Test Your Knowledge

The safety and labeling of supplements in the United States are governed by the Dietary Supplement Health and Education Act (DSHEA). Enacted in 1994, DSHEA defines which products are considered supplements (products taken by mouth that contain a dietary ingredient intended to supplement the diet) and establishes how they are to be regulated. Prior to DSHEA, supplements were regulated as a type of food.

Under DSHEA, manufacturers or distributors of supplements are responsible for determining their products are safe, and their product claims are substantiated by evidence to show they are not false or misleading. However, these companies are not required to provide this evidence to any government agency prior to marketing or distributing their product.

An exception applies to new dietary ingredients (those introduced after DSHEA was enacted). In these cases, the manufacturer/distributor is required to supply the U.S. Food and Drug Administration (FDA) with the evidence it relied upon to substantiate that the claims are truthful and not misleading. Even so, most supplements in the marketplace today have not been reviewed or approved by the FDA.

Some supplements have convincing scientific evidence supporting their claims. However, in most cases, there is a lack of well-designed scientific studies regarding the effect of supplements.

The FDA is responsible for overseeing labeling requirements for supplements. Certain information is required on supplement labels, and only certain types of product claims can be made regarding supplements. Product advertising of supplements is regulated by the U.S. Federal Trade Commission.

Supplements are required by law to contain the following information on product labels:

• Statement of identity.  The name of the product (e.g., vitamin C, ginseng) and the identifier, “supplement” (e.g., herbal supplement). If the product is botanical (e.g., an herb), the plant or plant part must be identified.
  
  
• Net quantity of contents. The total number of pills or volume of liquid contained in the product.
  
  
• Directions for use. Instructions on how to use the product (e.g., one capsule daily)
  
  
• Supplement Facts Panel. This should include serving (dosage) size, amount per serving and percentage of daily value per serving (e.g., 1 tablet, Vitamin C, 1000 mg, 1667 percent daily value). This information is contained in a bordered area of the label. Serving size is determined by the manufacturer.
  
  
• Other ingredients. This may include ingredients added for color, safety (e.g., preservatives) or taste, and is usually in the “Supplement Facts” panel on the label. These ingredients are not required to be listed in order of the predominance within the product.
  
  
• Name and place of manufacturer, packer or distributor. This usually includes company name and city and state where they are located.

Supplement labels may also contain the following information (although federal regulations do not require it):

• Warnings and cautions (e.g., product should not be used if pregnant)
  
  
• Interactions and possible side effects
  
  
• Expiration date (if applicable)

In addition, the following types of claims may also appear on supplement labels:

• Structure-function claims. Describes the effect of dietary ingredients on body structure or function (e.g., vitamin C is a powerful antioxidant that boosts the immune system). These claims may not imply or state an association with a disease or medical condition – except in the case of deficiency diseases, which may be mentioned as long as the national prevalence of the disease is also mentioned. Structure-function claims must including a disclaimer that: 1) the FDA has not evaluated the claim; and 2) the product is not intended to diagnose, treat, cure or prevent any disease. These types of product claims are commonly used on supplement labels.
  
  
• Nutrient content claims. Describes comparative references to nutrient levels in a product (e.g., excellent source of calcium). These claims are regulated by the FDA.
  
  
• Health claims. Confirmed statements about the relationship between dietary ingredients and risk of disease. Claims are approved by the FDA based on significant scientific agreement. Qualified health claims are statements about a developing relationship between dietary ingredients and risk of disease. Claims are approved by the FDA based on credible scientific evidence and must include a disclaimer on the limitations.
  
  FDA-approved health claims for supplements include:
  
  
• Folate (reduced risk of neural tube birth defects)
  
  
• Calcium (reduced risk of osteoporosis)
  
  
• Soluble fiber from oat bran and psyllium (reduced risk of cardiovascular disease)
  
  
• Omega-3 fatty acids (reduced risk of cardiovascular disease)

The FDA also monitors supplement safety through voluntary adverse event reporting. If a dietary ingredient in a supplement has a significant or unreasonable risk of illness or injury, the FDA can take action to remove the product from the market. However, adverse effects must be reported to the FDA before this can occur. Even then, the FDA has to prove the supplement is unsafe.

For example, the herbal supplement ephedra was banned from the marketplace by the FDA in 2004, after it had been associated with numerous complaints (e.g., cardiovascular problems) and the much-publicized death of a professional baseball player. In 2005, a federal district court in Utah overturned the FDA ban with regard to products sold in that state, because the FDA failed to prove adverse health risks at low doses. However, because of the seriousness of the health risks involved, the FDA is ethically unable to study its effects at low doses in humans. It is unclear whether the ban on ephedra will remain in most markets.

Regulatory concerns regarding the quality control of supplements include:

• Standardization. Supplements are not currently required to be standardized within the United States. Thus, it is not possible to ensure precise outcomes for every product. Levels of active ingredients in supplements may vary significantly from batch to batch. The amount of active ingredient in a product may also differ, depending on manufacturer, product type and form (e.g., capsule, liquid). Until formal national guidelines can be established, supplements that currently indicate “standardized” on their label do not necessarily indicate product quality.
  
  
• Purity. Supplements may be mixed or diluted with other matter. Thus, supplements may not in fact contain the amount of active ingredient they claim to contain.

The FDA intends to issue regulations on Good Manufacturing Practices (GMP) especially for dietary supplements. This will help to ensure the identity, purity, quality, strength and composition of supplements. In the interim, manufacturers for supplements are required to abide by the GMP for foods, which are generally more concerned with hygiene and sanitation.

Supplements carrying the term USP (U.S. Pharmacopeia) have met the standards for strength, purity and the ability to dissolve the organization requires. This organization also follows safe and sanitary manufacturing procedures. People may want to choose supplements with USP on the label.