About DSHEA & the FDA

Prior to 1990, all dietary supplements were tightly regulated by the Food & Drug Administration (FDA) and only included essential nutrients such as vitamins, minerals and proteins.  In 1990, the Nutrition Labeling and Education Act expanded the category to include "herbs or similar nutritional substances," and the FDA continued to maintain control over pre-market approval.   Then, in 1994, the landmark Dietary Supplement Health and Education Act (DSHEA) was passed which changed the category of dietary supplements to food and separated it from drugs and the regulations that applied to drugs.   In rapid succession over the next two years, a series of regulations refining the rules under the new DSHEA were passed that govern how nutritional supplements are to be marketed and sold, including regulations for structure/function and health claims, and requirements for a Supplement Facts panel on dietary supplement labels.

According to DSHEA, a dietary supplement is a product (other than tobacco) that

  • is intended to supplement the diet;
  • contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents;
  • is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and,
  • is labeled on the front panel as being a dietary supplement.

Why this matters:

Many customers who shop in health food stores ask store staff for information about nutritional products.  It is important that store staff understand what they are allowed to say and what they should not say to customers under the law.  Store staff may use information on a product label and in manufacturer education materials because that information is regulated and the manufacturer is responsible for the accuracy of the information.  Store staff should never make any statements giving customers the impression that any dietary products will treat or cure or prevent any illness or disease.

The FDA further defines dietary supplements this way:

A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

Although dietary supplements are regulated by the FDA as foods, they are regulated differently from other foods as well as drugs.  An example of how they differ from drugs is how health claims can be made on the labels.  Drug manufacturers are allowed to claim that their product will diagnose, cure, mitigate, treat, or prevent a disease.  Similar claims may not legally be made for dietary supplements.  

Instead, the label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim.

  • Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.
    • E.g. “supports relaxation, positive mood & sleep”, “supports brain & memory health”
  • Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product.
    • E.g. “144mg magnesium (as Magnesium L-Threonate)”, “2g of Magtein per Serving”
  • A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it cannot mention any specific disease.  Structure/function claims do not require FDA approval but the manufacturer must provide the FDA with the text of the claim within 30 days of putting the product on the market.
    • E.g., “highly bioavailable magnesium that significantly increases magnesium levels in the brain.  Brain magnesium supports cognition and brain health.”

Product labels containing these different types of claims must also include a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.  That means that the manufacturer is responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.  The FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

Why this matters:

There is a persistent belief that dietary supplements and other products labeled as “natural” are not regulated.  In fact, dietary supplements and other products found in a natural food stores are regulated by the FDA, FTC, and USDA.

Other Regulatory and Oversight Agencies

All consumer products, including natural foods, dietary supplements and body care products, and their marketing and advertising are subject to consumer protections under Federal Trade Commission Act of 1914, which established the Federal Trade Commission (FTC) as its oversight regulatory agency.   Although broad in its mission, the FTC is the watchdog over false and illegitimate claims made by marketers of natural foods and dietary supplements, most recently in cases where false claims were made for weight loss and treating and preventing diabetes.

The U.S. Department of Agriculture (USDA) oversees a broad array of programs and services, among them the National Organic Program and the Center for Nutrition Policy and Promotion which develops and promotes dietary guidelines.   It also operates the Food Safety and Inspection Service (FSIS) which enforces food safety regulations primarily in the areas of meat, poultry and eggs, conducts recalls of contaminated foods, and provides information to farmers and producers of food to help them comply with federal regulations. 

State-Level Regulatory Bodies

Typically every state has its own agencies that regulate and oversee food safety through state law, inspections, and testing.  In Florida, it is the Department of Agriculture and Consumer Services, in California it is the California Department of Public Health, and in Minnesota, there are two departments – the Department of Health and Department of Agriculture.

 

Words to Remember

DSHEA

The Dietary Supplement Health Education Act of 1994 under which nutritional supplements and packaged foods with health claims are regulated differently from food and from drugs. Under this law, manufacturers and retailers may not make health claims that diagnose, treat or cure any illness or disease.

 

HEALTH CLAIMS

Statements that nutritional product manufacturers and retailers may make that describe the relationship between an ingredient and reducing the risk of a disease health released condition.

 

STRUCTURE/FUNCTION CLAIMS

Statements that nutritional product manufacturers and retailers may make that describes how a product may affect the organs or systems of the body, but these statements may not mention a specific disease.

 

SUPPLEMENT FACTS

A defined required set of nutritional and ingredient information that is required by law to be part of the label for any dietary supplement product.

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