Dietary Supplement Labeling
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| ID | Author(s) | Title / Description | Publication Date |
|---|---|---|---|
| 6796 | Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Transcript of Public Meeting: Assessing Consumer Perceptions of Health Claims URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm109638.htm Format:
Transcript and presentations from this meeting held November 17, 2005 in College Park, Maryland on consumer research related to health claims on conventional foods and dietary supplements. Talks include…
Transcript and presentations from this meeting held November 17, 2005 in College Park, Maryland on consumer research related to health claims on conventional foods and dietary supplements. Talks include "Legal Context of Consumer Research on Health Claims and Other Food"/Nickerson, Louisa; "Overview of Qualified Health Claims (QHC)"/Schneeman, Barbara; "Presentation of FDA Results"/Derby, Brenda; "Federal Trade Commission Research"/Ippolito, Pauline; "International Food Information Council Foundation's Research"/Kapsak, Wendy Reinhardt; "West Virginia University Research Presentation"/Bone, Paula Fitzgerald; France, Karen Russo; "Ohio State Research"/Hooker, Neal; and more
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20051117Nov 17, 2005 |
| 6316 | Schneeman, B.O. |
Letter Responding to Health Claim Petition Dated December 19, 2003: Chromium Picolinate and Insulin Resistance (Docket No. 2004Q-0144) URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073017.htm Format:
Letter regarding proposed health claims for chromium picolinate and a reduced risk of several diseases and health-related conditions. Includes discussion of the safety review
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20050825Aug 25, 2005 |
| 5829 | Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Guidance for Industry: A Dietary Supplement Labeling Guide URL: http://www.fda.gov/Food/LabelingNutrition/default.htm Format:
Questions and answers regarding the labeling of dietary supplements, including coverage of such topics as statement of identity, net quantity of contents, nutrition labeling, ingredient labeling, claims, premarket notification…
Questions and answers regarding the labeling of dietary supplements, including coverage of such topics as statement of identity, net quantity of contents, nutrition labeling, ingredient labeling, claims, premarket notification of new dietary ingredients, and more. Appendices include "Daily Values for Adults and Children 4 or More Years of Age," "Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant of Lactating Women," "Nutrient Content Claims," "Authorized Health Claims," "Qualified Health Claims," and more
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20050400Apr 2005 |
| 5142 | Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act URL: http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/ucm107405.htm Format:
Guidance for industry regarding the substantiation of nutritional deficiency, structure/function, or general well-being claims on dietary supplements. Includes discussion of identifying the meaning of a claim, the relationship of…
Guidance for industry regarding the substantiation of nutritional deficiency, structure/function, or general well-being claims on dietary supplements. Includes discussion of identifying the meaning of a claim, the relationship of the evidence to the claim, quality of evidence, and the totality of the evidence
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20041100Nov 2004 |
| 5141 | Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 URL: http://www.cfsan.fda.gov/~dms/ds3strat.html Format:
This document outlines FDA's strategies for monitoring and evaluating product and ingredient safety, quality assurance and CGMP, and monitoring and evaluating product labeling
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20041100Nov 2004 |
| 6236 | Hubbard, W.K. |
Letter Regarding the Relationship Between the Consumption of Crystalline Glucosamine Sulfate and a Reduced Risk of Osteoarthritis (Docket No. 2004P-0060) URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073415.htm Format:
Letter that denies a petition for a health claim regarding dietary supplementation of crystalline glucosamine sulfate and the risk of osteoarthritis
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20041007Oct 7, 2004 |
| 6237 | Hubbard, W.K. |
Letter Regarding the Relationship Between the Consumption of Glucosamine and/or Chondroitin Sulfate and a Reduced Risk of: Osteoarthritis; Osteoarthritis-related Joint Pain, Joint Tenderness, and Joing Swelling; Joint Degeneration; and Cartilage ... URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073400.htm Format:
Letter that denies a petition for qualified health claims regarding glucosamine or chondroitin sulfate and the risk of osteoarthritis, joint degeneration, cartilage deterioration, and osteoarthritis-related joint pain, tenderness, and swelling
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20041007Oct 7, 2004 |
| 5018 | Engle, M.K./Bureau of Consumer Protection, Federal Trade Commission |
[Letter to Internet Advertisers of Products Claiming to Affect Cortisol] URL: http://www.ftc.gov/os/caselist/windowrock/041005ltrwindowrock.pdf Format:
Letter regarding marketing claims that products cause weight loss or produce other health benefits by affecting cortisol that are not supported by scientific evidence
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Source: Office of the Secretary, Federal Trade Commission
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20041001Oct 1, 2004 |
| 4849 | Hubbard, W.K. |
Letter Responding to Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No. 2003Q-0401) URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072932.htm Format:
Letter regarding a qualified health claim on dietary supplements and conventional foods regarding the consumption of eicosapentaenoic acid [EPA] and docohexaenoic acid [DHA] omega-3 fatty acids and a reduced…
Letter regarding a qualified health claim on dietary supplements and conventional foods regarding the consumption of eicosapentaenoic acid [EPA] and docohexaenoic acid [DHA] omega-3 fatty acids and a reduced risk of coronary heart disease. Includes discussion of FDA's review of the qualified health claim, including a safety review, issues associated with fish and mercury, and other related issues
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20040908Sep 8, 2004 |
| 4848 | Hubbard, W.K. |
Letter Responding to Health Claims Petition dated June 23, 2003 (Wellness petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No. 2003Q-0401) URL: http://www.fda.gov/SiteIndex/ucm072932.htm Format:
Letter regarding a qualified health claim on dietary supplements and conventional foods regarding the consumption of eicosapentaenoic acid [EPA] and docohexaenoic acid [DHA] omega-3 fatty acids and a reduced…
Letter regarding a qualified health claim on dietary supplements and conventional foods regarding the consumption of eicosapentaenoic acid [EPA] and docohexaenoic acid [DHA] omega-3 fatty acids and a reduced risk of coronary heart disease. Includes discussion of FDA's review of the qualified health claim, including a safety review, issues associated with fish and mercury, and other related issues
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20040908Sep 8, 2004 |
| 4149 | Food and Drug Administration (FDA) |
FDA Warns Distributors of Dietary Supplements Promoted Online for Weight Loss URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108274.htm Format:
Release regarding FDA's warning to distributors of dietary supplements over the Internet regarding false and misleading claims for weight loss products. Includes a link to follow to access copies…
Release regarding FDA's warning to distributors of dietary supplements over the Internet regarding false and misleading claims for weight loss products. Includes a link to follow to access copies of the warning letters that were sent
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Source: Food and Drug Administration
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20040401Apr 1, 2004 |
| 3372 | Food and Drug Administration (FDA) |
Food Labeling: Health Claims; Dietary Guidance URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-29448.htm Format:
Advance notice of proposed rulemaking, issued to solicit comments regarding the regulation of health claims and dietary guidance statements in the labeling of conventional foods and dietary supplements. The…
Advance notice of proposed rulemaking, issued to solicit comments regarding the regulation of health claims and dietary guidance statements in the labeling of conventional foods and dietary supplements. The comment period has been extended. See 69 FR 3868, available through GPO Access
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Source: Federal Register, Vol. 68, No. 227, Nov. 25, 2003, p. 66040-66048./Division of Dockets Management, Food and Drug Administration
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20031125Nov 25, 2003 |
| 3230 | Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Summary of Qualified Health Claims Permitted URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073992.htm Format:
Fact sheet providing an overview of permitted qualified health claims, including required claim statements, eligible foods, and conditions of use
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Source: Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20030900Sep 2003 |
| 3090 | Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Guidance for Industry: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims: Small Entity Compliance Guide URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0347-gdl0001.pdf Format:
Guidance document that explains the legal requirements set forth in 21 CFR 101.9 and 101.36 regarding the declaration of trans fatty acids on the nutrition labels of foods and…
Guidance document that explains the legal requirements set forth in 21 CFR 101.9 and 101.36 regarding the declaration of trans fatty acids on the nutrition labels of foods and dietary supplements
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Source: Food and Drug Administration
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20030800Aug 2003 |
| 2865 | Task Force on Consumer Health Information for Better Nutrition, Food and Drug Administration (FDA) |
Consumer Health Information for Better Nutrition Initiative: Task Force Final Report URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm096010.htm Format:
Report of this task force that was part of the Consumer Health Information for Better Nutrition Initiative. It includes the transmittal memorandum, an overview and executive summary of the…
Report of this task force that was part of the Consumer Health Information for Better Nutrition Initiative. It includes the transmittal memorandum, an overview and executive summary of the situation and the work of the Task Force, and several attachments. Attachments include "Possible Regulatory Frameworks for Qualified Health Claims in the Labeling of Conventional Human Food and Dietary Supplements," "Guidance: Interim Evidence-Based Ranking System for Scientific Data," "Consumer Studies Research Agenda -- Improving Consumer Understanding and Product Competition on the Health Consequences of Dietary Choices," "Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements," "?One-Year? Time Line for Qualified Health Claim Activities," "Task Force Membership," "Stakeholder Meetings Summary," and "Public Dockets Comments Summary"
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20030710Jul 10, 2003 |
| 5082 | Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm053832.htm Format:
Guidance document that outlines FDA's interim procedures for responding to qualified health claim petitions
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20030710Jul 10, 2003 |
| 3232 | Taylor, C.L. |
Phosphatidylserine and Cognitive Dysfunction and Dementia (Qualified Health Claim: Final Decision Letter) URL: http://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm072999.htm Format:
Letter in response to a petition to authorize health claims regarding the effects of phosphatidylserine consumption on dementia and cognitive dysfunction in the elderly. Includes discussion of the safety…
Letter in response to a petition to authorize health claims regarding the effects of phosphatidylserine consumption on dementia and cognitive dysfunction in the elderly. Includes discussion of the safety review, the scientific evidence, and other issues
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Source: Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20030513May 13, 2003 |
| 2066 | Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm Format:
This guidance document explains the FDA's criteria for considering exercising enforcement for health claims in dietary supplement and conventional foods labeling. It has been superceded by "Guidance for Industry…
This guidance document explains the FDA's criteria for considering exercising enforcement for health claims in dietary supplement and conventional foods labeling. It has been superceded by "Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements" and "Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data"
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Source: Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration hide details |
20021218Dec 18, 2002 |
| 2828 | Cleland, R.L.; Gross, W.C.; Koss, L.D.; Daynard, M.; Muoio, K.M. |
Weight-Loss Advertising: An Analysis of Current Trends URL: http://www.ftc.gov/bcp/reports/weightloss.pdf Format:
Report of an analysis of weight loss advertising and claims. Sections include "An Overview," "Collection Methodology and Coding," "Analysis of Weight-loss Advertisements" (including "Claims by Category"), "Historical Comparison: 1992/2001,"…
Report of an analysis of weight loss advertising and claims. Sections include "An Overview," "Collection Methodology and Coding," "Analysis of Weight-loss Advertisements" (including "Claims by Category"), "Historical Comparison: 1992/2001," "Regulatory Framework," "Media Responsibility," and "Conclusion." Appendices include "Product List" and "Examples of Questionable Ad Claims From 2001 Sample"
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Source: Federal Trade Commission
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20020900Sep 2002 |
| 2067 | Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
Guidance for Industry: Structure/Function Claims Small Entity Compliance Guide URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm103340.htm Format:
Guidance document on regulations related to structure/function claims and distinguishing structure/function claims from disease claims for dietary supplement labeling
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration
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20020111Jan 11, 2002 |
| 1463 | Elliott, V.S. |
Code Green: Seeing the Side Effects of Alternative Supplements URL: http://www.ama-assn.org/amednews/2001/03/05/hlsa0305.htm Format:
This report discusses side effects of herbal supplements as well as labeling and diagnosis issues. It also includes, under "Additional information," the reasons for taking, adverse reactions, and other…
This report discusses side effects of herbal supplements as well as labeling and diagnosis issues. It also includes, under "Additional information," the reasons for taking, adverse reactions, and other drug conflictions of ephedra/ma huang, St. John's Wort, kava kava, yohimbine, and ginkgo biloba
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Source: American Medical News, Mar 5, 2001, American Medical Association
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20010305Mar 5, 2001 |
| 1486 | Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA)/Research Triangle Institute (RTI) |
Dietary Supplement Sales Database (DSPD) URL: http://foodrisk.org/exclusives/DSPD/ Format:
A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The Access database contains labeling and catalogue information of approximately 3,000 dietary supplement products sold in the…
A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The Access database contains labeling and catalogue information of approximately 3,000 dietary supplement products sold in the United States. The database includes information such as the product's name, the name and address of the manufacturer or distributor, the product's ingredients, and claims about the product. Claims may be about the health benefits or nutrient content of the product or may be nutritional support statements. Thus, the database provides information on the range of products available for sale in the United States, where these products are sold, what they contain, and what claims are being made about these products. Also available are the final report of the project, which includes information on the procedures used and a description of the database, and a supplement to the final report, which includes detailed records from the data collection process
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Source: FoodRisk.org
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19991000Oct 1999 |
| 4567 | Food and Drug Administration (FDA) |
Food Labeling: Health Claims and Label Statements; Folate and Neural Tube Defects URL: http://foodrisk.org/downloads/FR/1996/FR_V61_N44_P8752-8781.htm Format:
Final rule that authorizes the use of health claims on food and dietary supplement labels regarding the association between adequate folate intake and the risk of neural tube defects.…
Final rule that authorizes the use of health claims on food and dietary supplement labels regarding the association between adequate folate intake and the risk of neural tube defects. Includes discussion of this association, a summary of comments in response to the proposed rule and the FDA's responses, and discussion of the economic impact of this rule
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Source: Federal Register, Vol. 61, No. 44, Mar. 5, 1996, p. 8752-8781./FoodRisk.org
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19960305Mar 5, 1996 |
| 2892 | Food and Drug Administration (FDA) |
Dietary Supplement Health and Education Act of 1994 URL: http://www.fda.gov/RegulatoryInformation/Legislation/default.htm Format:
Public Law 103-417, 103rd Congress. This act amends the Federal Food, Drug, and Cosmetic Act with regards to dietary supplements
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Source: Food and Drug Administration
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19941025Oct 25, 1994 |
| 8019 | Office of Dietary Supplements |
Dietary Supplement Ingredient Database URL: http://dietarysupplementdatabase.usda.nih.gov/ Format:
The Nutrient Data Laboratory (NDL), Beltsville Human Nutrition Research Center (BHNRC), part of the USDA Agricultural Research Service, working with the Office of Dietary Supplements, NIH, and other federal…
The Nutrient Data Laboratory (NDL), Beltsville Human Nutrition Research Center (BHNRC), part of the USDA Agricultural Research Service, working with the Office of Dietary Supplements, NIH, and other federal agencies, has developed a Dietary Supplement Ingredient Databases (DSID) to estimate levels of ingredients in dietary supplement products.
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Source: National Institutes of Health
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| 8018 | Food and Drug Administration (FDA) |
Dietary Supplement Labeling URL: http://www.fda.gov/food/dietarysupplements/dietarysupplementlabeling/default.htm Format:
Requirements and guidance for labeling and making claims for supplements (e.g. qualified and structure/function claims).
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Source: Food and Drug Administration
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| 1278 | Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) |
[ARCHIVE] Dietary Supplements/Food Labeling Electronic Newsletter (FDA-DSFL) URL: http://web.archive.org/web/20080617155151/http://www.cfsan.fda.gov/~dms/infonet.html Format:
Newsletter that addresses dietary supplements, food labeling and nutrition issues. Archives of past newsletters are available
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration
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| 1901 | International Cyber Business Services, Inc. |
Products Containing Ephedrine URL: http://www.holisticonline.com/Herbal-Med/_Herbs/products_containing_ephedra.htm Format:
Table of products that contain ephedrine. It includes product name, manufacturer, the amount of ephedrine per serving, whether caffeine is present, form, and the use/label claim
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Source: International Cyber Business Services, Inc.
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