Archive June 2023

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AHPA seeks ‘correction’ from FDA on Pinellia ternata ephedrine alkaloids warning letter

In a 2022 warning letter, the Food and Drug Administration accused a firm of selling a product containing prohibited ephedrine alkaloids, but through a subsequent review of public documents, the American Herbal Products Association concluded the agency failed to do its homework.

Josh Long | Jun 29, 2023

This story begins with an FDA inspection in 2021, which resulted in a 7-page warning letter the following year that “identified serious violations of the Federal, Food, Drug and Cosmetic Act (the Act) and applicable regulations.”

Among other observations, FDA identified an “adulterated” supplement whose product label listed a dietary ingredient called Pinellia ternata. The warning letter to Princess Lifestyles LLC said Pinellia ternata contains ephedrine alkaloids, which FDA banned in 2004 in dietary supplements based on a determination that the alkaloids “present an unreasonable risk of illness or injury.”

FDA, however, never tested Princess Lifestyles’ product to verify the presence of ephedrine alkaloids prior to sending the warning letter, and even when it eventually sampled and analyzed the product as part of a follow-up inspection, the results did not identify “any ephedrine alkaloid at or above the detection threshold,” according to the American Herbal Products Association (AHPA).

AHPA is now awaiting a substantive response to a request that “FDA issue a public correction” regarding the adulteration allegation in the warning letter pertaining to the product labeled as containing Pinellia ternata.

“Absent such a specific statement,” AHPA President Michael McGuffin wrote in an April 19, 2023, letter to Cara Welch, Ph.D., the director of FDA’s Office of Dietary Supplement Programs (ODSP), “I am concerned that Amazon, and possibly other retailers, will continue to require removal of products labeled as containing Pinellia ternata, even though that ingredient is a lawful dietary ingredient if it does not contain ephedrine alkaloids.”

Read full article on Natural Products Insider >>>

AHPA updates seven additional entries to the online Botanical Safety Handbook 2nd Ed.

June 26, 2023

The American Herbal Products Association (AHPA) has released updates to seven botanicals via the online Botanical Safety Handbook 2nd ed.
The following online entries have been updated:
  • Betula spp. (birch) – A review identified a clinical trial and an adverse event report associated with topical use, and a genotoxicity study.
  • Boerhavia diffusa (boerhavia) – Recent review identified additional pharmacology and toxicity studies.
  • Chaenomeles speciosa (flowering quince) – A review updated the botanical nomenclature and added a pharmacology study.
  • Eriodictyon spp. (yerba santa) – A literature review identified two clinical trials, pharmacology studies, and a genotoxicity assay.
  • Medicago sativa (alfalfa) – A review added animal pharmacology studies and an acute toxicity study.
  • Monarda spp. (bee balm) – Recent review identified an acute toxicity study.
  • Withania somnifera (ashwagandha) – A literature review identified additional clinical trial and case report information, as well as additional toxicity studies.
AHPA members can obtain a hard copy or an annual individual subscription to the online Botanical Safety Handbook for $95.00, with multi-user rates available for companies needing expanded access. Information about hard copy purchases and subscriptions can be found on the AHPA website.
Subscribers to the online Botanical Safety Handbook can review short descriptions of updated entries in the "Revisions" panel on the online version homepage when they log in. The online Botanical Safety Handbook is undergoing review of existing entries and the addition of new entries to provide the latest safety information before it can be included in the next print edition of the handbook. AHPA will continue to post additional updates to existing entries as well as develop new botanical entries.
AHPA's Botanical Safety Handbook is an essential tool for anyone who manufactures, recommends, or uses herbal products. The handbook provides safety information on over 500 species of herbs, derived from data compiled from clinical trials, pharmacological and toxicological studies, medical case reports, and historical texts. All entries are reviewed by an Expert Advisory Council that includes some of the most renowned herbal and integrative medicine experts in the United States.


AHPA attends CITES 26th Plants Committee and IADSA Annual Week meetings

   June 22, 2023
Jane Wilson, Director of Program Development for the American Herbal Products Association (AHPA), recently represented AHPA at recent CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora) and IADSA (International Alliance of Dietary/Food Supplement Associations) meetings. The 26th Meeting of the CITES Plants Committee took place in Geneva, Switzerland June 5-9, 2023. The IADSA World Supplement Forum and Annual Week meetings followed on June 13-15, 2023 in Copenhagen, Denmark.
This year marks CITES’ 50th anniversary and five decades of the landmark convention’s work to conserve wildlife across the world. Of note at the 26th CITES Plants Committee meeting were several actions regarding plant species of interest to AHPA members, including the following:
  • Rhodiola spp.: Following its recent inclusion in CITES Appendix II, assessment by the Plants Committee nomenclature specialist indicated a need to identify an authoritative reference of Rhodiola spp.; commonly used botanical references identify from 58 to 90 species in the genus. The nomenclature specialist will use a time stamped extract from Kew Garden’s Plants of the World Online and adjudicate any differences with the species list included in the approved listing proposal.
  • Panax quinquefolius (American ginseng): This species was proposed for inclusion in the CITES review of significant trade process, but was not selected. The U.S. delegation did not support the inclusion of this species.

  • Boswellia spp.: The Plants Committee formed an intersessional working group for ongoing discussion of concerns related to international trade in these species. The working group will consider mandates including identification of meetings or other venues that might provide opportunities to collaborate or share information regarding harvest and management of Boswellia species, and consider a possible range State meeting to be organized by the Secretariat, subject to available funding. India continues to state their opposition to any listing of B. serrata.


The 27th meeting of the CITES Plants Committee is tentatively expected to be held in July 2024, in preparation for the next CITES Conference of the Parties meeting (date to be determined).  
IADSA’s Annual Week meetings started with the World Supplement Forum on June 13. This one-day event featured presentations from:
  • FAO/WHO Codex Alimentarius, celebrating 60 years of standard setting in food safety and quality; the global economic impact of food and nutrition;
  • IADSA, marking 25 years of impact in the international dietary supplements industry;
  • and a summary of the findings of IADSA’s global survey of sustainability in the supplements industry.

Also included were panel discussions on building resilient regulatory frameworks for supplements and perspectives on the strategic outlook for changing mindsets on supplement use.
AHPA was part of the program for the IADSA Annual Week agenda on June 14, with Jane Wilson delivering a presentation on CITES and the Plants Committee activities that took place the prior week. The program also included presentations from several countries in which supplement regulations are in flux or are challenging to the industry, such as Germany, Latin America, China, South Africa, Turkey, and New Zealand. E-commerce and social media influences in the supplement industry were also explored, including a presentation by Katie Banaszewski of AHPA member NOW Foods.

AHPA attends Cosmetic Ingredient Review meeting

June 15, 2023

American Herbal Products Association (AHPA) Chief Information Analyst Merle Zimmermann, Ph.D., attended the 165th Cosmetic Ingredient Review (CIR) Expert Panel Meeting for Cosmetic Ingredient Safety held in a hybrid format in Washington, D.C., June 12-13, 2023.
The purpose of Cosmetic Ingredient Review is to determine those cosmetic ingredients for which there is a reasonable certainty in the judgment of competent scientists that the ingredient is safe under its conditions of use. The meetings include renowned academicians, industry leaders, and government officials from across the U.S. who regularly gather to report on the safety of cosmetics ingredients.
AHPA staff regularly attend the meetings of the CIR Expert Panel to engage and represent our industry regarding herbal cosmetic ingredients.
The June meeting of the expert panel included discussions of CIR safety reports in development on two groups of herbal cosmetic ingredients, Olea europaea (olive) and Zanththoxylum piperitum (Japanese pepper), as well as a revised draft report on yeast derived ingredients. Previous reports on Dioscorea villosa (wild yam), Prunus amygdalus (syn. Prunus dulcis; sweet almond) were revisited by the expert panel, as well as sixteen other groups of ingredients outside the botanical sphere at the session.
The revised draft report on yeast returned this June with a revision now including 56 distinct yeast-based ingredients. The discussion noted that between the established food uses as well as raw material processing which guaranteed lysis/dissolution of the cosmetic ingredients this group of ingredients was simpler to evaluate than previous discussions about red algae derived materials, some of which included live ingredients. The expert panel noted that common food yeasts were certainly well established as safe as used in the current concentration and practice, and voted to hold finalizing the report until the upcoming December 2023 CIR meeting, with an overall report that this class of ingredients are safe as used in the current concentration and practice likely.
For the tentative safety report on Japanese pepper ingredients, the discussion noted that the ingredients were safe as used when formulated to be non-sensitizing. With this conclusion, the report will next advance to a draft final, where the panel will be able to approve it for publication as a final report following a 60-day public comment period.
Another tentative safety report on olive derived ingredients was revisited since a request for additional data issued by CIR in December 2022, and concluded that with the information received and identified food uses, the ingredients derived from the fruit and leaf of the plant was safe as used in the present practices of strength and composition. Following a discussion, the seed and husk were also included as safe as used from the evidence provided in connection with olive fruit. Remaining parts, however, were noted to have insufficient data, including bark, branch, bud, flower, sap, and wood derived ingredients, with most retaining requests from the committee for method of manufacture, 28-day dermal toxicity, and dermal irritation and sensitization data to allow safe use to be well established. Companies working with these ingredients are welcomed to share this information with the expert panel to help support their evaluation as the report is moved towards finalization.
Re-review summaries of wild yam root extract and sweet almond seed meal were also visited by the safety panel, reaffirming previous conclusions of safety. Wild yam root extract was stated safe for use for extracts meeting a similar chemical profile as described in the assessment (with an expected upper limit of 3.5% diosgenin). Sweet almond seed meal also remains safe for topical application to humans in the present practices of use and concentration. Both determinations reaffirm the 2004 and 2005 conclusions regarding these two ingredients.
For the ingredients with insufficient data, additional information is welcomed by the panel.  Companies who wish to share data with the panel are asked to do so as soon as possible for it to be available for consideration prior to the upcoming September 11-12 and December 4-5, 2023 meetings, with 60 days from their posting allowed for as a minimum to be included in the discussion.
Safety information for the other ingredients under consideration is available on the CIR website.
AHPA staff will continue to be involved as herbal ingredients are evaluated by the expert panel. 
"As the regulatory landscape for consumer products in the U.S. maintains a safety focus on prevention, Cosmetic Ingredient Review continues dedicating thoughtful attention to maintaining ongoing validation to help ensure products for the American consumer interested in cleansing, beautifying, promoting attractiveness, or altering the appearance remain safe for use,” said Dr. Zimmermann.
CIR was established in 1976 by the industry trade association (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Care Products Council), with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. Although funded by the Personal Care Products Council, CIR and the review process are independent from the council and the cosmetics industry.

Herbs in History: Calendula & St. John’s Wort

June 14, 2023

Now it’s easier than ever to share herbal history with the click of a button at the top of every entry!

In an effort to preserve and share the fascinating histories of medicinal plants and herbs that have been used around the world for ages, the AHPA Foundation for Education and Research on Botanicals (AHPA-ERB Foundation) is honored to partner with Alain Touwaide, Ph.D., and Emanuela Appetiti of the Institute for the Preservation of Medical Traditions to tell the stories of Herbs in History.

June brings us to calendula and St. John’s Wort. June is also the month of the birth of St. John the Baptist, who became the eponym of Hypericum species. Preview the entries below and visit Herbs in History online to read more.

Calendula (Calendula officinalis L.)


Marigold (Calendula officinalis L.), specifically the variety with yellow-orange flowers, is now well established among medicinal plants. It easily grows in sunny positions and poor, well-drained soils, and is common in flower gardens, rock-gardens, borders, and also pots. Though annual, it self-sows and maintains itself, bringing a touch of sunny, warm color to the environment thanks to its bright flowers that gave her the fame to be the Bride of the Sun (Solis Sponsa). No wonder if its dense flowers with a pungent scent attract hoverflies, and butterflies. | Read more...


St. John’s Wort (Hypericum perforatum L.)

Daughter of the Sun

June is the month of the summer solstice (June 21), the astronomical zenith of the sun, the longest days of the year. It is also the month of St. John’s Wort (Hypericum perforatum L.), which flourishes and covers the land with its sunny-yellow flowers. June is also the month of the birth of St. John the Baptist (June 24), who became the eponym of Hypericum species. | Read more...


About the Project

Herbs in History is made possible by funding from the AHPA-ERB Foundation, as part of the nonprofit foundation’s mission promote education and research on medicinal, therapeutic, and health-promoting herbs. Tune in monthly for thoughtfully detailed historical accounts of herbs you know and love, and learn more about the origins of medicinal plants that have stood the test of time.

AHPA Chief Information Analyst presents at 2023 NIH ODS Dietary Supplement Research Practicum

June 8, 2023 

AHPA Chief Information Analyst Merle Zimmermann, Ph.D. presented at the Mary Frances Picciano Dietary Supplement Research Practicum held by the Office of Dietary Supplements (ODS) on May 24, 2023 at the National Institutes of Health (NIH) campus in Bethesda, MD. The webinar program covered a variety of issues, including background on dietary supplement use in the U.S., regulatory frameworks, support for academic research, and actions being taken to support quality.
AHPA participated in the third day’s session on dietary supplement quality. Dr. Zimmermann provided an overview of AHPA’s work supporting the herbal supplement industry; AHPA educational events, such as the 11th Annual Botanical Congress; and AHPA resources, including the Botanical Safety Handbook, Botanical Identity References Compendium, and the new edition of Herbs of Commerce. He also participated in a panel discussion among the industry and government representatives involved in the dietary supplement marketplace who also presented during the session.
This year's event also included vibrant discussion of the many ways that the regulatory framework in the U.S. provides access to traditional ethnobotanical uses. The U.S. Food & Drug Administration (FDA) shared talks on their regulatory responsibilities related to both pre- and post- market safety, including structure and function claims, from Gerie Foss, J.D., in addition to Rebecca Allen, Ph.D., discussing regular inspections of manufacturers with a prioritized focus on those the FDA identified as high risk. Federal Trade Commission staff member Mary Johnson, J.D., presented on her agency’s activities around supplements, focused around truthful and non-misleading advertising and the need for companies to have a basis in studies and research to support wellness claims.
AHPA has several educational webinars available on-demand with helpful information related to FDA inspections and dietary supplement claims, including “cGMP Facility Inspections Conducted by FDA: How Inspection Ready Are You,” “Setting Specifications on Strength & Composition,” “Post-Market Surveillance & Adverse Event Reports,” and “Navigating the Maze of Claims in the Dietary Supplements Market.”
One of the herbal highlights of the event took place during a session moderated by Dr. Barbara Sorkin, which included a particularly striking presentation from Ina Vandebroek, Ph.D., of the New York Botanical Garden. Dr, Vandebroek discussed ethnobotany and its translation to biomedical research, with her and Ella Vardeman, a Ph.D. candidate at the City University of New York, covering how the dietary supplement product class has allowed continued access to wellness traditions from regions in the Caribbean. Later in the same session, Nadja Cech, Ph.D., from the University of North Carolina at Greensboro, gave a presentation on the synergistic effects within botanicals and their positive impacts on health compared to individual marker compounds or chemical constituents and methods to study these synergistic effects.
Sessions on tools and best practices for research support rounded out the event, providing a firm foundation for scientists interested in partnering with NIH or ODS in dietary supplements and health.  AHPA’s presentation also touched on research, with a showcase of the grant activities of the AHPA-Education and Research on Botanicals Foundation, its regular biannual review of grant proposals and current projects supported by the foundation.
"The Office of Dietary Supplements at the National Institute of Health does a great public service through regularly organizing these events to support a broader understanding of wellness practices and tools brought to bear across the United States,” said Dr. Zimmermann. "AHPA’s regular participation has helped inform these members of the academic and medical professions of the deep commitment and support our trade and members receive through the association in our pursuit of excellence for the over three quarters of Americans who make them part of their lives. AHPA is thankful for the opportunity to share the voice of the herbal products industry at this important educational event."
NIH’s ODS Practicum was first held in May 2007, and was developed by Mary Frances Picciano, a Senior Nutrition Research Scientist at ODS until her passing in 2010. The practicum brings together representatives from government, commercial, and academic backgrounds, providing an annual opportunity for building a better understanding of how all these contributors to the dietary supplement market in the United States are committed to excellence. This year, approximately 300 full-time health care providers as well as academic faculty, research practitioners, doctoral students, postdocs, and fellows involved in dietary supplement research and students in allied health schools participated live at each session of the 3-day practicum, with over 1,600 registrations received in advance for the event.
Recordings from the practicum will be available to the public later this spring.

AHPA Chief Science Officer to lead two sessions at The Mushroom Summit


June 19-20, 2023 | Colorado Convention Center | Denver, CO

The Mushroom Summit 2023 will bring together industry veterans, entrepreneurs, investors, scientists and the curious to share knowledge, best practices and a common vision to support the strong, sustainable and responsible growth of this emerging sector.
Holly E. Johnson, Chief Science Officer of the American Herbal Products Association (AHPA), will moderate two sessions over the course of the 2-day event: "Mycelium on Grain vs Fruiting Body: Quality Control & Mushroom Biology" and "Extraction, Testing, and Measurement: Opportunities and Challenges for Industry Driven Standardization."
Dr. Johnson will be joined by several AHPA members with expertise in fungi and mushrooms for each session, as detailed below. AHPA members with interest are encouraged to attend the summit.

Monday June 19, 2023 • 4:15pm - 5:15pm MDT
Mycelium on Grain vs Fruiting Body: Quality Control & Mushroom Biology
Perhaps there is no greater topic of interest - and even division - amongst the functional mushroom industry than this one. Is the answer binary, or is it more complicated than simply “choosing a side”? What are the benefits and drawbacks of each, and how can you make the best decision for your product, your business, your consumer and, in some cases your investors?


  • Holly E. Johnson, Ph.D., Chief Science Officer, AHPA
  • Danielle Ryan Broida, Associate Brand Manager, Innovation, Four Sigmatic
  • Jeff Chilton, President, Nammex
  • Julie Daoust, Ph.D., Chief Scientific Officer, M2 Ingredients/Om Mushroom
  • Christopher Hobbs Ph.D., Institute for Natural Products Research, Consultant, Mushroom Harvest
  • Regan Nally, Ph.D., Senior Research Scientist, Fungi Perfecti

Tuesday, June 20 • 9:15am - 10:00am MDT
Extraction, Testing, and Measurement: Opportunities and Challenges for Industry Driven Standardization
Industry standardization can help accelerate the growth and reputation of the products and services delivered by an entire ecosystem. Look no further than what the standardization of USB cables did for the electronics industry as evidence, but when it comes to a product that grows naturally, and subject to a number of variables, how can an industry adopt universal standards for extraction, testing and measurement in a fair and effective manner? Also, are there any negative consequences to adopting standardizations that needs to be addressed by the industry? These types of conversations are not only vital to the growth of the functional mushroom industry, but can help ensure the entire sector is “lifted up” with a rising tide that considers fairness, opportunity and efficiency as key benchmarks.

  • Holly E. Johnson, Ph.D., Chief Science Officer, AHPA
  • Jeff Tassill, Founder, Alita Bioscience Corporation
  • Josh Swider, Co-Founder and Chief Executive Officer, Infinite Chemical Analysis Labs
  • Dr. Sidney Sudberg, Founder, CSO, Alkemists Labs

Dr. Stefan Pasiakos to lead NIH Office of Dietary Supplements

June 5, 2023

The National Institutes of Health (NIH) announced last week the selection of Stefan M. Pasiakos, Ph.D., FACSM, to serve as director of NIH’s Office of Dietary Supplements (ODS). Dr. Pasiakos will begin his new role as ODS Director on July 16, succeeding Dr. David M. Murray, who has served as Acting Director of ODS since January.
Dr. Pasiakos holds a Ph.D. in Nutritional Science and has published more than 150 scientific articles in the areas of diet and supplemental nutrition, muscle physiology, human performance, and bioenergetics of exercise metabolism. As a Research Physiologist and Chief of the Military Performance Division at the United States Army Research Institute of Environmental Medicine (USARIEM), Dr. Pasiakos directs a research team focused on physical and behavioral resiliency and performance in military training and operational settings.
In his new role at ODS, Dr. Pasiakos will “help lead NIH efforts in expanding the scientific knowledge base on dietary supplements, enhancing the dietary supplement research workforce, foster the development and dissemination of research resources and tools, and translating dietary supplement research findings into useful information for consumers, health professionals, researchers, and policymakers.”
“AHPA welcomes the selection of Dr. Pasiakos as ODS Director,” said Michael McGuffin, President of the American Herbal Products Association (AHPA). “We look forward to working with him and his team in support of advancing the science and safety of dietary supplements.”

AHPA to attend CITES Plants Committee meeting in Geneva

June 2, 2023

The 26th meeting of the CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora) Plants Committee will convene next week, June 5-9, in Geneva, Switzerland. Jane Wilson, Director of Program Development, will represent the American Herbal Products Association (AHPA) at the meeting. This will be the tenth CITES Plants Committee meeting – in addition to two Conference of the Parties meetings – that AHPA has attended as an authorized observer since the association initiated direct involvement with CITES in 2002.

CITES is an international agreement that became effective in 1975 and currently includes 182
countries and the European Union as members (known as “Parties”). CITES establishes specific requirements for plant and animal species that are intended to protect the listed species from extinction, endangerment, and exploitation in international trade.
Of significance to AHPA members and the wider industry are CITES-listed botanical species used in dietary supplements and other natural products that are subject to CITES controls. Most recently, at the 19th Conference of the Parties in November 2022, all species of Rhodiola spp. were added to CITES Appendix II, and the listing became effective as of February 2023.
“CITES listing of plant species have a direct impact on manufacturers and marketers of products containing these botanicals as ingredients,” explained Wilson. “It is crucial to keep our members informed of CITES requirements that may impact their supply and sourcing, and we are committed to doing so by attending CITES Plants Committee meetings and developing guidance materials.”
AHPA first published its CITES primer in November 2013 to provide an understanding of the processes and practices that must be followed to be in compliance when importing and exporting CITES-listed species. The primer was recently updated to reflect newly listed species, including rhodiola, and is available to AHPA members at no cost.
Additionally, AHPA hosted a webinar entitled “CITES Impact on Your Supply Chain” in January 2023 to provide an overview of CITES and the listing of rhodiola. The webinar features a Q&A session with a representative from U.S. Fish & Wildlife Service, the federal agency designated to carry out the provisions of CITES in the U.S, and is available to access on-demand.

A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

The mushroom renaissance has led to diverse product development, as stakeholders construct a long runway for future innovation.

By Sean Moloughney, Editor • 06.01.23

A fascination with fungi has spread quickly throughout the U.S.—and for good reason. According to the U.S. Forest Service: “The fungus kingdom is enormous in its diversity, with over 100,000 described species. It includes yeasts, molds, rusts, and the familiar mushrooms. Fungi are the primary decomposers and recyclers of the planet, breaking down organic matter and returning it back to the soil where they are absorbed by organisms in the ecosystem, through mutualistic partnerships.”
Various species of mushrooms have been cropping up at farmers markets and restaurants while also starring in ready-to-drink teas, coffees, and other functional beverages, as well as a broad menu of dietary supplements.
Mushrooms have also seeped into popular culture, exemplified by HBO’s hit drama series “The Last of Us”—based on a video game of the same name—in which a “zombie fungus” (Ophiocordyceps unilateralis) overwhelms humanity in an apocalyptic plague.
If that doesn’t sound like your cup of tea, “The Super Mario Bros. Movie”—replete with its toadstool themes, characters, and imagery from the original videogame series—has raked in more than $1.2 billion globally, becoming one of the top animated movies of all time. 
A Convergence of Market Drivers

Why are mushrooms seemingly everywhere, and in everything? They’ve certainly burst into the nutraceuticals market with voracity, as legacy mushroom companies experience a boom and broader brands extend product lines to meet consumer demand.
“People are always looking for new ways to take better care of themselves,” noted Michael McGuffin, president of the American Herbal Products Association (AHPA). So all the attention given to fungi and mushrooms is a clear reflection of consumer interest in health-promoting natural products, he said.
The ongoing influence of Asian cuisine, expansion of the public’s palate, and recognition of the health benefits of mushrooms are all contributing factors, McGuffin suggested. “It's no longer rare to find mushrooms in the grocery store, and I think that's part of what has driven the growth of medicinal mushrooms in dietary supplements.”

Read full article on Nutraceuticals World >>>





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