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Archive August 2025

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AHPA comments on FDA post-market assessment prioritization tool

August 27, 2025
 
The American Herbal Products Association (AHPA) has submitted comments on a method proposed by the Food and Drug Administration to rank substances in food for post-market assessment. This proposed assessment tool scores food chemicals on a variety of criteria to determine which should be subject to further scientific and regulatory scrutiny. 
 
Among its comments, AHPA strongly objected to the inclusion of subjective, perception-based criteria (such as social media attention) in the proposed scoring system, which would compromise an objective evaluation of objective, scientific evidence and potentially misdirect limited public health resources. AHPA's comments further call for greater specificity and standardization of remaining scoring criteria that are related to public health information. In particular, AHPA noted that any evaluation of a given food chemical must consider its specific form, history of use, and exposure context.
 
"The proposed system would apply the same standards to unlawful pesticide residues and staple crops", said Robert Marriott, AHPA Vice President for Government and Regulatory Affairs. "...and As proposed, these standards are critically underdeveloped. AHPA encourages a more detailed approach that narrows its focus to intentional food substances."
 
AHPA will continue to monitor, advise, and report on shifts in FDA approaches to the surveillance and evaluation of ingredients already in the marketplace.

AHPA to launch working group on kava

August 27, 2025

New initiative reflects AHPA’s commitment to support kava and its safe use amid recent regulatory actions

The American Herbal Products Association (AHPA) is forming a new working group on kava (Piper methysticum) in response to recent regulatory actions in Michigan and New York City that affect the availability and sale of kava products. This initiative builds on AHPA’s ongoing efforts to support kava and its safe use.

In March 2024, AHPA released an updated entry for kava in its online Botanical Safety Handbook, 2nd ed., providing comprehensive safety information compiled from clinical research, case reports, and traditional use. In February 2024, the Hawaii Department of Health issued a memorandum finding that traditionally prepared ‘awa (kava) beverages are generally recognized as safe (GRAS) based on a history of common use prior to 1958.
 
“Kava has a deep cultural history and a well-documented record of safe use,” said Holly E. Johnson, Ph.D., AHPA Chief Science Officer. “AHPA is committed to ensuring that both policymakers and consumers have access to accurate, science-based information about this important plant.”

“With regulators taking a closer look at kava, the industry must come together to present a clear and unified voice,” said Robert Marriott, AHPA VP of Regulatory & Government Affairs. “This working group will provide a forum to share knowledge, align strategies, and support responsible commerce — and we welcome participation from across the herbal community.”
 
The AHPA kava working group will hold its first meeting virtually on Friday, September 5, at 10-11am PT / 1-2pm ET. Participation is open to AHPA members as well as other industry stakeholders with an interest in kava. Register to receive the Zoom meeting details.

AHPA President & CEO to speak at 9th Annual SoCal Dietary Supplement Consortium

August 21, 2025



The American Herbal Products Association (AHPA) is pleased to announce AHPA President & CEO Graham Rigby will be a featured speaker at the 9th Annual SoCal Dietary Supplement Consortium on September 19, 2025. The premier event — held in collaboration with the U.S. Food and Drug Administration (FDA) and the American Society for Quality (ASQ) — will bring together industry leaders and regulatory experts in-person in Costa Mesa, CA, with the option to attend virtually also available.

Speaking in the “State of the Industry: FDA & Industry Perspective” session, Rigby will bring his expert insights to a discussion on the current landscape of the dietary supplement sector, including FDA organizational changes, regulatory priorities, enforcement trends, policy developments, and market shifts.

The consortium also features sessions on FDA import operations, supplier qualification, probiotic controls, manufacturing best practices, and more — making it a key event for regulatory, quality, and compliance professionals in the dietary supplement industry.

“I’m honored to be speaking at the SoCal Dietary Supplement Consortium, now in its ninth year,” said Rigby. “This event provides an essential forum for open dialogue between industry and regulators, and I’m grateful to the organizers for creating that space. I look forward to connecting with AHPA members and other professionals committed to strengthening compliance, quality, and consumer confidence in our field.”

AHPA encourages its members and the broader dietary supplement community with interest to register for the SoCal Dietary Supplement Consortium. Whether attending in person or virtually, attendees will gain valuable regulatory insights, practical strategies, and connections to help advance best practices and strengthen the industry.

Unmasking 7-OH: Drawing a line between plant and illegal drug

August 20, 2025

Bold scheduling action of 7-hydroxymitragynine, a kratom metabolite, would offer an unprecedented opportunity for clarity, transparency and regulatory action.

Robert Marriott, AHPA Vice President of Regulatory & Government Affairs, for SupplySide Supplement Journal
 
Last month, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and U.S. Food and Drug Administration (FDA) Commissioner Marty Makary, M.D., announced that FDA had recommended placement of 7-hydroxymitragynine (7-OH) on Schedule I under the Controlled Substances Act (CSA), which would ban it for virtually all uses in the United States.
 
This was cause for celebration among many in industry, not least the American Herbal Products Association (AHPA), which recognized this action as a sign of renewed regulatory attention to drugs falsely labeled as dietary supplements. AHPA members have long expressed frustration at a lack of federal enforcement against companies selling 7-OH products under the guise of dietary supplements.

AHPA publishes good stewardship harvesting brochure for black cohosh

August 19, 2025

The latest publication in AHPA’s series of good stewardship harvesting brochures

The American Herbal Products Association (AHPA) has released a new brochure highlighting good stewardship harvesting practices for black cohosh (Actaea racemosa), a North American native herbaceous perennial in the Ranunculaceae family, widely traded for the medicinal properties of its roots. Produced as part of AHPA’s ongoing educational efforts for the herbal community, the brochure is available for free download from the AHPA website.

“The AHPA good stewardship harvesting brochures are an essential resource for raw materials producers, who share them with the wildcrafters harvesting black cohosh to encourage more sustainable practices. Black cohosh has been in trade for a very long time, and demand for it continues to grow — so the more we can do to promote its sustainable harvest, the better,” said Edward Fletcher, Chair of the AHPA Botanical Raw Materials Committee.

AHPA Project Scientist Holly Chittum, M.S., led the brochure’s development in collaboration with Dr. Jim Chamberlain of the U.S. Forest Service (retired), and with contributions from members of the AHPA Botanical Raw Materials Committee — including Edward Fletcher (Native Botanicals), Nate Brennan (Foster Farm Botanicals), Trish Flaster (Botanical Liaisons LLC), and Steven Yeager (Mountain Rose Herbs). Special thanks also to Dr. Eric Burkhart of Penn State for providing images.
 

AHPA has previously published good stewardship harvesting brochures for American ginseng, goldenseal, oshá, saw palmetto, and boswellia.

AHPA issues updated guidance on food allergen labeling

August 13, 2025
 

The American Herbal Products Association (AHPA) has revised its guidance document on compliance with the Food Allergen Labeling and Consumer Protection Act (FALCPA) to align with the U.S. Food and Drug Administration’s (FDA’s) Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5), issued in January 2025.

 

The primary change is an updated list of “tree nuts,” one of the nine major food allergens that must be declared on product labels under FALCPA. The new FDA list removes several species previously identified as tree nuts in earlier guidance — including coconut — and clarifies that any tree nut not listed is not considered a major food allergen.

First developed in 2019 as a resource for the Chinese herbal products community, AHPA’s guidance is now applicable to all product types subject to FALCPA. Ingredient- and formulation-specific information for Chinese herbal products has been moved to an appendix for ease of reference.

 

The updated guidance is available now at no cost to members on the AHPA website.

IADSA Newsflash for August 2025

August 11, 2025

AHPA is an active member of IADSA, an association focused on the globalization of food supplement markets and regulatory challenges. AHPA distributes the IADSA Newsflash This issue covers:

 

  • Korea has proposed amendments to several functional ingredients listed in its Health Functional Food Code.
  • Indonesia has issued stricter guidelines for assessing and registering probiotic products.
  • Japan continues to issue reforms to operational practices for manufacturers of supplement products in response to the red yeast rice incident.
  • Taiwan has added knee joint care as a recognized health care effect under its Health Food Control Act..
  • Vietnam has proposed a new food safety framework that also applies to food supplements.
  • The European Parliament may take action to control the online marketing of supplement products that target minors.
  • The European Food Safety Agency (EFSA) has released a draft scientific opinion on the safety of preparations from sweet and bitter fennel (Foeniculum vulgare and Foeniculum piperitum respectively). The assessment focuses on the content of estragole and is open for comment until September 17, 2025.
  • EFSA has set new publication dates for several assessment in progress, including hydroxycitric acid and berberine.
  • The EU is considering how to best manage levels of mineral oil aromatic hydrocarbons (MOAHs) that may be present in food additives.
  • Belgium is undertaking major revisions to its list of recognized botanicals, including a major revision of the mushroom list. Kratom (Mitragyna speciosa) is proposed for prohibition.
  • Ireland has issued new guidance on determining novel food status under EU law.
  • Spain is looking to introduce mandatory accessible labeling for key consumer goods, including food supplements.
  • The UK Food Standards Agency has issued guidance for industry regarding the risks of caffeine overconsumption.
  • The UK Committee on Toxicity affirmed the safety of ginger supplements during pregnancy.
  • Argentina revised its Food Code to allow for food supplement health claims, which will be evaluated on a case-by-case basis.
  • Brazil has updated its list of authorized food supplement ingredients and health claims.
  • Peru has issued a caution to consumers regarding the use of ashwagandha (Withania somnifera) food supplements.
 

AHPA membership and login required.

Michael McGuffin honored posthumously with NBJ Lifetime Achievement Award

August 7, 2025

Amber Bennett (left), with Nutrition Business Journal and NBJ Summit Co-Founder Tom Aarts, and Staci Eisner
 

Last week, longtime American Herbal Products Association (AHPA) leader and natural products industry champion Michael McGuffin (1951-2025) was honored posthumously with the Nutrition Business Journal (NBJ) Lifetime Achievement Award at the NBJ Summit in Rancho Palos Verdes, California.

Presented annually, the NBJ Lifetime Achievement Award recognizes accomplished executives who go above and beyond the call of duty on behalf of the nutrition industry. McGuffin, who served as AHPA President for 25 years, was widely known as a passionate proponent of herbs and herbal products, a tireless advocate for consumers and industry, and an unwavering voice for responsible dietary supplement regulation.

The award was accepted on McGuffin’s behalf by Staci Eisner, AHPA Trustee and his life partner, alongside Amber Bennett, AHPA Vice President of Marketing & Engagement and close friend.

“I know that most of you knew Michael in a professional capacity — as a tremendous leader in the industry and a tremendous leader of AHPA — but I want you to know what a tremendous human being he was in his personal life,” said Eisner in her acceptance of the award. “He was the most kind, generous, giving, selfless person that I’ve ever seen. He could find the good and see the value in every human being that he met and he spent his life trying to help other people.”


As AHPA President, McGuffin played a central role in shaping policies that protected access to herbal products while promoting responsible commerce. His collaborative approach brought together scientists, regulators, business leaders, herbalists, and more, and established AHPA as a trusted authority and prominent voice in the dietary supplement industry.

Beyond his policy work, McGuffin was deeply admired for his mentorship, commitment to community, and ability to build lasting relationships. AHPA and its members remain dedicated to advancing the mission and values he championed — honoring the plants, people, and principles that defined his life’s work.

AHPA honored McGuffin's life and legacy at the association’s annual member meeting at Natural Products Expo West earlier this year. A celebration of life, hosted by Eisner along with family and close friends, will take place on August 31 in Venice, California — the beloved place McGuffin called home for decades.

To carry forward his extraordinary legacy, AHPA will also soon launch the Michael McGuffin Endowment Fund. The fund is intended to nurture new leaders in the botanical world, curate inspired industry vision, increase knowledge in the realm of herbs, support the viability and sustainability of the botanical supply chain and botanical products industry, and sustain the mission of AHPA for future generations. More details about the Michael McGuffin Endowment Fund, including how to contribute, will be shared soon.

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