FEDERAL COURT KICKS FDA IN TEETH ON THIRD PARTY LITERATURE!
EMORD & ASSOCIATES P.C.
1050 SEVENTEENTH STREET, N.W.
SUITE 600
WASHINGTON, D.C. 20036
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PHONE: (202) 466-6937 ● FAX: (202) 466-6938
WEB SITE: www.emord.com
E-MAIL: aferrenz@emord.com
MEMORANDUM
TO:
Steve Wallach, American Longevity
FROM:Emord & Associates, P.C.
RE: Legal Resume Before the FDA
DATE:April 18, 2005
_________________________________________________________________________________________________
Please find below an updated list of matters before the Food and Drug Administration (FDA) in which American Longevity participated. The pending nature or resolution of each issue is noted. Matters are in reverse chronological order with the currently active matters in each category listed first. Items 1 and 2 under Litigation and item 2 under Petitions were updated in this memo.
Litigation Against the FDA Editor's note: The FDA Won this case, but if you read the red highlights below they lost! Great going for getting the truth out about nutritionals!
1.Wallach v. FDA, Case No. 04 CV 0216BTM, U.S. District Court for the Southern District of California (Dr.Wallach and
American Longevity, Inc. were co-plaintiffs). Court decision issued March 29, 2005 in favor of the FDA, finding that
the restrictions of 21 U.S.C. § 343-2(a) (distribution of scientific literature in connection with the sale of dietary
supplements) was not an unconstitutional restriction on speech. However, the Court rejected FDA’s argument that
Wallach and American Longevity lacked standing, stating that “the chilling effect on [their] speech here is obvious.” The Court accepted Wallach and American Longevity’s argument that if the statutory exemption is satisfied, FDA cannot use its intended use policy to block the dissemination of scientific literature containing health claims and drug claims.
The Court also accepted Wallach and American Longevity’s argument that literature of this kind is not n inherently misleading and any restriction upon it must be evaluated under all prongs of the test for evaluating commercial speech (Central Hudson) but decided that the statute was constitutional under that test. The Court additionally accepted Wallach and American Longevity’s arguments that disclaimers were effective means to satisfy the statutory requirements and rejected FDA’s contrary argument.
2.CSPI v. Thompson, Case No. 03-1962 (RBW), U.S. District Court for D.C.. (Co-Intervenor/Defendant) Special
interest groups challenge qualified claims process and application to conventional foods. American Longevity joined
others and intervened to defend the right to make qualified health claims consistent with the U.S. Court of Appeals’
decision in Pearson v. Shalala. The Court rejected the plaintiffs’ claim stating that the groups lacked standing to sue
because they lacked an injury and could not point to a food label that was inaccurate or misleading.
3.Whitaker et al v. Thompson, 248 F.Supp.2d 1 (D.D.C. 2002). (Co-Plaintiff) Court granted Plaintiffs’ Motion for
Preliminary Injunction barring FDA suppression of Antioxidants Health Claim.
4.Thompson v. Western States Medical Center, 535 U.S. 357 (2002). (Co-Amicus) U.S. Supreme Court upheld lower
courts’ decision that Congress’ ban on the advertising of compounded drugs violated the First Amendment.
Comments Filed To the FDA
1.Comments on FDA’s Advance Notice of Proposed Rulemaking’s (ANPR’s) alternatives for regulating qualified health
claims in the labeling of conventional human foods and dietary supplement (filed February 20, 2004)(CoCommenters)
(Docket No. 2003N-0496. ANPR is tied to the CSPI case listed in previous section. No FDA activity on ANPR.
2.Comments on Task Force for Consumer Health Information for Better Nutrition (Co-Commenter); Docket No.
03N-0069; filed on 7/9/2003; no FDA activity on matter.
3.Reply Comments on First Amendment Issues (Co-Commenter); Docket No. 02N-0209; filed on 10/25/2002; no
FDA activity on matter.
4.Comments on First Amendment Issues (Co-Commenter); Docket No. 02N-0209; filed 9/12/2002; no FDA activity on
matter.
5.Comments on Guidance on Applying the Structure/Function Rule (Co-Commenter); Docket No. 01D-0058; filed on
5/23/2001; no FDA activity on matter.
Petitions Filed with the FDA
1.Petition for Amended Health Claim: Omega-3 Fatty Acids and Coronary Heart Disease (Co-Petitioner); Docket No.
03Q-0401; filed on 6/23/2003; qualified claim permitted by FDA on 9/8/2004.
2.Petition for the Modification of Disease Connotations 21 C.F.R. § 101.93 to Include Structure/Function Claims with
Disclaimers that Eliminate Perceived Disease Connotations (submitted March 16, 2004)(Sole Petitioner).
3.Petition for Health Claims: Lycopene and Tomato-based foods containing Lycopene and Reduction in the Risk of
Certain Cancers (Sole Petitioner)(filed 1/21/2004); Docket No.2004Q-0210; FDA decision due on 6/13/2005 (third
extension from original due date of December 24, 2004).
4.Petition for Health Claims: Selenium and Reduction in the Risk of Certain Cancers and Selenium and
Anticarcinogenic Effects (Sole Petitioner); Docket No. 02P-0457; filed on 7/10/2002; qualified claims approved by
FDA on 4/28/2003.
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