By Lou Caputo A Ponzi scheme, simply put, is a business model that promises to pay out more money than it takes in. New investors are generally promised a relatively very high return on their investment. The returns, though, are dependent upon the operator/debtor being able to find new sources of income perpetually. This will […]
According to Dr. Daniel Fabricant, Director of FDA’s Division of Dietary Supplement Programs, the agency is going through an evolution concerning its enforcement of dietary supplement good manufacturing practice (“GMP”) violations. Since the dietary supplement GMPs were rolled out five years ago, FDA’s main focus has been on enforcement against basic violations, such as the […]
By Jonathan W. Emord Emord Blog at Emord.com On occasion, when executives of an FDA regulated company face the potential for civil or criminal prosecution, they think members of Congress potential allies. While they are undoubtedly correct that the decision to devote government resources for prosecution is invariably a political one, they are ordinarily […]
By Jonathan W. Emord Emord Blog @ Emord.com Type II errors underlie FTC’s deceptive advertising law. Those same errors cause the FTC to violate the First Amendment in the ordinary course. Getting the FTC to conform to the requirements of the First Amendment requires significant judicial or legislative action. Until the FTC changes, parties […]
In 1999, the United States Court of Appeals for the Sixth Circuit decided United States v. Universal Management Services, 191 F.3d 750, finding that restitution was a proper equitable remedy for a violation of the Food, Drug, and Cosmetic Act, despite the absence of statutory authority. The decision has since been the topic of debate […]
FDA claims to be working on a revised “Draft Guidance: Dietary Supplements: New Dietary Ingredients” (“Draft NDI Guidance”) in light of industry concerns expressed in comments to the agency. It is unknown when a revised draft will be issued by the agency and, if issued, whether it will include any significant changes. In the interim […]
New Practice Areas: White Collar Crime and European Union Law Effective November 1, 2012, the firm is pleased to announce the expansion of its practice to include white collar crime as it pertains to alleged violations of, inter alia, the Food, Drug, and Cosmetic Act, the Postal Service Act, and the False Statements Act, among others, […]
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