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Archive September 2022

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California Governor vetoes weight loss product bill

September 30, 2022

California Governor Gavin Newsom yesterday vetoed Assembly Bill 1341, legislation that would have extensively limited access to a broadly defined class of dietary supplement and OTC products “sold for or used with the intent to achieve weight loss." Over the last two years, AHPA has worked closely and directly with Assemblymember Cristina Garcia, the bill’s sponsor, to present the interests of consumers and the responsible sports nutrition industry.

AB 1341 would have required the California Department of Public Health (CDPH) to develop a list of products that would be subject to the bill’s restrictions. In his veto message, Governor Newsom stated that this work is “beyond the scope of the department's capabilities.”

Governor Newsom also stated that CDPH is prepared to work with the legislature next session to address sales age limits and other potential legislative actions relevant to these product categories.

AHPA will continue its active engagement in any legislative developments on this matter. Related inquiries can be directed to Robert Marriott, AHPA’s Director of Regulatory Affairs, at rmarriott@ahpa.org.

Biennial food facility registration renewal due by Dec 31

September 30, 2022

AHPA reminds its members that the biennial registration period for food facilities required to register with the U.S. Food and Drug Administration (FDA)—including dietary supplement facilities—begins October 1 and ends December 31, 2022.

All registered facilities must renew their registrations during this period using the online system at this FDA site.

 
Registering facilities must provide a unique facility identifier (UFI) assigned through the Data Universal Numbering System (DUNS). If a facility already has a DUNS number, a new one is not needed. DUNS numbers are assigned by Dun & Bradstreet, and can be obtained for free here. Note that the process of obtaining a DUNS number may take 30 days or longer. Expedited number assignment requires a one-time charge.
 
Detailed, step-by-step information on the 2022 registration renewal process can be found at the FDA Food Facility Registration User Guide: Biennial Registration Renewal webpage

AHPA submits comments on proposed methods of analysis rule revocation

September 29, 2022

In comments submitted to the U.S. Food and Drug Administration (FDA) on September 28, AHPA expressed reservations about the agency’s proposed revocation of the “methods of analysis” regulation. Initially issued in 1977, this regulation establishes that FDA enforcement programs will use AOAC International’s (AOAC’s) officially published methods of analysis whenever a different method is not established in other regulations.

Although AOAC regularly publishes a new edition of its methods of analysis, the regulation currently still incorporates the 1980 version. FDA argues that this regulation should be revoked so that the agency methods can be more flexibly published in guidance documents.

In its comments, AHPA encourages FDA to not revoke the methods of analysis regulation, and to instead update it to reflect the most current AOAC analysis methods. AHPA argues that if FDA requires greater flexibility, this can be accomplished by amending current regulations to allow the publication of analytical methods in specifically identified publicly available sources.

“AHPA has been involved with the AOAC review process for years, and the AOAC official methods have been a bastion of consistency for stakeholders across FDA regulated industry,” said Holly E. Johnson, Ph.D., AHPA’s Chief Science Officer. “AOAC approved methods undergo public comment and rigorous scrutiny from scientists within the industry, academy and FDA.”

AHPA also commented that if FDA does choose to revoke the methods of analysis regulation, the agency should first publish a guidance that will avoid any gap in the use of appropriate analytic methods and ensure continued transparency for consumers and regulated industry.

FDA user fee agreement excludes MPL language

Congressional proponents of MPL will continue effort to enact MPL requirements in 2022

September 28, 2022

Following months of negotiations, key Congressional committee leaders have agreed on a final bill to reauthorize medical product user fee programs for the U.S. Food and Drug Administration (FDA). Importantly for AHPA members, the FDA user feel deal excludes language that would establish a mandatory product listing (MPL) requirement for dietary supplements and that would substantially increase FDA’s regulatory authorities over cosmetics that was previously passed by the Senate Health, Education, Labor, and Pensions (HELP) Committee.

The legislation, which will be attached to a continuing resolution (CR) that broadly funds the federal government through December 16, would reauthorize FDA medical product user fee programs for the next five fiscal years, ensuring funding from industry user fees for nearly half of the agency’s budget for fiscal years 2023 through 2027. Both the Senate and House are on track to pass the CR legislation this week. 

The top Democratic and Republican leaders of the key committees with jurisdiction over FDA – the House Energy and Commerce and HELP Committees – ultimately agreed to set aside MPL, cosmetics reform, and a handful of other major health policy initiatives to enact the user fee programs’ reauthorizations in time to avert looming layoffs of FDA personnel. However, the committee leaders have expressed their strong interest in continuing to negotiate on the outstanding policy provisions in the coming months with the possibility of inserting several of the reforms in an end-of-the year omnibus spending package that Congress is expected to take up in mid-December.  This stated commitment is a clear sign that the MPL debate is not over in the 117th Congress.

MPL has been the subject of debate among both lawmakers and the industry with increased attention since June, when the HELP Committee advanced the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348) that included language establishing an MPL requirement for dietary supplements.

AHPA has argued that MPL is unnecessary and would create significant and redundant burdens on industry. Moreover, to date, neither FDA nor other advocates for MPL have clearly articulated the need for this premarket product listing requirement. As the debate over MPL looks to continue, AHPA remains committed to advocating for legislative priorities that would actually benefit consumers and the industry.

AHPA releases guidance on liquid extract specs for cGMP compliance

September 27, 2022

AHPA has released a new guidance document titled, “Guidance for Liquid Extract Specifications for cGMP Compliance.” Developed to support liquid extract manufacturers in documenting compliance with current good manufacturing practices (cGMPs) and labeling requirements for dietary supplement products, the guidance document is now available for AHPA members to view and download on the AHPA website.
 
Current U.S. regulatory requirements for establishing dietary supplement product specifications and certain labeling requirements can be challenging to apply to liquid extract products. AHPA’s guidance provides a point of reference when corresponding with U.S. Food & Drug Administration (FDA) staff about how to apply cGMPs to specific liquid extract product types by incorporating key regulatory citations and providing suggested narrative justifications.
 
In addition, the guidance provides a menu of options with illustrative examples of different approaches to presenting liquid extract product information in various contexts, including Supplement Facts boxes, master formulas, and product specifications. The examples include narrative content that explains the alignment of the elements and their relationship to the product specifications. The examples provided are intended to function as customizable templates which are also available for download and use as separate documents.
 
Guidance is provided for the following extract categories:

  • Ratio liquid extracts

  • Marker liquid extracts

  • Liquid extracts with no ratio and no marker

  • Concentrated liquid extracts

  • Liquid extract blends

  • Liquid group extractions

 
AHPA produces guidance documents to help the dietary supplement and herbal products industries comply with applicable laws and regulations and institute best practices for ensuring quality and transparency. This guidance was developed by a working group of AHPA members who produce liquid extracts and other interested parties. Particular acknowledgement and thanks are due to Staci Eisner of Cortex Scientific Botanicals, who served as the primary editor of the document.

AHP releases White Mulberry Leaf Assessment Report

AHPA is sharing with its members the following press release and White Mulberry Leaf Assessment Report released today by the American Herbal Pharmacopoeia (AHP). This report assesses the purported association of white mulberry leaf (Morus alba) with the tragic death of Lori McClintock. AHPA – among other experts in the herbal products and dietary supplements industries – has questioned the conclusion that Mrs. McClintock’s death was related to white mulberry due to the herb’s long history of safe use in addition to the lack of information supporting such conclusion. AHPA is grateful to AHP for preparing and distributing this report.


September 23, 2022

AHP releases 65-page assessment report on white mulberry leaf. The report is an assessment of an article presented in Kaiser Health News on August 24, 2022 regarding the death of a California woman whose cause of death was reported by a local coroner to be due to ingestion of white mulberry leaf. 


On August 24, 2022, Kaiser Health News published an online article entitled Congressman’s Wife Died After Taking Herbal Remedy Marketed for Diabetes and Weight Loss. https://khn.org/news/article/tom-lori-mcclintock-death-herbal-remedy-diabetes-weight-loss-white-mulberry/

We first express our heartfelt sorrow to the family of the deceased and apologize that we felt the need to address the facts of this sad event of someone so close and so dear to you.

The “herbal remedy” presumably taken was white mulberry leaf, a botanical with a long and safe history of use throughout Asia and is also used in Greek cuisine. The official cause of this death was listed as “dehydration due to gastroenteritis…that was caused by adverse effects of white mulberry leaf ingestion.” This determination was apparently made without any formal review of causality and presumably because a leaf fragment was found in the stomach of the deceased. When such tragic events occur, it is contingent among all involved to be as conscientious as possible in determining their determinations, both to help prevent similar future events and to bring an accurate reporting of what happened to the family. According to AHP president and herbalist Roy Upton who compiled the report:

“Because adverse effects, especially fatalities, related to botanicals are so rare, I always pay special attention when they are reported. When I read about this I took particular interest as I drank copious amounts of white mulberry leaf tea when I had COVID early in 2020. I knew of an acupuncturist/herbalist friend who had given eight pounds of it to his mother-in-law for a chronic cough she had and she has been taking it for months. Just a month ago, I sent a pound of it to my sister who also had a chronic cough from COVID and my partner started drinking it for a cough she had just a few weeks ago. I needed to know right away if there was any reality that called into question the safety of mulberry leaf.”

All aspects of the use of mulberry as a food, supplement, and medicine were reviewed. AHP reached out to experts in traditional Chinese medicine, botanists, medical doctors, pharmacologists, and toxicologists and reviewed as much of the national and international pharmacovigilance data that was accessible. AHP also communicated with herbal experts in Mainland China, Hong Kong, Taiwan, United Kingdom, and the US. The consensus, with no equivocation among all experts, is that there is no way to know for certain that the fragment was white mulberry, and if it was, the combined historical and current use of white mulberry as a food and supplement, together with formal clinical trials and toxicological reviews, gives no indication that white mulberry leaf has any action that would have caused or contributed to this sad event.

The most glaring deficiency on the part of the coroner in assessing causation is that there is no indication a formal assessment for determining causality was employed. Nationally and internationally varying processes are used. The presence of a substance is not sufficient to assert causality. A second challenge is that the leaf fragment found was fairly small and according to some expert botanists and plant specialists extremely difficult to identify with certainty.

The article also took this event as an opportunity to disparage the supplement industry and as was stated the “risks of the vast, booming market of dietary supplements and herbal remedies.” AHP reached out to the writer who was largely unaware of supplements overall and came to her conclusion based on numerous health professionals and others she had spoken to in her investigation. Because of this, AHP also took the opportunity to address the frequently repeated myth of an underregulated industry. Subsequent to the original Kaiser article, the writer, after having spoken with those well-informed about herbs and supplements, released a follow-up article similarly calling into question how the coroner made the determination that the leaf fragment somehow caused or contributed to the death. She received no response from the coroner’s office. She additionally presented opinions of other experts who affirmed the safety of mulberry leaf and expressed doubt that based on everything known about mulberry leaf that it could have any contributory role. https://khn.org/news/article/lori-mcclintock-california-congressman-wife-experts-question-role-of-white-mulberry-in-death/

Following is the link to the full AHP report which also includes a four-page executive summary.


ABOUT AMERICAN HERBAL PHARMACOPOEIA (AHP)
AHP Monographs and Therapeutic Compendiums are regarded as among the most comprehensive and practically valuable of herbal publications and has set a new bar for herbal medicine reviews. 

Contact
Roy Upton
ahp@herbal-ahp.org
831-247-4607

AHPA-ERB Foundation supports launch of new American Ginseng online exhibition

September 22, 2022

Illustration by Rosalie Haizlett (@rosaliehaizlett)


The Smithsonian Center for Folklife and Cultural Heritage has launched American Ginseng: Local Knowledge, Global Roots, a new online exhibition presenting the stories of a wide variety of people with intimate knowledge of this endangered plant. The American Herbal Products Association Foundation for Education and Research on Botanicals (AHPA-ERB Foundation) is pleased to have provided funds in support of the development of this new resource.

American ginseng grows wild in the Appalachian region of the Eastern United States and on farms in the Midwest. Its roots are highly prized in East Asian traditional medicine as a natural cure-all, treating everything from low energy to cancer. Due to its high market value and the degradation of its natural habitat, wild American ginseng faces many threats. By sharing traditional knowledge about the many wonders of American ginseng, we seek to increase education and conservation efforts for the “green gold” of the forest.

The exhibition officially launched on September 1, in honor of the start of ginseng season, when the plant may be legally harvested and sold in many states. AHPA members and the herbal community are encouraged to explore the site and share their own ginseng stories by uploading text and images.

AHPA’s 40 Herbs We Love – No. 22: Hemp (with love from Columbia Laboratories)

September 21, 2022

AHPA's 40th anniversary celebrations continue with our showcase of the twenty-second of many beloved herbs at the heart of our robust industry and vibrant community.

No. 22: Hemp (Cannabis sativa L.)
 

Ancient cannabinoid medicine finally entered the mainstream global wellness industry.

Consumers crave the wonder herb that enhances mental, emotional and physical health, but nascent exposure to the beneficial properties leaves much more to be explored.

Ensure your products are represented and ready for market with trusted testing at Columbia Laboratories, the industry's leading cannabis safety and quality testing laboratory.

Stay tuned for Columbia Labs' evolving methods that open market doors while enhancing best practices for quality products.

Visit columbialaboratories.com to learn more.


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.

You can:

  • 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.

Click here to download more information on all the ways you can join us to celebrate 40 years of AHPA, and contact Melissa Do with any questions and to get started.

AHPA’s 40 Herbs We Love – No. 21: Dandelion Root (with love from Teeccino)

September 16, 2022

AHPA’s 40th anniversary celebrations continue with the twenty-first of many beloved herbs at the heart of our robust industry and vibrant community.


No. 21: Dandelion Root (Taraxacum officinale)

The supply of wild dandelion roots depends on people collecting them in the meadows of Eastern Europe where the roots have to be washed and dried under rural conditions. We are grateful for the collectors who make this effort every season for the benefit of those of us who love drinking dandelion teas and coffees.
 
The detoxification properties of dandelion roots have become ever more popular as more research reveals the health benefits of this ubiquitous wild herb that most people think of as ‘weeds’!


 


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.

You can:

  • 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 40th anniversary AHPA Herb Talks! Gather (virtually) with fellow AHPA founders and friends for a pre-recorded video chats 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.

Click here to download more information on all the ways you can join us to celebrate 40 years of AHPA, and contact Melissa Do with any questions and to get started.

Is It Time for a ‘New FDA’ to Regulate Food and Dietary Supplements?

By Michael McGuffin, President, American Herbal Products Association (AHPA) • 09.13.22
A recent Politico article reported that a long-running joke among U.S. Food and Drug Administration (FDA) officials is that “the ‘F' in FDA is silent.” As FDA dedicates most of its budget and resources to drugs and medical devices, regulating food—including dietary supplements—appears to be less of a priority for the agency. This perceived disparity in regulation has led some to express concerns over the safety and reliability of our food supply.
Recently, FDA's delayed responses to issues identified both during inspections and in whistleblower reporting likely contributed to the national infant formula shortage. Following criticism of the agency's handling of the formula shortage, FDA Commissioner Robert Califf has asked the Reagan-Udall Foundation—an independent nonprofit created by Congress to advance the mission of FDA—to evaluate the agency's food program.
Furthermore, recalls of conventional food products make up the majority of FDA recalls and are estimated to cost the country billions of dollars per year. In addition, millions of people in the U.S. are sickened by foodborne illness annually, despite the fact that most cases of foodborne illness are preventable. Altogether, confidence in FDA's ability to keep Americans and our food supply safe has waned.
Calls for Reform
Critical of FDA's inattention to food safety, dietary supplement industry leaders who have worked collaboratively with lawmakers on responsible regulation of the category—including the American Herbal Products Association (AHPA)—agree that improvements to federal oversight of food and dietary supplements are needed. This consensus raises the question: is it time to reassign the responsibility for the regulation and safety of the U.S. food supply?
Though such amendments to FDA authority would be unprecedented and complex to carry out, proponents in Washington have recently thrust the idea into the spotlight for public discourse. Chief among them are U.S. Senator Dick Durbin (D-IL) and Congresswoman Rosa DeLauro (D-CT), who introduced the Food Safety Administration Act of 2022 (S.4520; H.R.8358) earlier this year in response to FDA's “inadequate responses to recalls, a failure to implement a culture of outbreak prevention, and proposed rules and initiatives that languish for years.”
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