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GUIDELINES AND REGULATIONS FOR DIETARY SUPPLEMENTS

AUGUST 8, 2016

When developing a dietary supplement company there’s many regulations and guidelines you need to follow in order to be legal with the FDA. This is a quick guide of regulations and where to get in-depth explanations regarding marketing, labeling, and other aspects of your brand.

Dietary Supplement Regulation

A dietary supplement is defined as a product taken by mouth containing a dietary ingredient intended to supplement the diet. Dietary ingredients include vitamins, minerals, herbs or other botanicals, and amino acids. The Dietary Supplements Health and Education Act (DSHEA) was passed in 1994, which is the regulatory framework for assuring the safety of dietary supplements. This act granted the U.S Food and Drug Administration (FDA) authority to establish regulations regarding dietary supplement manufacturing, health claims and labeling of dietary supplements, creating organizations  to encourage research on supplements, along with dietary supplement label claims (Commission on Dietary Supplement Labels). Marketing, manufacturing, labeling, and advertising of dietary supplements are all covered by regulations enforced by FDA and the Federal Trade Commission.

Marketing Regulations

Manufacturers of a dietary supplements or dietary ingredients are responsible for ensuring that the product is safe before marketing. Once the product is available for purchase in the U.S market, The FDA is responsible for evaluating the safety and has the authority to remove unsafe and non compliant dietary supplements. The FDA regulations for dietary supplement Marketing and Label claims can be found here.

Labeling Regulations

The U.S. Food and Drug Administration regulations require that dietary supplement labeling include a descriptive name of the product stating that it is a “dietary supplement”; the name and place of business of the manufacturer, packer, or distributor; a list of ingredients; and the net contents of the product. Dietary supplement labeling must also contain nutrition labeling in the form of a “Supplement Facts” panel which identifies the dietary ingredients contained in the product.

Information required on dietary supplement labels includes:

  • Statement of identity (e.g., “ginseng”)
  • Net quantity of contents (e.g., “60 capsules”)
  • The statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” (If claims describing the role of a dietary supplement on a structure or function of the body are made)
  • Directions for use (e.g., “take one capsule daily”)
  • Supplement Facts Panel (lists serving size, amount, and dietary supplement ingredients)
  • Other ingredients, in descending order of predominance
  • Name and place of business of the manufacturer, packer, or distributor

Dietary Supplement Label Database is an online repository containing labels from a sample of dietary supplement products marketed in the U.S.

FDA Labeling Guidelines is guidelines for labeling compliance.

Advertising Regulations

Advertising for dietary supplements must be truthful and substantiated. FDA is primarily responsible for claims on product labeling, while FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials. These two agencies collaborate to ensure consistency in dietary supplement advertising regulation. Dietary supplements must contain the following disclaimer on the label: “This statement has not been evaluated by the U.S. Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Three types of claims for dietary supplements:

  1. A structure/function claim describes the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body
  2. Health claims describe a relationship between a food, food component, or dietary supplement ingredient and reduction in the risk of a disease or health-related condition.
  3. Nutrient content claims describe the level of a nutrient or dietary substance in the product, using terms such as “free”, “high”, and “low”.

For more information on Advertising Regulations go to National Advertising Division or Federal Trade Commission.

Dietary Supplements Postmarketing Safety

U.S. Food and Drug Administration (FDA) was given several post-marketing responsibilities to ensure the safety of dietary supplements. FDA has the authority to remove the product from the market if a dietary supplement presents “a significant or unreasonable risk of illness or injury” or contains a poisonous or deleterious substance which may render it injurious to health”. Effective December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act mandates that manufacturers, packers, and distributors of dietary supplements in the U.S. report information about serious adverse events associated with the use of these supplements to FDA.

Serious adverse events are defined as one the results in:

  • Death;
  • A life-threatening experience;
  • Inpatient hospitalization;
  • Persistent or significant disability or incapacity;
  • A congenital anomaly or birth defect; or
  • Requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

Other Useful Links.

FAQ

Tainted Dietary Supplements

FDA Website for Dietary Supplements