The 2009 USP Dietary Supplements Stakeholders Forum

From Dietary Supplements e-Newsletter - September 2009

• Sign up for the Dietary Supplements e-Newsletter

The United States Pharmacopeial Convention (USP) had its second Dietary Supplements Stakeholders Forum (DS SF) meeting during the 2005-2010 cycle, at its headquarters in Rockville, MD, USA, on August 5, 2009. Information for the DS SF is posted on the USP Web site at: www.usp.org/stakeholderForums/dietarySupp/.

USP Stakeholder Forums were initially established in the 2000-2005 cycle, and were formalized in an amendment to the USP Bylaws adopted at the 2005 Convention. The DS SF provides an effective way for USP to obtain information from interested parties, learn what's important to industry, and seek the advice of stakeholders on various dietary supplements (DS) issues.

The DS SF was attended by representatives from the United States Food and Drug Administration (FDA), National Institutes of Health (NIH), American Botanical Council (ABC), American Herbal Products Association (AHPA), AOAC International, Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA), NSF International, and a number of professional institutes, ingredients suppliers, and finished product manufacturers. Observers representing various organizations were also present.

The issues covered were the USP dietary supplements strategic directions, metal impurities, contaminants, USP monograph modernization, and USP monographs and adherence issues. Stakeholders' discussions resulted in the following recommendations for USP:

• Raise the awareness of stakeholders regarding new standards for botanicals, which could resolve some of the concerns that in the past prevented inclusion of botanicals in USP Verification Programs
• Proactive international harmonization
  • Explore bilateral harmonization with other pharmacopeias and within the Pharmacopeial Discussion Group (PDG)
  • Create a relevant forum to advance world-wide harmonization while considering the differences in regulatory statuses (traditional medicines vs. DS)
  • Continue current USP harmonization efforts with Indian, Chinese, and Latin-American pharmacopeias
• Increase education/awareness of the industry about USP, to promote further implementation of standards
  • Improve the USP processes for disseminating information (e.g., media presence, e-newsletters, free access to Pharmacopeial Forum (PF))
  • Work with different trade associations, other organizations, and agencies as conduits
  • Educate ingredient suppliers and testing labs on USP documentary/ reference standards
• USP methods
  • Collaborate more with others (AOAC, NIH-ODS, industry/trade groups, etc.)
  • Improve communication on supporting information for methods in USP
  • Consider methodologies for multi-component determination
• Areas to strengthen standard-setting activities
• Consider stability-indicating marker compounds in monograph development
• Consider addressing the issue of adulteration in light of recent instances of counterfeiting DS with active pharmaceutical ingredients and of FDA's interest in economically motivated adulteration
• Set standards for identification considering the above
• Metal impurities
  • Ensure an appropriate delayed implementation of the new USP General Chapter <2232> Elemental Contaminants in Dietary Supplements, which will enable industry preparation
  • Clarify a performance-based approach that allows stakeholders to use methods different from those suggested in the USP-NF to test for metal impurities
  • Use NIST or USP reference materials to evaluate the performance of other methods used by stakeholders
  • Reconsider the estimate of 50 kg/person in setting the new USP limits; 50 kg/person may be too low
  • Consider review of multi-lab data obtained using atomic absorption methods
  • Clarify limits for cross-compendial articles (those that are considered both DS and drugs in USP)
• Contaminants
  • Consider harmonization with Europe for pesticide limits in botanicals (EP now requires limits for about 70 pesticides up from 39)
  • Consider limits for cross-compendial articles
  • Evaluate microbiological limits in USP <2023> relative to those of botanicals in commerce and in EP/PharmEuropa 5.1.8 and 2.6.31
• Monograph modernization and USP revision process
  • Consider mechanisms, in addition to e-newsletters, to notify stakeholders of PF contents and upcoming USP meetings
  • Notify monograph submitters of status, comments, and outcome
  • Have compendial updates available for monitoring time-sensitive activities
• Adherence issues
  • USP monographs are one of several available tools for establishing specifications in the context of GMP requirements in the U.S.

Dr. Marcia D. Howard (CHPA), 2009 USP DS SF Chair, commented, "The USP Dietary Supplements Stakeholders Forum, held in conjunction with the companion Stakeholder Forum for Food Ingredients, offered an excellent opportunity for dialogue between manufacturers, suppliers, industry, government officials, trade association representatives, and USP staff about key issues in the dietary supplements and food industry. The forums allowed stakeholders to learn about current and future USP initiatives in the dietary supplements and food arenas and express their needs, concerns, and recommendations to USP staff. The 2009 stakeholder forums have laid a solid foundation for future meetings and ongoing discussions."

The 2010 USP DS SF incoming Chair, Dr. Andrew Shao (CRN), stated that "USP is an extremely valuable resource for the dietary supplement industry. The limits and standards provided in USP monographs serve as the basis for product specifications and analytical methods needed to ensure the quality of many dietary supplement products. Because USP's system of monograph development, review, and revision is stakeholder driven, it is critical for the dietary supplement industry (ingredient suppliers, manufacturers, trade groups, and others) to be as informed and engaged as possible. The Dietary Supplements Stakeholder Forum plays an important role in bringing stakeholders together to discuss key issues of interest. The Forum provides the opportunity for the industry to have an open dialogue with USP, and provide constructive input that can assist USP to better serve the needs of the industry. As incoming Chair of the Forum Planning Committee, I look forward to spearhe! ading the development of a robust program for 2010 and hope to see all key dietary supplement industry stakeholders in attendance."