surprise you that ibuprofen, one of the most common pain relievers, is responsible for more than 17,000 deaths annually [New England Journal of Medicine].
Prescription drugs, for all the testing they go through and copious usage directions that are issued with them, are estimated to be one of the top five leading causes of death in the U.S. at more than 106,000 annually [Journal of the American Medical Association].
More than 5,000 Americans are killed each year by food borne illnesses [U.S. Centers for Disease Control].
One reason there is so much fearmongering about supplements is because few experts can agree on accurate sources for statistical information about their safety. But even when trusted sources, such as the FDA or the American Association of Poison Control Centers, do issue statistics on adverse reactions connected with supplements, they are usually dismissed as being unrealistically low.
In 2013, the FDA received over 3,000 reports of serious adverse events regarding dietary supplements. That same year it received more than 800,000 serious adverse reports about drugs. So, supplements represent less than half-of-one percent of drug adverse events using FDA data.
Is the higher safety profile for dietary supplements unique to the FDA’s data? No. According to reports from poison control centers throughout the United States, adverse reactions to drugs are more than 800 percent higher than those to dietary supplements [American Association of Poison Control Centers].
Wolfe M. M., Lichtenstein D. R., Singh G.,”Medical Progress: Gastrointestinal Toxicity of Nonsteroidal Antiinflammatory Drugs,” New England Journal of Medicine 340:1888-1899 (1999).
Lazarou, Jason, Pomeranz, Bruce H., Corey, Paul N., “Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies,” Journal of the American Medical Association 279:1200-1205 (1998).
Paul S. Mead, et al, “Food-Related Illness and Death in the United States,” Morbidity and Mortality Weekly Report (Sept.-Oct. 1999). Electronic version available here.
U.S. Food and Drug Administration, “FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements,” backgrounder, March 7, 2003. Electronic version available here.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Financial Management, “Human Drugs,” report (2002). Electronic version available here.
Toby L. Litovitz, at al, “2001 Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System,” American Journal of Emergency Medicine, 20, no. 5 (2002). Electronic version available here.
Dietary supplements do work, and every week more and more scientific research upholds this fact. There are literally thousands of research articles supporting the efficacy of a wide range of dietary supplements. In fact, the Office of Dietary Supplements oversees a comprehensive online listing. The list below of recent dietary supplement research, taken from various Natural Products Association publications, demonstrates that there is no dearth of scientific fact supporting use of these products.
Study: Folic Acid Reduces Heart Attack, Stroke
A new study published in the British Medical Journal provides further evidence that lowering levels of the amino acid homocysteine can reduce the risk of heart attacks and strokes. And, since the B vitamin folic acid has been shown to reduce homocysteine levels, “Increasing intake of folic acid would be a relatively cheap and simple way of reducing heart disease,” according to researchers. The researchers analyzed a variety of previously published studies and concluded that homocysteine as a cause of cardiovascular disease “explains the observations from all the different types of study” and that “no single alternative explanation can account for all the observations. Since folic acid reduces homocysteine concentrations . . . it follows that increasing folic acid consumption will reduce the risk of heart attack and stroke by an amount related to the homocysteine reduction achieved.” To read the complete study, visit the British Medical Journal.
Carotenoids Battle Lymphoma
People with high intakes of the carotenoids lutein and zeaxanthin, and vegetables in general, could significantly reduce the risk of non-Hodgkin’s lymphoma (NHL), according to research published in the American Journal of Clinical Nutrition (2006, vol.83: 1401-1410). The diet of 466 people with NHL was compared with that of 391 matched controls. People with the highest intake of lutein and zeaxanthin had a 46 percent decreased risk compared to those with the lowest intake of the carotenoids. The researchers also found that those with a higher number of weekly servings of all vegetables was linked to a 42 percent lower risk of NHL than those with the lowest intake, while high intakes of green leafy vegetables and cruciferous vegetables were specifically associated with a 40 percent decreased risk of developing the disease.
Higher Folate Levels Linked to Reduced Risk for Alzheimer’s Disease
Individuals who get higher levels of the folic acid through both diet and supplements may have a reduced risk of developing Alzheimer’s disease, according to a report in the January issue of Archives of Neurology. Researchers interviewed and assessed the diets of 965 individuals without dementia between 1992 and 1994 and then followed them for an average of 6.1 years to see if they developed Alzheimer’s disease. During the follow-up period, 192 of the participants developed Alzheimer’s disease.
When the individuals were divided into four groups based on the total level of folate they took in through food and supplements and the analysis was adjusted for patient characteristics, comorbid diseases and B12 and B6 intake, the risk of Alzheimer’s disease was lower in the groups with higher intake. Neither dietary folate nor supplements alone were significantly linked to Alzheimer’s disease risk; only the two in combination appeared to produce an effect. Researchers suspect that elevated levels of the amino acid homocysteine in the blood, which is linked to a higher risk for cardiovascular disease and stroke, may also increase the risk for Alzheimer’s disease. (Arch Neurol. 2007;64:86-92)
Nutrient Combo Helps Inflamed Intestine
Omega-3 fatty acids and the flavonoid quercetin may work together to help alleviate inflammation of the large intestine associated with Crohn’s disease and ulcerative colitis, claims a new study. Published in the online version of Clinical Nutrition (doi: 10.1016/j.clnu.2005.12.009), the study examined the effect of fatty acid supplementation with or without quercetin on female rats with inflamed bowels. Five groups were formed: diets of four groups were supplemented with fish oil, soybean oil, fish oil plus quercetin, or soybean oil plus quercetin. The fifth group maintained a normal diet. After two weeks on these diets, colitis was induced in the rats and 10 days later, the researchers measured inflammatory responses. The fish oil group showed a reduction in response levels of up to 49 percent compared to the soybean oil group. When the fish oil group’s diet was also supplemented with quercetin, the levels were reduced even more, by up to 62 percent.
Zinc Protects the Heart
An animal study published online in Free Radical Biology and Medicine (doi: 10.1016/j.freeradbiomed.2006.03.017) showed that zinc supplements may protect against cardiovascular disease (CVD). For the study, researchers divided 18 white rabbits into three groups: the first ate a normal diet, the second, a high cholesterol diet, and the third, a high cholesterol diet plus zinc supplementation. After eight weeks, blood levels from the groups indicated that the zinc group experienced a significant reduction in HDL (“good”) cholesterol, leading the researchers to conclude that the mineral helped protect the heart by inhibiting lesion formations in the rabbits’ aorta.
Vitamin C Pretreatment May Ease Muscle Soreness and Stress
A University of North Carolina study investigated if vitamin C supplementation before and after exercise could reduce muscle soreness (MS), oxidative stress, and muscle function. Data suggest that vitamin C pretreatment can reduce muscle soreness, delay creatine kinase increase, and prevent blood glutathione oxidation with little influence on muscle function loss. (International Journal of Sport Nutrition and Exercise Metabolism, June 2006, vol. 16)
Pycnogenol for Muscle Cramps?
Results from a recent study at the University of L’Aquila in Italy suggest that Pycnogenol (the patented special extract of French maritime pine, Pinus maritime Lam) use is efficacious in preventing muscular cramps and pain at rest and during exercise in athletes and non-athletes and in patients with diabetes and chronic venous insufficiency without negative side effects.
Potassium Citrate Supplements Linked to Thicker Bones
Osteoporosis is estimated to affect about 75 million people in the US, Europe, and Japan. According to the International Osteoporosis Foundation, the total direct cost of osteoporotic fractures is $17.5 billion in the US. New research from the University of Basel says that taking potassium citrate supplements could boost bone mineral density by similar amounts as observed with pharmaceuticals.
Vitamin D Debate over Sunlight Heats Up
A new review by dermatology experts suggests that supplements and diet, rather than sunlight, should be one’s source of vitamin D. Publishing online in the Journal of the American Academy of Dermatologists (doi:10.1016/j.jaad.2005.11.1057), the dermatologists suggest that the trade-off between obtaining vitamin D from sunlight exposure and the effects of photo-ageing and skin cancer was sensible in our past, when life spans were not long. But in today’s society, where life spans have doubled, and potentially 30 percent of Caucasians will develop skin cancer, the trade-off no longer makes sense. This conclusion is partly in response to recent research that proposed 10 to 15 minutes of unprotected exposure to midday sun as a good source of vitamin D. The authors also discuss that raising the daily recommended allowance for the vitamin might also be considered.
Fish Oil Helps Asthma Sufferers
Omega-3 fatty acids may protect asthma sufferers from exercise-induced bronchoconstriction (EIB), a narrowing of the airways that can be triggered by vigorous exercise, reports a recent study in the journal Chest (2006, vol.129, no.1: 39-49). Researchers supplemented the diets of 16 volunteers with asthma and documented EIB for three weeks with either a fish oil capsule containing omega-3 fatty acids (3.2 grams of eicosapentaenoic acid (EPA) and 2.0 grams of docosahexaenoic acid (DHA)) or placebo. A two-week washout period followed then another three weeks of the supplemented diet. The fish oil diet improved pulmonary function to below the diagnostic EIB threshold. The improvement was accompanied by a reduction in bronchodilator use of more than 31 percent.
Frequently Asked Questions
According to DSHEA, a dietary supplement is any product that contains one or more dietary ingredients such as a vitamin, mineral, herb or other botanical, amino acid or other ingredient used to supplement the diet. Dietary supplements are not food additives (such as saccharin) or drugs.
Yes. Dietary supplements are regulated, although not in the way prescription or over-the-counter drugs are, because dietary supplements are foods – not drugs. The FDA has the power to ensure the safety of all dietary supplements on the market while assuring consumers’ accessibility to the supplements that they have come to use and trust.
Unfortunately, some journalists have incorrectly reported that the supplement industry is unregulated, which is absolutely false. All supplements, including vitamins, minerals, herbs and specialty products, must conform to federal regulations that control manufacturing, labeling and advertising practices.
There are many compelling reasons to consider dietary supplements as a complement to health care. While a good diet is the foundation for better health, research shows that most adults and children don’t eat the way that they should. Supplements are easy to add to the daily diet, and this is often the first step that people take toward greater nutritional awareness and the adoption of other healthy lifestyle choices. Whether taking a multivitamin, herb or specialty product, people can and do live healthier lives by supplementing their diets.
Today, more than 70 percent of Americans trust dietary supplements and use them as a way to complement inadequate diets and maintain a healthy lifestyle. As more and more consumers experience the health benefits of dietary supplements, major research institutions are validating their experience and the efficacy and safety of these products.
These scientific studies serve to substantiate the fact that dietary supplements have an enviable safety record when compared to other commonly consumed products.
DSHEA gives the FDA ample authority to ensure the safety of all dietary supplements sold to consumers and manufacturers’ compliance with good manufacturing practices. Additionally, the law empowers the FDA to immediately remove any supplement from the market it deems unsafe. The real question for policymakers today is not whether the FDA has sufficient authority to protect consumers from unsafe practices, but whether the FDA is adequately enforcing the law.
DSHEA is the acronym for the Dietary Supplement Health and Education Act of 1994, legislation that regulates dietary supplements. DSHEA was passed overwhelmingly by Congress in October 1994 and was signed into law (PL 103-417) on October 25, 1994.
At a time when the FDA was proposing to restrict access to dietary supplements, consumers became alarmed and urged Congressional action to recognize the value of supplements and the role they can play in promoting health and preventing disease. Congress wanted a new system that would guarantee consumer access to safe products and provide consumers with more information about the benefits of health supplements. Pleas from hundreds of thousands of health-conscious Americans prompted Congress to take much-needed action.
DSHEA increased the FDA’s ability to preserve consumer safety, ensure product labels are informative and truthful, and set higher manufacturing standards. Additionally, the Federal Trade Commission has regulatory authority over claims supplement manufacturers make about their products in advertising, including the Internet. The dietary supplement industry also takes responsible action to implement rigorous standards for self-regulation including regular, independent laboratory testing of products for safety and authenticity.