Archive August 2023
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Herbs in History - Mint & Marrubium
August 30, 2023
Now it’s easier than ever to share herbal history with the click of a button 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 tell the stories of Herbs in History.
The journey into herbal history continues with mint and Marrubium. Preview the entries below and visit Herbs in History online to read more.
Mint (Mentha L.)
From the Mediterranean to the North
With many subspecies and hybrids, the Mentha genus (Lamiaceae [Labiatae]) is considered to be native to the Mediterranean. Before appearing in the botanico-medical literature, it can be found in the Greek mythology, which antedates by far and large all medical written documentation. Going further back in time, the very name of Mint in Greek, minthe, is traditionally interpreted as Pre-Greek. | Read more...
Marrubium (Marrubium vulgare L.)
A Textbook Case
Horehound, White horehound, or Hoarhound (Marrubium vulgare L.) is a classic of medicinal plants therapy. It is widely used and is recognized to be specifically efficacious in treating coughs, colds, and congestion. On this basis, one would expect to easily trace it in the ancient literature and to possibly discover on this basis leads for possible renewed uses. The endeavour quickly appears to be more difficult than expected, however. | 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.
Senators Durbin and Blumenthal request information on FDA’s proposed changes to ODSP
FDA’s proposed reorganization to create a unified Human Foods Program includes relocating the Office of Dietary Supplement Programs and a new model for the Office for Regulatory Affairs
August 29, 2023
Last week, U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Richard Blumenthal (D-CT) sent a letter to the U.S. Food and Drug Administration (FDA) expressing concerns about proposed changes to the Office of Dietary Supplement Programs (ODSP) as part of the agency’s proposed reorganization to create a unified Human Foods Program. The proposal includes relocating ODSP and a new model for the Office of Regulatory Affairs (ORA) in response to the Reagan-Udall Foundation’s evaluation of and December 2022 report on FDA’s Human Foods Program.
“ODSP is the lead office at FDA responsible for oversight of the $50 billion supplement market in the United States. With a little more than $13 million in funding, it sets strategic priorities, and ensures that limited resources are used in the best manner possible to protect the health and well-being of consumers. According to the June 27, 2023, announcement, ODSP will be merged into the ‘Office of Food Chemical Safety, Dietary Supplements, and Innovation.’ We are concerned that these changes could divert resources, funding, and attention from the supplement market at a time when it is needed more than ever,” wrote the senators.
In the letter, Senators Durbin and Blumenthal also posed several questions about the proposed changes to ODSP -- including how the proposed changes would lead to greater oversight and enforcement of dietary supplement regulations, what metrics would be used to evaluate the effectiveness of the new office in regulating dietary supplements, and if FDA would request dedicated funding for the regulation of dietary supplements or general funding for the Office of Food Chemical Safety, Dietary Supplements, and Innovation. The senators requested that FDA respond to their questions by Sept. 8, 2023.
“AHPA shares the concerns expressed by Senators Durbin and Blumenthal about the potential impact on the regulation of dietary supplements of placing ODSP within a larger office,” said American Herbal Products Association (AHPA) President Michael McGuffin. “We too have expressed our concerns to FDA directly, and we await with interest the agency’s answers to the senators’ discerning questions.”
The letter follows FDA’s recent announcement of the selection of James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. In the new executive position, Jones would lead a unified Human Foods Program as part of the agency's proposed reorganization.
Last year, AHPA endorsed the Food Safety Administration Act of 2022 as introduced by Senator Durbin and Representative Rosa DeLauro (D-CT) in the 117th Congress. The legislation sought to separate food from drugs, medical devices, and other products regulated by 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, including dietary supplements, on the U.S. market.
FDA selects Deputy Commissioner for proposed unified Human Foods Program
James “Jim” Jones to begin new position at FDA on Sept. 24, reporting directly to the FDA Commissioner
August 24, 2023
The U.S. Food and Drug Administration (FDA) recently announced James “Jim” Jones will serve as the first Deputy Commissioner for Human Foods. In this new position, Jones would lead a unified Human Foods Program as part of the agency’s proposed reorganization that includes relocating the Office of Dietary Supplement Programs (ODSP) and a new model for the Office for Regulatory Affairs (ORA). Jones will begin his role at FDA on Sept. 24, reporting directly to FDA Commissioner Robert M. Califf, M.D.
Jones’ background includes 30 years in various roles with the U.S. Environmental Protection Agency (EPA) and private industry with a focus on lessening the impact of chemicals and pollution on the U.S. food supply.
Notably, Jones also served as a member of the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which performed an operational evaluation of FDA’s Human Foods Program and issued a December 2022 report recommending a unified vision and mission under a single leader to better equip the agency to regulate food in the United States.
“AHPA welcomes the selection of Jim Jones as Deputy Commissioner for Human Foods,” said Michael McGuffin, President of the American Herbal Products Association (AHPA). “We look forward to working with him as part of our ongoing engagement with FDA, and will communicate to him early in his tenure our continuing concern about the potential impacts of the proposed placement of ODSP under a larger office on the regulation of dietary supplements.”
AHPA publishes good stewardship harvesting brochure for Boswellia
August 24, 2023
The American Herbal Products Association (AHPA) today published a new brochure covering good stewardship harvesting practices for Boswellia serrata Roxb., one of 28 species in the Boswellia genus, family Burseraceae. The gum-resin from B. serrata is medicinal and is used within Unani, Ayurvedic, and western medicinal traditions. Produced as part of AHPA's ongoing educational efforts for the herbal community, the brochure can be downloaded for free from the AHPA website.
“AHPA has developed this brochure to help wildcrafters and other stakeholders involved with collecting botanical materials from wild populations be good stewards of the land,” said AHPA Chief Science Officer Holly E. Johnson, Ph.D. “Following good stewardship practices helps support a sustainable future for medicinal plant species and continued consumer access to beneficial herbs for generations to come.”
AHPA Project Scientist Holly Chittum, M.S., managed the brochure development, collaborating with AHPA staff and a working group of botanical experts who generously contributed their time and expertise to the project: Dr. Anjanette DeCarlo (University of Vermont), Bhaumik Darji (Verdure Sciences), Ashish Kumar (Verdure Sciences), Dr. Arvind Saklani (Sami-Sabinsa Group), Paul Flowerman (PLT Health Solutions), Laura Monti (Indena), Dr. Lal Hingorani (Pharmanza Herbals, Verdure Sciences), Trish Flaster (Botanical Liaisons LLC) and Erin Smith (Banyan Botanicals).
AHPA has previously published good stewardship harvesting brochures for American ginseng, goldenseal, oshá, and saw palmetto.
AHPA responds to request for information regarding FDA regulation of CBD
Existing statutes and regulations are sufficient for FDA to effectively regulate CBD dietary supplements
August 21, 2023
Last week, the American Herbal Products Association (AHPA) -- together with the Consumer Healthcare Products Association and United Natural Products Alliance -- submitted comments in response to the congressional Request for Information (RFI) regarding the U.S. Food and Drug Administration’s (FDA’s) regulation of cannabidiol (CBD). These comments outline how existing statutes and regulations are sufficient for FDA to effectively regulate CBD dietary supplements, thus making the congressional development of a new regulatory pathway for CBD dietary supplements, as sought by FDA, unnecessary.
Since the 2018 Farm Bill was enacted, FDA has proven unwilling to use its existing authorities to regulate CBD dietary supplements. Despite how the regulatory status of CBD products has remained unresolved, the market for CBD dietary supplements has proliferated. FDA’s delay in action has poorly served consumers, the medical community, and responsible industry.
“FDA could today, under its current authority and in the existing regulatory framework, move CBD containing dietary supplements out of the shadows and into the bright light of regulatory compliance,” said AHPA President Michael McGuffin. “AHPA remains committed to advocating for FDA’s prompt initiation of rulemaking to grant an exception to the exclusionary clauses for CBD as a dietary supplement, with appropriate controls, under the existing regulatory framework.”
On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA) issued the bipartisan RFI. In the comments submitted, AHPA and its co-signatories thanked the committee leaders for their work to resolve the regulatory status of CBD products and urged them to encourage FDA to “get to a yes” and establish the procedures by which CBD-containing dietary supplements can be marketed under current law.
FDA releases draft guidance on cosmetics facility registration, product listing
Initial compliance date of December 29, 2023
August 7, 2023
The U.S. Food and Drug Administration (FDA) has released a draft guidance describing its plans for the registration of cosmetic product facilities and listing of cosmetic products, two new regulatory requirements applicable to many cosmetic products and their manufacturers under the Modernization of Cosmetics Regulation Act (MoCRA).
There are no fees associated with product listing or facility registration. Additionally, “small businesses” (i.e., those whose average gross annual U.S. sales of cosmetics for the previous 3-year period is less than $1,000,000) who do not engage in the manufacturing or processing of certain categories of cosmetic products (e.g., those that regularly come into contact with the mucous membrane of the eye or that are injected) are exempt from the registration and listing requirements. Cosmetic products that are also drugs and facilities that manufacture such combined products (and do not also manufacture solely cosmetic products) are similarly exempt.
Among other elements, the draft guidance includes a list of cosmetic product categories and codes for industry use in registration/listing, and FDA seeks feedback and suggestions for improvements. Of particular note, while FDA states it will not disclose information that would link particular products with particular facilities in response to requests made under the Freedom of Information Act, the agency “intends to make relevant information from cosmetic product facility registration and listing available to the public to the extent permitted by law.”
Facilities that manufactured or processed cosmetics for distribution in the United States on December 29, 2022, must be registered by December 29, 2023. The same deadline applies to the listing of cosmetic products marketed on December 29, 2022. A facility that commenced operations after December 29, 2022, must submit a registration by the later of 60 days after the commencement of operations or February 27, 2024. An existing facility that introduced a new product after December 29, 2022, must submit a listing for that product by the later of 120 days after the product’s first marketing or 120 days after December 29, 2023.
Facility registrations must be renewed biannually, facility registrations must be amended within 60 days of any changes to previously submitted information, and product listings must be updated annually, including to state that a listed product is discontinued.
FDA will consider all comments received on the guidance by September 7, 2023.