Guest Article: AHPA reflects on 40-year history of defending herb safety as part of continued commitment to move industry forward
This year was a special one for us: AHPA was founded in 1982, making 2022 our 40th anniversary. We have celebrated all year in many ways, including by showcasing the many herbs at the heart of our industry through our 40 Herbs We Love campaign and inviting members to contribute articles about their fondest memories of AHPA for our monthly newsletter. In addition to these sentimental festivities, we honor our history every day by leveraging AHPA’s institutional memory to guide our ongoing efforts to move the industry forward.
Over the past four decades and under the leadership of many well-known and still-active industry pioneers, AHPA has actively engaged with the U.S. Food and Drug Administration (FDA) and other regulators to defend access to safe herbal ingredients. These prominent leaders (past and present) and our history of FDA engagement were on full display in March at AHPA’s annual member meeting at Natural Products Expo West in Anaheim, California.
At the meeting, we hosted a panel discussion entitled “40 Years of AHPA: A Timeline of Preserving Health Freedom.” The session chronicled FDA’s track record of attempting to limit access to dietary supplements and highlighted how AHPA and our members responded to keep safe herbal ingredients and products on the market. For example, in the earliest days of AHPA, the association supported member Fmali Herbs in its successful lawsuit against FDA (Fmali Herb, Inc. v. Heckler), ensuring that industry may demonstrate an herb’s safety based on a history of consumption outside of the United States.
Another highlight of our 40th anniversary panel was the display of the staying power of AHPA staff, both with the association and at the forefront of the industry. I have had the distinct pleasure to lead AHPA as president for over 20 years. Joseph Betz, who previously served as AHPA’s vice president for scientific and technical affairs, has been with the National Institutes of Health’s Office of Dietary Supplements (ODS) since 2002 and was appointed acting director of ODS in 2018. Rob McCaleb, a founding AHPA board member, co-founded the Herb Research Foundation (HRF) and has served as president of HRF for over 40 years. Other panelists, including Tony Young and Roy Upton, have also been actively engaged with AHPA and the natural products industry for decades.
In addition to those who took the stage in March, our long-serving trustees have also displayed great staying power and have continued to bring their expertise and experience to support AHPA’s efforts. Tenured trustees are those who have served on the AHPA board for more than 15 years each and include Mitch Coven (Vitality Works), Daniel Gagnon (Herbs, Etc.), Katie Huggins (Traditional Medicinals), and Beth Lambert (Herbalist & Alchemist). The board also includes many newcomers and reflects the different corners of our industry—representing ingredient suppliers, analytical labs, and consumer product brands.
AHPA’s experience on the frontlines of defending herbs and the combined knowledge of our staff, board of trustees, members, and network of trusted partners have been key to successfully taking on industry challenges (old and new) and adapting to the needs of the modern consumer.
A major affront to dietary supplement safety came in August of this year, when Kaiser Health News (KHN) reported that the Sacramento County (California) coroner's office concluded that “dehydration as a result of gastroenteritis caused by white mulberry leaf” caused the death of Lori McClintock, the wife of Congressman Tom McClintock (R-CA4). This report set off a media frenzy, with mainstream news outlets blasting dietary supplements as dangerous and “unregulated”—which is, as we have discussed elsewhere at length, untrue.
In response, AHPA quickly coordinated its staff and network of herbal experts to produce a statement endorsing the safety of white mulberry leaf (Morus alba) given its long history of use and consumption in traditional Chinese medicine, extensive clinical studies (including those conducted by Phynova for its white mulberry leaf extract product), and scientific consensus on the safety of white mulberry leaf as reflected in the Botanical Safety Handbook, Second Edition.
The statement resulted in a follow-up article by KHN that reported how botanical safety experts expressed doubt that white mulberry leaf had caused Mrs. McClintock’s death. AHPA later released an updated entry for white mulberry leaf in the online version of the Botanical Safety Handbook, adding more information supporting the safety of the plant. This rapid, coordinated response in defense of an herb with a long history of safe use was possible because of the knowledge and expertise of AHPA’s staff and members, the broader herbal community, and AHPA’s well-established resources on botanical safety.
Although our response seemed to quell the media frenzy, concerns about the safety and regulation of dietary supplements stemming from KHN’s initial reporting were nonetheless used to argue in favor of legislation establishing mandatory product listing (MPL) requirements for dietary supplements. The concept of MPL legislation—which would require marketers of dietary supplements sold in the United States to submit detailed product information to FDA—is not new but took centerstage this year thanks in part to the proposed MPL provisions in the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act.
As advocates for and against MPL have debated whether such legislation is needed, AHPA has maintained that the MPL requirements as proposed in the FDASLA Act would prove redundant and unnecessary. AHPA has further voiced concerns that the costs to comply would disproportionately burden small businesses and could ultimately reduce the size of the market and range of products available to consumers. The results of the midterm elections in November, in which Republicans took control of the House of Representatives while Democrats retained control of the Senate, likely will present additional hurdles for advocates of MPL in the 118th Congress. This reflects how Republicans historically oppose expanding FDA’s authority.
AHPA has always favored responsible regulation of herbal products and has supported changes to the law when appropriate. In fact, we led the coordinated and successful effort to establish a serious adverse event reporting law for dietary supplements (the Dietary Supplement and Nonprescription Drug Consumer Protection Act) nearly 20 years ago. As the new Congress dawns, it may well be time to broaden the focus beyond MPL and consider other amendments to the Federal Food, Drug, and Cosmetic Act that, if enacted, would better benefit consumers.
A lot has changed in the 28 years since the enactment of the landmark Dietary Supplement Health and Education Act (DSHEA). More consumers are interested in dietary supplements to support their health, and more products are available through more sales channels than ever. Given the growth of the industry, the statutes and regulations governing the product category are due for modernization to keep pace with the demands of today’s marketplace.
The legislature might start with the existing prior drug exclusion clause. This clause—which FDA has cited in its decisions regarding products containing cannabidiol (CBD), red yeast rice, N-acetyl-L-cysteine (NAC), and, most recently, β-nicotinamide mononucleotide (NMN)—excludes from the definition of “dietary supplement” products containing substances first approved or investigated as drugs, even if they would otherwise qualify as “dietary ingredients.” As currently written, it permanently prohibits consumers from accessing a dietary supplement that contains any such ingredient.
By contrast, 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 even long after the incentives for further pharmaceutical development of an ingredient have dwindled or outright vanished.
Consumers would also benefit from the removal of current legal restrictions that require certain scientific publications to be “physically separate” from dietary supplements. This law limits the ability of responsible marketers of dietary supplements to share truthful and not misleading information with the public. The companies investing resources into studying ingredients should be able to provide scientific research to consumers to assist them in making the most informed decisions about the products they buy to support their health.
The above examples are just a few of the legislative and regulatory topics currently under discussion among AHPA members. As our 40th anniversary year comes to a close, AHPA remains committed to promoting the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods for years to come. We will continue advocating on behalf of our members and developing resources—such as the long-anticipated third edition of Herbs of Commerce scheduled for publication in 2023—to improve the quality of dietary supplements and other natural products on the market.