More than half of America’s adults take at least one dietary supplement. And the number of these products or commodities on the market is growing, from about 4,000 in 1994 to about 80,000 today, with an estimated $40 billion in sales. For such heavy use of vitamins, customers have to be confident of their quality and health.

What is a dietary supplement?

A dietary supplement is a formulated substance designed to supplement your diet by consuming a pill, capsule, tablet, powder, or liquid.

One or more vitamins, nutrients, spices, or other botanical ingredients are used in a dietary supplement. In compliance with the Dietary Supplement Health and Education Act (DSHEA) of 1994, it can also contain amino acids or other nutritional ingredients. A dietary supplement is intended to be taken by mouth and labeled on the packaging as a pill, capsule, tablet, powder, or liquid.

Supplements range from infant food to weight loss to adult healthy sporting products sold. “According to “Dietary Recommendations for Americans,” a 2015 report published by the Departments of Agriculture and Health and Human Services, it may be useful to get one or more dietary supplements when a person does not get the recommended amount of nutrients from foods.

Examples of such nutrients include vitamin D for adults and children with limited sunlight exposure and iron and folic acid for pregnant women or become pregnant. However, most dietary supplements are not nutrients that are essential and have no established therapeutic effects.

What claims can supplements make?

The advertisement and labeling of dietary supplements can include claims or statements about their ingredients and benefits. Suppliers are obliged to ensure that all ads for dietary supplements are correct and not misleading.

The FDA and the FTC (Federal Trade Commission – in the case of advertising) are entitled to review these statements to determine if they agree with the regulatory requirements.

Promoting dietary supplements cannot suggest that the supplement can detect, treat, heal, or eliminate any illness; products that make such “disease claims” are regulated as medicines.

Qualified health claims

Qualified insurance claims allow employers to make health claims dependent on less evidence than the substantial scientific agreement standard. Manufacturers must apply to the FDA, which determines whether the claim misleads consumers.

Supportive but not definitive research shows that, as an indication of a qualified health argument, intake of EPA and DHA omega-3 fatty acids will lower the risk of coronary heart disease.

Health claims

Health claims characterize the relationship between a dietary ingredient and disease or other health-related conditions. In most cases, such claims require approval from the FDA.

They are based on the review of the evidence by the agency and conclude that the argument is validated by “significant scientific agreement.” “Adequate calcium and vitamin D can reduce the risk of osteoporosis throughout life as part of a well-balanced diet.” is an example of a codified health statement.

Structure/function claims

Structure/function claims shall describe the influence of a nutritional product on the structure or function of the body or establish the actions by which the structure or function is sustained. Examples include “calcium builds strong bones” or “fiber maintains bowel regularity.”

The scientific basis for these claims needs not be pre-approved or checked by the FDA, but advertisers must include supporting documentation and apply claims to the FDA no later than 30 days after the drug is first put on the market.