Qualified Health Claims permit nutrient-disease risk reduction claims to be made for dietary supplements without fear of FDA or FTC enforcement. The FDA allows such claims in reliance on its “enforcement discretion,” following submission of a health claim petition. The FDA’s “enforcement discretion” is a euphemism because the agency is constitutionally barred by precedent in […]
At the 30th annual Natural Products Expo West in Anaheim, CA, Whole Foods Market announced that it will require products containing genetically modified ingredients and sold in its U.S. and Canadian stores to be labeled as containing such ingredients by 2018. Whole Foods is requiring GMO labeling in response to its belief that consumers have […]
In 2009, the International Dairy Foods Association (“IDFA”) and the National Milk Producers Federation (“NMPF”) jointly submitted a petition to FDA requesting that the agency amend standard of identity regulations to allow the use of “any safe and suitable” sweetener in optional characterizing flavoring ingredients added to milk (e.g., chocolate flavoring added to milk) and […]
On September 5 and 6, 2014, Emord & Associates will celebrate its 20th Anniversary. This two day spectacular at the scenic Hyatt Regency Resort, Golf Course, and Spa is entitled “Rekindling Liberty’s Sacred Fire”[1] and will be emceed by a Hollywood celebrity and will include prominent speakers, among them: a Fox News Channel show host; […]
Although market leaders in the supplement industry appear to be coping with the present recession, most are experiencing a downturn in sales and a few are doing better than in prior years. The bulk of small to mid-sized companies are struggling, caught in a squeeze between a dramatic reduction in demand and a dramatic increase […]
By Lou Caputo On February 8, 2013, the White House Office of the Press Secretary released a Fact Sheet memorandum entitled “Examples of How the Sequester Would Impact Middle Class Families, Jobs and Economic Security.” The memo offered hypothetical examples of how the automatic budget cuts, known as “sequestration,” could affect various federal agencies, such […]
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 […]
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 […]
Effective today the FDA is implementing the Food Safety Modernization Act registration requirements. Section 102(a) of the FSMA, which created 21 U.S.C. § 350d(a)(3), requires biennial registration renewals beginning October 1st and ending December 1st of each even-numbered year. The FDA’s updated food facility registration system became operational today and, so, FDA is now accepting […]
by Jonathan Emord Link to Press Release Article Through at least gross negligence and, potentially, criminal negligence, Dr. Anthony Fauci; leading U.S. government scientists; Ralph Baric PhD and others at the University of North Carolina; private sector virologists like Peter Daszak at EcoHealth Alliance; officials in the Department of Defense and the Defense Threat Reduction […]
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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