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Archive April 2023
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AHPA submits comments to FTC on Green Guides
April 26, 2023The American Herbal Products Association (AHPA) has submitted comments to the Federal Trade Commission (FTC) regarding the review of its Guides for the Use of Environmental Claims. This regulation – commonly known as the “Green Guides” – sets out FTC’s expectations regarding what environmental marketing claims are considered unfair or deceptive under the Federal Trade Commission Act.
Among other elements, AHPA’s extensive comments called on FTC to expand the scope and depth of its environmental claim regulations in several areas, including to establish consistent national standards for what items can be called “recyclable,” to establish rules for what activities or products can be labeled “sustainable,” and to provide requirements for the placement and formatting of any qualifying statements associated with environmental claims. AHPA’s comments also underscored its position that the United Stated Department of Agriculture National Organic Program has the authority to regulate organic claims in dietary supplements.
“The Green Guides are a vital resource in need of expansion,” said Robert Marriott, AHPA Director of Regulatory Affairs. “A more detailed and consistent set of standards for product and packaging claims will ensure an even playing field for companies looking to promote their environmentally conscious activities.”
Herbs in History: Garlic & Rosemary
April 19, 2023
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.
Next up are garlic and rosemary. Preview the entries below and visit Herbs in History online to read more.
Garlic (Allium sativum L.)
To Know or Not to Know?
In the comedy The Bourgeois Gentleman (Le Bourgeois Gentilhomme in the French original title), the classical French playwright Jean-Baptiste Poquelin (1622-1673), best known as Molière, stages a wealthy tradesman, Monsieur Jourdain, aiming to climb in society and to delete the traces of his earlier lower economic and, hence, social origins. He hires tutors in music, dancing, fencing and philosophy believing that he will acquire the manners of a polished gentleman. In a remarkable scene, the philosophy master, all too aware of the absurd situation and not knowing where to start with, begins with the basics, that is, the difference between poetry and prose. After having invited him to compose verses—resulting in non-sensical verses by Mr Jourdain—the master shifts to prose. Mr Jourdain then marvels at his discovery that he had been living an entire life speaking in prose, without knowing, however, that he was doing so. | Read more...
Rosemary (Salvia rosmarinus Schleid.)
Losing One’s Mind
When searching information about rosemary in current scientific literature to better understand the ancient texts, a great many articles come up. Some indicate that the plant was named rosmarinus—with this classical Latin name understood as meaning sea dew in an exact translation of its two components, ros and marinus—as it allegedly grows on the seashores and is watered by the droplets of water lifted in the air by the sea waves. Or because its leaves are light grey/silver as if they were covered by salty dew. Other articles—more to the point here—indicate that rosemary is a memory booster and was associated in the ancient Greek mythology with the first-generation goddess Mnemosyne whose name exactly means memory. Along this line, some of these publications and others affirm that the effect of rosemary on memory was capitalized by students and scholars in ancient Greece who wore wreaths of rosemary when having to take an exam so as to improve their results. According to the same publications, this practice survived, and present-day students have some rosemary twig in their environment to enhance their intellectual performance. By extension, grooms are said to keep this memory booster to always remember their vows. | 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.
Amazon reportedly enforces erroneous FDA adulteration allegation
April 18, 2023
An American Herbal Products Association (AHPA) member recently informed AHPA that Amazon has prohibited the sale of products containing Pinellia ternata, presumably based on inaccurate information in a warning letter that the U.S. Food & Drug Administration (FDA) issued on February 23, 2022.
In March 2021, FDA conducted an inspection of dietary supplement manufacturer Princess Lifestyles LLC (San Gabriel, CA). In February 2022, FDA issued a warning letter to the manufacturer, alleging – among other details – that one of its products was “adulterated” because the product label “lists Pinellia ternata, a dietary ingredient which contains ephedrine alkaloids….” The warning letter references 21 C.F.R. § 119.1, the federal regulation deeming dietary supplements containing ephedrine alkaloids as “adulterated.”
The cited regulation, however, only deems as “adulterated” products actually containing ephedrine alkaloids. In 2004, FDA cited in the preamble to its final rule promulgating the prohibition on ephedrine alkaloids in dietary supplements one study published in a scientific journal in 1978 that claimed to isolate ephedrine hydrochloride from a tested sample described as dried tuber of Pinellia ternata. However, a 2021 analysis of 55 samples of Pinellia ternata tuber failed to detect ephedrine in any of the samples. This more-recent study also included DNA analysis to confirm the identity of the tested materials. Thus, there exists (at best) uncertainty about whether Pinellia ternata tuber actually contains ephedrine alkaloids.
Nonetheless, under its own regulations, FDA has the responsibility to confirm the presence of ephedrine alkaloids before asserting a violation of 21 C.F.R. § 119.1 and cannot rely only on a product label’s identifying the presence of the herb. However, based on records provided by FDA in response to Freedom of Information Act (FOIA) requests, it appears that FDA neither collected nor analyzed any samples of Princess Lifestyles LLC’s Pinellia ternata product before alleging that it contained ephedrine alkaloids in violation of the Agency’s regulation.
Moreover, based on these records, it appears that FDA conducted laboratory analysis on a later-collected sample (i.e., months after issuance of the warning letter). FDA’s own analysis determined that the sample collected from Princess Lifestyles LLC “did not show the presence for [sic] any ephedrine alkaloid at or above the detection threshold of 0.5 ug/g.” In other words, the Agency made a public allegation that the company’s product violatively contained ephedrine alkaloids without a factual basis to do so and later confirmed the absence of any such basis through its own laboratory analysis.
In February 2023, FDA responded to written correspondence from AHPA calling attention to this matter and stated, “As a general matter, FDA agrees that the determination of a dietary supplement as adulterated under 21 CFR 119.1 should be based on the product containing ephedrine alkaloids. In the absence of clear evidence that a product contains ephedrine alkaloids, FDA agrees that such a product would not be adulterated under 21 CFR 119.1.”
Although AHPA’s efforts seem to have resolved the issue at FDA, Amazon appears to treat the allegation in the 2022 warning letter that Pinellia ternata contains ephedrine alkaloids as valid.
“AHPA has expended significant staff time and resources in addressing this issue, and we will continue to advocate for the accurate interpretation of the robust regulations that govern dietary supplements under federal law,” said AHPA President Michael McGuffin. “With regard to the specific matter addressed here, AHPA will call on FDA to publicly acknowledge its error regarding Pinellia ternata and for Amazon to resume permitting sales of compliant Pinellia ternata dietary supplements on its platform.”
To further address this matter, AHPA will host a special meeting with members who would like to discuss this issue and other concerns regarding federal enforcement policies on Wednesday, April 26 at 10am PT / 1pm ET. Register for the Zoom meeting here.
If you have experienced similar issues, AHPA encourages you to confidentially share that information with Robert Marriott, AHPA Director of Regulatory Affairs, at rmarriott@ahpa.org, and Michael McGuffin at mmcguffin@ahpa.org ahead of the meeting.
FTC mass-mails claim penalty notice to health product companies
April 18, 2023
On April 13, the United States Federal Trade Commission (FTC) announced that it had sent an identical notice to approximately 670 companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, informing them of the penalties for violation of the prohibition on deceptive or unfair practices under Section 5 of the Federal Trade Commission Act.
FTC also requested that companies read the recently updated Health Products Compliance Guidance, the issuance of which was previously announced by AHPA. Along with its April 13 announcement of the mass mailing, FTC also released a list of recipients of the notice, specifying “[t]he fact that a company is on this list is NOT an indication that it has done anything wrong” [emphasis in original].
FTC has previously released similar mass notices, including, for example, to companies active in education, direct sales, or online marketing. FTC uses such notices, in part, to attempt to establish that marketers have actual knowledge of the unfairness or deceptiveness of making unsubstantiated health claims. The agency does this to facilitate its assessment of civil penalties for any future violations.
“There is nothing in this notice that responsible marketers of dietary supplements are not already aware of,” said Robert Marriott, AHPA Director of Regulatory Affairs. “Companies making health-related claims know that they must have competent and reliable scientific evidence to support those claims, although industry may differ at times with FTC on its interpretation of that legal standard.”
“It is important to note that – as expressly indicated on the recipient list – a marketer’s receipt of this notice does not necessarily reflect that FTC has a factual basis to assert a violation of Section 5,” added Michael McGuffin, AHPA President.
AHPA Chief Science Officer to present at Oxford ICSB
April 5, 2023
AHPA’s Chief Science Officer, Holly E. Johnson, Ph.D., will be presenting at the Oxford International Conference on the Science of Botanicals (ICSB), April 24-27, in Oxford, MS.
The Oxford ICSB is an international conference on important botanical quality and safety issues, hosted by the National Center for Natural Products Research (NCNPR) within the School of Pharmacy at The University of Mississippi.
The function of this conference is to review, discuss, and explore the confluence of current research topics in natural product chemistry, pharmacognosy and botanicals. Topic areas will include authentication of botanical identity, cultivation, collection, post-harvest practices for producing quality plant materials, as well as an exploration of chemical and toxicological methods regarding botanical quality/safety assessments.
Dr. Johnson, who serves on the Botanical Safety Consortium (BSC) Steering Committee, will present on “Analytical Tools to Support Botanical Safety” and chair a session on “Advancing Kratom Science: New Data on Kratom’s Pharmacology, Safety, Pharmacokinetics, Abuse Potential, and Real-World Surveys” on Day 2 of the conference.
More details about the event, including the agenda and registration information, are available at oxfordicsb.org.
AHPA updates ten entries to the online Botanical Safety Handbook 2nd Ed. in first 2023 release
April 3, 2023The American Herbal Products Association (AHPA) has released updates to ten botanicals via the online Botanical Safety Handbook 2nd ed.
The following online entries have been updated:
- Bauhinia forficata (false indigo): The latest review identified a clinical trial, and animal and in vitro pharmacology studies.
- Benincasa hispida (winter melon rind): A literature review conducted in November 2022 did not identify any new relevant safety information for winter melon.
- Benincasa hispida (winter melon seed): A recent review added a reference relevant to safety during pregnancy.
- Cephaelis ipecacuanha (ipecac): A literature search provided updated references for U.S. FDA and pediatric medicine association recommendations and added references for the established effects of this herb.
- Chamaelirium luteum (false unicorn): The most recent review identified additional references of historical uses of false unicorn.
- Corylus spp. (hazel): A recent review identified additional allergenicity studies (for nuts and pollen).
- Morinda citrifolia (noni):A literature review identified new references for an interactions case report, adverse events in clinical trials and case reports, human and animal pharmacology studies, and toxicity studies of various durations.
- Myrcia spp. (pedra hume): A review identified new studies for human and animal pharmacology and a cytotoxicity study. It also added additional Myrcia species to the entry.
- Myristica fragrans (mace, nutmeg): The recent review added references for adverse events, animal and in vitro pharmacology, and toxicity studies.
- Myroxylon spp. (tolu balsam tree): A literature review identified additional references for case reports and allergic reactions.
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.
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