Issue:
118
Page: 50-53
AHPA’s Self-Regulatory Initiatives in the US Herb Industry
The American Herbal Products Association adheres to its mission as it pursues responsible commerce in 30 years of self-regulatory efforts
by Karen Raterman
HerbalGram.
2018; American Botanical Council
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.’”
Lessons Learned
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.”
References
- 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
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- AHPA’s mission. AHPA website. Available at: www.ahpa.org/AboutUs/AHPAsPolicies.aspx.
Accessed December 6, 2017.
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- 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.
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- 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.
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