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 […]
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 […]
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 […]
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 […]
The Affordable Care Act contains a provision that imposes a 2.3% excise tax, effective January 1, 2013, on the total revenues, not net profits, of all medical device manufacturers in the United States. The excise tax will force many device companies to go out of business or go off shore. For all others, it will […]
The pyridoxamine example, well explained by Bethany in her blog post, proves the inherent pitfalls in 21 USC 321(ff)(3)(A)-(B). As we have seen, the new interpretation given by FDA to the term “New Dietary Ingredient,” the FDA’s redefinition of adulteration standards through its Good Manufacturing Practice Guidelines, and the changes effected by the Food Safety […]
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 […]
Foreign pharmaceuticals, active pharmaceutical ingredients (APIs), and other regulated drug products are more accessible than ever before. The internet fosters direct transactions between consumers and foreign retailers. Many physicians and practitioners purchase products from foreign sources in their routine practice. But certain drug products may not be “approved” for sale in the United States market. […]
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