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news.Plandaí Biotechnology has learned that it qualifies for an exemption that will allow the company to commence sales of its Phytofare Catechin Complex as a dietary supplement without the need to apply to the US Food and Drug Administration (FDA) for approval to market the product.
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The company’s Vice President of Sales Callum Baylis-Duffield said of the exemption, "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."
And, he’s right. The exemption is great news for investors who have been eagerly anticipating Plandaí getting its first product into the market, and now with the third quarter just days away, the company is entering truly exciting times. Plandaí’s long awaited Phytofare Catechin Complex is the realization of a great deal of hard work, planning and company expertise. It is that expertise that has garnered Plandaí the exemption that will save it a lot of time and money.
The product which includes the entire Catechin profile derived from live green tea that is grown and processed on the Company’s 30,000 square foot factory located on its Senteeko estate in South Africa qualifies for the exemption because it has been present in the food supply without being chemically altered — all thanks to Plandaí’s proprietary extraction process.
It is that process that led to the legal opinion letter that the noted law firm of Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug legal firm in the country, delivered stating that Plandaí will not be required to apply to the FDA for approval to market and sell its Phytofare Catechin Complex.
The Dietary Supplement Health and Education Act of 1994 makes it clear that a number of "physical modifications" like those undertaken in Plandaí’s extraction and processing do not constitute "chemical alteration."
Plandaí’s VP of Sales says, "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."