The FDA and FTC intend to require randomized clinical trials (RCTs) in support of promotional claims for dietary supplements and dietary ingredients. That much is clear. The FTC took that position in the recent POM Wonderful case, and the FDA memorialized that position in its Evidence Based Review System (EBRS). In practice, the FDA will […]
By Jonathan W. Emord Emord Blog at Emord.com In the FDA Modernization Act of 1997 Congress enacted an amendment that would permit health claims to appear on the labels of foods and dietary supplements if those claims were an accurate representation of an authoritative statement made by a scientific body of the United States […]
The U.S. District Court for the District of Columbia previously held that an individual’s own cultured stem cells constituted both a drug under the Food, Drug, and Cosmetic Act (“FDCA”) and a biological product under the Public Health Service Act (“PHSA”) subject to FDA regulation. U.S. v. Regenerative Sciences, LLC, 2012 WL 2989988 at *6 […]
On Monday, December 3, 2012, in a 2-1 decision, the U.S. Court of Appeals for the Second Circuit ruled “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” See United States v. Caronia, — F.3d —, 2012 WL 5992141 (2d […]
By Jonathan W. Emord As Bethany Kennedy explains in her recent post, the Federal Trade Commission’s staff expects advertisers of health benefits to possess competent and reliable scientific evidence in advance of advertising a health benefit claim. In particular, that means an advertiser must have written evidence on hand before advertising. The absence of the […]
In the POM Wonderful case, the FTC ALJ rejected FTC staff demands that certain claims there in issue had to be backed by at least two well-designed clinical trials or they would be deemed deceptive. The issue is before the full Commission and will be decided on January 18, 2013. Even if the full Commission […]
Elaine Watson of Nutraingredients.com interviewed Jonathan Emord concerning a possible legal challenge to California’s Proposition 37 on First Amendment Grounds. Read the full article here: GMO labeling: How vulnerable is Proposition 37 to a legal challenge? Jonathan explained: “The argument would be that proof of harm is lacking and thus that the state lacks a […]
In a 5 to 4 decision the Supreme Court upheld the Federal Patient Protection and Affordable Care Act (PPACA), known to many as “Obamacare.” Somewhat surprising was the Court’s rationale. Leading up to this decision many experts thought Chief Justice Roberts might uphold the law in an effort to overcome public concern for judicial activism. And when […]
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