Nutritional Outlook 2019 Best of the Industry Awards: Extended Interview with Michael McGuffin

Michael McGuffin. Photo courtesy of American Herbal Products Association.

Read Nutritional Outlook's extended interview with its 2019 Best of the Industry award winner, Industry Leader category: AHPA's president, Michael McGuffin.

Nutritional Outlook: What is your educational background? When did you first become interested in herbal products and their role in health? Why do you believe herbal supplements play an important role in people’s health?

Michael McGuffin: 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 had 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.

My interests in heath, herbs, and good food led me to be a cofounder of Venice Fruit Tramps in 1974, a retail store and accidental collective that sold fresh produce and bulk dried herbs on the Venice Boardwalk. Moving from retail to manufacturing, in 1979 my business partner Janet Zand and I cofounded McZand Herbal Inc. as an herbal tincture producer and marketer.

I have been a member of the natural products industry for 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 and to best serve the needs of consumers who demand access to high-quality herbal products.

What brought you to AHPA? How did the association approach you to first to serve on the Board of Trustees and, ultimately, as president? Why did you say yes to becoming president?

McZand joined AHPA as an Active member in 1985. In late 1989, I was contacted by Shel Weinberg of Trout Lake Farm to solicit my candidacy for an open board seat. 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.

This really is my life’s work. 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.

How has AHPA given the herbal products industry a voice and power, and how have you seen the association’s influence grow under your stewardship? How has AHPA made a difference in how the herbal products industry is represented and heard?

AHPA’s members have always realized the value of combining their interests, experiences, and resources in order to speak up when issues of mutual concern are recognized, and AHPA established from its very earliest years industry self-regulation and government engagement and advocacy as two of the main priorities for focusing the resultant voice of the herbal products industry.

There is a misconception that the supplement industry first initiated attention on self-regulation in response to the deeply flawed actions of the New York Attorney General in 2015. This telling, however, overlooks the significant history of attention by AHPA-and other organizations-on taking responsibility for our own practices when the need to do so becomes evident.

One early example of this, though focused on just one botanical, was significant as an early recognition of the herb industry’s responsibility for sustainable production of wild-sourced botanicals. Thus, in 1988, AHPA adopted as its first trade requirement that companies refrain from trade in wild-harvested lady’s slipper (Cypripedium spp.) due to concerns identified by the membership on the viability of wild populations of these plants. Over the next decades, AHPA established as self-regulatory initiatives additional trade requirements in the form of labeling recommendations for several specific herbs where cautions need to be communicated to consumers.

More substantive AHPA-driven efforts at self-regulation have included our issuance in 1992 of the first edition of Herbs of Commerce to bring order to naming of herbal ingredients (and since incorporated by reference in federal labeling rules) and publication in 1997 of AHPA’s Botanical Safety Handbook. Our attention on guidance for the trade continues to the present day, as reflected by the policy adopted by AHPA early this year calling on all companies that sell hemp and CBD products to be in strict compliance with all of the regulations that apply to any other botanical, and we will continue to advocate for best practices for this emerging market as the only voice informed by nearly 40 years’ experience with the regulation of herbal products and also by a decade of active engagement with this herb through the AHPA Cannabis Committee.

AHPA’s focus on government engagement and advocacy also dates back to some of our earliest meetings. For example, in 1983 AHPA went on record as supporting the efforts of the Fmali Herb Company in its lawsuit against the Food and Drug Administration (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.

AHPA continues to engage with FDA to present industry’s views on a wide range of regulatory topics, but our efforts also extend to other federal, and sometimes state, agencies. For example, any company today that sells dietary supplements labeled as “organic” in compliance with the United States Department of Agriculture’s (USDA’s) National Organic Program (NOP) should recall that NOP took the position in 2005 that the USDA organic seal should be reserved only for conventional foods and be prohibited for supplements and non-food products. AHPA and a few prominent organic marketers pushed back on this narrow interpretation of the law and ultimately won-and if we had not, the dynamic marketplace of organic herbal supplements we now enjoy might not exist today.

AHPA has also been successful in engaging with the U.S. Congress, and took the lead in getting the entire supplement industry aligned to support establishment of a new law in 2006 to require submission to FDA of serious adverse event reports associated with dietary supplements. A decade later, we can now claim to be taking full responsibility for the safety of the products we sell, and, at the same time, show that the supplement category is among the safest classes of goods under FDA’s jurisdiction.

The herbal supplements market continues to grow at an impressive rate, indicating that consumers are increasingly embracing these products. (I am also basing this observation of growth on HerbalGram’s latest Herb Market Report showing increased U.S. herbal supplement retail sales of 9.4% in 2018.) What kind of growing consumer appreciation and use of herbal supplements have you observed during your tenure at AHPA? How have these products become more mainstream in the past two decades? And do you predict continued growth and consumer awareness of herbal supplements in the future?

According the HerbalGram article you just cited, the U.S. retail value of herbal supplements was nearly $9 billion in 2018. This reflects a doubling of sales volume in the last decade, and, depending on the source of earlier information, a 5- to 20-fold increase in the last 25 years. This phenomenal growth is sometimes seen as evidence that the Dietary Supplement Health and Education Act (DSHEA), which amended existing federal law in 1994, created the demand for herbs and other supplements. In fact, it was the emergent supplement industry of the 1980s and 1990s that created DSHEA, with the avid support of supplement consumers who demanded a regulatory framework to ensure continued access to these products.

It should also be noted that herbal supplements represent only a portion of the herbal products market in the United States. Other significant product categories include beverage teas (both black and green tea (Camellia sinensis) and herbal teas), estimated to have a value in 2017 of $12 billion (or make that at least $12.5 million if kombucha is included here); and essential oils, reportedly exceeding $2 billion in annual sales in recent years. Even these additional details miss significant herbal segments, as botanicals are essential ingredients in the cosmetics trade, to say nothing of the reported market of more than $10 billion for Cannabis now sold legally in most states.

All of these figures indicate a broad-and broadening-acceptance by American consumers of herbal supplements. This should not be too surprising, though. From an historical perspective, use of botanicals has almost always been the norm, rather than the exception. It was only in our recent history that we abandoned this norm, and what we are witnessing now may just be a correction to our culture’s blind embrace of modernity in the early- to mid-20^th century. We are now witnessing a resurgent and growing focus on healthy living and holistic wellness as a way for consumers to take responsibility for their healthcare and improve quality of life, and herbs are just one part of this overall trend. And I see nothing to indicate that these trends are going to slow any time soon.

As herbal supplement usage has grown and garnered more mainstream attention, the industry has also generated its share of critics and negative headlines. Can you discuss how AHPA plays a role in generating correct information and correcting misinformation about the industry and herbal products through its relationship with the media? Also: does the need for media communication ebb and flow? Have you seen it grow increasingly important since you have been at AHPA. For instance, as the industry has grown in size, so has public criticism of it?

The herbal supplement industry has always had vocal critics, but is also very fortunate to have overwhelming support from consumers. Nonetheless, the myth of “unregulated supplements” persists, though those who voice this misinformation have come to sound strained in their insistence on this storyline in the face of the robust regulatory framework that governs the supplement marketplace and the overall safety of this class of goods.

There were certainly times in my career when supplements were bigger targets than they’ve been in the last few years. We have heard recently from some of our most staunch Congressional critics that they no longer give much attention to our products and don’t now have much concern for our category. It’s unlikely, though, that critics of supplements, or of any industry that challenges the status quo, will ever completely disappear, so AHPA continues to monitor media coverage of the industry and actively responds to inaccurate or misleading coverage.

More affirmatively, AHPA this year published an article that evaluated all of the recalls reported by FDA to date in 2019 for any FDA-regulated products. Not surprisingly, what we found was that less than 2% of the more than 800 such recalls were associated with any dietary supplement product. We intend to continue this focus on getting factual information to the trade, as well as to consumers and government officials, and we hope to continue to change the narrative with the addition of such important data.

AHPA has been a leading voice representing the industry in conversations with regulators, as well as through public comments submitted to federal and state agencies. You yourself have been an industry representative as a member of groups like 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). What kind of benefits do you believe AHPA and you have brought to these conversations with regulators, and how has your influence helped the dietary supplement products industry’s position where these regulatory developments are concerned? (I’m also thinking about recent important regulatory issues such as CBD’s regulatory status, the rollout of the Food Safety Modernization Act, the NDI draft guidance, and numerous others.)

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. Your question here points out some of the ways we 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.

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! 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.

Some examples of topics on which AHPA’s views have prevailed include:

• Recognition by FDA in its rulemaking for dietary supplement claims that many of the claims that had previously been limited just to over-the-counter drugs are, in fact, structure function claims and so are allowed on dietary supplement products

• Adoption of AHPA’s Herbs of Commerce as an incorporated reference in FDA’s labeling rules for herbal supplements

• Acceptance by FDA of AHPA’s position that liquid herbal products should be allowed to be declared by volume, rather than only by weight, as that agency had suggested in a proposed rule on supplement labeling

• A reversal by the National Organic Program at USDA of its prior position to disallow use of the “USDA Organic” seal on herbal supplements

• Clarification by California’s Office of Environmental Health Hazard Assessment (OEHHA) of the limited scope of several of that agency’s listing of botanicals ingredients and herbal constituents under the state’s Proposition 65

• Reversal by Arizona’s Board of Pharmacy of a reinterpretation of that state’s definition of dietary supplements that would have, if not reversed, led to a requirement for many supplements to register separately with that one state

We can provide many additional examples of the positive impact of AHPA’s engagement with regulators upon request.

With that said, much your work is also very specific to your herbal membership, such as comments submitted to regulators on matters very specific to herbal products (e.g., the recent comments AHPA submitted to EPA regarding crop-grouping regulations), the Prop 65 regulations that hugely impact the herbal industry, the work your scientists do to help develop analytical methods for herbal products such as through organizations like AOAC, the regulatory and scientific updates AHPA provides regarding specific herbal ingredients, the vast number of online and published resources AHPA provides on best practices, or guidelines and trade requirements urging best practices among its members. How has AHPA helped guide regulatory and scientific developments to the benefit of the herbal products industry and kept the industry informed of developments? Would there be a void of leadership and communication for the herbal community without AHPA?

Throughout the entire 20 years of my time here, AHPA’s Mission has been unchanged-“To promote the responsible commerce of herbal products.” Each of the activities you mentioned in your question are directly related to this mission-and I could almost read back most of the question to you in response to your inquiry on how AHPA has “helped guide regulatory and scientific developments to the benefit of the herbal products industry”! We do this by submitting comments to regulators on matters very specific to herbal products (e.g., the recent comments AHPA submitted to EPA regarding crop-grouping regulations); engagement with California’s OEHHA on Proposition 65 regulations that hugely impact the herbal industry; commitments by AHPA’s Chief Science Officer to help develop analytical methods for herbal products such as through organizations like AOAC International; preparation and dissemination of Legal and Scientific Alerts to provide insights on specific herbal ingredients; development of a vast number of online and published resources that AHPA provides on best practices for various herbal segments; AHPA’s numerous guidelines and trade requirements urging best practices among its members.

I am probably biased, but in response to your last question, 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.

I recently spoke with one prominent industry individual who was one of the leading voices just a few years ago to call for all of the trade associations to merge into the largest of these organizations, to create “a single unified voice” for the trade. I had shared my view that the industry already has unity, at least on most issues, but that the voice is a chorus, rather than a soloist, and that industry is actually better served with the implied harmony of that choral voice. In our recent conversation, though, this individual told me that he is now convinced of the value of the diversity represented by more than one trade group, and specifically mentioned his recognition of the unique role and benefit that AHPA brings to the broader community to the supplement industry. I, of course, agreed!

Under your leadership, AHPA has created many additional committees that reflect some of the most active and expanding herbal markets in the past 20 years (Sports Nutrition, Cannabis, Ayurvedic Products, Chinese Herbal Products, Analytical Labs, International, and Tea & Infusion Products Committees). How does the formation of these committees reflect how AHPA monitors the market to determine which herbal categories are growing and in need of guidance in terms of exchanging information and adopting guidelines for responsible manufacturing and commerce?

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.

If you could name one accomplishment you are most proud of as AHPA president, what would it be?

It is hard to pinpoint one single accomplishment. Aside from producing tangible publications like the AHPA Botanical Safety Handbook and our Herbs of Commerce, AHPA has also achieved legislative victories federally (e.g., passage in 2006 of the serious adverse event reporting law) and in individual states (most recently in Arizona, where we successfully challenged a new state registration scheme for most supplement products) and also been influential in many regulatory processes.

But I am probably most proud of the AHPA’s role in building and sustaining community within the herbal products industry. Companies in this trade work well together under the AHPA umbrella, where we balance respect for the traditions we came from, while acknowledging the need to bring products to the marketplace that comply with the current expectations for any product sold in the U.S. today. At the end of the day, this community effort has supported the development of an herbal industry that is financially sound while better serving the millions of Americans who rely on our products.

What are your greatest concerns for the herbal industry moving forward? What threats or challenges to the herbal industry is AHPA most concerned with/where is it focusing its attention? What kind of further assistance do you foresee the industry needing in the coming years?

The growing popularity of herbs, herbal products, and herbal ingredients in products makes sustainability an issue of ever-increasing importance. AHPA recently established a Sustainability Committee to work with our members to develop solutions and best practices for herbal product companies to promote sustainability. Fortunately, the industry is generally supportive of sustainability efforts, and many consumers have communicated strong support for these efforts and will hopefully reward companies that demonstrate progress in furthering sustainability goals.

We will also need to continue to pay attention to product quality in the herbal marketplace. I think we can best summarize the current reality by acknowledging that high-quality companies make and market high-quality products, but that poor-quality companies put poor-quality products in the market. This is to some degree related to demand from some customers for cheap prices, and we as an industry need to learn how to communicate to the public that cost should almost never be the first priority in selecting health products.

I am also concerned about the tendency for “regulatory creep” that seems to come naturally to many government agencies, and an apparent drift by some such agencies toward less transparent communications with the trade and the public. Of equal concern is that some in the trade are taking positions in support of increasing agencies’ regulatory authority without clearly articulating how increased authority would benefit consumers or the trade, or would at least hold out the promise of fixing specifically identified problems. As an example, some years ago I heard a senior representative of a key regulator defend a controversial position taken by that agency by rhetorically asking why industry would expect the regulator to take a different position, observing that by their very nature regulators love to regulate. Although this response may have been tongue in cheek, I believe it also reflected a basic truth about how some regulators view their roles and functions. Nevertheless, I continue to believe that resisting the regulatory drift implied by this reply best serves the interests of the trade and our consumers.

There are, of course, exceptional cases that arise in which increased regulation can help deliver clear benefits and solve identified problems, and I take pride in AHPA’s track record of supporting improvements to the regulatory framework in these cases. That’s why AHPA supported the Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2005, the Designer Anabolic Steroid Control Act of 2014, and the Hemp Farming Act of 2018, which was incorporated into the 2018 Farm Bill.