AHPA Board of Trustees meets at Supply Side West; acts on numerous issues
The American Herbal Products Association (AHPA) Board of Trustees took several actions in support of policies proposed by AHPA committees at a meeting held November 13 in Las Vegas in conjunction with the SupplySide West trade show.
Comments on FSMA proposed rules
The board's most timely action was its decision to authorize comments to be submitted in response to the first two proposed rules issued by the Food and Drug Administration (FDA) to implement portions of Food Safety Modernization Act (FSMA). These proposed rules will create entirely new regulations for food manufacturers ("cGMP and Hazard Analysis and Risk-based Preventive Controls") and will for the first time place farm produce under an FDA rule ("Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption").
"AHPA's Government Relations Committee has developed extensive comments to these first two proposed rules," commented Michael McGuffin, AHPA's president. "Our comments focus on minimizing costs of implementation by reducing redundancies and maximizing regulatory flexibility, and clarifying the specific language of these rules to eliminate as much confusion as possible when the rules are implemented."
Comments were due to be submitted by November 15, but on that date FDA announced a one week extension of the deadline to submit comments.
Opposition to DSHEA amendment formalized
The board's actions at last week's meeting also included adoption of a policy to express formal opposition to the Dietary Supplement Labeling Act (S. 1425). This bill was introduced by Senators Richard Durbin (D-IL) and Richard Blumenthal (D-CT) in August, and would require supplements to be registered with the Food and Drug Administration (FDA) and would amend certain supplement labeling requirements.
"AHPA has opposed similar legislation in the past and will continue to work against any attempt to increase burdens on supplement companies that do not in any way provide commensurate benefits for consumers," said AHPA's McGuffin in response to the board's decision.
The AHPA board also instructed its Government Relations Committee to establish an AHPA PAC Oversight Subcommittee to provide guidance to the management of the AHPA Political Action Committee.
Amendment to member application policy
The AHPA Board adopted a recommendation from the AHPA Finance and Governance Committee to clarify that botanical reference standards are considered to be an "herbal product" as identified in the AHPA Bylaws and for purposes of determining membership category. This action clarifies that companies that market botanical reference standards will be considered to be Active rather than Associate members, and will be allowed to stand for election to the board and to vote on matters before the membership.
The AHPA board also adopted a policy to amend the member application process to require applicants to meet additional criteria. Under the new policy AHPA member applications from dietary supplement marketers will be considered incomplete for an applicant that makes any claim that an ingredient it markets is a constituent of a botanical unless the applicant also provides substantiation of this claim if the ingredient is not a well-established constituent of a botanical. Applications will also be considered incomplete for applicants that claim to market a new dietary ingredient (NDI) but have not filed an NDI notification with FDA, if such notification is required for the specific NDI.
Strengthening the AHPA ERB Foundation
The AHPA board appointed two new members to the AHPA Foundation for Education and Research on Botanicals (the AHPA ERB Foundation) Board of Directors, Zoë Gardner, research and development manager at Traditional Medicinals, and Wendy Applequist, associate curator at the William L. Brown Center Missouri Botanical Garden.
In addition, the AHPA board approved the publication of a guidance document on the Convention on International Trade in Endangered Species (CITES) titled "Primer on Importing & Exporting CITES-Listed Species Used in Traditional Medicines and Dietary Supplements in the United States." This document was funded in part by the National Fish & Wildlife Foundation and is nearing completion through the efforts of Jane Wilson, AHPA's Director of Program Development, and with oversight by the Foundation's board.
The AHPA board expressed support for the Foundation by approving two unrestricted contribution of $10,000 each, one in 2013 and another in 2014.
"The board's financial support is a much appreciated recognition of the value of the work of the AHPA ERB Foundation," commented Beth Lambert, the Foundation's chair. "These additional resources will enable the Foundation to increase its research and education programs."
Expanding AHPA's presence in the tea industry
AHPA chartered a Tea Products Committee in 2011 to promote and protect responsible commerce of herbal products marketed as teas. Noting that this class of products is referred to as "infusions" in certain international markets, the board changed the committee's name to the Tea and Infusions Products Committee to more effectively encompass the global market for this class of goods.
"The tea and infusions category is one in which many AHPA members have a significant interest," commented Devon Powell, AHPA's chief operating officer and staff liaison for the newly renamed committee. "We will be increasing our involvement with these companies in the coming year, and we are planning activities at the World Tea Expo now scheduled in Long Beach, CA from May 29-31, 2014."
Guidance on cannabis cultivation and processing
The board authorized the submission, on behalf of the AHPA Cannabis Committee, of recommendations to regulators on cultivation and processing of cannabis in states where use of cannabis is allowed under state law. The AHPA Cannabis Committee has now developed three such recommendations to regulators (the others are for dispensing operations and analytical laboratories) and is currently working in one additional area to produce recommendations for manufacturing operations.