Manzo Pharmaceuticals Inc. (MNZO)

[Tadaaa]

Biologics was sent this email, Link:,

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=110786680

Biologics referred us to CFSAN, whose response is below:

This message is being sent in response to the following submitted inquiry:


I am inquiring on a business named Manzo Pharmaceuticals, which posted a PR explaining that their patent / product does not require FDA approval for their product is considered a Dietary supplement.

PR and Patent Links Below:

FDA PR,

http://ih.advfn.com/p.php?pid=nmona&article=63951026

Patent Link:

http://manzopharma.com/lacto-relief-for-people-with-la-ctose-intolerance/lacto-relief-patent/

My inquiry is to determine if the PR is accurate. Discussion blogs question the PR, stating it is not considered a Supplement due to the GMO aspects of the Patent, and will require CBER approval.

Who is correct ?

Thank you !!

____________________________________


The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC) has prepared a response for case number XXXXXXXXXXX.


Response:


The FDA regulates a dietary supplement as a food and does not approve it. A dietary supplement is taken by the mouth and contains a dietary ingredient that is intended to supplement the diet. The dietary ingredient can be a vitamin, mineral, herb or other botanical, or amino acid. If the dietary supplement exists in a form that is not taken by the mouth, such as a bar, then the product’s label cannot represent the product as a conventional food or a sole item of a meal or diet. However, the dietary supplement would still fall under the regulations of food and all supplements must be labeled as a dietary supplement.


The FDA’s guidelines and regulations for a dietary supplement product include a company notifying the FDA if it is using a new ingredient in a dietary supplement that has never been used in a dietary supplement product before in the U.S. (http://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm2006898.htm); not using an ingredient in the product that would make it into a drug or make a claim on the label of the product that would make it into a drug; and ensuring that the product is safe for consumers in the U.S. However, the company is not required to have any testing done on the dietary supplement product.


Thank you for contacting FDA’s FCIC.

_____________________________________________


I am of the opinion that Ken Manzo submitted the data, it was reviewed, and it was approved, via email to the link noted above then received a telephone follow-up of the Approval.

JMHO !

GLTA !!