Early in the 1980s, a number of companies active in the herb trade came together with an idea that a professional organization was needed to represent this unique product class. Quite of few of the people who were there are now some of the best known personalities and leaders in the herb and supplement world: Mark Blumenthal, Loren Israelsen, Peggy Brevoort, Lynda LeMole, Drake Sadler, Barry Meltzer, Chuck Stevens, Peter Landes and Rob McCaleb.

Those initial meetings led to the formation of the American Herbal Products Association (AHPA). It was at about the same time that other organizations, such as the American Botanical Council and the Herb Research Foundation (HRF), were also coming into existence.

Looking Back

AHPA was formed in the years following the U.S. Food and Drug Administration’s (FDA’s) sustained attempts, which began in 1962, to restrict the nutritional supplement category in regard to allowable vitamin and mineral content, according to AHPA’s current president, Michael McGuffin. Those attempts were eventually overturned by the courts and invalidated by the passing in 1976 of the Rogers- Proxmire vitamin amendments to the Federal Food, Drug and Cosmetic Act.

But there was still much work to be done to create a positive environment for the sale of herbal products and Dietary supplements. For example, starting in 1987, AHPA began sponsoring seminars to educate industry on preparing for and responding to FDA site inspections.

At the time, there were a lot of small, “mom and pop” health food stores and some regional food co-ops (back then a large store was about 4,000 square feet). Except for a few communities on The East and West Coasts and pockets of strong natural foods support in places such as Austin, TX; Ann Arbor, MI; Madison, WI and Boulder, CO.

Many of the herbal brands that are now the national leaders were still relatively young companies: Celestial Seasonings (1968); NOW Foods (1968); Tom’s of Maine (1968); Nature’s Way (1969); Nature’s Herbs (1969); Bio- Botanica (1972); Traditional Medicinals (1974); Frontier Natural Products Co-op (1976); and Whole Foods Market (1980).

In 1993, the FDA published an Advanced Notice of Proposed Rulemaking (ANPR) based on the recommendations of an FDA Task Force on Dietary Supplements that sought to revisit the idea of restricting the formulation of dietary supplements. “Specifically, as it relates to herbal ingredients, FDA noted that many herbs have no known food use and are primarily used for medicinal purposes irre-Spective of any drug claims on product labels,” McGuffin said. “This met with tremendous industry and consumer opposition, ultimately leading to pressure on Congress to address the issue and provide guidance to FDA regarding the regulation of dietary supplements. This could be seen as the beginning of the movement toward what would become the Dietary Supplement Health and Education Act (DSHEA) of 1994.”

Along with a number of the other trade Associations and key industry companies, AHPA was closely involved in the development of DSHEA legislation.

Impact

The association’s mission is simple and to the point: to promote the responsible commerce of herbal products. AHPA strives to meet that mission by providing services to its members in four key areas: representation, communication, education, and self-regulation.

“In terms of representation, AHPA has had a strong presence at the federal level, including working relationships with several members of the U.S. Congress,” said McGuffin, “We also work closely with a number of regulatory agencies, including the FDA, the Federal Trade Commission (FTC), the Fish & Wildlife Service, and the USDA’s Forest Service and the National Organic Program (NOP)—with the dual goals of ensuring consumer access to a broad variety of safe herbal products, and creating and maintaining an environment in which herbal companies can do business.”

AHPA is also very active at the state level. When California passed its Proposition 65 legislation in 1986, for example, AHPA published guidance documents for the industry and produced a number of symposiums to educate membership on how to comply with the many aspects of the law.

In the areas of science and technology, AHPA staff regularly interfaces and interacts with other organizations of importance to the dietary supplement industry and herbal products, such as the United States Pharmacopeia (USP), the National Center for Complimentary and Alternative Medicine (NCCAM), the Office of Dietary Supplements at the National Institutes of Health (NIH-ODS), AOAC International and others.

“It’s imperative that AHPA continue to maintain its level of interaction with USP and other botanical stake-holder organizations in order to ensure that they have the right information when it comes to herbs and herbal products,” said Steven Dentali, PhD, AHPA’s chief science officer.

Communications and Education

AHPA is in touch with its membership via three main vehicles: the AHPA Report, the association’s monthly newsletter; AHPA Updates, which are Semi-regular emails with information of interest to all of the membership; and AHPA Alerts, which include Media Alerts, Legal Alerts and Science Alerts, according to Frank Lampe, AHPA’s director of communications. These are generated and produced on an as-needed basis, often 30 to 40 each month, and provide the most timely and pertinent news and information of interest on a wide variety of topics. For example, Dentali scans the research literature for significant science and technology articles about herbs and botanicals in peerreviewed journals. AHPA members also benefit from its Washington-based legal counsel and lobbyist.

“In the March 2011 issue of the AHPA Report, for example, we presented a literature review of past articles on kava by renowned kava expert, Rolf Teschke, MD, that points to storage and processing issues—as opposed to an inherent problem with kava—as the reason for all of the reports of toxicity that led to label warnings and bans by some countries,” said Lampe. “This article received a lot of attention from industry press. As part of our outreach efforts, we interact regularly with members of the industry and mainstream press, providing background, information and commentary on issues affecting the industry.”

While effectively communicating with its membership, education is a cornerstone of AHPA’s efforts through numerous publications, seminars and symposiums. Since 1984, the association has been creating industry-driven deliverables in order to assist with regulatory, legislative and other business issues of import to businesses. AHPA established a legacy of education when it sponsored seminars for industry on FDA inspections in 1987. Since 1998, AHPA has regularly produced symposiums on a varie ty of topics from claims substantiation, adverse events reporting (AER) compliance, and green marketing and sustainability to educating medical practitioners on how to evaluate product quality.

Leadership

AHPA’s Board of Trustees consists of 24 representatives of member companies that oversee the direction and provide vision for the organization. “It is an engaged board of successful businesspeople that share a passion for herbs and herbal products, and a real-world view of the landscape within which we operate,” said McGuffin.

Additionally, AHPA maintains 16 very Active committees, which are considered the core of the association. The committees, representing everything from analytical laboratories and ayurvedic products to botanical raw materials and government relations, provide the nucleus and impetus for new publications, trade regulations and events.

“With the many years of experience of our senior management team—a combined 89 years of service—our expertise in legislative and regulatory affairs, our communications and education programs, our breadth of relationships and the access we provide our membership to that expertise, we continue to serve as the voice of the herbal and botanical products industry,” said McGuffin.

Inside the Beltway

For nearly 30 years, AHPA has forged respectful, productive working relationships with a growing number of industry supporters and champions in the House and Senate. Of possibly greater significance, AHPA has developed a unique skill in working with its Congressional critics, and the introduction and passage of the Adverse Event Reporting (AER) Law in 2006 is evidence of this ability.

Last year, the association was centrally involved in the withdrawal (by its sponsors) of the Dietary Supplement Safety Act of 2010 (S.3002). Introduced by Sen. John McCain (R-AZ), this legislation would have placed several onerous regulations and requirements on dietary supplements.

Accomplishments

Accomplishments

• In 1988, before sustainability was on many people’s radar screens, AHPA led the way for the herb industry by adopting trade policies on the sustainable harvesting of wild plants.

• The organization submitted a stevia petition to the FDA regarding gaining generally recognized as safe (GRAS) status for stevia as a food ingredient in 1991—17 years ahead of its acceptance by FDA in late 2008.

• AER law (2006). In March 2003, AHPA petitioned the FDA to establish a regulation to require submission to FDA of serious adverse event reports (SAERs) received by supplement marketers. FDA responded by saying that it did not Have the authority under current law. It took three years, but AHPA was able to get the industry to agree that this was a good idea and to find the right Congressional allies. “AHPA leadership on this issue directly led to Congress adopting the SAER law, which is the most significant action since the passage of DSHEA itself to ensure broad access to safe supplements,” said McGuffin.

• AHPA produced Herbs of Commerce in 1992 with the primary purpose of ensuring that consumers would be able to identify plants used in products by their common or usual names. This work was incorporated by reference in FDA’s labeling regulation for dietary supplements in 1997, and has since been revised to provide names for over 2,000 plant species.

• AHPA was instrumental in dietary supplements being included under the NOP in 2005.

• AHPA established a legacy of education when it sponsored seminars for the industry on FDA inspections in 1987. Since 1998, AHPA has regularly produced symposiums on a variety of topics from claims substantiation, AER compliance, green marketing and sustainability, and educating medical practitioners on how to evaluate product quality.

• AHPA published the Botanical Safety Handbook (BSH) in 1997, the definitive reference guide for safety information relevant to the labeling and use of more than 550 herbs. The BSH will be issued in a revised, expanded and updated version later this year or in early 2012.

AHPA-ERB Foundation

Founded to promote education and research on medicinal, therapeutic and health-promoting herbs, the AHPA-ERB (Education Research on Botanicals) Foundation serves the education and research needs not only of AHPA members, but also of the botanical and herbal industry at large. Noteworthy projects are:

. Funding the revision of the BSH.

• Funding research on the economics of wild American ginseng harvest. The project will result in a peer-reviewed publication, which will report—for the first time—the contribution the annual ginseng harvest makes to economies in rural American communities.

• Publishing A Field Guide to Herbal Dietary Supplements in 2008.

• Publishing Mending the Web of Life: Chinese Medicine and Species Conservation in 2006, a book for students and practitioners of Chinese medicine, conservationists and anyone interested in endangered animals and plants used in the Chinese materiamedica.

Holding Steady

AHPA’s membership—at its highest level in 2011—has grown to include companies that manufacture and market dietary supplements, as well as distributors, suppliers, growers, and processors, but it has also expanded into broader categories of finished goods such as personal care, animal products and sports nutrition.

The organization has “arrived” and is where its members want it to be, said McGuffin. “AHPA clearly understands our members’ values and the organizational functions that they expect us to undertake on their behalf, and we expect to maintain our focus in these areas.

“AHPA is in many ways a mature organization at the age of 30,” he added. “We still retain half a dozen of our founders as members; we have numerous trustees who have served on the AHPA board for over a decade; we are very consistent in representing our members’ views to legislators, regulators and the media, and in providing benefit through our communication and education programs.”

At the same time, AHPA is expanding its range of influence. “We just added 56 new members in 2010,” McGuffin said. “In interviewing these companies, it is clear that they have joined not because of where they think AHPA may be headed, but because of where we are today, and because they recognize the experience that AHPA offers to companies in the herbal products marketplace.”

Given the current consumer trend toward natural foods, AHPA is destined to play an even bigger role in the future of botanicals and dietary supplements, added James May, AHPA member and supporter, and president and CEO of Wisdom Natural Brands (Gilbert, AZ). “I have every expectation AHPA will continue to be essential to everyone involved in the herbal products industry and beyond. Its dedication to industry excellence and performance is unsurpassed.” NIE

AHPA says it exists for one purpose only: to promote the responsible commerce of herbal products, and it has been leading the way for nearly 30 years.

AHPA

1982 AHPA incorporated with an office in Long Island, NY

1983 Supported legal action against the FDA re: GRAS Status (common use of food in foreign countries vs. U.S. only—Fmali Herb vs. Heckler suit); 1st Herbalgram published as AHPA/HRF newsletter

1984 FDA Inspection Guide published 

1991 Food Ingredient Safety Review: Comfrey & Stevia published; Stevia GRAS submission; AHPA Herb Market Survey published 

1992 Herbs of Commerce, 1st edition published; Tonnage Survey 

1990-1992 published; AHPA responds to FDA proposed regulations on NLEA; Support for S. 2825 “Health Freedom Act of 1992” (precursor to DSHEA)

1993 Food Ingredient Safety Review: Eleuthero published; Comments to FDA on ANPR (Dykstra Report); Standards Committee begins work on development of good manufacturing practices (GMP) and considers proposals/ models for adverse event reporting (AER) 

1994 DSHEA signed into law; Ephedra warning label recommendations; Recommended Labeling & Use Guidelines for Herbs of Commerce (becomes BSH) issued; draft GMP provided to members for review/harmonization with other trade organizations

1995 Trade Requirement: Stimulant Laxatives & Chaparral issued; Board adopts position requiring statement on ephedra products; Submits “ODI List” to FDA 

1996 Trade Requirement on Pyrrolizidine Alkaloids issued; AHPA office moves to Silver Spring, MD; Comments re: DSHEA Commission 

1997 Botanical Safety Handbook published; AHPA-ERB Foundation incorporated; Herb Safety Review: Kava published; Trade Requirement: Kava issued

1998 Saw Palmetto Symposium held; St. John’s Wort Symposium held; Trade Requirement: Drug Masking Claims issued 

1999 AHPA Dietary Supplement Labeling Guide published; Tonnage Report (1999) published; International Ephedra Symposium held; Echinacea Symposium held; Michael McGuffin named AHPA president 

2000 Garlic Symposium held; Comments to FDA re: Botanical Drug Products Guidance 

2001 Herbs of Commerce, 2nd edition published; 

Tonnage Report (2000-2001) published; International Aloe Symposium held; Comments to FDA re: Proposed Health and Diet Survey

2002 Botanicals for Women’s Health International Symposium held; Comments to FDA re: Bioterrorism and First Amendment Issues 

2003 Guidance for the Manufacture and Sale of Botanical Extracts issued; Tonnage Report (2002-2003) published; Healthy Aging Symposium held; Comments to FDA re: Ephedra alkaloids; AER legislation 

2004 Proposition 65 Overview published; Deception in Weight Loss Advertising published; Seminars held: AER, Citizens for Health, Herbal Cleanliness; Comments to FDA re: Qualified Health Claims and Labeling of Dietary Supplements 

2005 FDA Inspection Guide revised and published; Tonnage Report (2004-2005) published; Seminars held: cGMP Compliance Series: FDA Inspections, Food Allergen Labeling; Comments to FDA re: Substantiation for Dietary Supplement Claims Under 403(r)(6) of the FD&C Act 

2006 Good Agricultural & Collection Practice for Herbal Raw Materials (GACP) published by AHPA and AHP; New Dietary Ingredient (NDI) Interim Guidance issued; first HerbDay (www.herbday.org) held; Seminars held: cGMP Compliance Series: Intro to GMP, Botanical ID and Herb Quality & The Quality Unit, Claims Substantiation, NDI; AHPA-ERB publishes Mending the Web of Life

(2006-2007) published; Seminars held: AER-2, AER-3, Structure- Function Claims, GMP—the Final Rule, FDA Debrief; Comments to FDA re: Draft Guidance for CAM Products and Regulation by FDA; Comments to FTC on Endorsement Guides Review

2008 Proposition 65 Overview revised and published; Seminars held: GACP, Shelf-Life Statements, Green Marketing; Comments to FDA re: OTC-DS combination products, re: GSK Citizen’s Petition, re: FDA to treat Weight Loss Claims for DS as Disease Claims, and re: FDAAA/Section 912; Comments to USDA Forest Service: Proposed Rule to Add Subpart G and H to Title 35 Pt. 223 of CFR

2009 FDA Inspection Guide (revised and published); Heavy Metal Guidance issued; Micro/Myco Guidance issued; Seminars held: cGMP Compliance Series: Setting Specifications, Recordkeeping and Document Control, FDA Inspections; Comments to FDA re: Economically Motivated Adulteration and re: Illegal Products Containing Synthetic Steroids

2010 Insurance Primer published; Seminars held: cGMP Compliance Series: Meeting Specifications—ID Testing and Vendor Quality, Microscopic Identification of Popular Botanicals, Prop. 65; Evaluating Product Quality in Dietary Supplements 

2011 Provides recommendations to Codex on use of steviol glycosides and sorbates as additives in food supplements 

2012 AHPA’s 30th anniversary


Member

AHPA members have the information, insight and opinions about the services, information and value they receive that inspires their loyalty. Here, AHPA members discuss the organization that, they agree, has helped promote the responsible growth of the industry.

“AHPA serves as a positive and unified voice for the herbal products industry. Whereas other organizations cover many aspects and interests of the nutrition industry, AHPA is focused entirely on the herbal products industry giving it a unique advantage in serving its members’ interests.

“At Indena, we see AHPA as an integral partner in our efforts. AHPA is the only trade organization with scientific and industry-related botanical expertise.We believe that its emphasis on promoting scientifically validated products is critical.We also believe a future emphasis in serving as an industry watchdog is necessary as adulteration in the herbal products industry is occurring.”

— Greg Ris, vice president of sales with Indena U.S.A., Inc. (Seattle, WA)

“AHPA makes a difference for the industry in many different ways. For example, AHPA’s advocacy has been important in both passing (AERs) and stopping (McCain’s bill last year) legislation that either made sense, or didn’t.

The quality of information AHPA’s staff provides to regulatory agencies, members of Congress, the media and its members is unparalleled. Its ability to set the record straight for members of the mainstream media often helps mitigate negative coverage by providing accurate information.

AHPA’s labeling and other technical guidelines help keep member manufacturers at the forefront of compliance.

“I would like to encourage more companies that buy and sell herbs and botanicals to join AHPA. You don’t know what you’re missing!”

— Michael Lelah, technical director of NOW Foods (Bloomingdale, IL)

“We first became involved with AHPA in the late 1990s. We became aware of AHPA when it contacted us for working together On ayurvedic herbs. I was intrigued by the dedication of the people involved in the association, and their willingness to represent the interest of all herbal companies.”

— P. K. Davé, president and CEO of Nature’s Formulary, LLC. (Clifton Park, NY)

“I became involved with AHPA about 16 years ago, right around the time DSHEA had passed. My business partner, David Winston, told me that it was the most important industry organization for herbal products. I attended the annual meeting and sat in on committee meetings. The information about all aspects of the industry was extremely helpful and really broadened our company’s understanding of the legal and supply issues in the industry.”

— Beth Lambert, CEO of Herbalist & Alchemist, Inc. (Washington, NJ)

“AHPA’s involvement with regulatory agencies, the scientific community and elected officials are of great benefit to any Company operating in the U.S. herbal industry. The organization’s knowledge and expertise are invaluable in furthering the industry. Michael McGuffin in particular, with his many years in the herbal industry, is extremely effective at setting the record straight with the media and legislators.”

— Shaheen Majeed, marketing director with Sabinsa (East Windsor, NJ)

“I was intrigued with AHPA because it had joined with me in the battle against FDA to make stevia available to North Americans. My battle had commenced years earlier.

“AHPA is the premier trade association for the herbal industry whose mission is to promote responsible herbal products commerce through self-regulation. The association is a valuable resource for the herbal industry, providing guidance informed by the collective experience of its members.”

— James May, president and CEO of Wisdom Natural Brands (Gilbert, AZ)