Archive July 2022
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AHPA’s 40 Herbs We Love – No. 17: Valerian Root (with love from Gaia Herbs)
AHPA’s 40 anniversary celebrations continue with our showcase of the seventeenth of many beloved herbs at the heart of our robust industry and vibrant community.
FDA to host webinar on food facility registration, UFI requirements
Biennial required registration period begins Oct 1, ends Dec 31
July 25, 2022
The U.S. Food and Drug Administration (FDA) will present a webinar to discuss how to comply with the food facility registration requirement on Thursday, August 11 at 10am PT/1pm ET.
U.S. and foreign human and animal food facilities that are required to register with the FDA must renew their registration between October 1 and December 31, 2022. Registration and access information for the webinar is available here.
This year’s registration period marks the end of FDA enforcement discretion on the requirement that registering facilities must obtain and provide a unique facility identifier (UFI). FDA requires the use of Dun & Bradstreet Data Universal Numbering system (DUNS) numbers for this purpose.
Details of facility registration, the process for obtaining a DUNS number, and the UFI requirement will all be covered in the August 11 webinar. Details on compliance with the UFI requirement are also available in an FDA guidance on the subject.
Companies looking to participate in the webinar can register at this address.
AHPA submits comments to FDA on NDIN guidance
In comments submitted to the U.S. Food and Drug Administration (FDA) on July 19, AHPA expressed support for the agency’s proposal to offer a period of enforcement discretion for the late submission of new dietary ingredient notifications (NDINs) and requested revisions to the draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.”
AHPA’s requested revisions included:
- Removing any quantitative estimate of unfiled but required NDINs because the 4,600 figure in the draft guidance lacked appropriate evidentiary support and including any such estimate would not prove necessary to advance the purposes of the draft guidance;
- Clarifying that FDA would deploy the appropriate resources to ensure that it substantively responds to all NDINs, including those submitted during the proposed period of enforcement discretion, within 75 days; and
- Including an accurate physical address at which the Center for Food Safety and Applied Nutrition would accept late NDIN submissions made in paper or other forms.
AHPA also repeated its request for FDA to focus on the development of draft guidance targeted specifically to issues and elements of the NDIN process that concern companies likely to consider filing NDINs, such as ingredient identity and cGMP requirements. Lastly, AHPA encouraged FDA to enforce NDIN submission requirements to a degree sufficient to deter noncompliance and incentivize compliance.
“Issuance of a final version of the NDIN enforcement discretion draft guidance may result in the submission of at least some NDINs that FDA may not have otherwise received,” said AHPA President Michael McGuffin. “However, we feel the agency must also prioritize compliance assessments and enforcement actions against non-compliant firms to keep unsafe products off of the market and protect consumers.”
AHPA’s 40 Herbs We Love – No. 16: Tea (with love from The Republic of Tea)
AHPA’s 40th anniversary celebrations continue with our showcase of the sixteenth of many beloved herbs at the heart of our robust industry and vibrant community.
The amazing and evergreen Camellia sinensis — which gives us green tea, white tea, oolong tea, black tea, and pu-erh — is the herb we love at The Republic of Tea.
Camellia sinensis leaves and buds are the source of the wide variety of delicious tastes and evocative aromas of tea. The endless array of flavors comes from the craft of oxidation and the "terroir" of where tea is grown.
Tea travels to our cups from places like China, Japan, India, and Sri Lanka to become invigorated again when infused with hot water. Often studied for health benefits, tea contains compounds such as L-theanine, catechins, and caffeine and is the most widely consumed drink around the world, second only to water.
At The Republic of Tea, we delight in tea and sharing it with you.
Share the LoveDo you want to celebrate an herb you love with AHPA’s 40 Herbs We Love campaign for AHPA’s 40th anniversary? Contact Amber Bennett to learn more about sponsoring your favorite herb!
More Ways to CelebrateIn addition to AHPA’s 40 Herbs We Love, there are more fun and exciting ways to get involved with AHPA’s 40th anniversary celebration.
- Share your photos from the 80s! Pay homage to the 1980s (the decade AHPA was founded) by submitting photos of yourself and/or friends and colleagues in the herbal industry. The photos will be shared in the AHPA Report and on social media for members and followers to guess who is in the photo!
- Author a 40th anniversary letter or guest article for the AHPA Report! Share a favorite memory or lesson learned, comment on a historical or present issue, or address AHPA members and friends of the herbal and natural products industry with your own 40th anniversary message in the monthly AHPA Report.
- Join us for the 40th anniversary Founders Series fireside chats! Gather (virtually) with fellow AHPA founders and friends for a pre-recorded fireside chat to discuss topics celebrating AHPA history, achievements, and what sets us apart in the herbal community. Videos will be available to watch on-demand and shared in AHPA Updates, the AHPA Report, and on social media.
AHPA endorses the Food Safety Administration Act
The American Herbal Products Association (AHPA) has endorsed the Food Safety Administration Act of 2022 (S. 4520; H.R. 8358) as introduced by Senator Dick Durbin (D-IL) and Representative Rosa DeLauro (D-CT) on July 13. This legislation would separate food from drugs, medical devices, and other products regulated by the Food and Drug Administration (FDA), rename FDA as the Federal Drug Administration, and establish the Food Safety Administration as a new federal agency responsible for ensuring the safety of food on the U.S. market.
In meetings and communications with Congressional staff over the last few weeks, AHPA was informed prior to the bills’ introduction that the dietary supplement category of food would be regulated by the new Federal Drug Administration. AHPA expressed strong concerns about such an approach and is pleased that the legislation as introduced does not distinguish dietary supplements from other foods. AHPA’s endorsement remains conditional upon the legislation’s continuing to ensure that the new Food Safety Administration would regulate dietary supplements with other foods.
In introducing the Food Safety Administration Act, Senator Durbin and Representative DeLauro cited concerns about FDA’s inattention to food safety – as evidenced by rates of foodborne illness and the recent infant formula shortage – and the lack of food policy experts at the current FDA as reasons for establishing a new agency dedicated to ensuring the safety of the American food supply.
“In discussing the legislation with our members, we heard strong support for reorganizing federal oversight to increase category-specific experience and expertise in the regulation of food, including dietary supplements – especially in the areas of facility compliance and development of guidances,” said AHPA President Michael McGuffin. “AHPA has long advocated for adequate federal resources to ensure that the American public has access to safe dietary supplements, and we are dedicated to continuing this work through our legislative engagement.”
AHPA’s 40 Herbs We Love – No. 15: Turkey Tail Mushroom (with love from Nammex)
July 14, 2022
AHPA’s 40th anniversary celebrations continue with our showcase of the fifteenth of many beloved herbs at the heart of our robust industry and vibrant community.
No. 15: Turkey Tail Mushroom (Trametes versicolor)
Called Yun zhi, the cloud fungus, due to its beautiful cloud-like form, this mushroom has been used in traditional Chinese medicine for millennia. Today, it is noted for its ability to help us meet health challenges both ancient and new by potentiating our immune system.
Nammex testing has demonstrated that this mushroom contains the highest level of the important beta-glucans of all functional mushrooms. In addition, turkey tail pure mycelium, produced in liquid culture and concentrated into a powerful extract has resulted in novel protein-bound beta-glucan products called PSP and PSK.
Turkey tail mushrooms grow on trees and are traditionally wildcrafted, a practice that is neither ecologically sound nor beneficial quality wise. Nammex has pioneered cultivation of turkey tail and today is the only large-scale grower in the world. We are pleased to be able to supply high quality, and consistent cultivated mushrooms and proud to be members of an organization with the dedication and drive of AHPA.
Share the Love
Do you want to celebrate an herb you love with AHPA’s 40 Herbs We Love campaign for AHPA’s 40th anniversary? Contact Amber Bennett to learn more about sponsoring your favorite herb!
More Ways to Celebrate
In addition to AHPA’s 40 Herbs We Love, there are more fun and exciting ways to get involved with AHPA’s 40th anniversary celebration.
Share your photos from the 80s! Pay homage to the 1980s (the decade AHPA was founded) by submitting photos of yourself and/or friends and colleagues in the herbal industry. The photos will be shared in the AHPA Report and on social media for members and followers to guess who is in the photo!
Author a 40th anniversary letter or guest article for the AHPA Report! Share a favorite memory or lesson learned, comment on a historical or present issue, or address AHPA members and friends of the herbal and natural products industry with your own 40th anniversary message in the monthly AHPA Report.
Join us for the 40th anniversary Founders Series fireside chats! Gather (virtually) with fellow AHPA founders and friends for a pre-recorded fireside chat to discuss topics celebrating AHPA history, achievements, and what sets us apart in the herbal community. Videos will be available to watch on-demand and shared in AHPA Updates, the AHPA Report, and on social media.
AHPA New Member Mingle
July 13, 2022
The best thing about AHPA? If you’re an AHPA member, you are not alone! But if limited travel and fewer in-person meetings have you missing the chance to connect with industry colleagues, then mark your calendars for our first-ever AHPA New Member Mingle!
Join us virtually on Thursday, August 4 at 1pm PT/4pm ET for the AHPA New Member Mingle: a virtual networking event open to all AHPA members.
Asa Waldstein, CEO of Supplement Advisory Group and AHPA Cannabis Committee Chair, will be your host for an hour of open discussion and Q&A. Get the scoop on AHPA committees, guidance documents, webinars and much more from Asa, a longtime member and expert on which AHPA resources to use and when.
That’s not all! All attendees will also be entered for the chance to win one of our amazing giveaway prizes, including:
(1) Registration for AHPA’s 10th Botanical Congress
(1) Registration for an upcoming AHPA webinar of your choice
(1) One-year subscription to AHPA’s online Botanical Safety Handbook, 2nd Ed.
(1) Print copy of AHPA’s forthcoming Herbs of Commerce, 3rd Ed.
Don’t miss out! Whether you joined AHPA this year, last year, or 20+ years ago, you are welcome to attend and meet fellow members. Can’t stay for the whole hour? That’s okay! Join us while you can!
AHPA updates nine entries to the online Botanical Safety Handbook 2nd Ed. in second 2022 release
July 12, 2022
The American Herbal Products Association (AHPA) has released updates to nine botanicals via the online Botanical Safety Handbook 2nd ed. A new entry for Verbena hastata (blue vervain) has been created.
The following online entries have been updated or introduced:
Foeniculum spp. (fennel): A recent review identified clinical trials, human and animal pharmacological studies, and toxicity studies.
Magnolia officinalis (magnolia): A review identified new adverse events and case reports as well as animal and in vitro pharmacological studies.
Magnolia spp. (magnolia flower bud): A review identified an additional pharmacological study.
Magnolia virginiana (sweetbay magnolia): A review did not identify any new relevant safety information for sweetbay magnolia.
Sambucus spp. (elder fruit): A review added references for adverse events in clinical trials, and human and invitro pharmacological studies.
Sambucus spp. (elder flower): A review identified an additional cytotoxicity study and added a Notice for cyanogenic glycosides.
Verbena officinalis (European vervain): A review identified new animal pharmacology and reproductive studies, as well as recent toxicity studies.
Verbena hastata (blue vervain): This entry for blue vervain was added in March 2022.
Veratrum viride (American hellebore): A review identified case reports for a closely related botanical.
Viscum album (European mistletoe): A review identified a new clinical trial, animal drug interaction trial, and an in vitro pharmacology study.
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 will be 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.
Statement of the American Herbal Products Association on herbal abortifacients
July 11, 2022
The American Herbal Products Association (AHPA), in cooperation with the Expert Advisory Committee of the AHPA Botanical Safety Handbook, issued the following statement today:
Abortifacients are agents used to induce abortion and terminate pregnancy. Use of herbal abortifacients is not recommended as a method of intentional pregnancy termination.
There is a long history of use of select botanicals as abortifacients. Research, however, on the use of botanicals to induce abortion is extremely limited, and available information comes from historical or empirical reports. Little reliable data exist on the effectiveness, toxicity, or possible effects of these plants on the developing embryo or fetus and the pregnant woman.
When attempting to utilize botanicals for the purpose of abortion, the dose of most of the herbs used historically to induce an abortion generally exceeds doses that are considered safe for other purposes, and may pose toxicity risks to the pregnant woman, or may have negative effects on the developing embryo or fetus if unsuccessful. The amount of an abortifacient herb required to terminate a pregnancy is likely enough to pose significant risk to the pregnant woman’s health, including potential kidney and liver damage, and may not result in a successful abortion. Because of the potential risks to the pregnant woman and the developing embryo or fetus, this method is not recommended. Should an attempted herbal abortion be ineffective, follow-up medical care, including medical abortion, would need to be discussed with a qualified health care provider.
For more information about specific case reports and botanicals historically used as abortifacients, see the Botanical Safety Handbook cited section.
AHPA-ERB Foundation supports American ginseng programming at Smithsonian Folklife Festival
July 6, 2022
From left: Teresa Boardwine (Green Comfort School of Herbal Medicine), Anna Lucio (Kentucky Department of Agriculture), Susan Leopold (United Plant Savers & AHPA-ERB Foundation)
The American Herbal Products Association Foundation for Education and Research on Botanicals (AHPA-ERB Foundation) is pleased to have provided funds in support of American ginseng programming at the Smithsonian Folklife Festival that concluded on July 4 in Washington, D.C.
Established in 1967, the Smithsonian Folklife Festival honors contemporary living cultural traditions and celebrates those who practice and sustain them. Produced annually by the Smithsonian Center for Folklife and Cultural Heritage, the festival has featured participants from all 50 states and more than 100 countries.
Thanks to funding provided by the AHPA-ERB Foundation and private donors, the festival was able to host a delegation of American ginseng researchers, conservators and practitioners to educate festival-goers about the history, use and conservation of American ginseng. Participants included Susan Leopold, AHPA-ERB Foundation Board Member and Executive Director of United Plant Savers, who attended the festival to discuss ginseng and forests and give lessons on how to make teas, tinctures and syrups.
“The AHPA ERB-Foundation congratulates the Smithsonian on another successful Folklife Festival,” said Beth Lambert, AHPA-ERB Foundation Chair and CEO of Herbalist & Alchemist. “Their ongoing dedication to creating space and providing a platform for cultural practitioners speak for themselves, with each other, and to the public is more important than ever. We are pleased to have supported their attention to American ginseng at this year’s festival as part of the AHPA ERB-Foundation’s mission to promote education and research on medicinal, therapeutic, and health-promoting herbs.”