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news.Plandaí Biotechnology has announced that it has received a legal opinion from the noted law firm of Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug legal firm in the country, in which it was determined that Plandaí will not be required to apply to the US Food and Drug Administration for approval to market and sell its Phytofare Catechin Complex as a dietary supplement.
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This opinion paves the way for Plandaí to immediately commence sales efforts in the United States.
The Federal Food, Drug and Cosmetic Act requires that the US FDA be notified of the use of any New Dietary Ingredient (NDI) and that the use of such ingredient be approved prior to the commencement of sales and marketing unless the NDI meets certain criteria for exemption.
Phytofare Catechin Complex, as an NDI, qualifies for exemption since it has been present in the food supply without being chemically altered. The Dietary Supplement Health and Education Act of 1994 makes it clear that a number of "physical modifications," such as those undertaken in Plandaí’s extraction and processing, do not constitute "chemical alteration."
Vice President of Sales Callum Baylis-Duffield commented, "As we gear up to commence marketing Phytofare in the coming quarter, qualifying for this exemption is a huge milestone. Had we been forced to apply to the FDA, the cost in terms of time, opportunity and hard dollars spent would have been tremendous. 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."
Plandaí’s first product to market will be Phytofare Catechin Complex, which includes the entire Catechin profile derived from live green tea that is grown and processed on the Company’s 30,000 sq. ft. factory located on its Senteeko estate in South Africa. The company’s Phytofare Citrus Complex, based on citrus bioflavonoids and limonoids, will start undergoing clinical testing later this year in anticipation of a 2015 release.