FDA requested from Congress a budget of $4.7 billion for fiscal year (“FY”) 2014, which covers the period from October 1, 2013 through September 30, 2014. That amount represents an increase of $200 million from the $4.5 billion requested for FY 2013. According to FDA Commissioner Margaret Hamburg, M.D., FDA requires a larger budget because […]
Dietary supplement companies should police their social media pages for disease claims from consumers and review how their website search fields operate to reduce the risk that FDA will regulate their products as drugs. As noted in a story by the Alliance for Natural Health, FDA recently issued two warning letters to companies based upon […]
Senator Dick Durbin (D-IL) plans to reintroduce a disastrous bill called the Dietary Supplement Labeling Act, which is aimed at further regulating the dietary supplement industry. The bill was originally introduced in 2011 as S. 1310. The bill requires food facilities that manufacture dietary supplements to submit the following information when registering with the FDA […]
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 […]
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 […]
In an excellent piece by Shane Starling in today’s Nutraingredients.com, Shane explains the debate now raging in the UK over the 2002 EU Food Supplements Directive provision requiring the setting of maximum permitted levels for nutrients in food supplements. He explains that an estimated 700 health food stores and 4000 jobs would be lost throughout […]
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 […]
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