May 11, 2015Posted on
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FDA Health Claims

Legal Resume as of December 10, 2012
Please find below a list of matters before the Food and Drug Administration (FDA) in which Youngevity (formerly 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:

  1. Alliance for Natural Health U.S. v. Sebelius, 714 F.Supp.2d 48 (D.D.C. 2010) (ANH I): After petitioning the FDA for site specific cancer claims for selenium in April of 2008, the FDA denied the claims or severely restricted them with lengthy disclaimers. A suit was filed in D.C. District Court challenging the FDA’s decision. On May 27, 2010, Judge Ellen Segal Huvelle ruled that FDA censorship of four selenium-cancer site specific qualified health claims violated the First Amendment commercial speech standard.She also held FDA allowance of a fifth claim accompanied by a long, contradictory qualification also violated the First Amendment commercial speech standard.She remanded the claims to FDA, requiring the agency to re-evaluate them consistent with First Amendment requirements. After further review and settlement discussions the FDA agreed to allow the following qualified selenium health claims:

Prostate Cancer Claim
“Selenium may reduce the risk of prostate cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of prostate cancer.”
Colon Cancer Claim
“Selenium may reduce the risk of colon cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of colon cancer.”
Certain Cancers Claim and Anticarcinogenic Effects Claim
“Selenium may reduce the risk of bladder, colon, prostate, rectal, and thyroid cancers. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers.”

  1. Alliance for Natural Health U.S. v. Sebelius, 786 F.Supp.2d 1 (D.D.C. 2011) (ANH II): After petitioning the FDA for site specific cancer claims for selenium in April of 2008, the FDA denied the claims or severely restricted them with lengthy disclaimers. A suit was filed in D.C. District Court challenging the FDA’s decision. On April 13, 2011, Judge Beryl A. Howell, Jr. renewed the Court’s findings from ANH I, finding FDA’s proposed disclaimer language was not a “ ‘reasonable fit between the government’s goal and the restrictions it imposes on commercial speech.’ ” The Court then remanded the claims to the FDA for the purpose of drafting appropriate disclaimers. Settlement discussions are ongoing with the FDA.
  1. Wallach v. FDA, Case No. 04 CV 0216BTM, U.S. District Court for the Southern District of California (Dr. Wallach and Youngevity [formerly 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.
  1. 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.
  1. 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.
  1. 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 qualified health claims: selenium and the reduction in the risk of site-specific cancers (Co-Petitioner); Docket No. FDA-2008-Q-0323; filed on April 24, 2008; See below Alliance for Natural Health U.S. v. Sebelius, 714 F.Supp.2d 48 (D.D.C. 2010) (ANH I).
  2. Petition for qualified health claims: antioxidant vitamins c and e and reduction in the risk of site-specific cancers (Co-Petitioner); Docket No. FDA-2008-Q-0299; filed on April 9, 2008; See below Alliance for Natural Health US v. Sebelius, Case No. 09-1546 (D.D.C.) (ANH II).
  3. 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).
  4. 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.
  5. 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.
  6. 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.