Читать книгу Food Regulation - Neal D. Fortin - Страница 289

1 5.9. Significant scientific agreement. In response to the court of appeals holding in Pearson, FDA announced the issuance of GUIDANCE FOR INDUSTRY: SIGNIFICANT SCIENTIFIC AGREEMENT IN THE REVIEW OF HEALTH CLAIMS FOR CONVENTIONAL FOODS AND DIETARY SUPPLEMENTS on Dec. 22, 1999 (64 Fed. Reg. 17494).

2 5.10 Evidence‐based scientific review. While the basic principles of significant scientific agreement have not changed, the above 1999 document was superseded by FDA, GUIDANCE FOR INDUSTRY: EVIDENCE-BASED REVIEW SYSTEM FOR THE SCIENTIFIC EVALUATION OF HEALTH CLAIMS (Jan. 2009) www.fda.gov.

Not everyone agrees with the decision of the U.S. Court of Appeals in Pearson v. Shalala.⁴³ It has been argued that disclaimers thwart the purpose of Congress when it enacted the NLEA to ensure that consumers would no longer be subjected to unreliable and unverifiable health claims for dietary supplements—that disclaimers will relegate consumers to a marketplace rife with unproven and unreliable health claims. It has also been argued that the reasoning of Pearson misconceives basic First Amendment commercial speech principles because the Supreme Court has never directed a government agency to permit potentially misleading speech so long as it is accompanied by a disclaimer.⁴⁴