Archive November 2022
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New botanical species added to CITES Appendix II during CITES 19th Conference of the Parties Meeting
November 30, 2022
The 19th meeting of the CITES Conference of the Parties (CoP19) recently met in Panama City, Panama, on November 14-25, 2022. Of interest to AHPA members are several agenda items related to botanical species that are used in dietary supplements and other natural products. Some of these proposals have resulted in new botanicals species being accepted for addition to CITES controls for international trade.
A proposal to list all species of Rhodiola spp. in CITES Appendix II was accepted by the Parties. This listing will include annotation #2: “All parts and derivatives except: a) seeds and pollen; and b) finished products packaged and ready for retail trade.” This new listing will become effective in 90 days (i.e., on or about February 22, 2023). In comments to U.S. Fish and Wildlife Service (the U.S. CITES representative) prior to the CoP19 meeting, AHPA requested that provisions be established for clearly identifying established cultivation operations for Rhodiola rosea as pre-Convention.
All genera of the trees Handroanthus, Roseodendron and Tabebuia were proposed for listing in CITES Appendix II with annotation #17: “Logs, sawn wood, veneer sheets, plywood and transformed wood.” This proposal was accepted by the Parties, with a delayed implementation period of 24 months as requested by the State of Bolivia. In comments to U.S. Fish and Wildlife Service prior to the CoP19 meeting, AHPA requested clarification as to whether the bark of these trees (which is used to produce pao d’arco) is included in the specimens defined in the annotation.
While not proposed for listing in the CITES Appendices at CoP19, a report on Boswellia spp. was on the CoP19 agenda, and was also discussed by the CITES Plants Committee at its meeting in June 2022. A new report on Boswellia spp. in international trade became available prior to the CoP19 meeting. The Parties adopted proposed draft decisions in which the Plants Committee and Parties will continue to collect information and evaluate whether some Boswellia species meet the criteria for CITES listing. AHPA has been working with several AHPA members involved in the international trade of Boswellia serrata materials, and is currently working on a sustainable harvest brochure for this species.
The CITES Conference of the Parties occurs every 2-3 years for the purpose of allowing Parties to the CITES Convention to review the implementation of the Convention through the following activities:
Consider (and where appropriate adopt) proposals to amend the lists of species in Appendices I and II;
Review progress in the conservation of species included in the CITES Appendices;
Consider discussion documents and reports from the Parties, the permanent committees, the Secretariat and working groups;
Recommend measures to improve the effectiveness of the Convention; and
Make provisions (including the adoption of a budget) necessary to allow the Secretariat to function effectively.
More information is available on the CITES website and in AHPA’s Primer on Importing and Exporting CITES Listed Species.
Editor's Note: This article was revised on 1/4/23 to reflect the correct effective date of the Rhodiola listing.
IADSA Newsflash for November 2022
November 29, 2022
AHPA is an active member of IADSA, an association focused on the globalization of food supplement markets and regulatory challenges. AHPA distributes the IADSA Newsflash as a member benefit. This issue covers:
China has proposed new rules for the evaluation of the function of health foods;
China is proposing to add ginseng, American ginseng, and reishi into its “Health Food Raw Material Directory;”
Exporters to India are being informed of new requirements for certain food categories related to registration and inspection of manufacturing facilities;
Indonesia has released guidelines for health claims in accordance with ASEAN guidelines on claims and claims substantiation;
Singapore is establishing a voluntary notification system for health supplements and traditional medicines;
Vietnam has issued a draft regulation for contaminant limits in health supplements;
The European Union (EU) General Court has nullified a European Commission decision to classify certain powder forms of titanium dioxide as carcinogens, but this does not impact its ban for use in food products;
Belgium has issued a monograph addressing the use of the essential oil of Zingiber officinale;
France has recommended against listing vitamin D3 as an endocrine disruptor in food products;
France is scrutinizing the labeling of melatonin products as not providing adequate warnings for sensitive consumers;
France is evaluating information about possible liver toxicity from turmeric products in which bioavailability has been enhanced with piperine and other ingredients;
Germany has confirmed certain dry Ginkgo biloba extracts can be considered as medicines and not food supplements;
Italy is prohibiting health claims and introduced new label warnings for turmeric products
The United Kingdom conducted an evaluation of the potential effects of ginger intake on pregnancy and lactation;
Canada issued new labeling requirements for natural health products that come into effects in three years;
New Zealand has concluded that titanium dioxide does not represent a health concern in food products;
Bolivia has issued its first ever draft regulations for food supplements based on established rules from several other countries;
Chile, Guatemala, Ukraine, and Uzbekistan are considering updated regulations for food additives and food supplements.
FDA publishes final food traceability rule
- By: AHPA
- On: 11/28/2022 11:14:29
- In: Regulation / Legislation
November 28, 2022
FDA has published the final version of its regulation on “Requirements for Additional Traceability Records for Certain Foods.” The rule, pursuant to the regulatory mandates of the Food Safety Modernization Act, establishes additional traceability recordkeeping requirements for foods on the “Food Traceability List” (FTL). The compliance date for all companies covered by the rule is January 20, 2026. FDA will release further compliance guidance on this rule, including a compliance guide for small entities, before that date.
Under the rule, the creator or first receiver of foods on the FTL will be required to create a lot-specific “traceability lot code” for the food. This code will then follow the lot through the supply chain until a documented kill step is applied or the lot enters retail sale. Companies that ship, receive or transform the food throughout the supply chain will also be required to maintain additional records depending upon their operations. Food products containing ingredients on the FTL will be subject to the same traceability requirements up to the point of retail.
The category of “Herbs (fresh)” is included on the FTL; however, dried herbs are considered a separate commodity and are not directly subject to its requirements. Companies that perform herb drying may need to maintain additional records under the rule.
FDA will hold an informational webinar on the traceability rule (anticipated to be the first of several) on Wednesday, December 7, 2022, from 10am-2pm (Pacific), 1-5pm (Eastern). Interested parties can register for the webinar here.
Herbs in History: Blueberry & Cannabis
November 17, 2022
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.
The journey into herbal history continues with blueberry and cannabis. Preview the entries below and visit Herbs in History online to read more.
Blueberry (Vaccinium spp.)
Blueberries, be they the so-called European or the Americano-Canadian species, along with blackberries, raspberries, cranberries, and mountain cranberries, Chinese lanterns, blackcurrants, or gooseberries have been on the rise over the past decades. Once found in the wild, they are now extensively cultivated to meet a constantly higher demand. And their health benefits are increasingly investigated, with numerous positive effects being discovered. | Read more...
Cannabis (Cannabis spp. L.)
A Non-Existing Species
The history of cannabis (Cannabis spp. L., Cannabaceae) has been abundantly narrated in the literature. It usually starts with the well-known description of cannabis’ uses among the population of Scythians made by Herodotus (5th cent. BCE) in the Histories. | 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 updates 12 entries to the online Botanical Safety Handbook 2nd Ed. in third 2022 release
- By: AHPA
- On: 11/16/2022 12:25:46
- In: AHPA Publications & Resources
The American Herbal Products Association (AHPA) has released updates to 12 botanicals via the online Botanical Safety Handbook 2nd ed. A new entry for Mentha canadensis (Chinese mint) has been created.
The following online entries have been updated or introduced:
Ballota nigra (black horehound) - A literature review did not identify any new relevant safety information for black horehound.
Malva sylvestris (high mallow) - A literature review identified adverse event information and toxicity studies for high mallow.
Marrubium vulgare (horehound) - A review identified several human and animal pharmacology studies, a reproductive study, and toxicity studies.
Matricaria discoidea (pineapple weed) - A review identified references of historical uses of pineapple weed.
Melia azedarach (melia bark) - A literature review identified an animal pharmacology study and toxicity studies for melia bark.
Melia azedarach (melia fruit) - A literature review identified additional case reports and toxicity studies for melia fruit.
Mentha x piperita (peppermint leaf) - A review identified additional case reports, pharmacology, and toxicity studies.
Mentha x piperita (peppermint oil) - A review identified additional clinical trials, case reports, pharmacology and toxicity studies.
Mentha pulegium (European pennyroyal leaf) - A review identified additional clinical trials, animal pharmacology, and toxicity studies.
Mentha pulegium (European pennyroyal essential oil) - A review identified additional toxicity studies for the constituent pulegone.
Mentha spicata (spearmint leaf) - A review identified additional clinical trials, animal pharmacology, and toxicity studies.
Mentha canadensis (Chinese mint) - The entry for Chinese mint was added based on a March 2022 literature review.
Vitex agnus (chaste tree) - A review identified additional clinical trial reports, in vitro pharmacology, 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.
Introducing AHPA's 40th Anniversary Shop
November 10, 2022
As part of our 40th anniversary celebration, AHPA is pleased to announce the launch of our online anniversary shop!
Show your support for AHPA with this exclusive collection of vintage inspired designs on t-shirts, hoodies and more, available now for a limited time.
Nominations for the 2023 AHPA Awards are now open
November 9, 2022
AHPA is pleased to announce that the association is now accepting nominations for the 2023 AHPA Awards.
First presented in 2006, the annual AHPA Awards acknowledge individuals and organizations for making positive and substantive contributions to the herbal products industry.
The 2023 AHPA Award categories are as follows:
AHPA Herbal Hero Award: Recognizes an individual who makes outstanding contributions to AHPA committees or initiatives.
AHPA Herbal Industry Leadership Award: Recognizes a company that sets an example of outstanding business practices or an organization that works to move the industry forward above and beyond normal business practices.
AHPA Herbal Insight Award: Recognizes individuals or non-commercial organizations that have a significant impact on furthering knowledge and understanding of botanicals and their uses.
AHPA Herbal Diversity & Inclusion Award: Recognizes excellence in commitment to the values of diversity, inclusion and equality benefitting both the herbal products industry and broader society.
AHPA Environmental Impact Award: Recognizes an individual, organization, or company that has implemented innovative sustainable or regenerative business practices that will continue to have a meaningful positive impact on the environment.
More information about the awards, including a list of previous winners, is available here.
Nominations can be submitted by using the online nomination form OR by email to firstname.lastname@example.org and must be received by December 16, 2022 for consideration.
To submit your nomination by email, please provide the following information:
AHPA Award category
Why you think this individual or organization should receive the AHPA Award (in 500 words or less)
OPTIONAL: Documents supporting your nomination of this individual or organization
After the nomination period closes, nominees will be reviewed by members of the AHPA Communications Committee, which represents a diverse group of industry stakeholders. The AHPA Communications Committee recommends recipients for each award category and presents these recommendations to the AHPA Board of Trustees for approval.
AHPA Awards will be presented at the AHPA Annual Member Meeting on March 8, 2023, during Natural Products Expo West in Anaheim, CA.
How congressional leadership changes could impact supplement industry
- By: AHPA
- On: 11/03/2022 15:46:44
- In: Regulation / Legislation
November 2, 2022
Recent polls indicate the upcoming midterm elections will include numerous tight races, with growing support for Republicans being reported as inflation persists, and Democrats seek to maintain control of both the U.S. Senate and House of Representatives.
If Republicans gain control of one or both houses, changes in the leadership ranks of the two key congressional committees responsible for overseeing policy and legislation impacting FDA would occur when the 118th Congress convenes on Jan. 3, 2023.
These pending shakeups at the top of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce (E&C) Committee would directly impact FDA and the agency’s enforcement and implementation of the laws and regulations that govern dietary supplements.
Senate HELP Committee
If a Democratic majority is retained in the Senate, then—following the pending retirement of longtime Sen. Patrick Leahy (D-Vermont)—Sen. Patty Murray (D-Washington) would reportedly relinquish her current role as chair of the Senate HELP Committee to assume the reins as chair of the Senate Appropriations Committee. The Senate Appropriations Committee, currently chaired by Leahy, is a powerful panel that oversees annual federal spending and sets budget priorities.
Murray has served as the top Democrat on the Senate HELP Committee since 2015 and has been leading the charge in the Senate to enact three pieces of legislation that would significantly amend the Federal Food, Drug, and Cosmetic Act (FDCA), one of which focuses on regulatory reforms for cosmetics and another on medical devices. The third policy rider that Murray, alongside Sen. Dick Durbin (D-Illinois), has strongly advocated for is mandatory product listing (MPL) legislation for dietary supplements. The Senate HELP Committee recently advanced all three of these proposals as so-called “super riders” on FDA user fee reauthorization legislation, but the legislation that was ultimately signed into law omitted them.
Should Murray—as the next in line to take over as chair of the Senate Appropriations Committee—opt to lead the spending panel in the 118th Congress, then the next most senior Democrat on the Senate HELP Committee is Sen. Bernie Sanders (I-Vermont). Sanders has indicated he is very interested in leading the HELP panel on the Democratic side of the aisle.
It is uncertain if Sanders would prioritize MPL or the other significant amendments to the FDCA in the same way as Murray has in the 117th Congress. Sanders voted against the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA) when the legislation was marked up by the Senate HELP Committee on June 14. MPL provisions were included in the FDASLA; however, Sanders stated the reason he voted against the proposed legislation was because it did not include drug reimportation language, which he has long advocated for.
If Republicans take control of the Senate, there would be a definite shift at the top of the Senate HELP Committee. Current ranking member Sen. Richard Burr (R-North Carolina) is set to retire at the end of 2022, with Sen. Rand Paul (R-Kentucky) next in line to serve as the lead Republican on the committee. Paul, an ophthalmologist, is widely known to be critical of FDA and the public health establishment that resides within other key federal government agencies. Further, Paul has a history of being a supporter of consumer access to natural health care options.
Paul’s critical eye and often adversarial approach—as indicated by his combative relationship with Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and lead member of the White House Coronavirus Task Force under President Donald Trump—is rare amongst his colleagues in the Senate. As such, with a leadership role on the Senate HELP Committee, Paul would bring a posture that is unique for the position.
Another consideration is that Paul would have the option to serve as the head Republican on the Senate Homeland Security Committee due to the retirement of current chair Sen. Rob Portman (R-Ohio). Should Paul opt to be the top Republican on the Senate Homeland Security Committee instead of the Senate HELP Committee, Senator Bill Cassidy (R-Louisiana), a gastroenterologist, is the next most senior Republican on the HELP panel after Paul.
Though who exactly will lead the committee is yet to be determined, the next Senate HELP Committee chair will come from the party in the majority, and the next ranking member will come from the other party in the minority.
House E&C Committee
On the House side, both Rep. Frank Pallone (D-New Jersey) and Rep. Cathy McMorris-Rodgers (R-Washington) are expected to remain as leaders of their respective parties on the House E&C Committee in the 118th Congress. Should Democrats maintain their majority, Pallone would continue as chair, while McMorris-Rogers would continue as ranking member. Should Republicans take control of the House, Pallone’s and McMorris-Rogers’ roles would reverse.
Though McMorris-Rodgers lacks a discernible track record regarding issues impacting dietary supplements, philosophically, she employs a critical eye on legislative proposals that add to FDA’s regulatory authority. Moreover, she is known for listening to and entrusting her GOP committee colleagues on key topics, including Rep. John Curtis (R-Utah), one of her very trusted confidants on the E&C panel. McMorris-Rodgers looked to Curtis to help vet early versions of proposed MPL legislation, knowing Curtis is a co-chair of the Congressional Dietary Supplement Caucus and how important the natural products community is to his state’s economic vitality.
Should House control flip to the GOP, another important Republican Committee member in the 118th Congress would be Rep. Brett Guthrie (R-Kentucky). Guthrie, who is currently the ranking member of E&C’s Health Subcommittee, would assume the role of chair of that important subcommittee. Even though Guthrie has not taken on a high-profile role related to dietary supplement regulatory issues, his existing membership on the Congressional Dietary Supplement Caucus is noteworthy.
With regard to Pallone, his very long history and close relationship with the dietary supplement sector is widely known. Prior to his ascendancy to chair of the House E&C Committee, Pallone served as the House’s Democratic co-chair of the Congressional Dietary Supplement Caucus. While Pallone is believed to be sympathetic to proposals to establish an MPL requirement for dietary supplements, he and his office have always maintained an open line of communication to American Herbal Products Association (AHPA) representatives and the natural products community at large.
If Democrats retain control of the House, it can be assumed any of the legislative priorities not passed into law in the 117th would resurface in the 118th Congress. Whereas, should the Republications gain control of the House, the appetite for significant amendments to the FDCA would likely be diminished or, more ideally, present a structure more receptive to industry input and provide more opportunity for engagement between trade representatives and policy makers.
A significant result of Republicans’ gaining control of the House in the next Congress would be that policy initiatives without broad support by industry would be unlikely to advance to the president’s desk in the 2023-2024 cycle. High-profile or ambitious federal policy legislation would fall victim to House-Senate congressional gridlock. With respect to proposed regulatory reforms for dietary supplements, cosmetics and medical devices, in particular, Republicans would not be expected to give any more authority to FDA.
The next leaders of these key committees will be determined by the outcomes of the midterm elections in November. Whether Democrats retain control of both the Senate and House, or Republicans take control of one or both, legislation influencing FDA and the laws and regulations governing dietary supplements may take a different course than what has been seen in the 117th Congress.
I invite members and the industry to attend AHPA’s virtual Congress on Regulatory Priorities in the Natural Products Market on Nov. 15 for a breakdown of midterm election results. In addition, AHPA legislative consultant Pete Evich and I will present an overview of what is in store for the 118th Congress and other political dynamics resulting from this November’s elections in terms of legislation that would directly impact the dietary supplement sector.
Michael McGuffin has served as president of the American Herbal Products Association since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master's degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974, and he has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades.