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Archive July 2024
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AHPA comments seek delay, tariff schedule modification in Phase VII of Lacey Act import declarations enforcement
July 31, 2024AHPA opposes Dietary Supplement Listing Act of 2024
- By: AHPA
- On: 07/29/2024 17:23:20
- In: Regulation / Legislation
The American Herbal Products Association (AHPA) is announcing opposition to the Dietary Supplement Listing Act of 2024 introduced by Senator Richard Durbin (D-IL). This proposed legislation, which Senator Durbin previously introduced in the 117th Congress to opposition from AHPA and the rest of the dietary supplement trade, seeks to establish a mandatory product listing (MPL) requirement for all dietary supplements sold in the United States.
AHPA has a strong history of backing amendments to the Federal Food, Drug, and Cosmetic Act when they clearly benefit consumers and minimize burdens on the industry. However, neither the U.S. Food and Drug Administration (FDA) nor any other proponent of MPL legislation has convincingly demonstrated the necessity of this premarket product listing requirement. Due to this lack of clear benefits, AHPA has for several years taken the position that it cannot support – but does not oppose – the concept of MPL requirements for dietary supplements. The latest version of this legislation from Senator Durbin does not alter this position. However, this particular MPL bill would impose unnecessary, significant, and redundant burdens on the industry.
At the same time, AHPA acknowledges FDA's interest in, and the support from some stakeholders for, additional FDA authorities regarding dietary supplements, particularly to address unlawful drug products masquerading as dietary supplements such as tianeptine capsules or tablets. AHPA will continue to engage with FDA, Congressional offices, industry colleagues, and advocacy groups to develop alternative modernizing reforms to dietary supplement laws.
“We have yet to be convinced that the potential benefits of MPL requirements would justify their costs – both to industry and FDA – as well as the potential unintended consequences that would result from the establishment of such a system,” said Robert Marriott, AHPA Director of Regulatory Affairs. “Even so, AHPA supports more narrowly tailored and effective legal reforms that will reflect the needs of an evolving marketplace. We will continue our work across the herbal products community, in cooperation with federal decisionmakers, to advance public health and ensure broad access to safe and well-regulated dietary supplement products.”
AHPA endorses Federal Food Administration Act
- By: AHPA
- On: 07/23/2024 16:58:37
- In: Regulation / Legislation
The American Herbal Products Association has endorsed the Federal Food Administration Act of 2024 as introduced by Senator Dick Durbin (D-IL) and Representative Rosa DeLauro (D-CT). Senator Richard Blumenthal (D-CT) also joined the introduction as an original cosponsor.
This legislation would separate food from drugs, medical devices, and other products regulated by the U.S. Food and Drug Administration (FDA), rename FDA as the Federal Drug Administration, and establish the Federal Food Administration as a new federal agency responsible for ensuring the safety of food on the U.S. market.
In introducing the bill, Senator Durbin and Representative DeLauro stated that, despite recent organizational efforts at FDA to improve the prioritization of food safety, a new agency with a single focus on foods and a directly Senate-confirmed commissioner was necessary, citing the 2022 infant formula shortage and a recent episode of applesauce pouches contaminated with lead.
AHPA’s support for the legislation follows from its endorsement of a substantively similar bill introduced in 2022. As with previous versions of the bill, AHPA's endorsement remains conditional upon the legislation continuing to ensure that the new Federal Food Administration would regulate dietary supplements with other foods.
Herbs in History: Ashwagandha & Purple Amaranth
July 23, 2024
Enjoying these herbal history lessons? Don’t forget to share with your network using the buttons at the top of every entry!
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 launch the Herbs in History project in 2022.
Next up, dive into the histories of Ayurvedic mainstay ashwagandha and Mediterranean superfood purple amaranth. Preview the entries below and visit Herbs in History online to read more.
Ashwagandha [Withania somnifera (L.) Dunal]
From India to the Mediterranean?
Withania somnifera (L.) Dunal (Solanaceae) is currently most known as ashwagandha according to its designation in the Indian tradition, especially Ayurvedic medicine. In English, it is called Indian ginseng, Withania, and winter cherry. Whereas its presence in traditional Indian medicine is widely acknowledged, its use, knowledge in the Mediterranean medical history and, going even further deep, its presence in the ancient Mediterranean environment is still the object of discussion. | Read more...
Purple Amaranth (Amaranthus blitum L.)
A Simple Leafy Green
Amaranthus blitum L. (Amaranthaceae), commonly known as purple or livid amaranth and pigweed, is a basic vegetable in the Mediterranean countries, including in Greece where it is usually cooked as a leafy green and often served as a side-dish boiled and sprinkled with lemon juice and extra-virgin olive oil. Whereas it is now considered a superfood, it did not always enjoy such a reputation. | 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 publishes new entry for kratom in the online Botanical Safety Handbook
- By: AHPA
- On: 07/18/2024 16:00:46
- In: AHPA Publications & Resources
The safety classification for kratom is on par with kava as public interest in both herbs continues to grow
July 18, 2024
The American Herbal Products Association (AHPA) has published an entry for kratom (Mitragyna speciosa [Korth.] Havil.) in the online Botanical Safety Handbook, 2nd ed. The new entry is based on the traditional use of kratom when consumed as fresh leaves or prepared as a tea, and not the highly concentrated kratom extract products also on the market.
As with all Botanical Safety Handbook entries, the kratom entry is based on review of published literature that documents the pharmacological and toxicological profile of this herb, as well as clinical investigations and case reports of adverse effects. The entry also includes information relevant to traditional use of kratom in Southeast Asia where it is indigenous to several countries, such as Cambodia, the Philippines, and Thailand.
Kratom is classified as not to be used during pregnancy (Safety Class 2b) or while nursing (Safety Class 2c) and as an herb for which clinically relevant interactions are biologically plausible (Interaction Class B). For comparison, the Botanical Safety Handbook safety classifications for kratom are the same as that of kava (Piper methysticum). Other well-known herbs classified as not for use during pregnancy include goldenseal (Hydrastis canadensis), boswellia (Boswellia serrata), and oshá (Ligusticum porteri). Additionally, as with kratom, American ginseng (Panax quinquefolius), ginkgo (Gingko biloba), and ginger (Zingiber officinale) are common herbs classified for possible drug and supplement interactions.
“Kratom has a long history of safe traditional use,” said Jane Wilson, AHPA Director of Program Development. “But, as with any botanical, we encourage consumers to take safety information available in the Botanical Safety Handbook and from other reputable sources into consideration when using herbs to support their personal health and wellness.”
AHPA members can obtain an annual individual subscription to the online Botanical Safety Handbook or a hard copy for $95.00, with multi-user rates available for companies needing expanded access. Information about subscriptions and hard copy purchases 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.
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.
Michael McGuffin named 2024 NutraChampion
July 16, 2024
The annual award presented by NutraIngredients-USA recognizes “those who leave a lasting impact on nutrition and the nutrition industry”
The American Herbal Products Association (AHPA) is proud to announce that AHPA President Michael McGuffin has been named 2024 NutraChampion by NutraIngredients-USA. This honor recognizes McGuffin's exceptional leadership, unwavering commitment, and significant contributions to the dietary supplements and natural products industry.
Presented as part of the annual NutraIngredients-USA Awards, the NutraChampion Award celebrates individuals “who leave a lasting impact on nutrition and the nutrition industry.” Through his visionary leadership at AHPA, decades of regulatory advocacy, and tireless efforts to promote the benefits and safety of herbal products, McGuffin has done just that.
“There cannot be anyone involved in herbs and botanicals who doesn’t know, or know of, Michael McGuffin and the American Herbal Products Association,” said Stephen Daniells, Ph.D., Editor-in-Chief of NutraIngredients-USA. “Michael has served as AHPA’s president for a quarter of a century, steadfastly advocating on behalf of members and the wider industry to support a safe, robust dietary supplement market. The NutraIngredients-USA Team is delighted to honor Michael as its 2024 NutraChampion for his leadership, passion, and commitment to the herbal industry at all levels.”
"Thank you to Stephen Daniels and the entire NutraIngredients-USA team for recognizing me as the appropriate recipient for this year's NutraChampion Award; I am honored," said McGuffin. “I managed to find a point of intersection between my personal and professional interests with the realization that there exists now and always will exist a need for leadership in ensuring that we maintain access to herbs for Americans. This is who I am. As NutraChampion, I hope to inspire those who would like to achieve this acknowledgement in the future to clarify and define the work that you do, to do that work in service to the trade and to the public, and to do so boldly so that we all see that that's who you are.”
About the NutraIngredients-USA Awards
Focusing on true innovation, long-term market success, and cutting-edge research, the NutraIngredients-USA Awards honor the best and brightest in ingredients, finished products, companies, people, and initiatives in the nutrition and dietary supplements industry. For more information, please visit: www.NutraIngredientsUSA-Awards.com.
IADSA Newsflash for July 2024
July 15, 2024
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. This issue covers:
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China has updated the market authorization regulations for ginseng, American ginseng, and Ganoderma.
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Indonesia has issued a new regulation for the labeling of health supplements.
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In India, the Ministry of AYUSH has challenged the Danish safety assessment for ashwagandha which led to its ban in Denmark and other countries.
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Japan is reconsidering its approach to labeling of functional foods in the wake of a recall of red yeast rice products, including the implementation of mandatory good manufacturing practices.
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The European Food Safety Authority (EFSA) recently undertook discussion of emerging issues in the food supplements category, such as understanding consumer habits regarding supplement consumption and psychedelic products being sold as microdosing supplements on-line.
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EFSA continues work on scientific opinions to be used for setting upper limits for vitamins and minerals.
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The Heads of European Food Safety Agencies have developed a list of substances used in food supplements that should not be used or used only with restrictions. These substances include Actaea racemosa, coumarin in plant preparations, curcumin in Curcuma spp.-preparations, Hypericum perforatum, Lepidium meyenii, Melaleuca spp.-essential oils, melatonin, Ocimum tenuiflorum, piperine, p-synephrine in Citrus spp.-preparations, Tribulus terrestri, tryptophan, and Withania somnifera.
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EFSA has concluded that the safety of products containing Rheum palmatum L., Rheum officinale Baill., and their hybrids, as well as Rhamnus purshiana DC cannot be established. It is anticipated that Article 8 listing will be pursued.
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EFSA recently released the proceedings of its Scientific Committee on Botanicals working group on toxicity characterization and is expected to update the Compendium on Botanicals database later this year.
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France has issued a caution about the use of ashwagandha in food supplements and the United Kingdom has issued a call for evidence in advance of a safety assessment.
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Brazil has made updates to permitted additives in food supplements and has issued an updated guide on determining shelf life.
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Australia has issued new guidelines for large dosage forms following choking incidents.
AHPA Sports Nutrition Committee Spotlight: Raza Bashir (Iovate)
Move Nutrition Network kicks off quarterly profile series spotlighting members of AHPA’s Sports Nutrition Committee
July 10, 2024
Earlier this year, Move Nutrition Network announced its content partnership with the American Herbal Products Association (AHPA) Sports Nutrition Committee to deliver insights on the latest issues and market trends in the sports and active nutrition industry. This collaboration includes a quarterly profile spotlighting a member of AHPA’s Sports Nutrition Committee.
The series kicks off with Raza Bashir (Iovate), member of AHPA’s Sports Nutrition Committee and AHPA’s Board of Trustees.
It’s no secret the AHPA Sports Nutrition Committee comprises some of the leading voices in sports nutrition formulation, supply, and regulation. And, it’s for that reason we’re partnering to profile one of its members in each Quarterly. Looking for a lesson in industry loyalty and innovation? Meet Raza Bashir.
Check out the full issue of Move Nutrition’s Cognitive Nutrition Quarterly here, subscribe to the Move Nutrition Community here, and follow along for more profiles on AHPA members making an impact in the sports and active nutrition space.
AHPA updates seven entries to the online Botanical Safety Handbook, 2nd Ed. and expands mushroom entries
New entry for lion’s mane underscores continued consumer interest in functional mushroom products
July 9, 2024
The American Herbal Products Association (AHPA) has released updates to seven botanicals via the online Botanical Safety Handbook, 2nd Ed., as well as added a new entry for lion’s mane mushrooms.
The following online entries have been updated or added in this release:
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Atropa belladonna (belladonna) – Updates to this entry identified U.S. FDA safety releases about belladonna homeopathic products and numerous reports of accidental ingestions.
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Azadiracta indica (neem bark) – Review for neem bark added references for adverse events in clinical trials and case reports, human and animal pharmacology studies, and toxicity studies.
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Azadiracta indica (neem leaf) – Review for neem leaf added references for an animal drug interaction study, reports of adverse events in clinical trials, human and animal pharmacology studies, animal reproductive studies, and toxicity studies.
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Boswellia spp. (boswellia) – Recent review for boswellia added adverse events in clinical trial references, human and animal pharmacology studies, and toxicity studies.
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Bupleurum spp. (bupleurum) – References for an epidemiological study and toxicity studies were added to this entry. Processing information for bupleurum root was added to the Editors' Notes.
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Buxus semperivens (boxwood) – In vitro pharmacology and cytotoxicity studies were added to this entry.
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Cetraria islandica (Iceland moss) – Review of this botanical added an historical food use reference and genotoxicity and cytotoxicity references.
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Hericium erinaceus (lion’s mane) – This new entry includes documentation of food use, clinical trial and adverse event reports, pharmacology studies, and toxicity studies.
AHPA members can obtain an annual individual subscription to the online Botanical Safety Handbook or a hard copy for $95.00, with multi-user rates available for companies needing expanded access. Information about subscriptions and hard copy purchases 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.
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.
2013 DNA barcoding article questioning integrity of herbal products retracted
- By: AHPA
- On: 07/08/2024 12:24:49
- In: Industry News
Editor “no longer has confidence in the presented data” following investigative findings of fabrication
July 8, 2024
The controversial article that inaccurately raised alarm over claims of ingredient contamination and substitution in U.S. and Canadian herbal products, which harmed the responsible dietary supplement industry in multiple respects, has been retracted.
On July 4, the editor of BMC Medicine announced the retraction of the 2013 article “DNA barcoding detects contamination and substitution in North American herbal products” by Steven G. Newmaster et al. The retraction notice states that an investigation by the University of Guelph “found evidence of data fabrication” in relation to the article and that, therefore, the editor “no longer has confidence in the presented data.”
The American Herbal Products Association (AHPA) and others roundly criticized the article when it was published, calling into question its use of DNA barcoding to report that a majority of herbal products tested by Dr. Newmaster and his group “contained species of plants not listed on the labels” and that many “also contained contaminants and or fillers not listed on the label.”
In a letter to BMC Medicine’s editor, AHPA President Michael McGuffin identified inaccuracies and communicated that the authors’ “blanket assertions about the accuracy of this novel analytical tool are premature.”
“As we pointed out at the time of its publication, Dr. Newmaster’s article contained significant inaccuracies, including the false claim that no best practices exist for identifying herbal ingredients, contrary to FDA regulations,” said McGuffin following announcement of the retraction. “Furthermore, the premature endorsement of DNA barcoding without acknowledging its limitations misled readers.”
The now-retracted article also prompted New York’s Attorney General to issue cease and desist letters in early 2015 to four large retailers of herbal products. These misdirected actions led to many news articles that challenged the quality and integrity of herbal products. These actions also ultimately led to many retailers’ requiring extra-regulatory compliance measures and documentation from dietary supplement suppliers, which continues to this day.
“Though long overdue, the retraction of this erroneous article underscores the importance of accuracy and integrity in scientific reporting,” added AHPA Chief Science Officer Holly E. Johnson, Ph.D.
