§3.4 Dietary Supplement Market in the United States

JurisdictionUnited States
Publication year2022

§3.4 Dietary Supplement Market in the United States

§3.4.1 Growth

Before 1994, the Food and Drug Administration (FDA) tightly controlled dietary supplement industry and market in the United States. The interpretations and applications by FDA of the various statutes governing a dietary supplement negatively impacted the growth of the dietary supplement industry.218 In fact, the U.S. Congress alleged that despite the fact that scientific literature had revealed potential health benefits of dietary supplements, FDA pursued a regulatory agenda that discouraged their use, and that the FDA has had a long history of bias against dietary supplements.219

In 1976, Congress passed the vitamin and mineral legislation (the Rogers/Proxmire amendment) which, among other things, prohibited FDA from classifying vitamin and mineral supplements as drugs solely because of their combinations or potency, unless drugs claims were made, prohibited FDA from establishing a standard of identity for dietary supplements, and prohibited FDA from limiting the quantity and combination of nutrients in them except for reasons of safety.220 The passing of this legislation by Congress revitalized the dietary supplement industry, and began its steady growth.221 Between 1976 and 1994, the growth witnessed in the dietary supplement industry prompted Congress to amend related food and drugs legislations.222 And, in recognition of the steady growth the industry had witnessed over the years, Congress in August 1994 enacted the Dietary Supplement Health and Education Act (DSHEA).223

§3.4.2 Present Day

Today, the dietary supplement industry represents a major segment of the U.S. import and export trade market.224 This is partly due to the fact that the scope of dietary supplements was widened by Congress in 1994 to include supplements from botanicals and herbal products.225 Congress may have been influenced by development in some European nations because they stated that many industrialized nations such as Canada, England, France, and Germany have regulatory systems that acknowledge the benefits of hundreds of herbs.226 Now in the United States, botanical and herbal products are also marketed as dietary supplements when properly labeled. The dietary supplement market in the United States has witnessed an astonishing growth.227 Today there are over 29,000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals, compared to 4,000 when DSHEA was enacted...

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