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Archive July 2023

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AHPA commends UPS, Teamsters on reaching labor deal to avoid strike

July 31, 2023

United Parcel Service (UPS) and the International Brotherhood of Teamsters announced last week that they have reached a tentative 5-year collective bargaining agreement. While the agreement still needs to be ratified by union members, this action will avert a potential strike that was previously authorized by UPS workers to start tomorrow, August 1, when the current agreement expires.
 
The American Herbal Products Association (AHPA) joined a coalition of trade organizations under the leadership of the U.S. Chamber of Commerce in sending a letter to President Biden on July 20 to urge the Administration to work with UPS and the Teamsters to help reach an agreement and to avoid the disruption that a strike would cause, especially to small businesses and online retailers.
 
“Even as other supply chain disruptions are resolving, AHPA members have let us know over the past few weeks of their concerns about the significant negative effects that would result from a UPS strike,” noted AHPA President Michael McGuffin. “On behalf of our members (and their customers) who rely on UPS, AHPA thanks and commends UPS and the Teamsters on reaching this tentative agreement, and we look forward to hearing news of its ratification.”

IADSA Newsflash for July 2023

July 31, 2023

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:

  • Thailand is introducing maximum levels for vitamins and minerals.

  • The European Food Safety Authority (EFSA) has recommended a lowering of the upper limit for vitamin B6 (12 mg/day), and is maintaining the current upper limit for folic acid (1000 mcg/day).

  • EFSA is consulting on a safety evaluation for berberine, fennel and plant preparations containing hydroxycitric acid following concerns raised about these constituents by France, Germany and Spain.

  • The European Commission has clarified that labeling requirements for epigallocatechin-3-gallate (EGCG) are not applicable to green tea used as a flavoring agent.

  • EFSA is exploring the possibility of building an interconnected network for nutrivigilance systems.

  • EFSA is planning to release an update of its Compendium COMBO database in early 2024, which is a tool to help risk assessors and risk managers to assess the safety of plant-derived products.

  • The French scientific assessment agency for food and nutrition (ANSES), has published an opinion taking into account the relevance of extending the warnings for interactions and side effects from medicinal plants to food supplements; ANSES has created a spreadsheet for 118 plants, addressing the potential interactions and contraindications.

  • Legislation has passed New Zealand to establish a regulatory system for food supplements.

AHPA Chief Science Officer presents at 2023 American Society of Pharmacognosy Annual Meeting

July 27, 2023
 

This week, American Herbal Products Association (AHPA) Chief Science Officer Holly E. Johnson, Ph.D., was featured as a speaker at the 2023 American Society of Pharmacognosy (ASP) Annual Meeting in Rockville, MD.

 

Dr. Johnson delivered her a presentation, “Cross-Pollination Between Herbal Industry and Pharmacognosy for Science Directed Towards Health, Quality, and Safety,” as part of the “Recent Advances in Traditional Herbals – Quality/Authenticity and Analysis (Industry Perspective)” session on the final day of the event. AHPA member Amit Chandra, Ph.D., Distinguished R&D Scientist and Fellow Botanical Strategy and Innovation at Amway, invited Dr. Johnson to speak at the annual meeting and also chaired the session.

Session speakers (from left): Dr. Monagas (USP), Dr. Pradhan-Nabzdyk (Canomiks), Dr. Chandra (Amway), Dr. Vidar (University of North Carolina Greensboro), Dr. Maier (Oregon State University), and Dr. Johnson (AHPA)

AHPA member Leena Pradhan-Nabzdyk, Ph.D. (Canomiks) also presented during the session that featured Dr. Chandra, Dr. Johnson, Maria Monagas, Ph.D. (United States Pharmacopeia), Warren Vidar, Ph.D (University of North Carolina Greensboro), and Claudia Maier, Ph.D. (Oregon State University).

ASP was founded in 1959. International in scope, members of the organization are experts dedicated to the promotion, growth, and development not only of pharmacognosy but all aspects of the sciences related to and dealing in natural products. The ASP Annual Meeting brings members together to share their expertise on regulatory developments, scientific advancements, and botanical safety, among other topics of importance to the natural products industry.

Also in attendance (from left): Dr. Ikhlas Kahn, Distinguished Professor & Director (National Center for Natural Products Research at the University of Mississippi), Dr. Hellen Oketch, Deputy Director (Office of Dietary Supplements Programs at the U.S. Food and Drug Administration), Dr. Joe Betz, former Acting Director (National Institutes for Health Office of Dietary Supplements), Dr. Johnson (AHPA), Dr. Pamela Tamez, Chief Officer (NIH Scientific Workforce Diversity Office)

AHPA welcomes new hires Alexis Durham and Daniela Gonzalez

July 24, 2023
 


Alexis Durham


Daniela Gonzalez

 

The American Herbal Products Association (AHPA) is pleased to welcome two additions to the AHPA team, with Alexis Durham as Director of Education and Daniela Gonzalez as Office Administrator.
 
Bringing a background in in finance, accounting, and administration to her new role at AHPA, Gonzalez manages the financial and administrative operations behind AHPA’s industry advocacy and service to members.
 
An herbalist and teacher coming to AHPA from her previous role as Director of Botanical Affairs at Herb Pharm, Durham develops and manages AHPA’s educational programs in addition to planning and coordinating AHPA meetings and events.
 
“AHPA is delighted to welcome Alexis and Daniela to the team,” said AHPA Vice President of Marketing & Engagement Amber Bennett. “They both bring strong experience to their positions and we look forward to their contributions to the association.”
 
“Every member of the team plays a key role in carrying out AHPA’s mission,” added AHPA President Michael McGuffin. “The expertise that Daniela and Alexis bring to AHPA further strengthens our ability to serve our members and support the herbal product and dietary supplement industries.”

Bipartisan legislation reintroduced in U.S. Senate would create regulatory pathways for hemp-derived CBD

Bill would remove restrictions for use in foods and dietary supplements

July 20, 2023

Today, U.S. Senators Ron Wyden (D-OR), Rand Paul (R-KY), and Jeff Merkley (D-OR), and U.S. Representative Earl Blumenauer (D-OR) reintroduced bipartisan legislation that would protect public health by providing legal clarity in the hemp and hemp-derived cannabidiol (CBD) product marketplace. The American Herbal Products Association (AHPA) previously endorsed the Hemp Access and Consumer Safety Act of 2021 and, subsequently, supports this latest version of the bill.
 
The Hemp Access and Consumer Safety Act of 2023 would amend the Federal Food, Drug, and Cosmetic Act (FD&CA) by establishing exceptions to certain statutory restrictions that have prevented the U.S. Food and Drug Administration (FDA) from setting clear regulatory frameworks for hemp and hemp-derived CBD that would assure consumer access. Importantly, the legislation would subject foods and dietary supplements containing these ingredients to all of the protections afforded by FDA’s current food and dietary supplement regulatory frameworks.
 
A growing number of Americans view hemp and hemp-derived CBD as useful for improving health and wellbeing, driving high consumer demand and a proliferation of hemp and CBD-containing products on the marketplace. While the 2018 Farm Bill changed the law to allow hemp farming, regulatory uncertainty has remained about the inclusion of hemp and hemp-derived CBD in foods and dietary supplements.
 
“Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated,” said AHPA President Michael McGuffin. “AHPA supports this legislation as it would clarify the lawful pathways for bringing such products to market.”
 
The legislation introduced today would allow hemp, hemp-derived CBD, and other ingredients derived from hemp to be legally marketed in foods and dietary supplements, and it would thus require such products to comply with all of the statutes and regulations that apply to other foods and dietary supplements. Establishment of these legal pathways will also provide much needed certainty to hemp farmers.
 
The bill would also specifically authorize FDA to establish labeling and packaging requirements for dietary supplements and foods that contain hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp.
 
In addition to endorsing the Hemp Access and Consumer Safety Act of 2023, AHPA also supports similar legislation introduced earlier this year: the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 (H.R.1629) and the CBD Product Safety and Standardization Act of 2023 (H.R.1628). Introduced by Reps. Morgan Griffith (R-VA) and Angie Craig (D-MN), both bills would similarly set forth a regulatory pathway allowing hemp, hemp-derived CBD, and other ingredients derived from hemp to be legally marketed in foods and dietary supplements.

Supplement Trade Associations Join Reps. LaHood, Boyle, Curtis, & Gottheimer to Give Americans Increased Flexibility to Purchase Nutritional Supplements for Better Health


FOR IMMEDIATE RELEASE
Date: July 20, 2023
Contacts:
Logan Tucker (CHPA), 202-429-3534, ltucker@chpa.org
John Rauber (LaHood), 202-225-6201, john.rauber@mail.house.gov
Sean Tobin (Boyle), 202-225-6111, sean.tobin@mail.house.gov
Adam Cloch (Curtis), 202-225-7751, adam.cloch@mail.house.gov
Melissa Do (AHPA), 301-588-1171 ext. 104, mdo@ahpa.org
Jeff Ventura (CRN), 202-204-7680, jventura@crnusa.org
Kyle Turk (NPA), 732-272-4643, kturk@npanational.org
Loren Israelsen (UNPA), 801-755-2570, loren@unpa.com

Supplement Trade Associations Join Reps. LaHood, Boyle, Curtis, & Gottheimer to Give Americans Increased Flexibility to Purchase Nutritional Supplements for Better Health

Bill proposes to make dietary supplements eligible expenses in FSA/HSA accounts, allowing consumers to use tax-preferred health savings to purchase wellness products.

 

(Washington, DC) – The Consumer Healthcare Products Association (CHPA), American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) – organizations representing dietary supplement manufacturers, marketers, and ingredient suppliers – applaud the introduction of the Dietary Supplements Access Act. This bipartisan legislation, introduced today by U.S. Representatives Darin LaHood (R-Ill.), Brendan Boyle (D-Pa.), John Curtis (R-Utah), and Josh Gottheimer (D-NJ) will provide greater choices to consumers by allowing them to use Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs) to purchase dietary supplements, giving millions of Americans increased health and wellness options for better self-care.
 
Results of a 2023 HSA & FSA Reimbursement Study confirmed that most Americans who currently have an FSA or HSA (78 percent) want the flexibility to choose how best to use their pre-tax dollars to stay healthy by using these accounts to purchase dietary supplements. However, current law does not routinely allow dietary supplements to be recognized as qualified medical expenses.
 
HSA plans are used by Americans from every income level, with the average HSA contribution being two percent of household income, according to findings from the Employee Benefits Research Institute (EBRI). While critics of similar legislation previously introduced in Congress expressed concern that expanding the allowable medical expenses to include dietary supplements would mean less overall tax revenue for the federal government, due to more money flowing to these tax-free accounts, the Reimbursement Study revealed only 34 percent of FSA/HSA holders said they are likely to increase their current investment levels, and only 25 percent of non-account holders said the change would prompt them to open an account and contribute to it. Furthermore, findings from a 2022 VISA FSA Survey show that, over the past decade, FSA/HSA contribution amounts have remained static regardless of policy changes such as expanded eligibility for over-the-counter (OTC) consumer products.
 
“Americans overwhelmingly want increased flexibility to take charge of their own health, and this legislation would deliver the type of reforms today’s proactive consumers are asking for and deserve,” said CHPA President & CEO Scott Melville. “By allowing dietary supplements to be added to the list of qualified medical expenses, this bill builds on previous legislative efforts, including a bipartisan victory in 2020, that expanded FSA and HSA eligibility to include over-the-counter medicines and feminine hygiene products. CHPA applauds Representatives LaHood, Boyle, Curtis, and Gottheimer for spearheading this effort, which will further empower millions of consumers to best determine how to use their pre-tax dollars to stay healthy and practice responsible self-care.”
 
“Ensuring that Americans are able to utilize their HSAs and FSAs as a tool to make personal healthcare choices for their families remains one of my priorities”, said Rep. LaHood (IL-16). “As enrollment in HSA’s continues to grow, our bill would remove unnecessary barriers to better meet the needs of consumers. This bipartisan approach would allow over-the-counter nutrition and dietary supplements to be considered as qualified medical expenses under HSAs and FSAs so that a patient can choose to utilize their health savings dollars to access these dietary supplements.”
 
"More than 22 million Americans have chosen to enroll in a health savings account coupled with a consumer-direct health plan", said Rep. Boyle (PA-02). "Given this substantial demand, action should be taken to better meet consumer needs. Since HSAs, FSAs, and HRAs, require a prescription for the reimbursement of vitamins it makes sense to remove barriers to supplementing nutrient-deficient diets. This legislation will serve to remove many impediments to self-care, with the goal of creating a sensible path toward better health for all."
 
“The bipartisan legislation is a big deal for Utahns who use these products to maintain a healthy lifestyle,” said Rep. Curtis (UT-03). “This bill also sends a clear message to consumers that Congress is serious about giving more Americans choice in how they take care of their health care needs, as well as the importance of proactive care. What works for one person may not work for another, and too often one-size-fits-all policymaking leads to higher costs for consumers and their families.”
 
“Putting consumers in charge of their health choices and allowing them to make informed decisions about their healthcare – as this legislation would do – makes good policy sense,” said AHPA President Michael McGuffin. “Treating purchases of dietary supplements as eligible expenditures under HSAs and FSAs would incentivize healthy behaviors and consumer choice. Reps. LaHood, Boyle, Curtis, and Gottheimer recognize the contributions of these products to maintaining and improving the health and wellness of Americans. AHPA is grateful for their leadership on this issue and wholeheartedly supports this important measure.”
 
“CRN welcomes the introduction of this legislation,” said President and CEO Steve Mister. “Dietary supplements play critical roles to fill nutrient gaps and promote overall health and wellness. They not only can reduce risks associated with chronic conditions but can also lead to billions in savings for America’s health care system, as evidenced by the CRN Foundation’s recent health care cost savings study, Supplements to Savings. We look forward to working with the bill sponsors to advance this much-needed policy, so that consumers can finally use their HSAs and FSAs to purchase vitamins, minerals, and other supplements like probiotics, herbals, and omega 3s.”
 
“Expanding access to nutritional supplements is an innovative solution that will keep more Americans healthy, which is the most cost-effective public health policy of all,” said NPA President and CEO Dr. Daniel Fabricant. “With industry champions like Reps. LaHood, Boyle, Curtis, and Gottheimer sponsoring this legislation, we have a good foundation for advancing this bill through Congress. As we build momentum and additional support for this proposal, we will work closely with congressional leadership to strengthen the legislation. We are grateful for the sponsors championing legislation focused on better nutrition for our nation and for those of us who represent the millions of Americans who enjoy, sell, distribute, and manufacture these important products.”
 
“UNPA commends the sponsors of this common-sense, bipartisan legislation for recognizing the important role that dietary supplements have in helping Americans lead healthier lives,” said President Loren Israelsen. “Taxpayers deserve the choice to control their own spending, and this long overdue bill will provide greater incentives for adopting and maintaining healthy lifestyles. UNPA will be working hard for its passage.”
 
Background:
 
Under current law, FSAs and HSAs allow employees to put aside money before it has been taxed to pay for healthcare costs related to medical care, including certain prescription drugs, dental and vision care, OTCs, menstrual products, and other health-related items. However, the law does not currently recognize dietary supplements as “qualified medical expenses.” Estimates show around 60 million consumers already utilize FSAs and HSAs to save money on eligible healthcare expenses. Additionally, according to Health E-Commerce, U.S. consumers who shop at its affiliated e-commerce stores consistently confirm they believe vitamins and other dietary supplements should be FSA and HSA eligible. In fact, vitamins have been a top-searched product on these websites for many months now. As consumers are increasingly turning to dietary supplements to support their overall health and wellness, expanding FSA/HSA eligibility to include dietary supplements is an efficient way to help consumers with their health and wellness expenses. CHPA, AHPA, CRN, NPA, and UNPA have long advocated for the expansion of FSA/HSA eligibility to include more personal healthcare products. In 2020, a new law was signed reinstating FSA/HSA eligibility for OTC products and, for the first time, feminine care products, and this bill would extend eligibility to dietary supplements as well.
 

###

 
The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices.
 
Rep. Darin LaHood (R-IL) represents constituents of the 16th District of Illinois and currently serves on the House Ways and Means Committee where he is Chairman of its Subcommittee on Work and Welfare and a member of its Subcommittee on Trade.
 
Rep. Brendan F. Boyle (D-PA) represents Pennsylvania’s 2nd Congressional District and currently serves as Ranking Member of the House Budget Committee and sits on the House Ways and Means Committee and its Subcommittees on Select Revenue Measures, Social Security, & Oversight.
 
Rep. John R. Curtis (R-UT) represents Utah’s 3rd Congressional District and currently serves on the House Energy and Commerce Committee including serving as the Vice Chair on the Energy, Climate, & Grid Security Subcommittee and the Communications & Technology Subcommittee.
 
Founded in 1982, the American Herbal Products Association (AHPA) is the national trade association and voice of the herbal and natural products industries. AHPA is comprised of more than 350 member companies, consisting primarily of domestic and foreign companies doing business as growers, processors, manufacturers and marketers of herbs and herbal products as foods, dietary supplements, cosmetics, and non-prescription drugs, and also including companies that provide expert services to the herbal trade.
 
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing more than 200 dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers.
 
Founded in 1936, the Natural Products Association (NPA) is the nation’s largest and oldest nonprofit organization dedicated to the natural products industry. NPA represents over 700 members accounting for more than 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/beauty aids.
 
Founded in 1992, the United Natural Products Alliance (UNPA) is an international association representing more than 100 best-in-class natural products, dietary supplement, functional food, and scientific and technology and related service companies that share a commitment to providing consumers with natural health products of superior quality, benefit and reliability.

Herbs in History: Valerian & Chamomile

July 19, 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 latest entries explore the histories of valerian and chamomile and feature new information about these botanicals that has remained overlooked – if not unknown – until very recently. Preview the entries below and visit Herbs in History online to read more.


Valerian (Valeriana officinalis L.)

Forgotten Uses

Valerian (Valeriana officinalis L., Caprifoliaceae, syn. Valerianaceae) does not need to be presented. It is well established in the world of medicinal plants as a tranquilizer, particularly for patients affected with nervous overstrain. In internal use, it induces sleep and improves sleep quality, reduces blood pressure, alleviates dysmenorrhea, treats cramps, and reduces hypertension, in addition to having a positive effect on rheumatism, migraine, and colic. And it is credited with alleviating anxiety and depression. In external use, it is beneficial in the treatment of eczema, ulcers, and minor injuries. | Read more...


 

Chamomile (Matricaria chamomilla L.)

Well Known, but Still Full of Promises?

Chamomile (Matricaria chamomilla L. = M. recutita L., and Chamomilla recutita (L.) Rauschert, Asteraceae) is now mostly known as a tea with a mild sedative effect that induces sleep. Over the centuries, it had a much more diversified range of applications that its humble appearance did not announce. | 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 highly anticipated third edition of Herbs of Commerce

Herbs of Commerce is the standard for all common and scientific plant names used for products containing botanical ingredients.

July 11, 2023

AHPA's Herbs of Commerce, 3rd Ed.

The American Herbal Products Association (AHPA) is pleased to announce the release of the highly anticipated third edition of Herbs of Commerce. The publication provides guidance on consistent naming of botanical ingredients on product labels, especially those marketed in the United States as dietary supplements, and is now available for purchase on Amazon.
 
AHPA published the first edition of Herbs of Commerce in 1992 as self-governing guidance to reduce confusion associated with labeling botanical ingredients and establish a single “standardized” common name for each listed herb. The publication took the force of federal law when it was incorporated by reference in 1997 as the U.S. Food and Drug Administration (FDA) initiated rulemaking to implement the Dietary Supplement Health and Education Act (DSHEA) of 1994.
 
AHPA published the second edition of Herbs of Commerce in 2000, with the aim to expand and update each subsequent edition to reflect herbs presently on the market and contemporary botanical nomenclature. The newly published third edition contains entries for over 2,800 separate plant species, over 1,000 botanical synonyms, over 300 Ayurvedic, and over 700 pinyin names.
 
Herbs of Commerce is a critically important reference for AHPA members and the wider dietary supplement industry,” said AHPA Chief Information Analyst Merle Zimmermann, Ph.D., who served as the managing editor of the third edition. “This latest version is the culmination of several years of conscientious work by experts dedicated to the science and study of herbs and supporting transparency in the trade.”
 
“Dietary supplements are currently of peak interest to health-minded consumers,” added AHPA President Michael McGuffin, who has been at the forefront of the dietary supplement industry from its start through its growth to a multibillion-dollar market, and who also served as an editor of the second edition of Herbs of Commerce. “Responsible marketers have a duty to clearly and accurately label herbal ingredients to help consumers make well-informed decisions about the products they buy, and Herbs of Commerce serves as an authoritative resource for naming botanical ingredients.”
 
AHPA extends immense gratitude to the many herbal experts who made producing and publishing the third edition of Herbs of Commerce possible. Supporting Dr. Zimmermann’s managing editorship were contributing editors McGuffin and Holly E. Johnson, Ph.D. (AHPA), and taxonomic editor Wendy Applequist, Ph.D. (Missouri Botanical Garden). In addition, David Bunting (Herb Pharm), Mitch Coven (Vitality Works), Daniel Gagnon (Herbs, Etc.), Wilson Lau (Nuherbs), Roy Upton (American Herbal Pharmacopoeia), David Winston (Herbalist & Alchemist), and Steven Yeager (Mountain Rose Herbs) generously volunteered their time and expertise to serve on the Expert Advisory Council for this edition of the text.
 
Last but not least, express recognition is due to Herbs, Etc., Mountain Rose Herbs, Vitality Works, Herb Pharm, Nuherbs, NutriOriginal, Givaudan, Indena, and Mueggenburg Group, whose sponsorship of Herbs of Commerce, 3rd Edition, demonstrates the commitment of these companies to supporting a responsible herbal market. Their financial contributions will help maximize the impact and availability of Herbs of Commerce.

Herbs of Commerce, 3rd Edition, is available for purchase on Amazon for $195.00. AHPA members can purchase the publication at the exclusive, members-only price of $95.00 using a promotional code accessible by logging into their AHPA web account and visiting the Herbs of Commerce webpage or by contacting communications@ahpa.org.

AHPA expresses concerns regarding proposed reorganization of FDA

July 5, 2023

In its updated proposal to reorganize the agency’s human foods program – which includes the creation of a new Deputy Commissioner of Human Foods position – the U.S. Food and Drug Administration (FDA) suggests relocating the functions of the current Office of Dietary Supplement Programs (ODSP) within a new Office of Food Chemical Safety, Dietary Supplements, and Innovation.
 
“FDA created the Office of Dietary Supplement Programs in 2015, elevating the program from its former status as a division under a parent office,” said Robert Marriott, AHPA Director of Regulatory Affairs. “Removing ODSP’s separate status and combining it with these other functions would unwind a structure that has ensured dedicated funding and attention to programs for the growing market for these health-promoting products.”
 
“Of additional significant concern is FDA’s incomprehensible proposal to place dietary supplement programs in its ‘Risk Management Functions,’” added Michael McGuffin, AHPA President. “Any review of adverse event reporting data and food recalls would demonstrate the remarkable safety record of dietary supplements over the last 30 years.”

FDA’s proposed reorganization comes in response to a report issued last December by the Reagan-Udall Foundation following a review of the agency’s Human Foods Programs. One specific recommendation from that report was that the inspection and compliance activities of the Office of Regulatory Affairs (ORA) should be reorganized to ensure that fieldwork aligns with food program policies. Apparently heeding that and related recommendations, FDA’s proposal also introduces a “new model” for ORA.

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