Individuals wanting to add a new substance to a conventional food have two options for achieving regulatory compliance. They can either submit a food additive petition to FDA or notify FDA of their determination that the substance is generally recognized as safe (“GRAS”). Under FDA’s food additive regulations, food additives require premarket approval. A “food […]
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 […]
A dietary supplement distributor that uses a contract manufacturer to make its dietary supplement can be held liable for the contract manufacturer’s failure to comply with current good manufacturing practices (“CGMPs”). Accordingly, distributors should ensure that their contract manufacturers follow CGMPs. According to the CGMP final rule, a company must only “comply with the CGMP […]
By Jonathan W. Emord When the Federal Trade Commission commences a non-public investigation of a company it suspects of deceptive health benefit advertising, it oftentimes resorts to use of a civil investigative demand, which is an administrative subpoena. The Supreme Court has upheld sweeping use of investigative powers by the federal government prior to the […]
One of the cases the U.S. Supreme Court will decide next year is the David and Goliath like suit between an Indiana soy bean farmer, Vernon Bowman, and Monsanto Co., the producer of seeds that are genetically engineered to be resistant to glyphosate based herbicides, including Monsanto’s Roundup. Farmers that plant Roundup Ready® crops can […]
We received word today that the President of Emord & Associates, Jonathan W. Emord, has been nominated for the prestigious 2012 WEGO Health Activist Award. Many of you are aware of his achievements for health freedom. You may not know that in addition to defeating FDA censorship on health claims 8 times in federal court, […]
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 […]
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.
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