Complementary and Alternative Medicine in the United States (2005) / Chapter Skim
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9 Dietary Supplements
9 Dietary Supplements
Pages 253-277
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From page 253... ...
. Today, dietary supplements comprise a major industry, responsible for $18.7 billion in sales in 2002 (Nutrition Business Journal, 2003)
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From page 254... ...
Market sensitivity to scientific reports as well as drug advertisements related to CAM therapies need to be further examined, as they have for conventional medicine. The American public's views on the federal regulation of dietary supplements are also instructive.
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From page 255... ...
255 from to b Change 2002 2003 Percent January January 1.5 28.9 18.9 +1.6 7.1 30.6 38.4 +27.4 +13.0 31.4 +9.2 +2.1 52.9 4.9 24.1 +1.0 9.8 +12.3 36.0 +1.1 5.9 +27.1 b Millions 8.1 7.7 6.0 4.4 3.3 3.0 2.4 1.7 1.0 0.9 0.5 8.5 $ 34.5 32.9 32.4 28.2 23.1 21.6 14.9 12.3 11.8 33.7 b wort above biloba 's primrose herbs herbs cohosh palmetto thistle kava seed tea vera John other listed Herbal Supplements Garlic Ginkgo Echinacea Soy Saw Ginseng St. Black Cranberry Valerian Milk Evening Kava Bilberry Grape Yohimbe Green Ginger Pycnogenol Aloe Multiple All not a Millions 8 7 6 $ 41 31 21 14 11 11 10 288 acid a fatty Supplements Supplements acids cartilage (2003a)
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From page 256... ...
Importantly, Blendon and colleagues (2001) also found that those who were regular users believed strongly in the usefulness of various dietary supplements, irrespective of the scientific evidence.
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REGULATION OF DIETARY SUPPLEMENTS Dietary Supplement Health and Education Act The capstone of herbal medicine regulation is the Dietary Supplement Health and Education Act of 1994 (DSHEA, 1994)
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This occurred in 2004, when FDA prohibited the sale of dietary supplements containing ephedrine alkaloids. To substantiate its ruling, FDA conducted a risk-benefit analysis of ephedra and examined evidence from the known pharmacology of ephedrine alkaloids, the peer-reviewed literature on effects of ephedrine alkaloids, and reported adverse events after consumption of the product.
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From page 259... ...
m) , 120 Review New Drugs Yes Yes Manufacturer har least FDA,( no Drug ingredients at of agency counterpart certainty containing the Food Additives Yes Yes Rarely Manufacturer Over-The-Counter notify to a (reasonable 's conventional d supplements its Foods No No No FDA safe FDA as under dietary safe as for biotechnology is considered are c regulated required through Supplements Dietary Supplements No No No FDA are product drugs, is the drugs that unlike Dietary developed approval, and food of required demonstrate thereof supplements)
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From page 260... ...
authorization by FDA after a careful review of the scientific literature, (2) an authoritative TABLE 9-4 Label Claims for Dietary Supplements Structure- Unallowable Nutrient Content Function Disease Claim or Health Claim Claim Claim Percentage Claim Regular exercise and a Supports the Supports the Excellent source of healthy diet with enough immune system body's ability to choline; contains calcium helps teens and resist infection 55 mg of choline young adult white and per serving, which Asian women maintain is 10 percent of good bone health and the daily value for may reduce their high risk choline (550 mg)
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From page 261... ...
of folic acid in dietary supplement form is more effective than a smaller amount obtained through foods for reducing neural tube defects. The final decision stated that FDA could not "reject health claims that the agency determines to be potentially misleading unless the agency also reasonably determines that no disclaimer would eliminate the potential deception" (FDA, 1999)
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From page 262... ...
. Off-Label Use of Dietary Supplements For the majority of dietary supplements, particularly herbal products, inadequate evidence exists to qualify them for health or nutrient content claims.
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. Dietary Supplement Regulation Outside of the United States The use of herbal products is prevalent throughout the world (WHO, 2002)
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Germany Since 1976 Germany has defined herbal medicines as medicinal products and required premarketing approval of their quality, safety, and efficacy. In addition, herbal medicinal products must contain only plant material in crude or processed form and may have a therapeutic or prophylactic claim.
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Unlike Canada, Germany, and France, the United States regulates dietary supplements similarly to foods, and does not require premarketing approval of safety, nor does the burden of proof rest on the manufacturer. PRODUCT QUALITY AND SAFETY As described above, many Americans are uncertain whether dietary supplements are subject to safety and efficacy evaluations similar to those used for over-the-counter medications (Blendon et al., 2001)
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From page 266... ...
They found that of the 59 separate samples purchased in the Denver, Colorado area, 10 percent contained no measurable echinacea. Proposed cGMPs would ensure proper labeling of a dietary supplement's identity, purity, quality, strength, and composition (FDA, 2003a)
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From page 267... ...
Topics must meet specific selection criteria, including high incidence; significance for the needs of users of Medicare, Medicaid, or other federal health programs; high cost; controversy about effectiveness; and availability of scientific data. On the basis of this process, reports on six dietary supplements3 have been reviewed as of October 2003.
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From page 268... ...
is a national trade association for the botanical products industry. AHPA reviewed safety data for 600 herbs and published the information in the American Herbal Products Associations' Botanical Safety Handbook (McGuffin et al., 1997)
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In addition, PDR published a reference volume for nonprescription drugs and dietary supplements in 2003 and a PDR for nutritional supplements in 2001. The World Health Organization (WHO)
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From page 270... ...
Even though they are natural products, herbs contain biological and chemical properties that may lead to rare, acute, or chronic adverse effects. Drug-herb interactions also present a potential risk to many consumers, given that one in six people take prescription or over-the-counter medications and dietary supplements concurrently (Kaufman et al., 2002)
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From page 271... ...
Because FDA evaluation of every dietary supplement ingredient is unrealistic, the first step of the framework relies on "signal detection" to indicate that there may be a safety concern warranting further examination. If a signal is found, the second step is to conduct a review of the available information, such as the quality of the adverse event report, its applicability to humans, or the route of exposure.
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From page 272... ...
In the last 5 years, ODS has initiated many efforts to improve the quality of dietary supplement research. It established a program to improve analytical methodologies and develop standard reference preparations of dietary supplements and has created two databases that are publicly accessible: the Computer Access to Research on Dietary Supplements (CARDS)
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From page 273... ...
NCCAM supports five Centers for Dietary Supplement Research, which are located at Purdue University, the University of Illinois at Chicago, the University of California at Los Angeles, the University of Arizona, and the University of Missouri-Columbia. Each center has a unique focus: agerelated diseases, women's health, botanicals, phytomedicines, and phytonutrients, respectively.
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From page 274... ...
Congress and federal agencies, in consultation with industry, research scientists, consumers, and other stakeholders, amend the Dietary Supplement Health and Education Act of 1994 and the current regulatory scheme for dietary supplements, with emphasis on strengthening: · Seed-to-shelf quality control, · Accuracy and comprehensiveness in labeling and other disclosures, · Enforcement efforts against inaccurate and misleading claims,
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:20462056. DSHEA (Dietary Supplement Health and Education Act of 1994)
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From page 276... ...
2004. Final rule declaring dietary supplements containing ephedrine alkaloids adultered because they present an unreasonable risk.
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From page 277... ...
2003a. Dietary Supplement Health and Education Act of 1994: Public Policy Considerations.
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