Dietary Supplements, Herbs and Botanicals Regulation
Today, dietary supplements, herbs and botanical products have become a multibillion-dollar industry. Interestingly, as early as 1944, in Barnes v. United States, the court held that the label on vitamins was false and misleading. The product label implied that the tablets consisted of a significant quantity of vitamins when in fact the product was deficient in vitamins A, B, and D. In a later decision, the court focused again on consumer protection, as exemplified in United States v. Aangamik 15 Calcium Pangamate. The court in Aangamik 15, held that the vitamin product was misbranded under the FDCA.
Fast forward to 1994 with enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), deemed significant yet controversial legislation. Approximately 4,000 supplements were in the marketplace when DSHEA was enacted in 1994. That has drastically escalated to approximately 75,000 available dietary supplement, herb and botanical products. According to the Centers for Disease Control and Prevention, sales surpassed $30 billion and sales are projected to increase. Back in 1996, consumers spent $6.5 billion dollars annually.
DSHEA amended the Food Drug and Cosmetic Act (FDCA) with provisions applicable to dietary supplements and the ingredients of dietary supplements. For example, the term “dietary supplement” under DSHEA is defined along with the term “dietary ingredients”. Dietary supplement products include vitamins, minerals, amino acids, herbs or other botanicals and substances such as enzymes, organ tissues, glandular and metabolites as well as extracts or concentrates. Dietary supplement forms include tablets, capsules, softgels, gelcaps, liquids, or powders. Other forms such as a bar could qualify as a dietary supplement; however, the label cannot represent the product as a conventional food or a sole item of a meal or diet. Importantly, DSHEA established a framework for safety including claims and nutritional support statements; ingredient and nutrition labeling; and granted FDA the authority to establish Good Manufacturing Practice (GMP) regulations.
This volume details landmark court decisions, namely Nutraceutical Corp. V. Eshenbach, Pearson v. Shalala, Alliance for Natural Health, Whitaker v. Thompson and Pharmanex, Inc. v. Shalala. Other topics include an explanation of good manufacturing practices for dietary supplements, claims on dietary supplements, selected enforcement actions and advertising. DSHEA does not provide FDA with authority to approve dietary supplements prior to marketing; therefore, safety and efficacy considerations remain contentious. However, FTC and FDA exercise post market regulatory authority through court actions, nationwide alerts, warning and cyber letters, advisories and product bans. Further, there is adverse reporting specific to dietary supplements. Yet, a Government Accounting Office Report (GAO) recommendation calls for Congress to provide FDA with additional regulatory oversight. This is essential as the multibillion dietary supplement industry continues to burgeon.
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Fast forward to 1994 with enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), deemed significant yet controversial legislation. Approximately 4,000 supplements were in the marketplace when DSHEA was enacted in 1994. That has drastically escalated to approximately 75,000 available dietary supplement, herb and botanical products. According to the Centers for Disease Control and Prevention, sales surpassed $30 billion and sales are projected to increase. Back in 1996, consumers spent $6.5 billion dollars annually.
DSHEA amended the Food Drug and Cosmetic Act (FDCA) with provisions applicable to dietary supplements and the ingredients of dietary supplements. For example, the term “dietary supplement” under DSHEA is defined along with the term “dietary ingredients”. Dietary supplement products include vitamins, minerals, amino acids, herbs or other botanicals and substances such as enzymes, organ tissues, glandular and metabolites as well as extracts or concentrates. Dietary supplement forms include tablets, capsules, softgels, gelcaps, liquids, or powders. Other forms such as a bar could qualify as a dietary supplement; however, the label cannot represent the product as a conventional food or a sole item of a meal or diet. Importantly, DSHEA established a framework for safety including claims and nutritional support statements; ingredient and nutrition labeling; and granted FDA the authority to establish Good Manufacturing Practice (GMP) regulations.
This volume details landmark court decisions, namely Nutraceutical Corp. V. Eshenbach, Pearson v. Shalala, Alliance for Natural Health, Whitaker v. Thompson and Pharmanex, Inc. v. Shalala. Other topics include an explanation of good manufacturing practices for dietary supplements, claims on dietary supplements, selected enforcement actions and advertising. DSHEA does not provide FDA with authority to approve dietary supplements prior to marketing; therefore, safety and efficacy considerations remain contentious. However, FTC and FDA exercise post market regulatory authority through court actions, nationwide alerts, warning and cyber letters, advisories and product bans. Further, there is adverse reporting specific to dietary supplements. Yet, a Government Accounting Office Report (GAO) recommendation calls for Congress to provide FDA with additional regulatory oversight. This is essential as the multibillion dietary supplement industry continues to burgeon.
Dietary Supplements, Herbs and Botanicals Regulation
Today, dietary supplements, herbs and botanical products have become a multibillion-dollar industry. Interestingly, as early as 1944, in Barnes v. United States, the court held that the label on vitamins was false and misleading. The product label implied that the tablets consisted of a significant quantity of vitamins when in fact the product was deficient in vitamins A, B, and D. In a later decision, the court focused again on consumer protection, as exemplified in United States v. Aangamik 15 Calcium Pangamate. The court in Aangamik 15, held that the vitamin product was misbranded under the FDCA.
Fast forward to 1994 with enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), deemed significant yet controversial legislation. Approximately 4,000 supplements were in the marketplace when DSHEA was enacted in 1994. That has drastically escalated to approximately 75,000 available dietary supplement, herb and botanical products. According to the Centers for Disease Control and Prevention, sales surpassed $30 billion and sales are projected to increase. Back in 1996, consumers spent $6.5 billion dollars annually.
DSHEA amended the Food Drug and Cosmetic Act (FDCA) with provisions applicable to dietary supplements and the ingredients of dietary supplements. For example, the term “dietary supplement” under DSHEA is defined along with the term “dietary ingredients”. Dietary supplement products include vitamins, minerals, amino acids, herbs or other botanicals and substances such as enzymes, organ tissues, glandular and metabolites as well as extracts or concentrates. Dietary supplement forms include tablets, capsules, softgels, gelcaps, liquids, or powders. Other forms such as a bar could qualify as a dietary supplement; however, the label cannot represent the product as a conventional food or a sole item of a meal or diet. Importantly, DSHEA established a framework for safety including claims and nutritional support statements; ingredient and nutrition labeling; and granted FDA the authority to establish Good Manufacturing Practice (GMP) regulations.
This volume details landmark court decisions, namely Nutraceutical Corp. V. Eshenbach, Pearson v. Shalala, Alliance for Natural Health, Whitaker v. Thompson and Pharmanex, Inc. v. Shalala. Other topics include an explanation of good manufacturing practices for dietary supplements, claims on dietary supplements, selected enforcement actions and advertising. DSHEA does not provide FDA with authority to approve dietary supplements prior to marketing; therefore, safety and efficacy considerations remain contentious. However, FTC and FDA exercise post market regulatory authority through court actions, nationwide alerts, warning and cyber letters, advisories and product bans. Further, there is adverse reporting specific to dietary supplements. Yet, a Government Accounting Office Report (GAO) recommendation calls for Congress to provide FDA with additional regulatory oversight. This is essential as the multibillion dietary supplement industry continues to burgeon.
Fast forward to 1994 with enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), deemed significant yet controversial legislation. Approximately 4,000 supplements were in the marketplace when DSHEA was enacted in 1994. That has drastically escalated to approximately 75,000 available dietary supplement, herb and botanical products. According to the Centers for Disease Control and Prevention, sales surpassed $30 billion and sales are projected to increase. Back in 1996, consumers spent $6.5 billion dollars annually.
DSHEA amended the Food Drug and Cosmetic Act (FDCA) with provisions applicable to dietary supplements and the ingredients of dietary supplements. For example, the term “dietary supplement” under DSHEA is defined along with the term “dietary ingredients”. Dietary supplement products include vitamins, minerals, amino acids, herbs or other botanicals and substances such as enzymes, organ tissues, glandular and metabolites as well as extracts or concentrates. Dietary supplement forms include tablets, capsules, softgels, gelcaps, liquids, or powders. Other forms such as a bar could qualify as a dietary supplement; however, the label cannot represent the product as a conventional food or a sole item of a meal or diet. Importantly, DSHEA established a framework for safety including claims and nutritional support statements; ingredient and nutrition labeling; and granted FDA the authority to establish Good Manufacturing Practice (GMP) regulations.
This volume details landmark court decisions, namely Nutraceutical Corp. V. Eshenbach, Pearson v. Shalala, Alliance for Natural Health, Whitaker v. Thompson and Pharmanex, Inc. v. Shalala. Other topics include an explanation of good manufacturing practices for dietary supplements, claims on dietary supplements, selected enforcement actions and advertising. DSHEA does not provide FDA with authority to approve dietary supplements prior to marketing; therefore, safety and efficacy considerations remain contentious. However, FTC and FDA exercise post market regulatory authority through court actions, nationwide alerts, warning and cyber letters, advisories and product bans. Further, there is adverse reporting specific to dietary supplements. Yet, a Government Accounting Office Report (GAO) recommendation calls for Congress to provide FDA with additional regulatory oversight. This is essential as the multibillion dietary supplement industry continues to burgeon.
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Dietary Supplements, Herbs and Botanicals Regulation
Dietary Supplements, Herbs and Botanicals Regulation
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Product Details
BN ID: | 2940016720371 |
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Publisher: | Forti Publications |
Publication date: | 02/23/2015 |
Series: | Food and Drug Law , #10 |
Sold by: | Barnes & Noble |
Format: | eBook |
File size: | 235 KB |
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