Highlights from the American Conference Institute’s 2nd Annual Legal, Regulatory and Compliance Forum on Dietary Supplements and Nutritionals

Published on August 1, 2014

The 2nd Annual Legal, Regulatory and Compliance Forum sponsored by the American Conference Institute (ACI)…

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Serious Adverse Events: Are SAEs as underreported as GAO suggests? (Part II)

Published on December 1, 2013

In Part II of this two-part series, we pick up from Part I by further…

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Serious Adverse Events: Are SAEs as underreported as GAO suggests? (Part I)

Published on September 1, 2013

In Part I of this two-part series, background will be provided regarding the origin and…

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Diacetyl: Inhalation of a GRAS Substance Not GRAS When It Came to Lung Disease

Published on March 1, 2013

Nearly everyone knows how it feels to swallow a bite of food or sip of…

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Grandfathered Dietary Ingredients, DSHEA, and the New Draft Guidance

Published on December 1, 2012

Dietary ingredients having a “history of use” in accordance with the “Dietary Supplement Health and…

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New draft NDIN guidance – Timeline

Published on March 1, 2012

Dietary Supplement Health and Education Act of 1994 (DSHEA) enacted on October 14, 1994 and…

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Holiday Fare and Pets

Published on December 1, 2011

“Mistletoe, holly, Santa Claus jolly… and, oops! The pet’s not feeling so well.”   Not…

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FDA’s New Draft Interpretation of DSHEA: Notifications by the Number

Published on September 1, 2011

On July 1, 2011, four days ahead of the July 5th deadline imposed by the…

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Adverse Event Reporting for Dietary Supplements and OTCs: What is required and when? How does postmarketing surveillance fit in?

Published on March 1, 2011

No over-the-counter (OTC) drug or dietary supplement manufacturer wants a consumer to sicken, become incapacitated…

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Food Factoid: Stevia

Published on December 1, 2010

Stevia, the all-natural sweetener and sugar-substitute, is derived from the leaves of the Stevia rebaudiana…

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DSHEA Post-IND: Can A Supplement Be Marketed After Its Inclusion in an IND?

Published on October 1, 2010

New questions have arisen concerning the approval of substances as dietary supplements which may have…

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