Virginia (202) 466-6937 | Arizona (602) 388-8899

FDA’s New Suspension Authority Under FSMA Supplants Adulteration Standards in Section 342(f)

On November 26, 2012, the FDA suspended Sunland, Inc.’s food facility registration.  Sunland is the nation’s largest producer of organic peanut butter.  The FDA acted under the Food Safety Modernization Act’s (FSMA’s) new suspension/revocation authority contained in Section 415(b) of the Federal Food, Drug, and Cosmetic Act (FDCA).  FDA discovered salmonella contamination in Sunland’s operation […]

Second Circuit Invalidates FDA Regulation of Drug Advertising on First Amendment Grounds in Landmark Decision that Portends Far Reaching Effects

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 […]

FTC Burden of Proof Offends the First Amendment

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 […]

FTC Staff’s Two Clinical Trials Standard Likely to Continue Even if POM Wins

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 […]


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Virginia (Firm HQ)

11808 Wolf Run Lane
Clifton, VA 20124
Telephone: (202) 466-6937
Telecopier: (202) 466-6938

Arizona

2730 S. Val. Vista Dr.
Bldg. 6, Ste 133
Gilbert, AZ 85295
Telephone: (602) 388-8899
Telecopier: (602) 393-4361