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Refresher on the Definition of Dietary Supplements

The Food, Drug and Cosmetic Act (FDCA) passed in 1906. It legislates foods, drugs and cosmetics, vitamins, minerals, botanical extracts and supplements of many sorts that were sold on the US market. The law made it clear that products should be safe. There have been many amendments to this original law.

In 1938, the intended use of a substance was more important than the source of substance in determining how it was to be regulated (foods versus drugs).

In 1976, the vitamin and minerals amendment prohibited FDA from limiting potency of vitamins or minerals and prevented the government from limiting any combination of vitamins or minerals or other food ingredients. FDA retained its ability to pursue false and misleading labeling of supplements and to classify as drugs supplements represented to treat or prevent diseases.

In 1990 the Nutrition Labeling and Education Act (NLEA) set the framework for meaningful nutrition labels, allowed for health claims (i.e. folic acid and neural tube defects etc.) and established definitions for nutrient content claims for “free”, “low” and “light” etc.

And finally in 1994, an official definition of Dietary Supplement came to pass in the Dietary Supplement Health and Education Act (DSHEA).

What is a dietary supplement?

A “dietary supplement” means a product intended to supplement the diet that contains one or more dietary ingredients. A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients. A dietary supplement cannot be represented for use as a conventional food or as a sole item of a meal or the diet.

Simply said, a dietary supplement can be made of various compounds that may not be related to traditional food compounds. The key concept is the word “supplement” and the condition of its intended use.

The other important points described in DSHEA include:

  • The form of ingestion includes tablet, capsule, powder, softgel, gelcap, or liquid form.
  • Even though a marketer or a manufacturer legally has to put a safe product on the market, the law requires the government to bear burden of proof to show that a dietary supplement is adulterated or unsafe. This is why there are been instances of unsafe products on the US market and it took FDA many years to remove them.
  • The DSHEA law allows for statements of nutritional support that would not cause supplement to be classified as a drug (deficiency diseases).  
  • It allows for making claims that are described as Structure-Function statements (see the executive summary on Claims).
  • It requires that the manufacturer or marketer of a finished product notify the FDA of structure-function statements no later than 30 days after the first placing of the product on the market.
  • It establishes the elements needed on the label of a supplement above and beyond that a food product label should include. FDA regulates both food and dietary supplement labels.  
  • It requires that the manufacturer or marketer of a finished product use a standardized disclaimer language for structure-function statements.
  • It defines what constitute a new dietary ingredient and allows for petitioners (raw materials suppliers, or manufacturers, or distributors, or marketers) to submit a dossier to use a New Dietary Ingredient (NDI) in their product. The NDI dossier must be submitted at least 75 days before the new ingredient is introduced to interstate commerce.
  • It provides for the issuance of good manufacturing practices (GMPs).

I hope this will help you in your understanding of dietary supplements. Stay tune for the continuation of refresher posts on the new dietary ingredients and GRAS substances. Until then….