FDA Exemption Has Plandai Biotechnology Heading Into Third Quarter Ready to Commence Sales of First Phytofare(TM) Product
26 June 2014 - 11:00PM
Marketwired
FDA Exemption Has Plandai Biotechnology Heading Into Third Quarter
Ready to Commence Sales of First Phytofare(TM) Product
NEW YORK, NY--(Marketwired - Jun 26, 2014) - Plandaí
Biotechnology (OTCQB: PLPL) recently 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.
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."
About Stock Market Media Group SMMG is a Research and Content
Development IR firm offering a platform for corporate stories to
unfold in the media with Reports, Interviews and Articles. SMMG is
compensated for Plandaí content by a third party who reserves the
right to buy, sell or remain neutral on securities after the
publication of this article. To date, SMMG has received total
compensation of $52,670 for content related to Plandaí. For more
information: www.stockmarketmediagroup.com.
Contact: Stock Market Media Group Email Contact
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