Fwd: The Latest Update on S.510 & S.3002 [on dietary supplements]

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"National Health Federation" <thenhfMarch 17, 2010 2:29:56 PM HST"vivlerner" <vivlernerThe Latest Update on S.510 & S.3002 PRESS RELEASE THE LATEST NEWS ON THE S.510 AND S.3002 ATTACKS ON HEALTH March 17, 2010 There is much confusion and debate swirling around the pending, or near-pending, demise of Senator McCain’s so-called “Dietary Supplement Safety Act of 2010 (S.3002). After Senators John McCain (R-AZ) and Byron Dorgan (D-ND) issued their letter of March 10th, what is clear about the bill’s status is the following:S.3002 will wither on the vine in the Senate.Instead, when the so-called Food Safety Act (S.510) is brought up again in the Senate, there may be a McCain-Dorgan amendment offered to it, which Senators Hatch and Harkin will have to review first.This amendment could be accepted and added by unanimous consent before S.510 is voted upon.If it passes the Senate, then the House and Senate leadership would work out any differences and pass it on to Mr. Obama. The best estimates are that this would not happen until after Congress returns in mid-April 2010.As of today, S.510 is still on the Senate calendar and not scheduled for a vote. On the issues, the following are the important new points:In S.510 as written, registration applies only to food companies, not to supplement manufacturers. So, biennial registration for supplement manufacturing, processing, and holding (technically including MLM marketers) would be added, which would overlap with AER requirements.FDA authority to recall supplements would be granted if found to be adulterated or misbranded for serious adverse event (although the McCain/Dorgan letter says mandatory recall would apply if supplements are either adulterated, misbranded, or cause serious injury or death). This authority already exists under AER law, but the issue here is standards as the current “death clause” requirement limits its range and impact. Issued regulations would clarify this point. As is often the case, getting approval on regulations will take some time. In the bill, the simple change of one connector word could extend this recall power dramatically, so it must be watched carefully.For New Dietary Ingredients (NDIs), the FDA has dragged its feet for ten years in issuing an Industry Guidance on what is and what is not needed when filing. This is hardly a new issue, but the McCain/Dorgan letter wants the Senate to hold the FDA’s feet to the fire until it does issue guidance.McCain and Dorgan would also want to amend S.510 to require mandatory notification by the FDA to the Drug Enforcement Agency on any supplements found to contain synthetic anabolic steroid ingredients. In essence, the compromise substance of the coming McCain/Dorgan/Hatch/Harkin amendment to S.510 is that all of the bad, over-the-top control aspects of Senator Dick Durbin’s S.510 remain, with the compromise heaping upon it even more reasons for us to oppose this bad bill. The Federation has opposed S.510 from the beginning, and this compromise gives us absolutely no reason to change our position. To the contrary, we will have more reasons to oppose this bill if it is amended. Unfortunately, in its belief that S.3002 will be eliminated, the supposedly supplement-friendly trade organization Natural Products Association (NPA) actually supports this compromise! (See http://www.npainfo.org/index.php?src=news & srctype=detail & category=pressreleases10 & refno=243 and http://www.npainfo.org/index.php?src=news & srctype=detail & category=pressreleases10 & refno=243) This is a shortsighted mistake, one all too-often made by spineless trade organizations. As before with S.3002, the compromise wording is redundant and unnecessary. We urge you to contact your Senators and Congressmen and –women to oppose S.510 and its House companion bill, H.R.2749. Above all, keep your eyes on Rep. Waxman, as he is the key here. McCain/Dorgan/Hatch/Harkin Letter of March 10th: Click Here********************Click on this address to find your U.S. Senators: http://www.senate.gov Contact Information to E-mail Senators: http://www.senate.gov/general/contact_information/senators_cfm.cfmThe Senate main number is (202) 224-3121******************Click for complete list of House of Representatives contact info: http://www.theorator.com/government/house.htmlFax List for House of Representatives********************As the oldest and best-respected health-freedom group on Capitol Hill, the NHF continues to be the credible source of objective assessment of, and proactive actions on, Congressional legislation and FDA matters that have material impact upon our freedom-of-health choices and access to dietary supplements and nutritional foods.********************Click here for the permanent link to this press release, use this link to inform others.National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings. www.thenhf.com*************************************P.O. Box 688, Monrovia, CA 91017 USA ~ 1 (626) 357-2181 ~ Fax 1 (626) 303-0642Website: www.thenhf.com E-mail: contact-us@... =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.