AHPA News - Expo East 2003 Schedule and Latest Developments

AHPA Schedule of Events for Expo East 2003
September 4 ¨C 7, 2003 Washington, DC

The industry trade show Natural Products Expo East will be held in Washington, DC, from September 4 to 7, 2003. AHPA has scheduled a meeting of the Board of Trustees, a Member Breakfast Meeting, a Member Reception, and numerous committee meetings that are important to AHPA members. The full schedule of AHPA events, as well as the registration form for the Member Breakfast Meeting, can be reviewed at the following link: http://www.ahpa.org/03SeptemberMeetingSchedule.pdf.

Representatives of both the Federal Trade Commission (FTC) and the Office of Dietary Supplements (ODS) will make presentations at the AHPA Membership Breakfast and Meeting scheduled from 8:00 to 11:45 am next Thursday, September 4, 2003.

Mary Engle is the Director of FTC's Division of Advertising Practices. She will discuss that agency's current dietary supplement enforcement priorities and some recent enforcement actions that have been directed at supplement advertising. AHPA has worked closely with FTC over the past year in developing draft guidelines for advertising dietary supplements that are marketed for weight loss, as the agency has identified this as an area in need of new regulatory approaches.

Joseph Betz, Ph.D. has been the Director of ODS' Dietary Supplements Methods and Reference Materials Program since its inception in December 2001. He will provide an overview of the Program's current activities, including their interest in fostering the development of data that will assist herbal companies in identifying adulterants in botanical raw materials.

Please join us at the September 4th meeting to welcome these speakers and to hear what they have to say about the current activities of these federal organizations. Both Ms. Engle and Dr. Betz will provide information that is important to all manufacturers and marketers of herbal products.

AHPA President McGuffin Appointed to FDA Food Advisory Subcommittee

The Food and Drug Administration (FDA) has completed its appointments for current terms to its Food Advisory Committee (FAC) and to each of the FAC's subcommittees and has appointed Michael McGuffin, AHPA¡¯s President, as the industry representative to the Dietary Supplement Subcommittee.

FDA solicited nominations for technically qualified persons "with special insight into, and direct experience in, specific industrywide issues, practices and concerns" to serve as industry representatives to each of the FAC's six subcommittees in August 2002. These industry positions all serve in a nonvoting capacity.

Other subcommittees and the selected representatives are:

  • Food Additives and Ingredients Subcommittee - George Burdock (Burdock Group
  • Contaminants and Natural Toxicants Subcommittee - Henry Chin (National Food Processors Association)
  • Food Biotechnology Subcommittee - Jeffery Barach (National Food Processors Association)
  • Infant Formula Subcommittee - William MacLean, M.D.
  • Nutrition Subcommittee - Guy Johnson (Nutrition Solutions)

In addition, a second industry representative was selected to the full FAC. Mark Nelson (Grocery Manufacturers of America) will therefore be joining Annette Dickinson (Council for Responsible Nutrition) on the full FAC.

FDA describes the FAC as a technical and scientific committee that provides advice primarily to the Director of the Center for Food Safety and Applied Nutrition (CFSAN) and as needed to the FDA Commissioner and other appropriate officials, on emerging food safety, food science, nutrition, and other food-related health issues that the FDA considers of primary importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) broad scientific and technical food or cosmetic related issues; (2) the safety of new foods and food ingredients; (3) labeling of foods and cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues.

FDA Publishes Rule to Incorporate Herbs of Commerce, 2nd edition

The Food and Drug Administration (FDA) published in yesterday's edition of the Federal Register a direct final rule to amend its regulations on labeling of botanical ingredients in dietary supplements by incorporating the current editions of AHPA's Herbs of Commerce and of the International Code of Botanical Nomenclature (St. Louis Code). The new rule will become effective on January 1, 2006, consistent with FDA's published policy on uniform effective dates for food labeling regulations.

FDA currently requires, in Title 21 of the Code of Federal Regulations, Part 101.4(h) (21 CFR 101.4(h)), that the common or usual name of botanical ingredients in dietary supplements be consistent with the names standardized in the first edition of Herbs of Commerce. The current rules also allow dietary supplement products to omit the Latin name of those herbal ingredients that are included in this document, whereas the Latin name is required on the label to identify all such other herbal ingredients. In addition, all Latin names are currently required to conform to internationally accepted rules on nomenclature and the 1994 edition of the International Code of Botanical Nomenclature (Tokyo Code) is identified as an authoritative reference.

The new rule will replace both of these references with their current (2000) editions. Because the 2nd edition of Herbs of Commerce included almost 1500 additional plants (2048 separate species as opposed to 550 in the original), many additional ingredients will be required to use consistent common names and will be relieved from the need to provide Latin names on labeling. The new rule also clarifies the regulation¡¯s language so that there is greater clarity in the meaning of this rule.

AHPA Board Adopts Micro Limits

At its last meeting, the AHPA Board adopted, as guidance, specific recommended limits for dried raw agricultural commodities, including cut and powdered commodities, used as botanical ingredients in dietary supplements. They are as follows:

  • total aerobic plate count ¨C 107 cfu/gm
  • total yeasts and molds ¨C 105 cfu/gm
  • total coliforms ¨C 104 cfu/gm
  • salmonella ¨C absent in 10 gm
  • E. coli ¨C not detected in one gm

The Board also defined the following limitations and conditions for this guidance:

  • that the specific recommended limits described above may not be relevant to production processes in which microorganisms present in raw materials are significantly reduced;
  • that manufacturers bear responsibility to assure that finished consumer goods do not contain levels of microorganisms that would cause the product to be adulterated;
  • that manufacturers should control storage conditions to prevent degradation of botanical raw materials;
  • that producers of raw agricultural commodities should be encouraged to conform to good agricultural practice; and
  • that this guidance does not constitute a trade recommendation that places a requirement on AHPA members.

AHPA established these realistic limits based on levels of normal background microflora found on properly harvested and dried botanical raw commodities. Companies may find them useful in developing purity specifications for raw materials as would be required by FDA¡¯s proposed rules for good manufacturing practices of dietary supplements.

While lower limits for raw botanical materials have sometimes been discussed, requirements to meet these levels are problematic. Foods do not normally have microbial limits established because there is no correlation between a normal background of non-pathogenic microflora and a risk to human health. AHPA recognizes the importance of establishing purity specifications that are realistic and do not require sterilization procedures in order for such levels to be met.

The limits adopted by this policy protect the public health by allowing the use of properly handled materials without the imposition of a sterilization requirement. Sterilization procedures can serve to hide a primary indicator of poorly dried material (unusually high microbial counts), mask materials that have been unacceptably contaminated, and possibly introduce undesirable changes in the raw material through the sterilization process itself.

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