In a recent opinion, the Federal Trade Commission (“FTC”) affirmed in part and reversed in part an Administrative Law Judge’s decision that Pom Wonderful deceptively advertised its products. According to the Commission, Pom Wonderful did not have sufficient substantiation to support claims the FTC deemed implied that POM’s products could treat, prevent, or reduce the […]
It is a truism that words have multiple meanings. String them together in a sentence and greater opportunity exists for construing them to mean something other than intended by the speaker. Add to that meanings not overtly expressed but interpretable as implied and you can transform an intended meaning into an unintended one with relative […]
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 […]
During the Bush Administration, FDA had an unwritten and informal enforcement policy that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question. That Bush era policy appears […]
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 […]
Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.
11808 Wolf Run Lane
Clifton, VA 20124
Telephone: (202) 466-6937
Telecopier: (202) 466-6938
