In my last post, I explained the broad regulatory scheme maintained by the Food and Drug Administration and how the agency and the Department of Justice have been increasingly going after corporate executives in companies that have allegedly violated the Food, Drug, and Cosmetic Act (FDCA) and related statutes. That new focus is part of […]
In a recent opinion, the Federal Trade Commission (“FTC”) affirmed in part and reversed in part an Administrative Law Judge’s decision that Pom Wonderful deceptively advertised its products. According to the Commission, Pom Wonderful did not have sufficient substantiation to support claims the FTC deemed implied that POM’s products could treat, prevent, or reduce the […]
If you have had occasion or reason to interact with the FDA, it may come as little surprise that the FDA maintains arguably one of the broadest regulatory schemes in the United States. The Food, Drug, and Cosmetic Act (FDCA) as well as other legislation such as the Food Safety and Modernization Act allocates the […]
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 […]
FDA announced it has received hundreds of public comments on a proposed rule implementing section 4205 of the Patient Protection and Affordable Care Act (“PPACA”). Section 4205 of PPACA requires restaurants and similar retail food establishments that are part of a chain with 20 or more locations to provide calorie and other nutrition information for […]
Today, FDA issued a new final rule amending its regulations on administrative detention as required by the Food Safety Modernization Act (“FSMA”). Under FSMA and the new final rule, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. See 21 U.S.C. § 334(h)(1)(A); 21 […]
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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