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Demystifying Dietary Supplement Claims part I: What is and What …

WebSince the enactment of the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA has lacked authority to approve structure/function claims (and …

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URL: https://www.burdockgroup.com/demystifying-dietary-supplement-claims-part-i-what-is-and-what-isn-t-a-structure-function-claim

The Difference between “Food” and “Functional Food” and the

WebGuidance provided by FDA for SFC states that “the FTC has typically applied a substantiation standard of ‘competent and reliable scientific evidence’ to claims about the …

Category: Health Go Health

Structure / Function Claims: Not Just for Supplements Anymore

WebTraditionally, when a regulator, a consultant, or an ingredient marketer thought of “claims,” they pigeon-holed them into two broad categories, (1) structure / function …

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What Makes a Beverage a Supplement or a Conventional Food

WebThe framers of the bill, which eventually became the Dietary Supplement Health and Education Act, were logical in their thinking that a dietary supplement should …

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Dietary Supplements in the U.S. and Abroad: Similarities and …

WebThe annual growth rate of dietary supplements in the U.S. was 7.1% between 2008 and 2012. According to one survey, the U.S. and Asia lead the world in supplement …

Category: Supplements Go Health

Adverse Event Reporting for Dietary Supplements and OTCs: What …

WebAn adverse event is defined as “any health-related event associated with the use of a dietary supplement that is adverse.” (Section 761 (a) (1) of the FD&C Act (21 …

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Claims: The United States and European Perspective

WebIn the United States (U.S.), several different types of claims can be made for dietary supplement ingredients (depending on the ingredient and degree of support for …

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Grandfathered Dietary Ingredients, DSHEA, and the New Draft …

WebDietary ingredients having a “history of use” in accordance with the “Dietary Supplement Health and Education Act of 1994” (DSHEA) are not new dietary ingredients …

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International Regulations on Dietary Supplements: Challenges and

WebAn aging population has increasingly become a global phenomenon, not just in developed countries, but also among emerging regions.1 The shift to an elderly population adds to …

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Insect Protein: What are the Food Safety and Regulatory Challenges

WebQuestions on protein availability and quality have been around since the 1950s, under the idea of the “World Protein Gap” [5] (seen as a cause of health issues in …

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Regulatory Framework of Terpenes for Dietary Supplements

WebThe pharmacological potential of terpenes also makes them appealing candidates for ingredients for dietary supplements; for instance, d-limonene, a terpene …

Category: Supplements Go Health

Can a Food Be a Drug and a Supplement

Web“Let food be thy medicine and medicine be thy food” — Hippocrates of Cos (ca.460 BC – ca. 370 BC)The Drug-Like Properties of FoodsMany foods have drug-like …

Category: Food, Medicine Go Health

Updated Health Food Registration and Notification Process in China

WebIn China, the concept of “Health Food” encompasses both functional food and dietary supplement. It refers to any food with claimed health beneficial functions or those …

Category: Food Go Health

Colors from Natural Sources: Are They Safe for New Uses

WebWith today’s focus on “clean” labels, food manufacturers are replacing artificial colors with colors from “natural” sources. Some of these substances have …

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What data will FDA consider as evidence that a substance is a pre …

WebOn Oct.3, 2017, the Food and Drug Administration (FDA) held a public meeting to discuss the development of a list of substances that were in use as dietary ingredients prior to …

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Ask the Expert: Are Naturals Necessarily Better

WebAre naturals necessarily better? On Wednesday, February 23rd, George A. Burdock, Ph.D., President of Burdock Group, answered this question along with viewers' …

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“The Dose Makes the Poison” – The Right and Wrong Way to …

WebIntroduction The first lesson in toxicology is that “the dose makes the poison”; meaning that all things are toxic, even water when consumed in unsafe quantities. In this …

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The Heated Debate over FTC Claims Substantiation and the …

WebSubstantiation of health claims has been under scrutiny by the Federal Trade Commission (FTC) since its 1972 decision in the Pfizer case, which established the …

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