American Journal of Law & Medicine

Dietary supplements: a definition that is black, white, and gray.(The Dietary Supplement Health and Education Act: Regulation at a Crossroads)

I. INTRODUCTION

The Dietary Supplement Health and Education Act of 1994 ("DSHEA" or "the Act") was a seminal event in the world of food and drug law. The Act took a controversial category of product traditionally regulated by FDA as either a food or a drug, depending upon the product claims and formulation, and created a new regulatory category called "dietary supplement" that was placed within the "food" definition. (1) As such, products meeting the "dietary supplement" definition benefited in two significant ways, (1) dietary supplements could make "structure/function" claims traditionally within the realm of drug products; and (2) unlike food ingredients, dietary ingredients could be used in dietary supplements without being either approved food additives or generally recognized as safe ("GRAS") ingredients. These legislative provisions significantly changed the legal, corporate, and consumer landscape, allowing products to enter the marketplace with broad-based claims without FDA premarket review or approval of the ingredients, formulation, or product claims.

Because of the marketing advantages, many companies have sought to characterize their products as "dietary supplements." While DSHEA provides a specific definition of the term, statutory and regulatory ambiguities remain that offer both opportunities and risks for businesses.

II. STATUTORY DEFINITION

A "dietary supplement" is defined in section 3(a) of DSHEA as a product "intended to supplement the diet" that contains one or more of the following ingredients: a vitamin; mineral; herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above. (2)

A dietary supplement is typically marketed in the form of a pill, capsule, or powder, but can be marketed in other forms. To be a supplement, the item must be "ingested," "labeled as a dietary supplement," and not "represented for use as a conventional food or a sole item of a meal or diet." (3) Additionally, the dietary supplement definition in DSHEA specifically excludes (1) articles that were approved as new drugs prior to being marketed as a dietary supplement or food and (2) articles authorized for investigation as a new drug for which substantial and public clinical investigations have been instituted prior to being marketed as a dietary supplement or food. (4)

While these requirements appear to be straightforward, companies have aggressively explored ambiguities in the meanings of "dietary substance," "ingestion," and "conventional food," as well as the scope of the drug exclusion from the dietary supplement definition in order to take advantage of the more lenient rules for marketing a dietary supplement. This article addresses each of these items in turn.

III. TERMS OF REGULATORY SIGNIFICANCE

A. "DIETARY SUBSTANCE"

The term "dietary substance" is not defined in DSHEA or any other statutory or regulatory provision. However, it is a critical element to the "catchall" portion of the dietary supplement definition, "a dietary substance for use by man to supplement the diet by increasing the total dietary intake." (5) Until recently, industry, with little to no "push back" from FDA, interpreted the term "dietary substance" broadly to include diverse substances such as melatonin, shark cartilage, and coenzyme Q10. Ingredients such as these do not fit the definition of vitamins, minerals, botanicals or amino acid, but represent a significant portion of the dietary supplement marketplace. Relatively little attention was given to the fact that these products do not "supplement the diet by increasing the total dietary intake."

Within the past two years, however, FDA has begun suggesting that the term "dietary substance" only refers to dietary ingredients commonly used in human food or drink. …

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