FDA breaks promise - sends out NDI warning letters

FDA had promised to wait until the investigation was final before enforcing any NDI guidelines, BUT on April 24 they sent out warning letters to 10 companies!  They have 15 business days to respond.  Here's an update on several articles covering it:

http://www.anh-usa.org/fda-breaks-promise-on-proposed-new-supplement-rules/ "FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise."

http://www.naturalproductsinsider.com/news/2012/04/fda-warns-dmaa-marketers.aspx "FDA has not issued a final guidance of for NDIs, but these warning letters show the agency is not putting NDIs on hold while it reviews the 7,000 comments, which totaled 150,000 pages...'It's a little surprising that FDA made NDI a one of the points in light of the fact that they are still pouring through the comments,' Prochnow said. 'That being said, Dan Fabricant and the rest of FDA have not backed off the fact that they believe companies should be filing NDI notifications.'"

http://blog.usfoodsafety.com/2012/04/30/fda-cites-10-dietary-supplement-companies-for-dmaa-use/  "FDA issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA...Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a 'natural' stimulant."

Updated: FDA cracks down on DMAA - but this is just the start, not the end, of the debate, predicts CRN   It’s official, says the FDA. “Synthetically-produced DMAA (1,3-Dimethylamylamine) is not a dietary ingredient and is not, therefore, eligible to be used as an active ingredient in dietary supplements”. Read more here:  http://www.nutraingredients-usa.com/Regulation/Updated-FDA-cracks-down-on-DMAA-but-this-is-just-the-start-not-the-end-of-the-debate-predicts-CRN

http://www.naturalproductsinsider.com/news/2012/05/ahpa-fda-wrong-about-synthetic-botanicals.aspx  "But if the language of the warning letters is read carefully, it appears that the agency does leave room for a synthetic constituent of a botanical to be included as a 'dietary substance for use by man,' so long as that synthetic constituent is 'commonly used as a food or drink' (examples might be synthetic caffeine, or synthetic lycopene)."