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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
If you ask a consumer what makes a dietary supplement adulterated, he or she will say that it contains an ingredient or contaminant that makes it unfit for human consumption. That is, of course, the logical and historically plain meaning of the term adulteration, but that is not the meaning of adulteration FDA gives to […]
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