Plandai Biotechnology, Inc. Announces Phytofare(TM) Catechin Complex Can Be Used as a Dietary Supplement Without Prior FDA No...
June 18 2014 - 8:55AM
Marketwired
Plandai Biotechnology, Inc. Announces Phytofare(TM) Catechin
Complex Can Be Used as a Dietary Supplement Without Prior FDA
Notification or Approval
Legal Opinion Regarding New Dietary Ingredients Determines That
Phytofare(TM) Qualifies for Exemption
SEATTLE, WA--(Marketwired - Jun 18, 2014) - Plandaí
Biotechnology, Inc. (OTCQB: PLPL), a producer of highly
bioavailable plant extracts for industries including health,
wellness, nutriceutical, and pharmaceutical, today 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. 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.
About Plandaí Biotechnology, Inc.
Plandaí Biotechnology, Inc. and its subsidiaries develop highly
bioavailable, phytonutrient rich extracts which are being utilized
to deliver a new family of drugs to safely and affordably treat a
multitude of diseases and conditions. Plandaí Biotechnology
controls every aspect of the process, from growing the raw
materials on its farms in South Africa, to producing its patented
Phytofare™ extracts in-house, allowing the Company to guarantee the
continuity of supply as well as quality control throughout the
entire process. Targeted industries for the Company's products
include beverage, cosmeceutical, wellness, nutriceutical,
anti-aging, and pharmaceutical. For more information, please visit
http://www.plandaibiotech.com.
Safe Harbor Statement
The information provided may contain forward-looking statements
and involve risks and uncertainties. Results, events and
performances could vary from those contemplated. These statements
involve risks and uncertainties which may cause actual results,
expressed or implied, to differ from predicted outcomes. Risks and
uncertainties include product demand, market competition, and
Plandaí's ability to meet current or future plans. Investors should
study and understand all risks before making an investment
decision. Readers are recommended not to place undue reliance on
forward-looking statements or information. Plandaí is not obliged
to publicly release revisions to any forward-looking statement, to
reflect events or circumstances afterward, or to disclose
unanticipated occurrences, except as required under applicable
laws.
Contact: Andrew Beyer Phone: 619-202-7456 Email:
investor@Plandaíbiotech.com
Plandai Biotechnology (PK) (USOTC:PLPL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Plandai Biotechnology (PK) (USOTC:PLPL)
Historical Stock Chart
From Apr 2023 to Apr 2024