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 […]
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 […]
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 […]
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 […]
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 […]
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