NDIN - from FDA Website...
<<What happens after I submit a premarket notification for a new dietary ingredient to FDA?
Once you submit a premarket notification for a new dietary ingredient, we will acknowledge its receipt in writing within 75 days after we receive it. We will also notify you of the date it was received, which is the filing date for the premarket notification. For 75 days after the filing date, you cannot market (that is, introduce or deliver for introduction into interstate commerce) the new dietary ingredient or the dietary supplement that contains the new dietary ingredient.
We may contact you again if:
you did not provide all of the information required in the regulations (see 21 CFR §190.6),
we have questions about the information contained in the notification.>>
Now from RCPI August 11 Clinical Update...
<<With regard to the nutritional supplement business, the company filed a New Dietary Ingredient Notification (NDIN) in June 2014 as a measure to address certain provisions in the December 2013 FDA warning letter. Although the company does not believe that an NDIN is a prerequisite to the lawful marketing of the nutritional supplement, the NDIN was voluntarily submitted to provide the FDA with preclinical and clinical data concerning the supplement. In addition, the company is also voluntarily suspending its sale of CigRx® and Anatabloc® until such time as the company can complete its review of the FDA's response to the company's pending NDIN, which has not yet been received, as well as a review of how the nutritional supplement business may affect the company's drug development program. However, the company does anticipate these actions will bring the FDA warning letter matter to a close.>>
I'm guessing that some people were speculating that Anatabloc would be back on the market in 75 days (prospective mid Sep if they filed the NDIN at end of June) based on FDA "75 day rule". But it is hard to tell from RCPI statement whether objections or questions have actually been raised by FDA on the NDIN. It seems to me that RCPI is really telling the FDA to tell us the complete story..aka what is it that you want...and if you prefer that we not have both a neutraceutical AND a new drug, we will opt for having just the new drug. But tell us what you really want to say!!! Comments?
AI
