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 associations existence has been led by AHPAs current president, Michael McGuffin. This year, McGuffin celebrates his 20th 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.

McGuffins 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 Id 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 Trampsan accidental collective, he calls itselling fresh produce and bulk herbs on Californias 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 AHPAs 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: Were all too busy, Michael. But its your turn. This message somehow resonated with me, and I was elected to AHPAs board of trustees in 1990 and served there until I was hired as AHPAs 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, AHPAs work has benefitted the growing number of consumers relying on natural products and herbal remedies for healthcare. This really is my lifes work, McGuffin says. I think there is a tendency for trade associations to be thought of as only advocating for industry. That isnt true, at least not for AHPA. Were doing this for consumers and my fellow American citizens who want to use herbs without undue legal obstructions. Thats 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 AHPAs voice isnt 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 FDAs 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 agencys 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 foods history of use. Fmali eventually won this case on appeal, which had ramifications for the entire food industry.

That was just the beginning. During McGuffins presidency, another key win was the associations push for the USDAs 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).

AHPAs 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 FDAs 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 FDAs 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 Californias 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 AHPAs membership on international regulatory developments. McGuffin himself has served as an industry representative for groups such as FDAs Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements (1998-1999) and Californias 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, AHPAs chief science officer, Holly Johnson, PhD, and AHPAs 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

Its hard to separate AHPAs achievements from McGuffins own; they are one and the same. McGuffin attributes the associations accomplishments to its members.

One of AHPAs 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 McGuffins stewardship, AHPAs 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 membersnearly 400 companies, including growers, processors, manufacturers, and marketers of herbs and herbal products (foods, dietary supplements, cosmetics, and non-prescription drugs).

AHPAs educational and technical tools for its members are vast, including the associations 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 McGuffins presidency, AHPAs board has adopted nearly 30 trade requirements or guidance policies to help promote responsible herb commerce and, in AHPAs words, represent meaningful self-regulation for the herbal products industry. During McGuffins tenure, the association also issued second editions of its Herbs of Commerce (an incorporated reference in FDAs labeling rules for herbal supplements) and Botanical Safety Handbookboth 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 McGuffins 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 organizationsthe American Herbal Pharmacopoeia, the American Botanical Council, the American Herbalist Guildand 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 marketsthe Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Allianceand 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 Councils (Austin, TX) journal HerbalGram and its latest Herb Market Report1, 2018 marked the U.S. herbal supplement markets strongest year of sales growth yet9.4% in 2018 to $8.8 billion. This means that U.S. herbal supplement sales are the strongest since McGuffin became AHPAs president. AHPAs 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 AHPAs 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 McGuffins 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 AHPAwhether they consider themselves herb companies or simply dietary supplement companies that happen to sell herbal ingredients as part of their product line.

Michaels impact goes well beyond the U.S. market; it also includes benefits to foreign companies, whether they manufacture their own herbal products that theyre selling in the U.S. or whether they are botanical ingredient suppliers trying to sell to U.S. manufacturers. Either way, Michaels 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, Californias 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

Originally posted here:

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