By Riëtte van Laack – Approximately three years ago, the Federal Trade Commission ("FTC") filed a complaint against Daniel Chapter One and James Fijio (“DCO”) for the advertising of four dietary supplements as cures for various cancers. The FTC ruled that DCO’s claims were deceptive and …
By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. ("Matrixx") for allegedly violating § 10(b) of the Securities Exchange Act and Exchange Commission Rule 10b-5. As …
By Ricardo Carvajal – FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that asked the agency to issue a regulation under FDC Act § 201(ff)(3)(B) or § 301(ll) acknowledging that marketing of homotaurine as a dietary ingredient in dietary supplements …
By Ricardo Carvajal & Wes Siegner – As we would wager is true of all major pieces of legislation, the Food Safety Modernization Act (“FSMA”) can be expected to have significant unanticipated consequences. By way of background, the FSMA requires all food facilities subject to registration …
By Ricardo Carvajal – The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) is presenting its First Annual Workshop on Food and Supplements on February 17 in Atlanta. Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be …
By Riëtte van Laack – In a short, unpublished decision issued on December 10, 2010, the D.C. Circuit denied a petition filed by Daniel Chapter One and James Fejio (“DCO”) seeking review of an FTC cease and desist order. The FTC Order, issued in 2009, concluded …
By Riëtte van Laack – Direct Marketing Concepts, Inc. (“DMC”) and other companies and individuals marketed Coral Calcium and Supreme Greens by producing and distributing infomercials claiming that these products were an effective cure against many diseases including heart disease, cancer, lupus, etc. The district court …
By Susan J. Matthees – Two consumers, a resident of Florida and a resident of New Jersey, have filed a putative class action against Basic Research LLC, Carter-Reed Company, LLC, Dennis Gay, Daniel Mowrey, and Mitchell Friedlander, alleging that Defendants made false and deceptive claims about …
By Dara Katcher Levy & Diane B. McColl - Last week, FDA issued a draft guidance intended to assist sponsors and investigators with decisions as to whether human research studies can be conducted on products without an investigational new drug application ("IND"). The draft guidance explains …
By Ricardo Carvajal – Last October, we noted that FDA and FTC issued a joint warning letter to an internet marketer of a dietary supplement promoted as helpful in preventing swine flu, seasonal flu, and colds. That letter was one of several that targeted similar products …
By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous post here), the Agency filed a Complaint against POM, its sister corporation Roll International Corp. and …
By Riëtte van Laack & Wes Siegner – In recent consent decrees against Nestle, discussed here, and Iovate, discussed here, the Federal Trade Commission (“FTC”) appeared to be tightening its substantiation standard, prohibiting future claims for defendants’ food and dietary supplements unless they are supported by …
By Ricardo Carvajal – Section 10(b) of the Exchange Act and Securities and Exchange Commission (“SEC”) Rule 10b-5 prohibits “any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person, in connection with the purchase or …
By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) held a press conference in Chicago to announce a lawsuit against several companies, including Central Coast Nutraceuticals, iLife, Simply Naturals, Fit for Life, and Health and Beauty, for their marketing of acai berry weight-loss …
By Ricardo Carvajal – Late on August 12th, the U.S. Senate Committee on Health, Education, Labor, and Pensions (“HELP”) announced the release its 225-page compromise agreement of the Food Safety Modernization Act (S. 510). The Congressional Budget Office simultaneously released its estimate of the bill, …
