Archive December 2022
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117th Congress says “no” to mandatory product listing (MPL)
- By: AHPA
- On: 12/28/2022 15:30:33
- In: Regulation / Legislation
December 28, 2022
On Friday, December 23, President Joe Biden signed the $1.7 trillion omnibus spending bill passed by the House that same day and by the Senate earlier in the week. As reported by the American Herbal Products Association (AHPA) last week, the omnibus bill notably excluded provisions that would have established a mandatory product listing (MPL) requirement for dietary supplements marketed in the United States. Following unsuccessful efforts to pass standalone MPL legislation this year, a last-ditch attempt to include MPL provisions in the omnibus has failed.
The exclusion of MPL provisions comes within weeks of AHPA’s letter to the leadership of the Senate and House of Representatives committees with oversight over the U.S. Food and Drug Administration (FDA) in which the association requested that MPL language be excluded from any must-pass appropriations legislation considered during the last weeks of the 117th Congress. The decision to shelve MPL legislation in the current Congress also followed a December 7 floor speech in which Sen. Dick Durbin (D-IL) made his final appeal to his Senate colleagues to include MPL legislation in the omnibus bill.
A longtime proponent of establishing a legal requirement for listing of dietary supplements with the FDA, Sen. Durbin introduced the Dietary Supplement Listing Act of 2022 with Sen. Mike Braun (R-IN) in April and has reportedly vowed to continue to push for MPL legislation in the next Congress, which will convene in January 2023.
AHPA has actively engaged in discussions with legislators, committee staffs, the FDA, and other stakeholders on MPL for years and will continue to represent the diverse perspectives of AHPA’s membership in future discussions. These efforts, among others, represent only a part of AHPA’s continued advocacy for modern dietary supplement regulations that will provide greater consumer access to truthful information and a more equitable and transparent path to market for new dietary ingredients.
AHPA updates 14 entries to the online Botanical Safety Handbook, 2nd ed. in final 2022 release
- By: AHPA
- On: 12/21/2022 14:22:12
- In: AHPA Publications & Resources
Oregon grape and pinellia among recently updated entries
December 21, 2022
The American Herbal Products Association (AHPA) has released updates to 14 botanicals via the online Botanical Safety Handbook, 2nd ed. In 2022, 44 entries in the online Botanical Safety Handbook have been updated, and two have been added. Since 2018, when revisions to the online Botanical Safety Handbook were initiated, 127 entries have been updated, and six new entries have been added.
The following online entries have been updated in this final 2022 release:
Artemesia annua (sweet wormwood) – A literature review identified numerous clinical trials, toxicity studies, and safety information regarding use of artemisinin for the treatment of malaria during pregnancy.
Baptisia tinctoria (wild indigo) – A review identified a new clinical trial for wild indigo.
Berberis spp. (Oregon grape) – This review incorporated a change in botanical nomenclature to Berberis spp. (formerly Mahonia spp.) and added clinical trial information and a human pharmacology study.
Castanea sativa (Spanish chestnut) – A review of recent literature identified genotoxicity and cytotoxicity studies.
Ceanothus americanus (red root) – A review identified additional secondary references on use during pregnancy.
Corydalis yanhusuo (corydalis) – A literature review identified an animal interaction study, a systematic review of hepatotoxicity case reports, animal pharmacology, and toxicity studies.
Maranta arundinacea (arrowroot) – New clinical trial and acute toxicity studies were identified in the most recent review.
Menyanthes trifoliata (bog bean) – A recent review added cytotoxicity studies.
Mitchella repens (partridge berry) – An animal pharmacology study was added during the most recent review.
Morella spp. (bayberry) – A literature review did not identify any new relevant safety information for bayberry.
Morus alba (white mulberry bark) – A new animal pharmacology study was identified in the most recent review.
Morus alba (white mulberry fruit) – A review identified new animal pharmacology and toxicity studies.
Morus alba (white mulberry twig) – The most recent review added references for human and animal pharmacology and acute toxicity.
Pinellia ternata (pinellia) – A recent review amended the Safety class to 2d (previously Safety class 3) and added an analytical reference and toxicity studies.
AHPA members can obtain a hard copy or an annual individual subscription to the online Botanical Safety Handbook for $95.00, with multi-user rates available for companies needing expanded access. Information about hard copy purchases and subscriptions can be found on the AHPA website.
Subscribers to the online Botanical Safety Handbook can review short descriptions of updated entries in the "Revisions" panel on the online version homepage when they log in. The online Botanical Safety Handbook is undergoing review of existing entries and the addition of new entries to provide the latest safety information before it can be included in the next print edition of the handbook. AHPA will continue to post additional updates to existing entries as well as develop new botanical entries. Current subscribers are notified of these updates when they become available.
AHPA's Botanical Safety Handbook is an essential tool for anyone who manufactures, recommends, or uses herbal products. The handbook provides safety information on over 500 species of herbs, derived from data compiled from clinical trials, pharmacological and toxicological studies, medical case reports, and historical texts. All entries are reviewed by an Expert Advisory Council that includes some of the most renowned herbal and integrative medicine experts in the United States.
MPL legislation not included in FY 2023 omnibus spending bill
- By: AHPA
- On: 12/20/2022 13:59:31
- In: Regulation / Legislation
December 20, 2022
Today, Congress released the FY 2023 omnibus spending bill, which is formally called the Consolidated Appropriations Act of 2023 (H.R. 2617). Notably, the $1.7 trillion bill—which will fund the federal government through September 2023—did not include provisions establishing a mandatory product listing (MPL) requirement for dietary supplements marketed in the United States. The House and Senate are expected to pass H.R. 2617 this week with President Biden signing the measure into law no later than Friday, December 23.
The exclusion of MPL provisions comes within weeks of the American Herbal Products Association’s (AHPA’s) letter to the leadership of the Senate and House of Representatives committees with oversight over the U.S. Food and Drug Administration (FDA) in which the association requested that MPL language be excluded from any must-pass appropriations legislation considered during the last weeks of the 117th Congress. The decision to shelve MPL legislation in the current Congress also followed a December 7 floor speech in which Sen. Dick Durbin (D-IL) made his final appeal to his Senate colleagues to include MPL legislation in the omnibus bill.
A longtime proponent of establishing a legal requirement for dietary supplements to be listed with the FDA, Durbin introduced the Dietary Supplement Listing Act of 2022 with Sen. Mike Braun (R-IN) in April and has reportedly vowed to continue to push for MPL legislation in the next Congress, which will convene in January 2023.
AHPA has been actively engaged with legislative discussions on MPL for years and will continue to represent the diverse perspectives of AHPA’s membership in future discussions. These efforts, among others, are part of AHPA’s continued advocacy for modern dietary supplement regulations that will provide greater consumer access to truthful information and a more equitable and transparent path to market for new dietary ingredients.
Save the Dates for AHPA Events & Meetings at Expo West 2023
AHPA has released its schedule for in-person events and hybrid meetings at Natural Products Expo West, March 7-9, 2023, in Anaheim, CA.
In-person events include the AHPA Annual Member Meeting, where the AHPA Board of Trustees elections will take place and AHPA Awards will be presented, on Wednesday, March 8, and the AHPA Member Reception on Thursday, March 9.
AHPA committee meetings during Expo West will be hosted in-person with the option to attend virtually via Zoom. Additional committee meetings will take place virtually on Zoom in the weeks that follow Expo West.
Specific locations and Zoom links for all events and meetings will be shared soon.
See you online and in Anaheim!
AHPA reflects on 40-year history of defending herb safety as part of continued commitment to move industry forward
For the last 40 years, the American Herbal Products Association (AHPA) has defended the safety of herbs and herbal ingredients and worked to ensure that herbal products remain accessible to our families, friends, and neighbors. As the industry has grown—through research, innovation, and increased interest in health and wellness—so too have the challenges that threaten the reputation and availability of safe, high-quality dietary supplements and other natural products. To address such challenges, we look to both our history as an association and our vision for the future of the industry.
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.
Herbs in History: Elderberry & Fennel
In an effort to preserve and share the fascinating histories of medicinal plants and herbs that have been used around the world for ages, the AHPA Foundation for Education and Research on Botanicals (AHPA-ERB Foundation) is honored to partner with Alain Touwaide, Ph.D., and Emanuela Appetiti of the Institute for the Preservation of Medical Traditions to tell the stories of Herbs in History.
We close out 2022 with entries on elderberry and fennel. Preview the entries below and visit Herbs in History online to read more.
Elderberry (Sambucus nigra L.)
Simple, Yet Valuable
Black Elder (Sambucus nigra L., Adoxaceae) is an easy-growing multi-stemmed deciduous shrub or small tree typical of the North-central European landscape, close to farms and farmhouses, in gardens, and in hedges, with fetid leaves, aromatic late-spring flowers, and clusters of glossy black edible fruits in late summer. It is native to Europe, southwestern Asia, and northern Africa, growing in temperate to subtropical regions, particularly in the Northern Hemisphere, with some populations in parts of Australasia and South America. | Read more...
Fennel (Foeniculum vulgare Mill.)
When athletes run a marathon (26.2 miles), they re-enact the exploit by the Greek soldier Pheidippides who ran from Marathon to Athens in 490 BCE to announce the victory of the lightly armed Athenian troops on the heavy infantry of the Persian king Darius I, who was trying to invade and conquer Greece. Marathon runners probably do not know that the battle took place in a region where fennel (marathon in ancient Greek) grew abundantly, giving its name to the area as the fennel field. | Read more...
About the Project
Herbs in History is made possible by funding from the AHPA-ERB Foundation, as part of the nonprofit foundation’s mission promote education and research on medicinal, therapeutic, and health-promoting herbs. Tune in monthly for thoughtfully detailed historical accounts of herbs you know and love, and learn more about the origins of medicinal plants that have stood the test of time.
AHPA’s 40 Herbs We Love – No. 26: Ayahuasca (with love from Alkemist Labs)
- By: AHPA
- On: 12/13/2022 08:34:03
- In: Herbs We Love
December 13, 2022
AHPA's 40th anniversary celebrations continue with our showcase of the twenty-fifth of many beloved herbs at the heart of our robust industry and vibrant community.
No. 26: Ayahuasca (Banisteriopsis caapi + Psychotria viridis)
Ayahuasca is a decoction used as a shamanic spiritual medicine among the indigenous peoples of the Amazon basin. Made from boiling two plants, Banisteriopsis caapi vine and Psychotria viridis shrub, the final preparation contains the powerful psychedelic drug DMT and MAO inhibiting harmala alkaloids. People who consume it report having ego dismantling and life-changing revelations. Others describe it as 10,000 hours of therapy overnight where they work through trauma, depression, addiction and other mental and emotional conditions.
Alkemist Labs has a rare DEA registration and can legally confirm Identity, Potency and Contamination of all plants and fungi including scheduled substances (Schedules 1, 2, 3n and 4). Celebrating its 25th year, Alkemist Labs is the natural product industry's leading botanical and fungal lab.
View the Collection
Explore the list of 40 Herbs We Love so far.
Share the Love
Do you want to celebrate an herb you love for AHPA’s 40th anniversary? Contact Amber Bennett to learn more about sponsoring your favorite herb!
AHPA’s Board of Trustees Call for Candidates
December 9, 2022
The American Herbal Products Association (AHPA) is issuing its annual call for candidates for elected trustees to the association's Board of Trustees. AHPA's bylaws and election policies govern this nomination process and election.
"AHPA’s trustees provide invaluable experience and expertise to our staff and membership, and we are grateful for their leadership and contributions to the association," said AHPA President Michael McGuffin. "We encourage all eligible companies to nominate a representative for this opportunity to help shape the future of this industry."
About the Board
The number of seats on AHPA’s Board of Trustees consists of a minimum of 22. Two elected seats are reserved for "small business members," defined as Active Members with $5 million or less in annual herbal revenues. The remaining elected seats are available to all Active Members in good standing. The term of office for all elected trustees is three years.
AHPA’s Board of Trustees meets three times each year (including in-person meetings at the Natural Products Expo West and SupplySide West trade shows), and trustees are expected to attend all meetings. In addition, trustees are expected to participate in ongoing functions of the organization. While trustees receive no remuneration for their services, the benefits to the companies represented, and to the industry as a whole, are well recognized.
Nomination & Election
A candidate must be officially nominated in writing by submitting a completed Intent to Stand for Election Form and Candidate’s Statement by no later than Friday, February 3, 2023.
A candidate for AHPA’s Board of Trustees may be an owner, employee, consultant, or other designated representative of the company wishing to be represented on the board. All Active Members in good standing are qualified and encouraged to nominate a candidate.
The election for the 2023 cycle will be held in a virtual format during AHPA's Annual Member Meeting on Wednesday, March 8, 2023 at Natural Products Expo West in Anaheim, Calif. Candidates will be asked to record a short video address in advance for the membership that will be played during the meeting before voting closes.
For any questions about the election process, please contact Melissa Do, Director of Communications, at email@example.com.
Senator Durbin seeks support for MPL legislation
- By: AHPA
- On: 12/08/2022 13:47:25
- In: Regulation / Legislation
December 8, 2022
Yesterday, U.S. Senate Majority Whip Dick Durbin (D-IL) delivered a speech on the Senate floor seeking support from his colleagues to include mandatory product listing (MPL) provisions from his Dietary Supplement Listing Act (DSLA) in the end-of-year omnibus appropriations bill.
The MPL provisions from the DSLA, which Durbin introduced with U.S. Senator Mike Braun (R-IN) in April, would amend the Food Drug and Cosmetic Act (FD&CA) to require marketers of dietary supplements sold in the United States to list their products with the U.S. Food and Drug Administration (FDA). Durbin’s bid to include MPL provisions in the omnibus bill comes as the current continuing resolution funding the federal government is set to expire on December 16.
Last week, in a letter sent to the leadership of the Senate and House of Representatives committees with oversight over FDA, the American Herbal Products Association (AHPA) requested that Congress not include MPL language in any must-pass appropriations legislation considered during the last weeks of the 117th Congress. AHPA also suggested that any discussion of changes to federal laws regulating dietary supplements should occur as part of a transparent and stakeholder-inclusive process in the 118th Congress that will convene in January 2023.
AHPA will continue to advocate for commonsense reforms to dietary supplement laws, including greater consumer access to truthful information about dietary supplements and a more equitable and transparent path to market for new dietary ingredients.
Join AHPA at the ASA Unity Conference
December 6, 2022
AHPA is pleased to support the upcoming Americans for Safe Access (ASA) National Medical Cannabis Unity Conference as a Host Committee Sponsor. The annual event recently moved to a virtual format and will focus on highlighting past accomplishments, discussing current issues that remain, and looking forward to a future in which patients, no matter where they live or what condition they have, will have access to safe and affordable cannabis-based therapeutics.
ASA was founded in 2002 to give voice to the needs of medical cannabis patients. Over the last 20 years, ASA has brought together patients, policy experts, public health experts, attorneys, lobbyists, scientists, industry associations, and medical professionals to create the campaigns, projects, and programs that have broken down political, social, academic, and legal barriers across the world.