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Michael McGuffin has served as president of the American Herbal Products Association (AHPA) since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the University of Southern California (USC) School of Pharmacy regulatory science master’s degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974 and has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades.
Question: What is the history of AHPA?
Answer: The origins of AHPA date back to the formation of the modern herbal products market in the United States. AHPA was founded in 1982 to create a forum for these emerging businesses to work cooperatively on topics of shared interests.
AHPA’s founding members recognized the need for organized industry collaboration, communications and standards under the banner of a trade group. It was a crucial time to come together as a community to promote and defend herbs in the face of scrutiny by the U.S. Food & Drug Administration (FDA), even as consumer interest in natural products was growing.
Question: AHPA recently celebrated its 40th anniversary. What are some of the organization’s achievements?
Answer: AHPA celebrated its 40th anniversary in 2022 and our achievements over the past four decades have helped shape the natural product and dietary supplement industries that we see today. I’m happy to provide a few examples of our work, but these provide only a narrow snapshot of our considerable successful record.
From adopting our first and still-standing trade requirement to prohibit trade in wild-harvest lady’s slipper orchids—a conservation action that arguably helped save the species—to publishing the first edition of Herbs of Commerce (1992)—which was subsequently incorporated by reference into federal labeling regulations for botanical ingredients—our early efforts set the stage for our bigger and broader achievements in regulatory and legislative matters.
As a significant example of our later focus, in 2003, AHPA petitioned FDA to establish adverse event reporting requirements for dietary supplements. As a result of our leadership on this controversial topic, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was enacted in 2006 to establish a serious adverse event reporting law for dietary supplements and also for over-the-counter drugs.
AHPA represents responsible industry that welcomes sensible regulation, and this continues to drive our legislative efforts and regulatory advocacy today.
Question: How has the herbal industry evolved over this time?
Answer: Herbal products have grown from only being provided by trained herbalists and sold at health food stores and specialty shops to being available at mainstream retailers both online and in-store. Many herbs are part of the dietary supplement market, which has grown from 4,000 to 90,000 products and from $4 billion to $60 billion in annual sales over the last 30 years. Herbal teas also continue to experience significant market growth.
Even as the industry has experienced this tremendous market growth, case reports of adverse events associated with herbal products are exceedingly rare. In spite of this long-established safety record, FDA continues to question the safety of many herbal ingredients.
For example, the agency published in 1983 an issue of FDA Consumer featuring a danger sign warning that herbs are “often more toxic than magical” on the cover of the magazine. More recently, FDA has concluded that CBD (cannabidiol) and NAC (N-acetyl cysteine) are excluded from the definition of dietary supplements and are, thus, unlawful. Even today, the agency’s public communications on dietary supplements emphasize safety concerns over the potential therapeutic value of these goods. FDA’s actions can be fairly summarized as preferring to limit the market, despite consumer interest in herbal products and continued industry support for advancing scientific research on botanicals.
In fact, there was a huge spike in consumer interest in herbs and herbal products to support immune health over the course of the COVID-19 pandemic. This surge in demand has led to consecutive year-over-year growth in retail sales of herbal dietary supplements by upwards of more than $1 billion annually. Clearly, herbs are not going anywhere.
Question: What obstacles are there to work on for the herbal industry?
Answer: It has been almost 20 years since the Dietary Supplement Health and Education Act (DSHEA) was passed, which amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to create the current regulatory framework for dietary supplements—and a lot has changed in those two decades. At AHPA, we believe dietary supplement regulations are due for sensible modernizations to meet the demands of today’s market.
A good place to start would be with revisiting the existing prior drug exclusion clause. This provision, which is the basis for FDA’s decisions on CBD and NAC mentioned earlier, excludes products containing substances first approved or investigated as drugs from being marketed as dietary supplements, even if they would otherwise qualify as dietary ingredients.
This means that if the pharmaceutical industry brings a drug derived from a botanical to market first, consumers will never have lawful access to dietary supplements containing that ingredient. However, if an ingredient is first marketed as or in a dietary supplement, the pharmaceutical industry can produce a drug containing that same ingredient and share the marketplace with dietary supplements. This imbalance limits consumer choice and access.
Michael McGuffin has served as president of the American Herbal Products Association (AHPA) since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the University of Southern California (USC) School of Pharmacy regulatory science master’s degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974 and has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades.
Question: What is the history of AHPA?
Answer: The origins of AHPA date back to the formation of the modern herbal products market in the United States. AHPA was founded in 1982 to create a forum for these emerging businesses to work cooperatively on topics of shared interests.
AHPA’s founding members recognized the need for organized industry collaboration, communications and standards under the banner of a trade group. It was a crucial time to come together as a community to promote and defend herbs in the face of scrutiny by the U.S. Food & Drug Administration (FDA), even as consumer interest in natural products was growing.
Question: AHPA recently celebrated its 40th anniversary. What are some of the organization’s achievements?
Answer: AHPA celebrated its 40th anniversary in 2022 and our achievements over the past four decades have helped shape the natural product and dietary supplement industries that we see today. I’m happy to provide a few examples of our work, but these provide only a narrow snapshot of our considerable successful record.
From adopting our first and still-standing trade requirement to prohibit trade in wild-harvest lady’s slipper orchids—a conservation action that arguably helped save the species—to publishing the first edition of Herbs of Commerce (1992)—which was subsequently incorporated by reference into federal labeling regulations for botanical ingredients—our early efforts set the stage for our bigger and broader achievements in regulatory and legislative matters.
As a significant example of our later focus, in 2003, AHPA petitioned FDA to establish adverse event reporting requirements for dietary supplements. As a result of our leadership on this controversial topic, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was enacted in 2006 to establish a serious adverse event reporting law for dietary supplements and also for over-the-counter drugs.
AHPA represents responsible industry that welcomes sensible regulation, and this continues to drive our legislative efforts and regulatory advocacy today.
Question: How has the herbal industry evolved over this time?
Answer: Herbal products have grown from only being provided by trained herbalists and sold at health food stores and specialty shops to being available at mainstream retailers both online and in-store. Many herbs are part of the dietary supplement market, which has grown from 4,000 to 90,000 products and from $4 billion to $60 billion in annual sales over the last 30 years. Herbal teas also continue to experience significant market growth.
Even as the industry has experienced this tremendous market growth, case reports of adverse events associated with herbal products are exceedingly rare. In spite of this long-established safety record, FDA continues to question the safety of many herbal ingredients.
For example, the agency published in 1983 an issue of FDA Consumer featuring a danger sign warning that herbs are “often more toxic than magical” on the cover of the magazine. More recently, FDA has concluded that CBD (cannabidiol) and NAC (N-acetyl cysteine) are excluded from the definition of dietary supplements and are, thus, unlawful. Even today, the agency’s public communications on dietary supplements emphasize safety concerns over the potential therapeutic value of these goods. FDA’s actions can be fairly summarized as preferring to limit the market, despite consumer interest in herbal products and continued industry support for advancing scientific research on botanicals.
In fact, there was a huge spike in consumer interest in herbs and herbal products to support immune health over the course of the COVID-19 pandemic. This surge in demand has led to consecutive year-over-year growth in retail sales of herbal dietary supplements by upwards of more than $1 billion annually. Clearly, herbs are not going anywhere.
Question: What obstacles are there to work on for the herbal industry?
Answer: It has been almost 20 years since the Dietary Supplement Health and Education Act (DSHEA) was passed, which amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to create the current regulatory framework for dietary supplements—and a lot has changed in those two decades. At AHPA, we believe dietary supplement regulations are due for sensible modernizations to meet the demands of today’s market.
A good place to start would be with revisiting the existing prior drug exclusion clause. This provision, which is the basis for FDA’s decisions on CBD and NAC mentioned earlier, excludes products containing substances first approved or investigated as drugs from being marketed as dietary supplements, even if they would otherwise qualify as dietary ingredients.
This means that if the pharmaceutical industry brings a drug derived from a botanical to market first, consumers will never have lawful access to dietary supplements containing that ingredient. However, if an ingredient is first marketed as or in a dietary supplement, the pharmaceutical industry can produce a drug containing that same ingredient and share the marketplace with dietary supplements. This imbalance limits consumer choice and access.
