Legal Resume Before the FDA

TO: Steve Wallach, American Longevity
FROM: Emord & Associates, P.C.
RE: Legal Resume Before the FDA
DATE: March 31, 2004

Please find below a 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.

Litigation Against the FDA

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. are co-plaintiffs). The Complaint was filed on February 3, 2004. Plaintiffs challenge 21 U.S.C. § 343-2 as an unconstitutional restraint on speech because it drastically limits the circumstances in which dietary supplement companies can distribute peer-reviewed literature.

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; currently ongoing.

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)(Co-Commenters)(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 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).

2. 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); No Docket Assigned Yet; FDA response on preliminary review due April 30, 2004.

3. 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 allowed by FDA on 9/8/2004.

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.