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The idea of turning 40 may or may not seem momentous in the grand scheme of things. But in trade association years, reaching the 40-year mark is a significant achievement — especially in a modern US industry that is, itself, not much older. This longevity involves trailblazing, education, community building, and, perhaps most importantly, a leap of faith. All these attributes describe the daily workings of the American Herbal Products Association (AHPA), which was founded in 1982 and is celebrating its 40th anniversary in 2022.¹

Although its name indicates it is an “American” association, AHPA is now a global endeavor, with 400 member companies across five continents. The organization has 18 committees that represent key areas of the herbal products industry, from analytical laboratories to sustainability, and it provides important resources like the Botanical Safety Handbook, 2nd ed. (CRC Press, 2013),² and Herbs of Commerce, 2nd ed. (AHPA, 2000).³ AHPA also has been a leader and central player regarding self-regulatory efforts in the industry.⁴

AHPA President Michael McGuffin, who first served on the AHPA board in 1990 and became president of the association in 1999, said it feels “fabulous” to reach this milestone. He also noted that despite four decades in a quickly evolving industry and many changes in the perception of AHPA’s role within the industry, the association is right where it wants to be. “We have moved along and engaged in strategic planning over the years as we envisioned,” he said (oral communication, February 9, 2022). “We still have a vision for the future, but we have arrived at the role and area of service we intended right from the beginning.”

Although the push and pull between industry and regulators will certainly continue, McGuffin added, “AHPA will continue to advocate for broad unfettered access and informed consumer education about dietary supplements and herbs.” 

AHPA’s Early Years

AHPA had to bridge some significant industry opinion gaps over the past four decades. Its predecessor organization, the Herb Trade Association (HTA), founded in 1976, did not last long due to cultural conflicts, McGuffin noted. “I have said for years that AHPA was founded by hippies and Mormons. It’s just true,” he said. “We had Nature’s Way, Nature’s Herbs, and Nature’s Sunshine and others in Utah, the coastal companies like Traditional Medicinals [founded by Drake Sadler and Rosemary Gladstar], and Sweethardt Herbs in Texas, founded by Mark Blumenthal. But it got complicated.”

Some of those complications included major differences of opinion, a wide variety of priorities, and few resources, with members volunteering their time. For example, research and compiling a library of scientific material were important to Rob McCaleb, an HTA member who ran the quality and research laboratories at Celestial Seasonings at the time (from 1976 to 1989). While he was involved with HTA, McCaleb, along with Blumenthal, the founder and executive director of the American Botanical Council (ABC), co-founded the Herb Research Foundation (HRF) in 1983 to focus on compiling this library and distributing information to researchers, practitioners, and the public.⁵ “We wanted to get past the difficulties and focus on the science, acknowledging that physicians and pharmacists learn very little about herbs in school and what they do learn is from other physicians and pharmacists, so they often had a negative attitude about botanicals and dietary supplements* — that they were unproven and probably unsafe,” McCaleb said in a March 2022 presentation at AHPA’s annual meeting at Natural Products Expo West in Anaheim, California. At the time, he saw that high-quality research made even skeptics become more receptive. Informing the public and practitioners became the mission of HRF.

The importance of industry communications and community also became clear. During HTA’s five-year existence, relationships started developing and “many of us, especially the founding board members of HTA, started to form those communities,” said Blumenthal, a former founding board member and president of HTA and a founding board member of AHPA (email communication, April 5, 2022).

That sense of community — and the realization that the young industry needed an organization to help promote cohesion and establish communication, standards, and more — may be why a small group of those people came back together after HTA disbanded to make it work. That was the beginning of AHPA.

McGuffin believes that a trade association proves its worth in the first few years of existence, and he offered kudos to those who were there from the beginning of AHPA. One of those people was Peter Landes of KHL Flavors (Maspeth, New York), who served as the first AHPA board chair from 1982 to 1986. Landes, like others from the early days, recalled a very informal, collaborative atmosphere.

“I attended the first formative meeting of AHPA with about 30 industry members,” Landes said (email, March 22, 2022). “I recall the focus of the meeting was to form a trade association with the first initiative to be the defense of spirulina [Arthrospira spp.] — a hot item at the time and the focus of a US Food and Drug Administration (FDA) crackdown.” Some attendees wanted to confront the FDA on this topic. “I, along with a few others, expressed that view and that this confrontation would not only fail but also doom the incipient trade association to irrelevance or worse,” Landes added.

Landes immediately appointed a founding board of people he “knew were competent.” The names read like a “who’s who” of industry pioneers (Table 1). “I also received much support from Ken Murdock [owner of Nature’s Way], Drake Sadler, Barry Meltzer [founder and owner of San Francisco Herb & Natural Food Company], and the oh-so-indispensable Lynda LeMole [Traditional Medicinals].”

“Peter is a great guy and quite a character,” recalled Loren Israelsen during the AHPA Expo West presentation. “His campaign platform was: ‘We will hold a golf tournament once a year here [at Expo West] and that’s all. This was actually a brilliant strategy,” he added. “Peter is a smart guy, and he knew that we needed to do something that we could all agree on.”

LeMole, who was president and co-owner of Traditional Medicinals (Sebastopol, California) and served as AHPA’s second president** from 1986 to 1990, recalled early meetings where they discussed everything from golf to herbal issues. “We talked about why we needed to be an organization,” LeMole said (oral communication, March 21, 2022). It came down to the fact, she noted, “that there were lots of threats to the herbal industry, with common herbs being listed as safety concerns.”

Before DSHEA, she added, herbs did not have a regulatory category and were regulated by an informal and internal FDA document put in place in November 1975 called Herb Ratings by the FDA. This document, which evaluated 171 herbs offered for sale in teas, noted that 27 were “unsafe,” 53 were of “undefined safety,” and the remaining 91 were “safe.”6 The industry was seeing increasing FDA actions like that at the time, said Israelsen in his presentation, noting that FDA aggression against herbs was growing, so the need for a trade group was palpable.5

The push for AHPA, LeMole said, “was to quell safety concerns and get a dialogue going with FDA and try to put in place a self-regulatory framework around identification of herbs and early contamination problems that inevitably happen in any industry.” It was a daunting task, she said, adding that the organization was still loosely put together and needed everything from budgets to committees and records.

It was also a time when members forged ahead because they did not have much to lose, according to Peggy Brevoort, co-founder and former CEO of East Earth Herb, Inc. (Eugene, Oregon). “I remember thinking at the time that a trade organization was a way to grow my business, never mind the industry or the category,” she said (oral communication, March 18, 2022). “We just loved the herbs, and we wanted to share them with people. If we could make enough money to pay the bills and buy groceries, then we were good.”

As the fledgling organization took shape, community spirit within AHPA began to flourish. “[I]t struck me that I had finally found a group of like-minded people from around the country who had discovered [a love of] herbs,” Brevoort said. “We were enthusiastic but separated, so we came together with a lot of passion and learned things we didn’t know. It fueled the fire. All of a sudden you were talking with people who knew about some other herb that might grow in the South, versus what we were growing in the Pacific Northwest. It was like meeting an old friend you didn’t know you had.” The community was also important, Brevoort added, because “we didn’t have a legal category [for herbs per se], and most people thought we were quacks and crazies.”

It was a very exciting time for herb companies, LeMole said, “because they were part of an herbal renaissance. We had a great wind at our backs and growing consumer interest in the natural products industry.”

One of the early priorities within AHPA was the formation of a communications committee, which was led by Blumenthal and, among other things, established a newsletter initially published for both AHPA and HRF. This newsletter, called “Herbalgram” (the “g” was capitalized beginning with issue 7 in 1985), was the official communication organ for AHPA from 1983 to 1988. Then, HerbalGram was moved under the aegis of the newly formed ABC and continued under the leadership of Blumenthal, who served as editor and publisher.

Communications were important, primarily because some big issues needed to be addressed. For at least a decade before AHPA was founded, the FDA had been ramping up restrictions on herbal products and supplements and proposed limits on the vitamins levels, for example. The so-called “Proxmire Amendment” of 1976, a bill that Senator William Proxmire (D-WI) (1915–2005) sponsored, eventually countered these limits and prevented the FDA from setting relatively low concentration levels for vitamins and mineral supplements.7

It was a very difficult regulatory environment, recalled McCaleb. “People don’t realize how tough the regulatory mindset was at the time,” he said in his remarks at Expo West. “It was illegal to say coffee was a stimulant. FDA believed that any physiological effect from food made it a drug, and that was their guiding principal.”

Although the tide began to turn with the Proxmire Amendment, the time period was the start of a long but necessary learning curve for the herbal products industry, according to Israelsen. “That was the first moment we realized we had Congressional champions as well as a lot of consumers who deeply supported these issues. It was a fundamental learning [period] we had to go through, but we felt very alone at that time. There was a critical sense that ‘We’ve got big problems, if this is what [regulators] are going to do.’” Senator Proxmire was a tremendous champion, Israelsen added, and “without him, the US market would be like any other market around the world, and we’d all be taking mini vitamins [with very limited and low dosages] and that’s about it.”

Another landmark ruling in 1983, Fmali versus Heckler, a case not often noted in herbal histories, helped lead to a better understanding of herbal products.⁸ Fmali, a company importing herbs from China, founded by Ben Zaricor and Louise Veninga, filed suit against FDA, arguing that herbs with documentation of safe use anywhere in the world should be evaluated for safe human consumption in the United States. The case was important because it allowed for safety and use data from other countries to be considered in demonstrating that an ingredient was generally recognized as safe (GRAS) as a food substance or additive.⁹ Before that, LeMole explained, the FDA narrowly interpreted the “common use in food” provision to mean common use in the United States only. But many herbs came from around the world, she explained, with well-established and safe traditional uses as food ingredients. “We recognized the current and historical significance of this case at the time,” added Blumenthal. “It was the top story in the second issue of ‘Herbalgram’ when Rob McCaleb and I were publishing it as a newsletter for AHPA and HRF.”⁹

The Volatile ’80s and ’90s

By the mid-1980s, Landes believed that while he had helped to build the foundation for a cohesive, functioning trade association, it was time for some new leadership. And he knew someone who he thought could fill that role: Lynda LeMole, who, he said, was competent, hardworking, and well liked.

When LeMole became president of the AHPA board in 1986, she recognized that the work ahead involved AHPA’s structural issues, the continuing fight against unworkable regulations, and the need for category-specific regulation. “During my tenure, claims were really the next frontier,” she said. “Up to the early ’90s, it was about safety, identity, processing, and standards. We also needed a list of common names, so we created an amazing document spearheaded by our first Standards Committee chair and a remarkable researcher, Timothy Moley [who was working for Frontier Herbs at the time and later became founder and CEO of Chocolove®].”

Moley initiated early standards work, including AHPA’s Code of Ethics, an Endangered Species document, and a list of botanical common names, which later became the publication Herbs of Commerce. In 1990, AHPA produced a draft of Herbs of Commerce, which was edited by the late Steven Foster, a renowned botanical expert, author, and medicinal plant photographer. The first edition of the book was published in 1992,¹⁰ and the expanded second edition was published in 2000,3 which the FDA then accepted as an official standard for nomenclature for herbal products.¹¹

When LeMole passed the AHPA torch in 1990, the first person she thought of was Brevoort, who had little idea of what was coming next. “Lynda made me a deal that if I took over as president of the AHPA board, she would take my call whenever I had questions,” said Brevoort. “I thought, ‘OK, I’ve got a sister. I’ve got a backup.’”

But in the 1990s, the industry was beginning to go mainstream, and Brevoort, who was president of the board from 1990 to 1994, found herself in the middle of politics at a much deeper level than she anticipated as the industry began working toward passage of seminal legislation: the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was an amendment to the Federal Food, Drug, and Cosmetic Act and established standards for dietary supplements.¹²

The contentious relationship between the natural products industry and FDA ramped up in the early ’90s. A flashpoint was in 1992, when the FDA raided the Tahoma Clinic, a natural medicine clinic in Washington state, because the founder and medical director Jonathan Wright, MD, was administering vitamin B12 injections.^13,14 Although this incident did not involve orally ingested dietary supplements, it became emblematic of freedom of choice on health-related issues. Wright was acquitted in 1995, but the raid, sometimes referred to as the “Vitamin B Bust,” was symbolic for those who believed FDA held a bias against natural medicine and its practitioners.¹⁵ “It became a national story and was a deep embarrassment for FDA,” Israelsen recalled.

This was followed by a two-page bill that was sponsored by Senator Orrin Hatch (R-UT) (1934–2022) and became the Health Freedom Act of 1992.¹⁶ FDA countered by doubling down on Commissioner David Kessler’s “food additive theory,” in which he saw botanicals as illegal food additives, and introducing the FDA Dietary Supplement Task Force Report,¹⁷ also known as the “Dykstra report” (named for its principle author, FDA official Gary Dykstra), in June 1993. The Dykstra report, which proposed that herbs, amino acids, and other non-nutrients would be regulated as drugs, led to a public outcry.

Israelsen recalled: “The Health Freedom Act was our declaration of independence, and the Dykstra report was FDA’s declaration of war.” This back and forth continued until Hatch, later with the support of Senator Tom Harkin (D-IA) and Representative Bill Richardson (D-NM), introduced DSHEA. After a consumer letter-writing campaign that reportedly involved more letters to Congress than any other issue since the Vietnam War, a revised version of DSHEA eventually was passed and signed into law in October 1994.

Brevoort said: “Working toward the passage of DSHEA was huge for AHPA for several reasons. “We realized that we had to go into territory we never thought we would, and we had to do all this official stuff that, as hippies, we had given up on. I was raising my kids in the woods. All of a sudden, I am board chair of AHPA, and I have to go to Washington, DC. I am realizing I have to buy a suit and panty hose and put on makeup, if I can remember how.

“We learned that you do what you need to do, and we learned to deal with the government,” Brevoort added. In other words, they had to make compromises. For example, the AHPA team learned they had to support Senator Hatch, whose overall conservative politics were not always aligned with many of the liberal-leaning members of the herb industry. Ultimately, she said, AHPA supported Hatch and in the process, learned about politics, trading favors, and how to stand for a constituency. “DSHEA’s passage,” she said, “gave a legitimate base to our growing industry, and we no longer had to worry about being shut down.”

Post-DSHEA Challenges

After the passage of DHSEA, AHPA had become a stable and established organization, but challenges remained. The organization did stay small, but served the industry well, said Anthony Young, an attorney with Kleinfeld, Kaplan & Becker, LLP (Washington, DC), who represented AHPA from 1996 to 2017. “AHPA became the ‘Little Engine that Could,’” he said (oral communication, March 21, 2022).

An early regulatory challenge under DSHEA was proposed regulation of structure/function claims, which are provided in Section 5 of DSHEA. AHPA was actively involved in the conversation, Young said, and adopted a position that opposed FDA’s proposition that any dietary supplement claims that fall under any of the Over-the-Counter (OTC) Drug review categories, which would by doing so have redefined the word “disease” and potentially restricted the scope of structure/function claims under DSHEA.¹⁸

Young said: “AHPA filed comments [essentially] saying, ‘Wait a second, many of these claims are not disease claims; they are structure/function claims. We identified 70 claims that were not disease claims, and we came away with FDA agreement on 25-plus of those claims. I believe it was very significant because a lot of these claims are now [structure/function claim] categories in the dietary supplement industry, [such as digestive support and sexual function support]. We made a big impact, and I don’t know any other organization that took the same position or addressed it the way AHPA did.”

Adverse events reporting was another important issue, and AHPA petitioned to make serious adverse event reports mandatory,¹⁹ believing that such information and diligence would be expected from a responsible industry, Young explained. “But FDA took a position against it. The fact that we proposed it and FDA opposed it meant that Congress voted to make it law,” he joked. Ultimately, he added “we were instrumental in moving that process along.” In fact, beginning in 2003, AHPA led a coordinated and successful effort for the establishment of a serious adverse event reporting (SAER) law. The Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law on December 22, 2006.²⁰ Young believes this has been very helpful for the industry, as serious adverse event reports are somewhat uncommon, so the feedback from the system showed that supplements are generally safe.

DSHEA created a legal and regulatory category for botanicals and other dietary supplements, and the industry began to see exponential growth in the 1990s and 2000s. After McGuffin joined AHPA in 1999, he became the leader that the association needed at the time, LeMole noted. “Michael McGuffin is absolutely a remarkable champion for AHPA and the herb industry. I think that we couldn’t ask for better. He is so articulate and has been able to walk that line among FDA and [the Federal Trade Commission], industry companies, and the growing association in an excellent way.”

This effort continues today, she added, noting that when the industry saw hemp (Cannabis spp., Cannabaceae) and cannabidiol (CBD) products enter the market, AHPA formed the Cannabis Committee²¹ to talk with regulators and help shape upcoming regulations. Most recently, in March 2022, AHPA introduced the Psychedelic Plants and Fungi Committee to support safe use and responsible commerce in this emerging category.²² “I think this is an excellent example of what a trade association can do: to answer the need and call when ‘new’ ingredients emerge,” LeMole said.

Like-minded Community

AHPA’s reputation in the industry has evolved over the years, McGuffin said. “I think for some years AHPA was viewed as the little brother/little sister association, the one less important than the longer-established NNFA [National Nutritional Foods Association — now the Natural Products Association (NPA)] and the higher-budgeted CRN [Council for Responsible Nutrition].” But at this point, McGuffin noted, “we are seriously considered an important voice and organization with unique attributes in terms of how we engage with membership and the regulatory and legislative entities we need to deal with. We use the word ‘community’ a lot because we believe we have not just created an organization with a kind of sterile structure, but it is a community.”

Longtime AHPA members agree. Cindy Angerhofer, PhD, the executive fellow of botanical research at Aveda/ Estee Lauder Companies (Minneapolis, Minnesota), said the idea of community has been central to AHPA’s mission during her 25 years with the organization (oral communication, February 28, 2022). She noted that everyone comes with their own set of expertise and needs, no matter the size or type of company. “We are all outsiders in some sense, but we are still embraced by the AHPA community,” she said.

It also helped that McGuffin is a quintessential community builder. Active in the industry since 1974, running both a retail and manufacturing business, and serving as AHPA board chair from 1995 to 1998, McGuffin has expertise in both building teams and bringing disparate groups together. He was given the ABC Mark Blumenthal Herbal Community Builder Award in 2021. “Michael is a master of important details on a wide spectrum of significant issues necessary for the success of small, medium, and large herb companies,” Blumenthal said when presenting the eponymous award. “Without his strong and seemingly tireless energy and leadership, it is questionable that the herb industry in the United States would be as successful, and as large, as it is today.”²³

Another part of AHPA’s success is its attention to the plants themselves, Angerhofer added. “Above all, AHPA is a voice for the plants and the people who use their active healing entities…. To do that, they know you have to pay attention to the whole lifecycle of the plant.”

AHPA also recognized that increased knowledge of global herbal traditions and research brings more interest, said Beth Lambert, former AHPA board chair (2003 to 2006), and CEO of long-term AHPA member Herbalist and Alkemist in Washington, New Jersey (email, February 23, 2022). AHPA “recognizes that fads come and go, and no one herb is a panacea,” she explained, adding that the organization realizes that increased demand can have an adverse impact on the sustainability of specific herbs.

“I am so glad that AHPA never consolidated [with one or more organizations], and there was talk of that at times,” Young said. “It meant that AHPA is and was a leaner operation that doesn’t get too involved in the bureaucracy of trade organizations, so they could focus on the issues. It also allowed small companies with articulate board members to be in the mix and bring that small-company wisdom to counter larger companies, which have a different perspective at times.”

A rising tide lifts all boats, as the saying goes, so the tight-knit community was ultimately beneficial to all. LeMole put it this way: “Someone said, ‘It is always better to hang out with people who are better than you, so you drift in that direction.’ So, good companies with herbal ingredients need each other, and AHPA will continue to be an excellent trade organization that is needed more than ever.”

Putting It in Perspective

One thing AHPA is proud of, McGuffin said, is that, from the beginning, it has taken a leadership role on industry standards. For example, he said, AHPA has adopted more than 20 trade requirements for members and more than 20 guidance policies, or recommendations. AHPA’s first trade requirement, he noted, was adopted in 1988 to stop trade in wild-harvested lady’s slipper orchids (Cypripedium spp., Orchidaceae).² Steven Foster first proposed the resolution at the annual meeting of the now-defunct International Herb Growers and Marketers Association, where it was adopted. A month later, Blumenthal presented the resolution to AHPA, which also adopted it.²⁴

AHPA recently saw a product that was marketed as an organic herbal capsule but did not claim to be compliant with the National Organic Program (NOP) standards, a federal regulatory program to develop and enforce consistent national standards for organically produced agricultural products in the United States.²⁵ The Organic Trade Association informed AHPA that the NOP did not have the authority to enforce the rule if a company does not label the product as “NOP organic.” AHPA leadership took the issue to a committee and developed an immediate requirement that herbal products, if they claim to be “organic,” must comply with the NOP, McGuffin said.

It takes a lot patience for an organization to work through details of issues like labeling regulations, structure/function claims, and adverse events and determine how they will impact business, noted Lambert (oral communication, February 25, 2022). “There is no other place where that occurs. Every year there is a different issue,” she said, noting that many were concerned when the serious adverse event reporting law passed. “But Michael worked through all those issues and got people talking, even those with really different political views, and created a forum where we all come together to make a right livelihood out of this business.”

Early disparate opinions helped AHPA develop meaningful discourse both internally and with regulators and legislative entities to stay informed and vigilant about the issues. AHPA’s ability to reach consensus also has served it well in today’s politically polarized environment. McGuffin said the organization has always reached out to other industry associations and works closely with trade groups that represent aligned industries, like cosmetics, flavors, and fragrances. Although members may disagree about the news, they have a shared concern and must work together, he added.

Battles Still to Fight

Now, some of AHPA’s main challenges include the quality of botanical raw materials and manufacturing them in compliance with current Good Manufacturing Practices (cGMPs). “The industry is now dependent on overseas suppliers for a large amount of raw materials, and some of these companies may have been producing these ingredients for many years,” Young said. Producing herbal ingredients is a way of life in some of these countries, which often lack an internal regulatory structure to address modern sourcing and manufacturing issues, he noted. “That puts a larger obligation on the manufacturing community to be diligent in the raw materials they purchase.”

Another challenge is fostering the next generation of industry leaders. Looking ahead, McGuffin feels optimistic about AHPA’s future and a new era of leadership coming up through the ranks. “We don’t need to cultivate a new generation of leaders — it is self-cultivating,” he said. “[W]hat is important is that we invite the next generation to … come into leadership positions.”

One benefit of having a board of 32 people, many of whom have been involved with AHPA for more than 20 years, is that it has created organizational mentors. “Leadership has to be recognized by others, but there also has to be a spark that comes from the individuals who show up, raise the questions, express opinions, rally others, and listen,” McGuffin said. Hopefully, he added, the next generation will come into the industry with as much passion as Lambert or Daniel Gagnon (owner of Herbs, Etc., AHPA president in 1998, and a longtime board member of AHPA) and will be similarly engaged and enthusiastic.

In the meantime, he said, AHPA will continue its main mission: to protect the plants and the integrity of the herbal products industry. “To some degree, all of it is about protecting consumers — I prefer to say our family, friends, and neighbors, who consume these products. This means protecting the plants and environment, which is important to all of us, and protecting the integrity of high-quality products. And we will continue to do that.”

References

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