Botanical Safety Taken on by New Consortium

Dr. Cynthia Rider leads several NTP studies that evaluate the safety of botanicals such as echinacea, black cohosh and valerian root.

Photo:  Steve McCaw

Looking to address concerns about the safety of botanicals, NIEHS joined forces with FDA and the nonprofit Health and Environmental Sciences Institute (HESI) to form the Botanical Safety Consortium, through a recent memorandum of understanding. The group serves as a collaborative forum on botanical safety research, drawing global scientists from government, academia, consumer health groups, industry and nonprofit organizations. 

Information on opportunities to contribute to and participate in the consortium are available at http://botanicalsafetyconsortium.org/. This page includes an application form that stakeholders can submit to note their interest. 

“There are legitimate concerns about the lack of safety data and variable quality of products in the marketplace,” said Dr. Cynthia Rider, a toxicologist at NIEHS’s Division of the National Toxicology Program (NTP). “The Botanical Safety Consortium is dedicated to providing a sound scientific basis for using cutting-edge toxicological tools to evaluate the safety of botanical ingredients.” 

NIH and the National Center for Health Statistics conducted a study from 2002 to 2012 and reported that approximately 18 percent of Americans use botanical supplements. According to the NIH Dietary Supplement Label Database, there are an estimated 27,000 such supplements on the market. These products are intentionally marketed for their health effects yet have few of the usual standards of quality, effectiveness and safety that are applied to pharmaceuticals, said NTP associate director Dr. Brian Berridge. “The consortium will enable this field to collaboratively identify the most pressing challenges in botanical safety,” he said. “The community can then develop approaches to address those challenges.”  

The Botanical Safety Consortium has the following objectives:

• Engage with a broad group of stakeholders to apply the best scientific approaches.
• Establish levels of various chemicals to characterize complex biological products.
• Identify cell- and computer-based toxicity assays to evaluate botanical safety.
• Evaluate these tools through comparison to available safety information.
•  Integrate these tools and approaches into a framework for effective evaluation of botanical substances.

According to the NIH Dietary Supplement Label Database, there are an estimated 27,000 botanical supplements on the market.

“NTP, working with scientific partners and stakeholders, is uniquely positioned to build a better understanding of the possible harms from botanicals,” said Berridge. “A better understanding of harms will allow the industry to design safer products and the public to make better informed choices.” 

As convener and facilitator of the consortium, HESI drafted specific guidelines for membership and participation in the effort. “We are in the process of identifying interested parties who would like to engage with us, particularly as members of the Stakeholder Council or as experts for the technical working groups,” said HESI associate director Dr. Michelle Embry.

The consortium is one pillar of a recent FDA statement about new steps to modernize dietary supplement regulation. The group plans to hold an informational meeting in Washington, D.C., on May 29 to recruit new members and solicit input into current scientific challenges and opportunities related to botanical dietary supplement safety. The meeting will be webcast.—Marla Broadfoot