March 2016

Botanical Dietary Supplement Safety Assessment and Challenges

In the U.S., botanical dietary supplements are regulated as foods, but with additional established requirements for labeling, cGMP, adverse event reporting, and several more.

Botanicals dietary supplements have a number of unique characteristics that add to the complexity of assessing their safety. They are complex mixtures with chemical constituents and active ingredient(s) that may or may not be defined, and their biological activity may not be well characterized.

The National Toxicology Program (NTP), an interagency program under the National Institutes of Environmental and Health Sciences (NIEHS) is organizing the April 26-27, 2016 workshop, Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety. The workshop will convene experts from government, industry, and other organizations to discuss several of the challenges and propose practical solutions (registration closes on April 12).

Dr. Cynthia Rider, a toxicologist at the NTP and the contact person for this event, explains that “Evaluating the safety of botanical dietary supplements can be challenging because they are often complex mixtures and the composition of products with similar labels can vary widely across the marketplace. The NTP has organized a workshop to focus attention on key issues related to appropriate methods for the evaluation of botanical dietary supplements in order to inform future research.”

Our latest In the Spotlight article, “Botanical Dietary Supplement Safety Assessment and Challenges,” provides background information on several topics relevant to the workshop, such as: the regulation of botanical dietary supplements in the U.S., the NTP Botanical Dietary Supplements Program, methods and unique challenges encountered in assessing botanical dietary supplement safety, and industry progress in the use of in vitro methods to identify botanical-drug interactions.

Dr. Amy Roe, Senior Scientist at Procter & Gamble, explains that “As herbal product usage in combination with conventional medicines continues to increase, the potential for herb-drug interactions should be evaluated. A number of well-established in vitro human metabolic systems are available; including fully-integrated primary hepatocyte systems with proven in vitro to clinical correlation.”

ARDF Grant Application Deadline - May 2

The Alternatives Research and Development Fund (ARDF) will award up to $40,000 to individual projects with the potential to significantly replace or reduce laboratory animals in research. This year, preference will be given to projects that use pathway-based approaches as exemplified by the 2007 National Academy of Sciences report, Toxicity Testing in the Twenty-first Century: A Vision and A Strategy. Applications must be received by Monday, May 2. Guidelines and application form available here:

IFER Grant Application Deadline - April 29

The International Foundation for Ethical Research (IFER) is accepting pre-proposal applications for 2016-2017 Graduate Fellowships. Applications are due no later than 5:00 pm CDT on Friday, April 29, 2016. IFER Graduate Fellowships are one-year grants of up to $15,000 for projects that support the development, validation, and implementation of innovative scientific methodologies that advance science and replace the use of animals in research, testing or education. More information can be found on the IFER website:

EPA invites public comments on draft waiver guidance for dermal toxicity testing

EPA released draft guidance for public comment, “Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations.” EPA is accepting comments on the draft policy for 60 days, until May 16, 2016. Comments should be marked Docket No. EPA-HQ-OPP-2016-0093 and filed via

New & Updated Information on

In the Spotlight

Botanical Dietary Supplement Safety Assessment Challenges

Upcoming Events

In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products
April 4-6, Bethesda, Maryland

Toxicology and Risk Assessment Conference
April 4-7, Cincinnati, Ohio

Organ-on-a-Chip Europe
April 5-6, Cambridge, UK

Biocuration 2016
April 10-14, Geneva, Switzerland

National Toxicology Program Board of Scientific Counselors Meeting
April 11, Research Triangle Park, North Carolina

OpenTox USA
April 11-12, Baltimore, Maryland

Pan- American Conference for Alternative Methods
April 14-16, Baltimore, Maryland

ECHA Topical Scientific Workshop – New Approach Methodologies in Regulatory Science
April 19-20, Helsinki, Finland

Course: In silico ADME and Predictive Toxicology
April 25-29, University of Copenhagen, Denmark

NICEATM webinar series, Alternative Approaches for Acute Inhalation Toxicity to Address Global Regulatory and Non-regulatory Data Requirements, Webinar 2: State-of-the-science, Practical Application, and Dosimetry Considerations for In Vitro and Ex Vivo Methods
April 26, 11:00 AM-12:00 PM EDT

Cell Culture Engineering XV
May 8-13, Palm Springs, California

More events >


Recent Blog Posts

Mechanistic Oral Absorption Modeling and Simulation – FDA Workshop, May 19, 2016

Join SETAC in Advancing the Adverse Outcome Pathway Concept

New Guidance Documents for Pesticide Testing and GHS Pilot Program Support EPA OPP’s Goal to Reduce Animal Testing

AltTox Editorial Board and Management Team members at SOT 2016

Webinar Series on Inhalation Toxicity Begins March 29

Hands-On AOP Seminar at SOT: Creating an Adverse Outcome Pathway in the AOP Wiki

February ECHA Newsletter

Congratulations to the 2015 NC3Rs Prize Winners

ASCCT Webinar: Integrating In Silico Predictions with Physiologically Based Pharmacokinetic (PBPK) Modeling

Good Read-Across Practice (GRAP) Guidance Workshop

More on the Community Blog >


Follow AltTox on Twitter
Join AltTox on LinkedIn
Copyright © 2016 The Humane Society of the United States and Procter & Gamble, All rights reserved.


unsubscribe from this list    update subscription preferences