Comment on FR Doc # 2011-29857

Dec 1, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Draft Guidance for Industry; Dietary Supplements New Dietary Ingredient Notifications and Related Issues (FDA Docket No: 2011-D-0376) Dear Sir or Madam: I submit the following comments to the Record on FDA Docket No: 2011-D-0376. While Congress asked that the FDA clarify the existing New Dietary Ingredient (NDI) regulation established in 1997 as a result of the 1994 Dietary Supplement Health and Education Act (DSHEA), the draft Guide Document is fatally flawed and needs to be retracted in its entirety. This guidance document if finalized as written will have a number of far-reaching effects on industry and the marketplace. Consumers, like my family, and me are not well served by the resulting higher prices and reduction in some products in the market that surely will follow if industry is forced to comply with these overburdened proposed procedures. As such, I call for the FDA to retract this draft NDI Guidance document in its entirety and craft a simpler, more appropriate guidance document in coordination with the industry and interested citizens.