Nutritional Outlook’s 2019 Best of the Industry Awards, Industry Leader: Michael McGuffin

Photo from the American Herbal Products Association

The American Herbal Products Association (AHPA; Silver Spring, MD) has been the chief U.S. trade association for the herbal products industry for nearly four decades. More than half of the association’s existence has been led by AHPA’s current president, Michael McGuffin. This year, McGuffin celebrates his 20^th anniversary as AHPA president, and Nutritional Outlook is honored to recognize his longstanding work on behalf of the industry by naming him our 2019 Industry Leader.

McGuffin’s dedication to “health, herbs, and good food” is personal and far-reaching. His journey began long before he joined AHPA. “Before moving to California in 1973, I had made a few gallons of sassafras tea during my youth in pre-paved Maryland suburbs. And though I’d eaten wild ‘poke salat’ as a kid, I gained my first appreciation of proper plant identification by mistaking the toxic Nicotiana glauca in a Venice alley as a Western cousin of poke,” he tells Nutritional Outlook.

In 1974, McGuffin cofounded a retail store called Venice Fruit Tramps-an “accidental collective,” he calls it-selling fresh produce and bulk herbs on California’s Venice Boardwalk. In 1979, McGuffin and a business partner, Janet Zand, who is a now a doctor of naturopathy and oriental medicine, and a board-certified acupuncturist, took their “combined fortune of $2200” to build an herbal tincture manufacturing and marketing firm called McZand Herbal. In 1985, McZand Herbal became a member of the recently formed American Herbal Products Association. (The association was founded in 1982.)

In 1990, McGuffin was elected to AHPA’s board of trustees. “In late 1989, I was contacted by Shel Weinberg of Trout Lake Farm to solicit my candidacy for an open board seat,” McGuffin says. “When I told Shel I was just too busy with my company to take on a volunteer role, he replied: ‘We’re all too busy, Michael. But it’s your turn.’ This message somehow resonated with me, and I was elected to AHPA’s board of trustees in 1990 and served there until I was hired as AHPA’s president in 1999.”

Twenty years later, McGuffin and AHPA are a leading voice not only for the herbal products industry but for the entire dietary supplement industry, helping to shape the regulatory environment and the multibillion-dollar market for these products.

More importantly, AHPA’s work has benefitted the growing number of consumers relying on natural products and herbal remedies for healthcare. “This really is my life’s work,” McGuffin says. “I think there is a tendency for trade associations to be thought of as only advocating for industry. That isn’t true, at least not for AHPA. We’re doing this for consumers and my fellow American citizens who want to use herbs without undue legal obstructions. That’s why I have devoted my life to advocating for ready, informed access to herbal products in a regulatory framework that protects public health and simultaneously ensures the right to make personal healthcare choices.”

A Crucial Advocate

One would be hard-pressed to find a regulatory issue related to the herbal and dietary supplement industry in which AHPA’s voice isn’t heard.

In the early days, even before McGuffin came on board, AHPA had begun speaking out to protect the herbal category. McGuffin says, “For example, in 1983 AHPA went on record as supporting the efforts of the Fmali Herb Company in its lawsuit against FDA in response to FDA’s refusal to allow import of an herbal product containing schizandra seed (Schisandra chinensis) and other herbal ingredients with a long history of human consumption in Asia. This enforcement position was based on that agency’s interpretation of the 1958 food additive amendments to federal law as disallowing consideration of food use outside of the U.S. as relevant to a food’s history of use. Fmali eventually won this case on appeal, which had ramifications for the entire food industry.”

That was just the beginning. During McGuffin’s presidency, another key win was the association’s push for the USDA’s National Organic Program (NOP) to allow supplement products to be labeled as “organic” and to carry the USDA Organic seal. At the time in 2005, the NOP was only granting use of the seal to conventional food products. AHPA was also involved when FDA was establishing its 2006 law for serious adverse event reporting (AERs).

AHPA’s advocacy has not only helped the herbal products industry but the larger dietary supplement industry as well. The association has been one of the leaders in conversations with regulators, including through public comments submitted to federal and state agencies. Notably, AHPA submitted more than 400 pages of comments regarding regulations proposed under the Food Safety Modernization Act (FSMA), as well as voluminous comments regarding FDA’s new dietary ingredient (NDI) draft guidance (both the initial draft in 2011 and the revised draft in 2016). This year alone, AHPA submitted comments to regulators expressing its opinion on topics ranging from FDA’s intention to revamp dietary supplement regulations, tariffs on herbal ingredients during the current U.S.-China trade war, crop-grouping regulations under the purview of the U.S. Environmental Protection Agency, and even a matter as specific as the use of dairy names for plant-based products.

With McGuffin as its head, the association regularly engages with federal agencies, including FDA, the FTC, USDA, the U.S. Department of Commerce, and the U.S. Fish & Wildlife Service. AHPA actively monitors government activity at the state level as well, stepping in when issues and legislation could negatively impact herbal commerce. It has, for instance, been a leading participant in regulatory issues involving California’s Proposition 65 law. The association also extends its representation abroad via its International Committee, which works to ensure responsible international commerce of herbal products. AHPA is also an active member of the International Alliance of Dietary/Food Supplements Associations (IADSA) and regularly updates AHPA’s membership on international regulatory developments. McGuffin himself has served as an industry representative for groups such as FDA’s Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements (1998-1999) and California’s Office of Environmental Health Hazard Analysis Food Warning Workgroup (2008-2010).

AHPA is also an active presence on Capitol Hill. In addition to its own lobbying work, AHPA is one of the associations that participates in the annual Day on the Hill event during which associations share education about the benefits of dietary and herbal supplements, alongside industry concerns, with lawmakers.

On the scientific front, AHPA’s chief science officer, Holly Johnson, PhD, and AHPA’s science staff participate in organizations such as the U.S. Pharmacopeia, the American Herbal Pharmacopeia, AOAC International, NSF International, and the National Institutes of Health, communicating on matters of research and natural product standards. McGuffin himself has been published in scholarly and scientific journals.

Always Looking Forward

It’s hard to separate AHPA’s achievements from McGuffin’s own; they are one and the same. McGuffin attributes the association’s accomplishments to its members.

“One of AHPA’s strengths, reflected in the breadth and diversity of our membership, is the ability to connect many industry leaders to address the many, evolving issues and opportunities we encounter,” he says. “[W]e focus this combined experience and expertise, both through active engagement with regulatory working groups and with other authoritative bodies, such as the U.S. Pharmacopeia, AOAC International, and NSF International, and through submission of comments during rulemaking procedures.” Under McGuffin’s stewardship, AHPA’s Board of Trustees has grown nearly 40%.

“I would like to be able to report that our positions are always embraced by regulators, but of course it would be unrealistic to have any such expectation!” says McGuffin. “But we have had important influence on many and diverse regulations adopted by federal agencies and occasionally by states. And we maximize opportunities for such outcomes by first engaging with our members and then communicating to regulators with as much clarity as we can. Importantly, we have also built and continue to maintain respectful relationships with government agencies, even when we disagree with them.”

Click here to read our full interview with Michael McGuffin

AHPA will always serve first and foremost as a resource for its members-nearly 400 companies, including growers, processors, manufacturers, and marketers of herbs and herbal products (foods, dietary supplements, cosmetics, and non-prescription drugs).

AHPA’s educational and technical tools for its members are vast, including the association’s AHPA NDI Database, created in 2005, which helps the entire supplements industry by providing a searchable repository of new dietary ingredient notifications submitted to FDA. During McGuffin’s presidency, AHPA’s board has adopted nearly 30 trade requirements or guidance policies to help promote responsible herb commerce and, in AHPA’s words, “represent meaningful self-regulation for the herbal products industry.” During McGuffin’s tenure, the association also issued second editions of its Herbs of Commerce (an incorporated reference in FDA’s labeling rules for herbal supplements) and Botanical Safety Handbook-both key industry primers, with McGuffin serving as managing editor. It also regularly hosts in-person events and webcasts on regulatory and technical issues, and keeps its membership informed through newsletters and e-mail alerts.

McGuffin also ensures that the association monitors the current market, keeping its eye on which herbal categories are growing and in need of guidance and exchange of information. Under McGuffin’s watch, the association has created additional committees reflecting some of the most active herbal markets in the past 20 years: Sports Nutrition, Cannabis, Ayurvedic Products, Chinese Herbal Products, Analytical Labs, Tea & Infusion Products, and Sustainability. Says McGuffin: “It is important to remember that the herbal products industry is not monolithic. We see emerging niche interests, expertise, and needs. In order to serve the many and diverse needs of the industry, it has been vital for AHPA to tap the experts in various of these niches, and we do that by chartering committees that serve these separate and specific segments.”

AHPA serves a unique function that no other trade association does. Says McGuffin, “I am probably biased, but...I certainly think there would be a void of leadership for the herbal community without AHPA. There are other herb-focused organizations-the American Herbal Pharmacopoeia, the American Botanical Council, the American Herbalist Guild-and each of these also plays important roles in service to the herbal community. But AHPA plays a different role than any of these, as we have come to be relied on to serve the interests of the trade and to be the primary resource for industry advocacy. There are also several trade associations and other organizations that focus exclusively on the supplement and natural product markets-the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance-and each of these also makes significant contributions. But AHPA is again unique among these with the focused expertise of both our staff and our membership on the unique needs of the herbal products sector of the trade.”

According to the American Botanical Council’s (Austin, TX) journal HerbalGram and its latest Herb Market Report¹, 2018 marked the U.S. herbal supplement market’s strongest year of sales growth yet-9.4% in 2018 to $8.8 billion. This means that U.S. herbal supplement sales are the strongest since McGuffin became AHPA’s president. AHPA’s guidance, both within and outside of the industry, will remain invaluable as this category increasingly goes mainstream and encounters more regulatory pressure and criticism. As AHPA continually monitors media coverage, it will continue to disseminate accurate information and correct misinformation. One pressing example of how AHPA’s voice is especially valued today is in the emerging hemp cannabidiol (CBD) market. To this end, AHPA has hosted both in-depth in-person and online events to bring regulators and stakeholders closer together and to help the industry navigate the waters to ensure a responsible market. With more than 40 years of experience with herbal product regulation and what McGuffin calls a “decade of engagement with this controversial herb,” AHPA is an authoritative figure on Capitol Hill, urging FDA to create a lawful pathway to market for CBD products.

In looking back on his 20 years of AHPA leadership, McGuffin says, “I have been a member of the natural products industry for nearly 45 years, and the bulk of my education has come from on-the-job experience. This experience in the industry and at AHPA has provided me with a valuable understanding of the distinct, but compatible, needs that individual businesses and the broader industry require to succeed.”

We turned to an equally respected authority in the herbal community to offer a few words about McGuffin’s many contributions. Mark Blumenthal, founder and executive director of the American Botanical Council, shared these words with us:

It is highly appropriate for Nutritional Outlook to be acknowledging Michael McGuffin for his immeasurable contributions to the American herb and dietary supplement industries. Everyone in the U.S. herb industry owes a profound and genuine debt of gratitude and appreciation to him for his strategic contributions to the overall industry. This debt applies to all companies that sell botanical ingredients, whether or not they are members of AHPA-whether they consider themselves ‘herb’ companies or simply dietary supplement companies that happen to sell herbal ingredients as part of their product line.

Michael’s impact goes well beyond the U.S. market; it also includes benefits to foreign companies, whether they manufacture their own herbal products that they’re selling in the U.S. or whether they are botanical ingredient suppliers trying to sell to U.S. manufacturers. Either way, Michael’s excellent work for over 20 years as president of AHPA has helped to create a strong and stable American herb industry where many businesses have been able to flourish due to his efforts. Under his tireless and strategic leadership, AHPA has grown to be a major trade association dealing with many different issues on numerous fronts; AHPA is very possibly the most significant trade association dedicated to botanicals in the entire world.

As one of the founders of AHPA in 1982, I know that none of us ever envisioned the size and complexity of the modern herbal industry, and by extension, the various communities of industry and non-industry stakeholders with which Michael has so deftly worked and supported. Michael has worked very strategically and has mastered many key areas of the herb industry, including the compelling areas of standardizing botanical nomenclature for herbs sold in the U.S.; providing guidance to companies on issues of safety labeling; exerting leadership on the intricacies of GMPs, California’s Proposition 65, adverse event reporting; and so much more. His deep knowledge of government regulations and energetic efforts in submitting public comments to various agencies is well-known and highly respected, including within the government agencies themselves.

Click here to read our full interview with Michael McGuffin

References:

1. Smith T et al. “Herbal supplement sales in US increase by 9.4% in 2018.” HerbalGram, issue 123 (2019): 62-73