The Richard and Hinda Rosenthal Lectures -- 2001 Exploring Complementary and Alternative Medicine (2003) / Chapter Skim
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The Extraordinary Case of Dietary Supplements
The Extraordinary Case of Dietary Supplements
Pages 25-32
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From page 25... ...
The legal definition of a dietary supplement is: a product that is intended to supplement the diet; that contains a vitamin, a mineral, an amino acid, an herb; or a dietary substance for use to supplement the diet, by increasing the total dietary intake (that last phrase is generally taken to mean substances like enzymes, glandular extracts, or other types of substances that might be present in foods, but are not a nutrient or herb) ; of a concentrate, metabolite, constituent, extract or combination of any ingredient above; and are intended for ingestion as a capsule, powder, soft gel or gel cap; and not a conventional food or sole item of the meal or the diet (Table 1~.
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From page 26... ...
They tend to be non-smokers; if they drink alcoholic beverages, they TABLE 2 Dietary Supplement Sales and Market Share, 1996 Product Sales ($m) % of market Vitamins 4,900 48 Herbals & botanicals 3,000 Sports nutrition products 927 Meal supplements 618 28 9 6 Minerals 309 3 Total 10,372 100
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From page 27... ...
of companies Revenue ($b) Supplement manufacturers 1,050 6.05 Vitamin raw mineral suppliers 40 0.93 Herb and botanical raw material suppliers 150 0.489
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From page 28... ...
As I think about alternative medicine and dietary supplements, I am reminded of Ruth Eng's description of the "clean living movement" that has been going on in the United States since the early 1970s. Antagonism to modern agricultural practices, concern about food safety, advocacy for organic food and for vegetarianism, and strident calls for dietary change to prevent disease characterize the movement.
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From page 29... ...
Safety determination for dietary supplements rests with the manufacturer, and the substantiation of label claims also rests with the manufacturer. The law provides FDA no authority for premarket approval for dietary supplements with one single exception: new dietary ingredients.
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From page 30... ...
TABLE 6 Adverse Event Reports Dietary Supplement Foods Types Many Limited Etiologies Multiple Pathogens Sensitivities Duration Acute Acute Chronic Information source Evaluation Health care providers Consumer Extensive followup Limited
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From page 31... ...
Lastly, FDA is confined to reliance on post-market surveillance and its own resource-constrained ability to investigate adverse events, which further complicates the medical community's ability to assemble a substantial database on the safety and efficacy of these products. When a good base of science helps to inform legislation in areas of public health, we have a good public health policy.
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