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Archive November 2023

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AHPA advocates for members with correspondence addressing dietary supplement trade challenges in Canada and Mexico

AHPA’s communications to relevant governmental bodies seek clarification, resolution to regulatory cost concerns in Canada and import challenges in Mexico

November 11, 2023

On behalf of its members that have commercial interests in Canada and Mexico, the American Herbal Products Association (AHPA) has sent communications on two separate issues impacting the dietary supplement trade with these countries. As geographical neighbors and long-standing trading partners, Canada and Mexico represent significant economic markets for United States-based natural products companies.

Regulatory cost concerns in Canada

In Canada, a regulatory proposal to establish user fees for the registration, manufacture, and sale of natural health products (NHPs) was introduced by Health Canada. While such a proposal was expected by the industry, significant concerns have been raised about the overall structure of the proposal and the calculation of the associated fees. Health Canada conducted a public consultation on the proposal that concluded in August 2023, and AHPA’s International Committee developed and submitted responses to the questions that formed the consultation.

AHPA has now also communicated with the U.S. Trade Representative and the U.S. World Trade Organization Technical Barriers to Trade inquiry point. These communications raised concerns about whether the structure of the Health Canada user fee proposal complies with specific provisions of the United States-Mexico-Canada Agreement with respect to the calculation of the proposed user fees and whether the user fees impose an inequitable burden on foreign products.

Import challenges in Mexico

With Mexico, AHPA member companies have been experiencing challenges in obtaining import permits for dietary supplement products from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the regulatory agency charged with this authority. No changes have been made to the Mexican national regulations, and local supplement associations have been unsuccessful in meeting with COFEPRIS to better understand the issue. In the absence of a functional import permit process, inventories of some dietary supplement products have become critically low, causing supply chain issues for Mexican distributors and retailers.

AHPA, along with other U.S. and international supplement associations, has submitted communications to the Mexican Ministry of Health and the Mexican Ambassador to the United States with the objective of gaining an understanding of the issues inhibiting the process of issuing import permits. AHPA respectfully requested that companies with established business in Mexico be promptly informed of any changes to the import permit processes and allowed a reasonable amount of time to take actions such as reformulation or changes to product labeling as may be needed.

AHPA appreciates the work of its International Committee in bringing these concerns forward and supporting the development of appropriate responses that represent the interests of AHPA members and the wider industry impacted by these issues.

AHPA requests FDA update federal regulation to reference Herbs of Commerce, 3rd Edition

November 16, 2023

On November 14, 2023, the American Herbal Products Association (AHPA) submitted a Citizen Petition amendment requesting that the U.S. Food and Drug Administration (FDA) amend the federal regulation referencing the first edition of AHPA’s Herbs of Commerce (1992) to reflect the updated, third edition published this year. AHPA’s Herbs of Commerce provides guidance on consistent naming of botanical ingredients on product labels, especially those marketed in the United States as dietary supplements.
 
Specifically, AHPA’s updated request seeks to have FDA issue a direct final rule to amend 21 C.F.R. § 101.4(h) to remove the reference to the 1992 edition of Herbs of Commerce and require that the common or usual name of ingredients in dietary supplements that are botanicals (including fungi and algae) be consistent with the standardized common names in Herbs of Commerce, 3rd Edition (2023).
 
This request amends the Citizen Petition that AHPA submitted in 2017, in which the association also sought to have FDA remove the reference to the first edition of Herbs of Commerce and replace it with the latest edition at the time. In a 2018 response to AHPA’s Citizen Petition, FDA stated that the agency “ha[d] not reached [a] decision on your petition due to competing agency priorities” and that the “petition is currently under active evaluation by our staff.” To AHPA’s knowledge, FDA has not taken any subsequent action in response to the 2017 Citizen Petition.
 
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 FDA completed rulemaking regarding the labeling of dietary supplements to implement the Dietary Supplement Health and Education Act (DSHEA) of 1994. AHPA’s third edition of Herbs of Commerce added standardized common names for approximately 800 more botanicals than included in the second edition referenced in AHPA’s initial Citizen Petition and over 2,000 more botanicals than included in the 1992 edition currently referenced in 21 C.F.R. § 101.4(h).
 
“The third edition of Herbs of Commerce reflects the most current taxonomic nomenclature for botanicals used as dietary ingredients in dietary supplements marketed in the United States,” said AHPA President Michael McGuffin. “Responsible marketers clearly and accurately label herbal ingredients to help consumers make well-informed decisions about the products they buy. We encourage FDA to amend the regulation to require use of the most current and accurate botanical names for dietary ingredients.”
 
Herbs of Commerce, 3rd Edition is available for purchase now.

2024 AHPA Award nominations now open

Nominate an industry colleague or organization by Monday, December 4, 2023 for consideration

November 13, 2024
 

The American Herbal Products Association (AHPA) is pleased to invite members to help us recognize standout leaders in our community by nominating an individual or organization for the 2024 AHPA Awards.

 

Nominations can be submitted using the online nomination form (preferred) or by email to communications@ahpa.org. Nominations must be received by Monday, December 4, 2023 for consideration.


2023 AHPA Award winners (from left): Asa Waldstein and AHPA's Amber Bennett; Natural Remedies' Punit Dashottar; Herbalist & Alchemist's Beth Lambert and David Winston; Shawn Donnille; Lise Groleau; AHPA's Michael McGuffin and Joseph Betz


About the AHPA Awards

 

First presented in 2006, the annual AHPA Awards acknowledge individuals and organizations for making positive and substantive contributions to the herbal and natural products industry.

 

After the nomination period closes on Monday, December 4, 2023, nominees will be reviewed by members of the AHPA Communications Committee, which represents a diverse group of industry stakeholders. The AHPA Communications Committee recommends recipients for each award category and presents these recommendations to the AHPA Board of Trustees for approval.

 

Winners will be notified in January 2024. AHPA Awards will be presented at the AHPA Annual Member Meeting on Wednesday, March 13, 2024 at Natural Products Expo West in Anaheim, CA.

 

2024 AHPA Award Categories

 

  • AHPA Herbal Hero Award: Recognizes an individual who makes outstanding contributions to AHPA committees or initiatives. (Nominee must be an AHPA member.)

  • AHPA Herbal Industry Leadership Award: Recognizes a company that sets an example of outstanding business practices or an organization that works to move the industry forward above and beyond normal business practices.

  • AHPA Herbal Insight Award: Recognizes individuals or non-commercial organizations that have a significant impact on furthering knowledge and understanding of botanicals and their uses.

  • AHPA Herbal Diversity & Inclusion Award: Recognizes excellence in commitment to the values of diversity, inclusion and equality benefitting both the herbal products industry and broader society.

  • AHPA Environmental Impact Award: Recognizes an individual, organization, or company that has implemented innovative sustainable or regenerative business practices that will continue to have a meaningful positive impact on the environment.

 

More information about the awards, including a list of previous winners, is available here.

IADSA Newsflash for November 2023

November 9, 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:
 
  • China has released new rules for the technical evaluation of new function claims for health foods.
  • Indonesia is planning to limit sales of imported goods via e-platforms and is introducing regulations for the health supplement product industry.
  • Armenia is introducing legislation to restrict the sale of dietary supplements to pharmacies.
  • Belgium has issued an opinion that may ease restrictions on the use of Canarium indicum as a traditional food.
  • Health authorities in Belgium have expressed concern regarding the amount of alcohol that may be consumed through the use of tinctures and extracts that contain this substance.
  • The European Commission has clarified that food and food supplements are not subject to the information and reporting requirements of REACH regarding microplastics.
  • The European Commission may restart its process for evaluation of health claims for botanicals.
  • The EU has determined that hemp leaves are not novel foods, but some member states have expressed concern about the amounts of delta-9 and delta-8 THC that may be present when using hemp leaves to make tea for example.
  • France has decide to publish a decree identifying vitamin D3 as an endocrine disruptor, despite concerns that this may cause confusion among consumers who should take supplements due to inadequate intake.
  • Poland has published a list of substances prohibited for use in supplements, which includes Piper methysticum (kava).
  • The UK Food Standards Agency has lowered its recommended safe intake of cannabidiol to 10 mg/day for health adults; the prior recommendation was 70 mg/day.
  • Turkey has followed several other countries in banning the use of titanium dioxide as a food additive.
  • New Zealand adopted the Therapeutic Products Act, which will be come effective in 2026; implementing regulations will be developed in the coming years.
  • Argentina has banned health claims for food supplements, which previously were allowed on a case-by-case basis.
  • Chile has authorized the use of hemp derivatives in all food products, including supplements.
  • Guatemala has updated its regulations regarding the identification of pharmaceutical products, including dietary supplements.

AHPA Chief Science Officer to present at WIN webinar on empowering women in science

November 8, 2023


The WIN Science Committee is launching a quarterly webinar series as a resource to women in science interested in launching and advancing their careers, as well as those seeking to actively bridge the knowledge gap in women’s health research.
 
Dr. Leena Pradhan-Nabzdyk, co-chair of the WIN Science committee will kick off with an introduction to WIN and the science committee’s mission. The science committee’s webinar series coordinators, Dr. Karin Hermoni and Dr. Karen Hecht, will moderate a panel discussion with accomplished career scientists who have bridged multiple industries. Panelists will share insights on science career options and how to navigate and prepare for a non-linear career path in science.
 
Panelists include:

  • Susan Hewlings, Ph.D., is co-founder of Substantiation Sciences and Vice President of research affairs at Radicle Science. She works as a science consultant in the dietary supplement, food, beverage, CBD and Cannabis industries. She also often works as a freelance Medical Writer and serves as an adjunct professor at Nova Southeastern, teaching graduate Nutrition courses.

  • Dr. Jacqueline Jacques, Naturopathic Doctor and Fellow of the Obesity Society with over 20 years of leadership experience in the medical nutrition and wellness industries. She is well known in our nutraceutical industry as an executive, board member, speaker, and entrepreneur. She is the author of the book Micronutrition for the Weight Loss Surgery Patient and has contributed to numerous professional publications.

  • Holly E. Johnson, Ph.D., is a pharmacognosist and ethnobotanist, serving as the Chief Science Officer at the American Herbal Products Association (AHPA). In her role as CSO, she is the primary scientific resource for the organization, helping the herbal industry use the latest science, technology and research to ensure consumers continue to have informed access to innovative, safe and effective herbal products. Before joining AHPA, Dr. Johnson served as the Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanicals.

  • Sibyl Swift, Ph.D., is the Chief Science Officer & VP Regulatory Affairs for cbdMD and the co-chair of cbdMD Therapeutics. She also serves as a Member of the Board of Directors for cbdMD. As CSO for cbdMD, she directs the company’s research partnerships, clinical trials, advises on regulatory matters, guides new product development and R&D, and provides guidance on cGMP. Prior to joining cbdMD, Dr. Swift was the Senior Vice President for Scientific & Regulatory Affairs at the Natural Products Association (NPA).

This 50-minute webinar is being broadcast live on Thursday November 16th at 10:00 AM Eastern time and will be available on demand. Attendees are encouraged to submit their questions throughout the webinar and stay on for a live 10-minute Q&A with the panelists.

 

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