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 […]
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; […]
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 […]
Opting-out of Medicare Part B gives physicians greater control over the prices for their services. But, if it is not done correctly, there are serious consequences. Regardless of whether or not a physician is a participating provider in the Medicare program, he or she must submit claims to Medicare for items and services he or […]
FDA has taken a relatively hands off approach to pharmacy compounding in the past, but that may all change after steroid injections from the New England Compounding Center resulted in a deadly fungal meningitis outbreak. Under FDA’s tiered regulatory approach concerning pharmacy compounding, state boards of pharmacy regulate traditional compounding and FDA regulates nontraditional compounding. […]
There are two types of product recalls: mandatory and voluntary. Prior to the Food Safety Modernization Act (“FSMA”), FDA did not possess mandatory recall powers with respect to foods, excluding infant formula. Rather, the agency was limited to requesting that a firm voluntarily initiate a recall, which it usually reserved for urgent situations. If the […]
When evaluating whether an ingredient can be used in a dietary supplement, one must assess not only whether the ingredient is a new dietary ingredient (“NDI”), i.e., “a dietary ingredient that was not marketed in the United States before October 15, 1994,” 21 U.S.C. § 350b(d), but also whether prior to its sale as a dietary […]
On January 4, 2013, FDA proposed the two new regulations implementing the FDA Food Safety Modernization Act (“FSMA”) that are aimed at preventing foodborne illness. The first proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food,” would revise FDA’s CGMP regulations. It would require foreign and domestic food […]
Walk into any mainstream pet store and it is evident that the pet supplement industry is booming. Pet store shelves are packed with animal counterparts to human supplements, such as joint health supplements for cats and dogs. Because of the prevalence of such products, one would never guess that FDA does not recognize dietary supplements […]
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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