11.08.16
The Council for Responsible Nutrition’s (CRN) Senior Vice President, Scientific & Regulatory Affairs, Douglas “Duffy” MacKay, N.D. submitted comments to the Food and Drug Administration (FDA) regarding its recent motion to ban the dietary ingredient vinpocetine.
In the letter to FDA, Dr. MacKay stated: “Such a reversal on the status of a dietary ingredient is inappropriate when, as here, there are no safety concerns. Further, it is an unprecedented move by FDA that threatens to undermine the dietary supplement industry’s confidence in the NDI notification process. The notice is also legally deficient because it fails to acknowledge FDA’s prior position on vinpocetine, to explain adequately its new position, or to assess the economic impact of its new position on companies that have invested in the market development of vinpocetine over the past 19 years.”
CRN’s comments do not address the substance of FDA’s claims about the manufacture of vinpocetine or the previous investigational study of this ingredient; but rather focus on “the process FDA has set in motion for vinpocetine, and the dangerous precedent it would set.”
For CRN’s full letter to FDA, visit: http://crnusa.org/pdfs/CRN_Comment_Status_Vinpocetine_110716.pdf
In the letter to FDA, Dr. MacKay stated: “Such a reversal on the status of a dietary ingredient is inappropriate when, as here, there are no safety concerns. Further, it is an unprecedented move by FDA that threatens to undermine the dietary supplement industry’s confidence in the NDI notification process. The notice is also legally deficient because it fails to acknowledge FDA’s prior position on vinpocetine, to explain adequately its new position, or to assess the economic impact of its new position on companies that have invested in the market development of vinpocetine over the past 19 years.”
CRN’s comments do not address the substance of FDA’s claims about the manufacture of vinpocetine or the previous investigational study of this ingredient; but rather focus on “the process FDA has set in motion for vinpocetine, and the dangerous precedent it would set.”
For CRN’s full letter to FDA, visit: http://crnusa.org/pdfs/CRN_Comment_Status_Vinpocetine_110716.pdf