Plandai Biotechnology Inc. will not be required to apply to the US Food and Drug Administration for New Dietary Ingredient status in order to market and sell its Phytofare Catechin Complex as a dietary supplement, enabling the firm to start marketing the supplement in the imminent third quarter.
According to a legal opinion issued by food and drug law firm Hyman, Phelps & McNamara, Phytofare Catechin Complex has been present in the food supply without being chemically altered, thus qualifying it for exemption.
"Had we been forced to apply to the FDA, the cost in terms of time, opportunity and hard dollars spent would have been tremendous,” said Plandai’s vice president of sales Callum Baylis-Duffield. “Having a firm with the reputation and standing of Hyman, Phelps & McNamara issue us this opinion gives us ideal positioning within the marketplace and enables our distributors to immediately commence marketing the product in the US and abroad."
The Federal Food, Drug and Cosmetic Act requires that the FDA be notified of the use of any New Dietary Ingredient (NDI) and that the use of such ingredient be approved before the manufacturer begins sales and marketing efforts, unless it meets certain criteria for exemption. The Dietary Supplement Health and Education Act of 1994 exempts certain physical modifications (including those undertaken in Plandai's proprietary extraction and handling process) from consideration as chemical alteration.
Phytofare Catechin Complex, which comprises the entire catechin profile derived from live green tea, is grown and processed in a 30,000 sq. ft. factory on the firm’s Senteeko estate in South Africa. Like its generic counterparts, the dominant catechin found in Phytofare is EGCG (epigallocatechin-3-gallate), which has been extensively tested for potential therapeutic use in a range of applications, including HIV, cancers, malaria, neuro-degradation diseases, skin health , weight loss and anti-aging.
Because Plandai uses live plant material as opposed to dried leaves, the antioxidants and other nutrients are still living and malleable, according to a spokesman.
“We use a hydrodynamic sheering process that rearranges the crystalline structure into an amorphous state. So, the molecule itself is unaltered chemically, but it is altered structurally,” Plandai US representative Shane Traveller told NutraIngredients-USA. “We then use a series of different evaporation and cooling towers to further purify the extract so that we are left with about 90% pure catechins in an amorphous crystalline structure.”
Phytofare supplement has more than double catechins than generic green tea extract: trial
In conjunction with the opinion issuance, Plandai released the test results it received from North-West University in South Africe, which indicate that its Phytofare Catechin Complex contains 2.2 times the amount of catechins by weight compared to generic green tea extracts. Phytofare contained between 80 and 88% catechins by weight, compared to around 40% in the generic samples, according to the results of the study, conducted by Anne Grobler, director of the Preclinical Platform in North-West University’s Department of Pharmacology in Potchefstroom, South Africa.
"While the increased level of catechins should not be confused with increased bioavailability, it does show that our live-plant extraction process is more efficient,” Bayliss-Duffield noted. “Further refinements to the system, as we draw closer to commercial production, should help us push that efficiency even higher towards our goal of 95% catechin purity by weight."
In order to better understand the solubility, absorption and bioavailability of catechins through its proprietary process, the firm is also awaiting the complete results of a three-arm bioavailability study on Phytofare’s cat echins, which will likely be released in early August, Traveller said.
“During our extraction process, we reduce the molecules to nano particles, then these particles reform in an amorphous state, which has considerably higher absorption. Amorphous crystals also have a fairly unstable structure, which is why for many applications we will be entrapping the molecules into a Pheroid delivery system, which is a long-chain fatty acid that protects the molecules through the digestive process and into the bloodstream.”
Phytofare Catechin Complex will price a little under the market for pharmaceutical-grade catechins and a bit higher than generic green tea extract. “However, since we have twice the level of catechins by weight, the price equals out, and that’s before considering purity, effectiveness and bioavailability,” Traveller added.
Elsewhere, Plandai's Phytofare Citrus Complex, a supplement based on citrus bioflavonoids and limonoids, will undergo clinical testing later this year ahead of its anticipated release to market in 2015.