From: Dianelstrauss@aol.com Sent: Sunday, August 03, 2003 1:24 PM To: fdadockets@oc.fda.gov Subject: Docket No 96-0417 FDA: I agree with Jonathan Emord's comments regarding Docket No. 96-0417 Good Manufacturing Practice regulations for dietary supplements (see his comments below) By sending this to you I have standing to sue you over the illegal GMP regs you're about to come out with for dietary supplements which will be even more stringent than pharmaceutical GMPs. We have a 80 million dollar family owned business. This business raises animal for the consumption of meet. We are doing everything in our power to be able to switch over to a new system that would eliminate the need for antibiotics and added growth hormones. This is something that every consumer in the US and around the world are demanding! Many NGO's are gaining much support and power to make this mandatory. It will be impossible for us to be able to continue to move our business in this important direction if Docket No. 96-0417 comes about. If we don't move our business in the direction described above the GMOs will put us out of business! You are affecting the health and livelihoods of every American family and farmer. The American farmer can barely make a living now - the only way they can stay afloat is to continue to improve the health of their animals through supplements. I realize you intend to attempt to attack the dietary supplement industry by using site licensing as a weapon the way the TGA did in Australia where they pulled 1600 products off the shelves under false pretenses, but don't even THINK about trying that in America! DSHEA only allows you to come out with FOOD BASED GMPs for dietary supplements, but you're attempting to destroy all the small supplement companies under an avalanche of unnecessary red tape. Emord will be suing to get an injunction in Federal Court to stop you from enforcing an illegal law, so you better pay attention to his comments below and save yourself the humiliation of being sued successfully again. Diane L Strauss Strauss Veal and Lamb International Franklin, WI John C. Hammell, President International Advocates for Health Freedom POB 10632 Blacksburg VA 24062 http://www.emord.com/proposed.htm Before the FOOD AND DRUG ADMINISTRATION Rockville, MD In re: FDA Advance Notice of Proposed ------------) Rule Making, 62 Fed. Reg. 5700 --------------------) (Feb. 6, 1997); Current Good -----------------------) -----Docket No. 96-0417 Manufacturing Practice in Manufacturing ------------ ) Packing, or Holding Dietary Supplements ----------- )