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 FTC is once again intruding into the marketplace by investigating The Vitamin Shoppe’s planned $50 million acquisition of Super Supplements, Inc. The specifics of the investigation are unclear because the FTC does not comment on investigations and Vitamin Shoppe’s brief statement concerning the investigation did not detail the reason for it, but stated that […]
FDA recommends that dietary supplement manufacturers and distributors voluntarily consult with it concerning the safety of supplements containing high amounts of new dietary ingredients (“NDIs”) that are approved direct food additives or GRAS. An NDI notification must be submitted to FDA at least 75 days before selling a dietary supplement if the dietary supplement contains […]
By Jonathan W. Emord Under the Budget Control Act of 2011, Congress must either agree to spending cuts or a 7.8% across-the-board cut will be imposed on all federal agencies. With the White House and Congressional Republicans at an impasse, those automatic cuts appear likely. For the FDA, that means a reduction in about $68 […]
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 […]
Today, FDA published a notice in the Federal Register informing the public that it is requesting comments and information on conducting a risk assessment to establish regulatory thresholds for major food allergens. 77 Fed. Reg. 74485 (Dec. 14, 2012). Comments must be submitted by February 12, 2013. The Food Allergen Labeling and Consumer Protection Act […]
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 […]
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