Hawaiian Hoodia™ Division
Quality Assurance Program and Certifications
FRESH HOODIA FROM HAWAII
Harvested with Aloha!!!
Photo © Edward Rau, Sustainable Bioresources, LLC
Unfortunately, over the 10-15 years many, perhaps most, of the Hoodia products that have been sold for weight loss were advertised with excessive, unverifiable claims and they often had formulations that were of questionable potency, efficacy and safety. Some were adulterated and may not have even contained Hoodia. Of those that did, the origin, handling and processing of these ingredients could not be verified. Most of the real hoodia ingredients were unsustainably harvested from wild plants in Africa.
We want our customers to have complete confidence in the quality of our hoodia products and are establishing a robust quality assurance program to build your trust. All aspects of this program are intended to be transparent, fully permitted and verifiable by independent parties. Each claimed quality attribute is described below with reference to associated permits and certifications.
No Plants or Seeds from Wild Sources Used in Our Research or Products
All of the Hoodia plants that we obtained to begin our research program were purchased from suppliers in Western Europe or the United States that grew the plants in artificial cultivation. No plants or seeds were ever obtained from Africa. USDA import and protected plant permits were required and obtained for imports. Documentation in the form of invoices and/or phytosanitary certificates for these purchases, both foreign and domestic, was provided to the U.S. Fish and Wildlife Service with our application for approval of exports under CITES requirements (See CITES Compliance, below). Export shipments must include declarations affirming that the seeds, plants or plant materials were from artificial cultivation.
Additionally, all certified (nematode-free) Hoodia plants that we sell must be from our nursery and listed on the Hawaii Department of Agriculture website.
Control of Pests and Diseases in Nursery Stock
Most of our Hoodia plants are certified (nematode-free) and grown in areas of our nursery certified and inspected by the Hawaii Department of Agriculture (HDOA). These areas and the plants grown in them are subject to a detailed set of pest and disease surveillance and control requirements found in Hawaii regulations and permits of other states that restrict imports of plants from Hawaii. The most extensive requirements are imposed by the California Department of Food and Agriculture Master Permit QC 650 that was renewed in October 2019 (CDFA 2019).
Certification of our nursery can be confirmed by visiting the website of the Plant Industry Division of the Hawaii Department of Agriculture. We are BRN# 0482. The website also lists our inspection dates, the plants and container sizes that we are authorized to ship. We inspect all outgoing shipments of certified plants and place a certification stamp on the packaging.
We are phasing out growing Hoodia outdoors but still have a small number of plants that were grown outdoors in non-certified areas of our nursery. These can be shipped to all states except Arizona, California, Louisiana and Texas. All seeds, and non-certified plants going to other states must be inspected, approved and stamped by the HDOA before shipment. International shipments are inspected by the U.S. Department of Agriculture and phytosanitary certificates and/or CITES clearances may be issued.
Non-Invasiveness
No Hoodia species are listed on the Global Invasive Species Database (ISSG 2019). The potential invasiveness of these species in Hawaii has also be assessed through the Big Island Invasive Species Committee (BIISC) and determined to be low risk. The BIISC is an organization with a mission to prevent, detect, and control the establishment and spread of invasive species threats to the Big Island environment, economy, and way of life. The BIISC has a program referred to as Plant Pono that seeks to recognize exemplary businesses who voluntarily act to protect their business and their community from the threat of invasive species. To avoid planting a potential pest, nurseries can use a tool called the Hawai‘i Pacific Weed Risk Assessment (HPWRA) to evaluate plants before importing any new species to the Hawaiian Islands.
Sustainable Bioresources, LLC operates its facility as a Plant Pono Endorsed Nursery, which can be confirmed by visiting the BIISC Plant Pono website. Endorsed nurseries agree to follow several practices intended to reduce impacts from invasive species. When considering introducing a new plant species to the state, nurseries request a free, non-binding assessment from the HPWRA. It is a screening tool to ask “background questions” about a plant before it is imported or widely planted in Hawai‘i. Botanists look up published and on-line information to answer 49 questions about a plant’s biology, ecology and invasive tendencies elsewhere. The answers result in a score that predicts whether a plant is likely to be invasive in Hawai‘i or other tropical Pacific islands sharing a similar climate. The HPWRA is 95% accurate in catching the would-be invasive plants and 85% accurate at identifying non-pests (HWPRA 2019a).
In 2015 we submitted a list of the Hoodia species that we were intending to introduce in Hawaii for assessment by the HPWRA. They all received Weed Risk Assessment (WRA) scores ranging from -2 to 0, indicating they were Low Risk, or “Pono Plants” (HPWRA 2019b). The detailed assessments can be downloaded from the Plant Pono website.
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CITES Compliance
The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), also known as the Washington Convention is an international multilateral treaty agreement between governments. Its aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival.
In the United States the management authority for CITES is the Fish and Wildlife Service (FWS). Importers of CITES regulated plants must have and comply with the provisions of Protected Plant Permits issued by the USDA. All exporters in the U.S. must also have and comply with the provisions of permits issued by the FWS.
All Hoodia species are listed on CITES Appendix II and subject to CITES requirements as the live plants of the pure species and hybrids (Shippmann 2016), and plant derived materials. Unlike most other plants listed on Appendix II, Hoodia seeds are also regulated by CITES (Harcum 2019) contrary to the information posted on the FWS website (USFWS 2019). In 2019 we applied for and obtained authorization (a Master File) from the FWS that allows us to request issuance of unique, single use permits or certificates for exports of our artificially propagated Hoodia and Hoodiopsis species and hybrids for the purpose of commercial trade. Each export shipment must be accompanied by a single use permit.
Organic Production
Consumers are increasingly seeking and preferring agricultural products grown, processed and certified as organic and this attribute may be particularly important for high value produce and products sold in health food stores. Since the inception of our research one of our goals has been to develop Hoodia cultivars that can be grown using organic farming methods. This has been difficult to achieve because of the very limited selection and availability of organic pesticides approved and effective for treatment of the many pests and diseases affecting Hoodia, particularly root mealy bugs and anthracnose. Hoodia also grows best with higher nitrogen fertilizers. Most organic high nitrogen fertilizers contain or are derived from animal manures, which may be incompatible with food safety requirements. These problems have now been overcome and our first crop of new cultivars has been grown strictly following organic methods.
Before beginning test marketing of our Hoodia products we evaluated the various options for organic certification and decided to apply to the Certified Naturally Grown (CNG) program. CNG is a U.S. based farm assurance program certifying produce, apiaries and livestock for organic producers who sell locally and directly to their customers. CNG was founded in 2002 by organic farmers in the mid-Hudson Valley, as a simpler to administer and less expensive alternative to the USDA’s National Organic Program (NOP) certification, using a production standard based on the NOP. Quality assurance is maintained using a Participatory Guarantee System (PGS), a method supported by the International Federation of Organic Agriculture Movements (IFOAM). CNG is operated as a non-profit corporation headquartered in New York. Because of our small size, direct marketing methods and need to expedite entry into test markets we felt that participation in the CNG program was the best alternative to the USDA program available to us.
We are very pleased to report that our company has completed all requirements for participation in the CNG program and obtained certification. All of our Hoodia products and Moringa seedlings will be produced following CNG requirements and plants and seeds in our existing inventory that meet these requirements will carry the CNG logo. If sales grow to a sufficient size to justify the time and expense, we may pursue organic certification under the USDA’s National Organic Program program, which will be more a more widely recognized form of certification, especially for international customers.
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No Genetically Modified Organisms (GMOs)
None of the plants or seeds we offer are Genetically Modified Organisms (GMOs). The use of GMOs is generally prohibited in organic farming and would violate the requirements for the Certified Naturally Grown program that we now participate in. All of our new Hoodia cultivars have been developed by traditional plant breeding techniques, primarily artificial selection of specific desirable, naturally occurring traits such as disease resistance. Plants showing these traits are used to breed and improve successive generations. If the traits are stable between generations, we consider these plants to be new cultivars.
Early in our plant breeding program we also used colchicine, a naturally occurring substance originally found in the bulb-like corms of the autumn crocus plant (Colchicum autumnale) to induce polyploidy, the presence of more than the normal two sets of chromosomes in plants. Colchicine is widely used in plant breeding to produce new cultivars because polyploid plants are often larger, faster growing, more pest and stress resistant and may present fewer barriers to hybridization than the normally diploid plants. Many common vegetable and fruit crops have polyploid genetics such as watermelons, muskmelons, corn, radishes, beans and strawberries. Unlike transgenic plants, polyploids have only more copies of their own chromosomes and genetics, not genes incorporated from other unrelated species. Our plant breeding program has yielded several polyploid Hoodia cultivars. All of these appear to be tetraploids – with four sets of chromosomes. Generally, these appear to be larger and faster growing than diploids of the same Hoodia species.
We do not intend to pursue certification of our products as Non-GMO at this time because such certifications because we feel that they may be misunderstood by consumers, giving the impression that all GMOs are inherently undesirable or unsafe. GMOs benefit mankind when used wisely and for appropriate purposes (Phillips 2008). Virtually all organisms that have directly or indirectly interacted with humans have been genetically modified by that interaction. Some of these modifications result in traits that may have undesirable consequences, such as the ability of herbicide resistant crops to accumulate herbicides or toxic residues in plant tissues that are later consumed as foods. Other traits, such as the incorporation of genes for resistance to the ring-spot virus that causes an incurable, highly destructive disease in papaya trees has been very beneficial. In short, we believe that the nature of traits being developed in organisms determines their risks and desirability, not the method (genetic engineering or traditional) by which the traits are induced.
Food Safety
Our first product offerings will be live plants and seeds intended only for non-commercial, propagative uses by purchasers. However, we understand that many potential customers intend to use these seeds and plants for personal medicinal purposes and consumption. Since our Hoodia is grown in containers off the ground, irrigated with potable water and only organic pesticides are used we believe the food safety risks associated with our current nursery stock production methods are minimal. Strict disinfection requirements for nematode control in our certified nursery areas further minimize these risks.
The first minimum federal standards for the safe production and harvesting of fruits and vegetables were established in the Food Safety Modernization Act (FSMA) of 2011 and the FDA Produce Safety Rule adopted pursuant to the FSMA in 2015. It is unclear if Hoodia is regulated under FSMA and small grower firms such as ours with an average annual value of produce sold during the previous three-year period of $25,000 or less are not covered by the regulations. However, we attempt to grow our Hoodia in a sanitary manner that minimizes food safety risks. Additionally, our company president who oversees growing and harvesting operations, has successfully completed the Produce Safety Alliance Grower Training Course and has many years of food facility inspection experience as a Registered Sanitarian and Licensed Environmental Health Professional.
We may begin local test marketing of raw, unprocessed cuttings for consumptive purposes next year but may not be able to ship these to U.S. Mainland destinations because raw Hoodia may be considered a new crop requiring a completion of a comprehensive plant pest and disease risk assessment. If there is sufficient demand for the cuttings we may expand growing operations and conduct microbiological assays of the cuttings to better assess food safety risks and the effectiveness of reduction measures.
Freedom from Adulterants
Most of the adulterated Hoodia products that have been marketed consisted of liquids, pills, dried or powdered materials. If materials derived from Hoodia were present, they were in forms that were unrecognizable and could not be distinguished from adulterants without laboratory analyses. Our first product offerings for consumptive uses will be as raw, unprocessed Hoodia cuttings that are easily identified. Some of our other Hoodia products under development may contain processed Hoodia in forms that are not readily recognizable. Before these are sold methods of confirming the content of Hoodia derived materials in these products will be developed, such as analyses by independent laboratories and issuance of Certificates of Analyses.
Confirmation of Hawaiian Origin and Quality Standards
The origin of our products is confirmed in by highly detailed data submissions and inspections performed by multiple regulatory agencies including the U.S. Fish and Wildlife Service (CITES application and permit), the Hawaii Department of Agriculture (Certified Nursery applications and operations). Additionally, we have made application to the Agricultural Development Division of the HDOA for a license to apply the Hawaii Seal of Quality to our products. Compliance with requirements for using the Seal is confirmed by additional data submissions, reviews of other applicable licenses and onsite inspections.
Launched in May 2006, the Hawaii Seals of Quality represents the cream of the crop of Hawaii’s agricultural producers. It was established to protect the integrity and value of the marketing cachet for Hawaii branded farm and value-added products. Products with this seal are genuine, Hawaii-grown or Hawaii-made premium products, a guarantee that is enforced by the State of Hawaii.
To meet program standards, all fresh agricultural products must be entirely produced in Hawaii and meet applicable food safety requirements.
The program was founded by 12 notable agricultural producers and is supported by many of Hawaii’s most prominent chefs (ADD 2019).
We are pleased to report that we have met all requirements of the program and have received a license from the HDOA Agricultural Development Division to apply the Seal of Quality to our Hawaiian Hoodia™ Products.
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