In June of 2017, more than 30 years after the passage of the signature legislation dealing with supplements, the Dietary Supplement Health and Education Act of 1994 (DSHEA), several industry trade associations, including the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN), went to Capitol Hill to meet with members of Congress to discuss past accomplishments and ongoing efforts regarding industry self-regulation.1
Such visits are a never-ending requirement for an industry often suffering from a mistaken view of its efforts and a long-held misperception that it is unregulated.2
Michael McGuffin, president of AHPA, knows this as well as anyone. Although he acknowledges the many other industry groups that are committed to long-term self-regulatory efforts, such as CRN, the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA), he stated that AHPA, founded in 1982, has been a central player in relation to self-regulation and has long forged a trail in these programs (oral communication, December 5, 2017).
McGuffin said that the efforts were not from some prescient knowledge of issues to come, but rather because doing so was consistent with AHPA’s mission, which is “to promote the responsible commerce of herbal products to ensure that consumers continue to enjoy informed access to a wide variety of herbal goods.”3
Supporting Responsible Commerce
“I think it is fair to say we were a trailblazer in these types of efforts, and [it is] accurate that we established standards of practice early in our existence to respond to circumstances as we became aware of them,” McGuffin said. “We have always felt that this was part of our identity and service to the trade, which extends beyond our members. But I will tell you, it is directly associated with our mission to support responsible commerce. We weren’t just trying to support ‘commerce,’ but ‘responsible commerce.’ By adding the word ‘responsible,’ it made our jobs a lot harder.”
Loren Israelsen, president of UNPA, was an early officer of AHPA and remembers the pioneering days when AHPA was “working to build a new voice for the still-adolescent herb industry” (email, December 11, 2017).
“For reasons beyond me, I was elected a founding officer of AHPA in 1982,” said Israelsen. “AHPA was my ‘hood,’ and many of my oldest and most cherished relationships came out of those early days. While AHPA board meetings are now highly organized and committees tackle the toughest issues of the day, at the heart of AHPA remains a deep commitment to advancing the safe and beneficial use of herbs.”
McGuffin noted that AHPA programs have always evolved and reflected a balance between the reactive and the proactive. AHPA may have adopted certain programs earlier, he said, if, for example, it could have foreseen the need for Herbs of Commerce or restrictions on caffeine-containing products. “But that is not how the world works,” he said. “What we are expected to do is respond to situations as they arise. We do try to predict or adopt some initiatives before there is a problem to be fixed. That is the nature of things as we move through our business lives. There are always new issues to deal with” (oral communication, November 28, 2017).
That being said, AHPA didn’t see a clear or significant problem when they set out to publish the Botanical Safety Handbook, the 1997 publication intended to evaluate herb safety and ensure safe access to a wide range of herbs and herbal products, which is arguably one of the group’s signature achievements. However, there was a realization within the organization that it would be best to address the issues of botanical safety internally rather than leave the issue to other groups without the knowledge and expertise in herbs or with a position contrary to supporting consumer use of herbs.
McGuffin largely attributed the genesis of this philosophy to one member: Daniel Gagnon, a Santa Fe, New Mexico-based herbalist and owner of Herbs, Etc., a retail store and extract manufacturer, who was standing for election to the AHPA board during the mid-1990s when the association was working on the Botanical Safety Handbook. “Daniel said that AHPA needed to control the message on botanical safety rather than let our detractors control that message,” he said.
The book, which was years in the making, started with this concept, and McGuffin, Gagnon, and other members investigated potential models from other organizations that had done self-regulatory work. They found one such model from the Flavor and Extract Manufacturers Association (FEMA), which had developed an industry-sponsored generally recognized as safe (GRAS) assessment program after the US Food and Drug Administration (FDA) took action to reclassify flavors as food additives (substances requiring premarket safety approval from the FDA before they can be added to food products). It has become an extensive program with a sound record of scientific rigor and transparency.4,5
McGuffin, Gagnon, and other AHPA representatives went to John Hallagan, general counsel for FEMA, to discuss the program. “He was very supportive and encouraged us to take on the task,” McGuffin said. He recalled that Hallagan was very stern and advised them to be thorough and not look for shortcuts. “He told us ‘you can’t exonerate everything.’”
“The point is,” McGuffin added, “people at the time were not talking about unsafe herbs. There weren’t gross numbers [of consumers] being harmed by chamomile [Matricaria chamomilla, Asteraceae] and echinacea [Echinacea spp., Asteraceae]. But one in our community said: ‘We need to take responsibility for this. It is not a clear and present danger, and we are not being damaged by a regulator. We must do this because it is the right thing to do and we have the expertise.’”
It was a premise that has since served AHPA well, and the association continuously strives to adapt and bring as many players to the table as possible to develop the programs. It was a lesson, McGuffin said, that he learned early.
AHPA’s first initiative, established in 1988 to prohibit the international and domestic trade of wildcrafted lady slipper (Cypripedium spp., Orchidaceae), is a good example of this thinking. At the time, the entire orchid family was listed in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), a designation that lists species that are not currently threatened with extinction but may become so unless trade is closely controlled.6
AHPA leaders knew that lady slipper had the attention of the international treaty, but that it wouldn’t have an impact on domestic trade, which made up a majority of the market.
AHPA quickly learned that these types of programs would not be an easy sell. In establishing the lady slipper policy, for example, McGuffin said they considered the impact of the ban on its members and the community beforehand, and recognized that there were adequate herbal substitutes for lady slipper that could offer beneficial value and provide quality products. “We felt that the impact would be minimal,” he said. However, initial reaction to the initiative was mixed. “We did hear from some companies that were marketers of wild material and herbal ingredient suppliers who thought that our action was unnecessary, and that the plant was not at risk due to harvest pressure,” he said. “But mostly, what I remember was that members said they would have liked to have been more a part of the discussion.”
The early feedback was that such programs were not completely wrong, he said, but the stronger message was that the decision-making process was not inclusive of the broader community. To address these concerns, AHPA now engages a broad cross-section when it initiates a new self-regulatory recommendation.
Bringing stakeholders to the table is an ongoing process that continues to develop. In 2017, McGuffin said, AHPA adopted a policy for supplements containing fungal ingredients and had to deal with widely divergent points of view regarding the value of the fruiting body and the mycelium and how products should be labeled. “We kept bringing both sides together to create a respectful forum to talk. There were still disagreements, but we pushed each side for what they could give,” he said. It is a difficult process, he added, but “one way to know you have a good compromise is that neither party likes it much. Is everybody happy? Maybe not, but we are seeing compliance.”
Throughout the 1990s, AHPA established a number of initiatives, such as labeling guidelines and usage cautions for herbs and products, such as chaparral (Larrea tridentata, Zygophyllaceae), stimulant laxatives, pyrrolizidine alkaloids, and kava (Piper methysticum, Piperaceae), as well as policies regarding added constituents and claims that a supplement can mask the presence of illegal drugs in the body.2 One of the self-regulatory highlights of the decade was the 1992 publication of the first edition of Herbs of Commerce, which established a single standardized common name for each of the herbs listed, with a goal to help prevent potential confusion and misuse of botanicals by manufacturers and consumers.
“We realized that the same ingredients were being sold in the market under different names and, to a degree, the consumer couldn’t tell what they were buying,” McGuffin explained. For example, eleuthero (Eleutherococcus senticosus, Araliaceae) was being sold under various names such as “Siberian ginseng,” and kola nut (Cola spp., Malvaceae) was being sold as “bissy nut.” There was concern that the name was being used instead of kola nut to move consumers away from the idea that the product contained caffeine, McGuffin explained. AHPA took on the task of becoming the authority for standardizing these common names, contracting with author and botanical expert Steven Foster to produce the document.
The publication eventually became incorporated in 1997 into the Food and Drug Administration’s (FDA) rules for labeling dietary supplements as directed in DSHEA.7 The regulation was codified in 21 CFR 101.4 (h) and states that “The common or usual name of the ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. (a) and 1 CFR part 51.”8
AHPA published a second edition of Herbs of Commerce in 2000, which includes nearly 1,500 more species than the first edition (2,048 separate species as opposed to 550). The second edition allowed many ingredients that had been used in products to be identified from then on by their common names rather than their Latin binomials.7
“The incorporation of Herbs of Commerce was a great acknowledgement of the value of our work,” McGuffin said, “and, more importantly, it was a stepping stone to help move industry self-regulatory efforts into formal regulatory references.”
From Self-Regulation to Law
This was not the only time that an AHPA program served as a credible and authoritative option for regulators. AHPA’s position on adverse event reporting in 2002 moved from an industry self-regulatory effort all the way to law and is an example of how these policies can progress. It began when the AHPA board took the position that the FDA should establish a requirement for marketers of dietary supplements to communicate reports of serious adverse events caused by their products to the FDA.9 The process took several years, with AHPA filing a Citizen Petition in 2003 asking the FDA to create regulations that would mandate adverse event reporting and noting that the administration had in numerous instances exercised its rulemaking authority to put in place requirements that would advance its public health objectives.9
The FDA originally said it did not have the authority to do this, McGuffin recalled, but AHPA believed that it was wrong and partnered with other groups, such as the Consumer Healthcare Products Association (CHPA), to convince them otherwise. Beyond CHPA, AHPA also garnered support from numerous industry watchers with a wide spectrum of views about supplement regulation. “We got bipartisan support from industry leaders in Congress, including some of our staunchest allies, such as Sen. Orrin Hatch [R-UT] and our most committed detractors, like Sen. Dick Durbin [D-IL], as well as support from consumer groups like CSPI [the Center for Science in the Public Interest] and Consumers Union. It was a remarkable exercise, but everyone recognized the need,” he said.
The adverse event proposal was eventually adopted as part of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which was signed into law in December 2006, with compliance required a year later.10 “There was initially some support and some resistance to this, but we felt we had a responsibility to support responsible commerce and that included informing regulators when something goes wrong. In this instance, we took something that started as a self-regulatory initiative to engage our members and support the community and then moved to make it a formal, public initiative,” McGuffin said.
Another signature program is AHPA’s Botanical Authentication Program that was established in 1997, originally as AHPA’s Guidance on Known Adulterants.11 At the time, McGuffin said, AHPA recognized that there were potential mix-ups or intentional substitutions of certain herbs, so the program set out to identify herbs and potential adulterants that were known to be in trade. “We didn’t evaluate whether it was an intentional adulteration or simply an accident. In each case, there was a known substitute that had the potential to cause significant [adverse] health effects, so we were focused on safety issues.” The program started with a list of four ingredients, including aristolochic acids (a family of phytochemicals commonly found in the family Aristolochiaceae), stephania (Stephania tetrandra, Menispermaceae) root, skullcap (Scutellaria lateriflora, Lamiaceae) herb, and eleuthero root, which were identified as potentially adulterated. The program provided guidance to help manufacturers dealing with those ingredients, so they could double- and triple-check that they had the correct ingredient.
The ongoing and dynamic program has evolved over the past 20 years as part of AHPA’s Botanical Authentication Program with additional ingredients, such as black cohosh (Actaea racemosa, Ranunculaceae) as well as grapefruit (Citrus paradisi, Rutaceae) seed extract added to the list. The program also provides members and industry with online tools to ensure ingredient identity and quality.
AHPA also has led the way with guidance documents that provide specific and detailed information about herbal ingredients. “AHPA’s 2000 Guidance Policy on extract retail labeling continues to be instructive to companies that want to increase their supply chain knowledge and transparency,” said Steven Dentali, PhD, a former AHPA chief science officer. “Knowing the precise nature of the extracts manufacturers purchase from suppliers is made easier when the basic botanical principles are understood. AHPA continues to be at the forefront of trade associations focused on developing herbal standards and communicating them to the wider stakeholder community.”
What Has the Industry Learned?
Despite AHPA’s extensive list of self-regulatory accomplishments, the investigation by New York attorney general Eric Schneiderman that began in early 2015 once again indicated that the botanical and dietary supplement industries still faced many powerful detractors and significant misconceptions about regulatory status. While the allegations against numerous manufacturers and retailers prompted an unprecedented industry effort to work together toward self-regulation, it still rankles McGuffin for a number of reasons. “The primary issue that I challenge is the idea that world history went like this: Step one: We are bad. Step two: Eric Schneiderman said, ‘You are bad.’ Step 3: We decided to be good. That is a false narrative. The true story is, we were good to begin with. We were always involved with these issues. We didn’t start self-regulating in 2015.”
Correcting the record is a common theme when McGuffin speaks. In his keynote address of the 2016 Rocky Mountain Dietary Supplement Forum, he rejected the idea that the 2015 investigation by the New York attorney general was the sole event that prompted the industry to behave honorably. “These new initiatives do not represent the industry’s first foray into self-regulation, and I reject any suggestion that we have arrived at the point of creating new programs under duress.”12
He does acknowledge that the investigation has provided a stepping-off point for more self-regulatory initiatives. One such effort, he said, is the re-emergence of AHPA’s Good Agricultural and Collection Practices (GACPs), first established in 2006 in partnership with Roy Upton and the American Herbal Pharmacopoeia. The initiative was modeled after various other programs around the world. Some ideas were original, and some were borrowed with a focus on the US market, McGuffin explained. “We produced it. We posted it, but we didn’t keep our attention on it.”
That is, until consultants for GNC, facing legal issues from Schneiderman, copied the document from the AHPA website and then crafted a revised version with a more contemporary focus and input from herbal suppliers and manufacturers to establish appropriate controls all the way back to seed and harvest, McGuffin said. GNC then gave the document back to AHPA to put in additional context from a trade association perspective. The document, which now includes Good Manufacturing Practices for Botanical Material, as well as GACPs, was formally approved in March 2017 and has since been endorsed by a variety of other industry associations, such as CHPA, CRN, and UNPA. The free assessment tools are designed to help the herbal products industry evaluate and document policies and procedures that ensure high-quality herbs and herbal ingredients throughout the supply chain.2
In a letter of endorsement for the guidance, Israelsen wrote: “UNPA is confident that this comprehensive guidance and its accompanying assessment tools will help promote proper identification of and reduce the adulteration of botanical raw materials, with a goal of providing high-quality ingredients for dietary supplements and other natural health products. We will encourage our member companies to incorporate the AHPA GACP-GMP into their own growing, procurement and processing operations.”13
A New Era
Though the challenges will likely continue, McGuffin remains optimistic for the future and believes there is still strong momentum going forward. “I think there is still a lot of interest in countering the image of the dietary supplements industry as unregulated,” he added. “We know it’s false, but we also recognize now that we are not going to change that by just saying ‘nu uh.’ The only way to change that is with respect for the foundational companies that are making the best-quality products, and then indicating to consumers in a public manner that they are going a step beyond what is required.”
In the end, McGuffin added, it comes down to the consumer who will continue to demand access to herbal products and, as they become more knowledgeable and information is more accessible, they will buy from companies that meet appropriate quality standards and share their values. The industry in turn will have no choice but to continue with self-regulatory initiatives that meet this demand. “One thing is not leading the other,” he said. “There is a valuable and productive tension between consumers and industry, and the next generation will keep the process going and industry self-regulation will be a part of the program then, just as it is today.”
- Crawford E. Dietary supplement industry promotes self-regulation, need for increased access on Capitol Hill. FoodNavigator-USA. June 21, 2017. Available at: www.foodnavigator-usa.com/Article/2017/06/21/CRN-AHPA-promote-self-regulation-increased-supplement-access#. Accessed December 6, 2017.
- AHPA Staff. Herbal supplement industry’s long history of self-regulation. AHPA Report. October 2016. Volume 31. Number 10.
- AHPA’s mission. AHPA website. Available at: www.ahpa.org/AboutUs/AHPAsPolicies.aspx. Accessed December 6, 2017.
- FEMA GRAS Program. Available at: www.femaflavor.org/gras. Accessed December 7, 2017.
- Hallagan JB, Hall R. Under the conditions of intended us — New Developments in the FEMA GRAS program and the safety assessment of flavor ingredients. Food Chemical Toxicology. February 2009; 47(2): 267-278. Available at www.sciencedirect.com/science/article/pii/S0278691508006443.
- The CITES Appendices. Available at: https://cites.org/eng/app/index.php. Accessed December 6, 2017.
- Herbs of Commerce becomes law of the land for labeling. [press release]. Silver Spring, MD; American Herbal Products Association. November 7, 2005. Available at: www.newhope.com/supply-news-amp-analysis/herbs-commerce-2nd-edition-becomes-law-land-labeling. Accessed December 8, 2017.
- US Food and Drug Administration. 21 CFR §101.4. Food for human consumption: food labeling. In: Code of Federal Regulations. Washington, DC: US Government Printing Office; 2017. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.4. Accessed February 1, 2018.
- American Herbal Products Association Supports Serious Adverse Event Reporting for Dietary Supplements [press release]. Silver Spring, MD. American Herbal Products Association. June 6, 2004. Available at New hope.com. www.newhope.com/supply-news-amp-analysis/american-herbal-products-association-supports-serious-adverse-event-reporti. Accessed on December 8, 2017.
- Adverse Event Reporting: Considerations and Med Watch Worksheet for Receiving AERs Associated with Dietary Supplements. AHPA website. Available at: www.ahpa.org/Resources/TechnicalGuidance/AHPAGuidanceDocuments/TabId/401/ArtMID/1244/ArticleID/222/Adverse-Event-Reporting-Considerations-MedWatch-Worksheet-for-Receiving-AERs-Associated-with-Dietary-Supplements.aspx. Accessed Dec. 8, 2017.
- AHPA Botanical Authentication Program. AHPA website. Available at: www.ahpa.org/Resources/TechnicalGuidance/ScientificAffairs/BotanicalAuthenticationProgram.aspx. Accessed December 8, 2017.
- AHPA Launches GACP-GMP Assessment Program. AHPA Website. Latest news. Available at www.ahpa.org/News/LatestNews/TabId/96/ArtMID/1179/ArticleID/847/AHPA-Launches-GACP-GMP-Assessment-Program.aspx. Accessed December, 8, 2017.
- UNPA Endorses AHPA’s Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Material [press release]. Salt Lake City. November 28, 2017. Available at: www.ahpa.org/News/LatestNews/TabId/96/ArtMID/1179/ArticleID/890/UNPA-endorses-AHPAs-Good-Agricultural-and-Collection-Practices-and-Good-Manufacturing-Practices-for-Botanical-Material.aspx. Accessed December 10, 2017.