§5.2 "A dietary supplement . . ."

• Jurisdiction: United States
• Publication year: 2022

§5.2 "A dietary supplement . . ."

"Dietary supplement" is defined under DSHEA to be a product "intended to supplement the diet (excluding tobacco) and that contains a vitamin, mineral, herb, or other botanical, amino acid, substance to increase the total dietary intake in man, or a concentrate, metabolite, constituent, extract, or combination of the previous listing."¹³

The report accompanying S. 784 stated it is the intended use of the finished product that determines whether a product and its ingredient will be considered a dietary supplement or a drug.¹⁴ Pre-DSHEA, courts had adjudicated the classification of articles based on intent.¹⁵

As a "dietary supplement" defined under DSHEA required a product to be ". . . intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form . . .,"¹⁶ a product intended to be administered a different way may not be a dietary supplement.¹⁷ Further, under the definition of "dietary supplement," articles or products that are already being investigated as new drugs may be stopped from re-declaring the article or product to be a dietary supplement.¹⁸

The definition of a dietary supplement was intended to encompass all substances and materials that were contained in dietary supplements at the time of enactment of the Act, and substances derived from foods.¹⁹ To be classified as a dietary supplement, an article should not be represented as the sole item of a meal or diet.²⁰

§5.2.1 ". . . a vitamin; a mineral . . ."

"Vitamin" and "mineral" were not explicitly defined terms; however, as the term is used freely throughout the S. 784 accompanying report without definition, they may be defined in their usual course.²¹ In the accompanying report, B-12, B-6, and folate are given as examples of vitamins.²²

§5.2.2 ". . . an herb or other botanical . . ."

The accompanying report states "Herb or other botanical" as "containing combinations of numerous naturally-occurring plant chemicals . . ."²³ Specific references for herbs are given for Echinacea,²⁴ milk thistle,²⁵ silybum marianum,²⁶ garlic,²⁷ ginkgo biloba,²⁸ ginseng (panax),²⁹ ginger root,³⁰ and pine bark.³¹ Reference was also made to World Health Organization (WHO) guidelines regarding herbal medicines.³² ". . . [o]r other botanical" may be apparently broad; however, the doctrine of ejusdem generis may set the metes and bounds of the phrase. In an earlier Federal Register publication, the FDA had provided two listings regarding herbs: SPICES AND OTHER NATURAL SEASONINGS AND FLAVORINGS (Leaves, Roots, Barks, Berries, etc.) and ESSENTIAL OILS, OLEORESINS, AND NATURAL EXTRACTIVES (Including Distillates).³³

§5.2.3 ". . . an amino acid . . ."

"Amino acid" was referred to in the accompanying report as being used in the creation of body protein and ". . . other important nitrogen-containing compounds, such as creatine peptide hormones and . . . neurotransmitters."³⁴ Given examples of amino acids, termed "essential amino acids," are histidine, isoleucine, leucine, lysine, methionine, phenylamine, threonine, tryptophan, and raline.³⁵ Other given examples of amino acids include cystine,³⁶ arginine,³⁷ L-lysine,³⁸ L-tyrosine,³⁹ and L-carnitine.⁴⁰

In remarks to H.R. 1709, L-tryptophan was given as an example of an amino acid.⁴¹

§5.2.4 ". . . dietary substance . . . to supplement the diet by increasing the total dietary intake . . ."

Substances falling within this category were indicated in the accompanying report as substances that enhanced the functioning of normal processes or metabolism and termed "accessory nutrients."⁴² Examples of accessory nutrients included coenzyme Q10 (CoQ10),⁴³ bioflavonoids, and glucosamine sulfate.⁴⁴ CoQ10 was deemed to be a component of mitochondria, useful for conditions such as angina, hypertension, mitral valve prolapse, and congestive heart failure.⁴⁵ Flavonoids, compounds present in fruits and flowers, were stated as being beneficial for health.⁴⁶ Bioflavonoids, in particular, were stated as being useful in the treatment of prostatitis.⁴⁷ Glucosamine sulfate as delivered in dietary supplements was stated to produce better results than non-steroidal anti-inflammatory drugs such as aspirin in relieving pain for osteoarthritis.⁴⁸

Evening primrose oil was also stated as being useful as an oral supplement for the symptoms of eczema.⁴⁹

§5.2.5 ". . . a concentrate, metabolite, constituent, extract, or combination of any ingredient describe [in the above clauses] . . ."

This group was added to counteract the FDA's previous action of classifying ingredients as drugs based on their...