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. […]
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 […]
It is a truism that words have multiple meanings. String them together in a sentence and greater opportunity exists for construing them to mean something other than intended by the speaker. Add to that meanings not overtly expressed but interpretable as implied and you can transform an intended meaning into an unintended one with relative […]
By Lou Caputo Among the so-called winners and losers of Congress’ American Taxpayer Relief Act of 2012 (ATRA), otherwise referred to as the “Fiscal Cliff Bill,” the FDA and other agencies narrowly escaped having their federal allowance trimmed. This comes as welcome news to the agency; however, those who consider the FDA budget currently bloated […]
The FTC is once again intruding into the marketplace by investigating The Vitamin Shoppe’s planned $50 million acquisition of Super Supplements, Inc. The specifics of the investigation are unclear because the FTC does not comment on investigations and Vitamin Shoppe’s brief statement concerning the investigation did not detail the reason for it, but stated that […]
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.
11808 Wolf Run Lane
Clifton, VA 20124
Telephone: (202) 466-6937
Telecopier: (202) 466-6938
