Here are those articles. The first…
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, Jun 18, 2014 (Marketwired via COMTEX) — Plandai 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 Plandai will not be required to apply to the US Food and Drug Administration for approval to market and sell its Phytofare(TM) Catechin Complex as a dietary supplement. This opinion paves the way for Plandai 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(TM) 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 Plandai’s extraction and processing, do not constitute “chemical alteration.” (More on the wire.)