Using data to ensure sustainable harvest of botanicals: AHPA recently launched its eighth tonnage survey with an expanded list of 46 herbal commodities.
The AHPA Tonnage Survey is considered'^ vital index of native U.S. botanical consumption," according to the Fish and Wildlife Service of the U.S. Department of the Interior, and a key resource that supports sustainable harvests.
While individual companies track harvest information, it is a more powerful tool when harvest amounts are tabulated to include combined total usage. By working together, AHPA and the herbal products industry gain valuable information that helps plan for sustainable growth and stability.
AHPA limits participation in the survey to primary raw material producers in order to count raw materials once and minimize duplicate reporting of the same lot of goods at various distribution stages.
A primary raw material producer is defined in the survey as individuals or companies that obtain plant material directly from a wild or cultivated source or by contracting, purchasing and/or consolidating these plants from another entity that harvests them directly and was not likely to fill out the survey.
A primary raw material producer could include companies that use the plants directly (to manufacture herbal extracts for sale to other manufacturers, or to manufacture finished products), and companies that sell raw material to other companies.
Participation in the survey is voluntary and respondents are not publically identified. The information gathered is kept strictly confidential and the data gathered are represented in aggregate quantities of harvest.
AHPA has not attempted to extensively evaluate the relationship between market demand for each herb and their relative scarcity or abundance, but a review of data since the inception of the survey reveals that patterns in market demand are reflected in annual variations of harvests of wild and cultivated sources of these herbal commodities. Several species with large market demands are sufficiently cultivated so that a meaningful portion of the total usage is provided by farmers rather than wild plant harvesters.
The AHPA Tonnage Survey dates back to the 1990s. The first survey addressed only the plant goldenseal (Hydrastis canadensis), which was listed on the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) in 1997 due to supposed over-harvesting.
The number of articles tracked by the survey continually increased over the years. Selection of articles is based on a balance of importance for therapeutic use in traditional herbal medicines of North America (regardless of trade volume), trade volume, value and economic importance for local communities making their livelihoods from these herbs, and conservation status (e.g., does the population need to be carefully managed and monitored due to increasing demand?).
The last published survey (2010) provided harvest data for 26 herbal com modifies, representing 22 different plant species. AHPA recently launched its eighth survey with an expanded list of 46 herbal commodities representing 40 species. This latest survey includes high-sale volume and popular ingredients such as American ginseng, black cohosh, cascara sagrada, echinacea and saw palmetto. The survey also tracks lower-volume economically important commodities such as arnica, false unicorn and osha.
The latest survey also covers herbs that are native to the entire continent of North America, including Mexican plants. AHPA continues to work to identify and involve more primary raw material producers, and explore and include additional commodities based on communication with various producers. In addition to this survey, AHPA will be starting another survey to track select economically important North American herbs that are mostly cultivated.
AHPA President Offers Advice on NDI Notifications
FDA files more than half of submissions that comply with the current NDI regulations without substantive objections on the initial submission.
American Herbal Product Association (AHPA) President Michael McGuffin discussed how marketers of new dietary ingredients (NDIs) could successfully meet NDI notification requirements at the American Conference Institute's (ACI) second annual Legal, Regulatory and Compliance Forum on Dietary Supplements and Nutritionals held in New York, NY.
Mr. McGuffin's presentation was part of a three-person panel, "Strategies for Filing NDI Notifications with No FDA Objections Try and Try Again," presented with Ashish Talati (Amin Talati LLC) and Claire Kruger, PhD, DABT (Spherix Consulting).
"There is a false impression in the supplement industry that the NDI notification system is a bound-to-fail effort for most companies," Mr. McGuffin said. "In fact, more than half of submissions that are in full compliance with the current NDI regulations are filed by FDA without substantive objections on the initial submission, and this rate increases with attentive resubmissions when needed."
Using data derived from the AHPA NDI Database, Mr. McGuffin demonstrated that companies could effectively navigate the NDI notification system by avoiding common pitfalls and persistently addressing specific concerns identified by FDA in reviewing notifications. The AHPA NDI Database is a subscription-based repository of the more than 700 NDI notifications that have been submitted to FDA since 1995.
To reduce the chances of FDA objections to an NDI notification, Mr. McGuffin advised companies to:
* Accurately and completely describe the NDI;
* Create an informative narrative that clearly associates the NDI to the evidence submitted;
* Comply with all regulatory details (per 21 CFR 190.6);
* Avoid making drug claims in notifications;
* Be prepared to document pre-IND marketing and conformity with the statutory definition of a dietary ingredient (per 21 U.S.C. 321(ff)(1));
* Get good legal and scientific advice; and
* Address FDA's identified concerns in initial notifications in follow-up resubmission.
Maged Sharaf, PhD, is the chief science officer of the American Herbal Products Association (AHPA), the national trade association with a focus primarily on herbs and herbal products. AHPA's membership represents U.S. and international growers, processors, manufacturers, marketers and institutes specializing in botanicals and herbal products. Before AHPA, Dr. Sharaf was the director, Foods, Dietary Supplements and Herbal Medicines at the United States Pharmacopeial Convention (USP). Before USP he was pharmacy associate professor, and has preceding experience conducting bioanalytical assay development and validation, and human bioequivalence studies in support of the pharmaceutical industry; and quality control and manufacturing of pharmaceutical dosage forms. He can be reached a t 301-588-1171; email@example.com; umrw.ahpa.org.
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|Title Annotation:||Botanical Basics|
|Date:||Sep 1, 2014|
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