The American Conference Institute’s 4th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements will be presented in collaboration with the Council for Responsible Nutrition, and is scheduled for June 27-28 in New York. The Forum will feature presentations on policy initiatives, federal and state …
By Ricardo Carvajal – The would-be marketer of a probiotic suppository submitted a citizen petition (Docket No. FDA-2016-P-1133) to FDA asking the agency to “amend the definition of dietary supplement under the present statutory authority [of DSHEA] and to treat probiotic suppositories the same as oral probiotic …
By Jenifer R. Stach & Wes Siegner – If you weren’t aware that the Department of Justice (DOJ) has unsafe dietary supplements on its list of enforcement priorities, you should take notice. On Tuesday March 8th, 2016 as part of National Consumer Protection Week, United States Attorney …
By Ricardo Carvajal – FDA announced the seizure of dietary supplements purportedly containing kratom, which the agency describes as “a botanical substance that could pose a risk to public health and have the potential for abuse.” The seizure followed on the heels of an administrative detention – a …
By Riëtte van Laack – As we previously reported, POM Wonderful (“POM”) petitioned the U.S. Court of Appeals for the D.C. Circuit for en banc review of that Court’s earlier decision which had largely upheld the FTC’s cease and desist order issued against POM. That petition was …
By James R. Phelps & Wes Siegner – “Bad reactions to dietary supplements are sending thousands of Americans to the ER every year, a new study shows.” That’s the attention-getting lead in a CBS News story dated October 15. It was based on a study report …
By Jennifer M. Thomas – On October 1, 2015, the U.S. District Court for the District of New Jersey unsealed its opinion in United States v. Bayer Corp., No. 07-cv-00001 (D.N.J. Sept. 24, 2015), confirming a significant defeat for the government, and a clear victory for …
By Riëtte van Laack – On July 30, FDA announced the publication of a draft guidance titled “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels”. The draft guidance addresses an apparent conflict between FDA’s compliance guidelines and FDA’s rounding rules for nutrition …
By Wes Siegner – In 2005, FDA published a Dietary Supplement Labeling Guide that, among other things, provided guidance on whether the words “Dietary Supplement” by themselves satisfied the requirement that the front panel of all dietary supplement products include a statement of identity. FDA’s answer? …
By Riëtte van Laack – The Court of Appeals for the Eleventh Circuit overturned a contempt order against Hi-Tech, Jared Wheat, Stephen Smith, and Dr. Terrill Mark Wright (“Hi-Tech”) because, according to the Court, the order was incorrectly premised on collateral estoppel. As we discussed in a …
By John R. Fleder & Riëtte van Laack – On Friday, January 30, almost nine months after the oral argument, the U.S. Court of Appeals for the D.C. Circuit issued its Opinion in POM Wonderful Inc. v. FTC. We have previously blogged on this case (see …
By Riëtte van Laack – According to an FTC Complaint, filed in the United States District Court for the Northern District of Illinois, the advertising practices of NourishLife, an Illinois Company, and its owner, Mark Nottili, (“Defendants”) violated the FTC Act. The FTC alleges that Defendants …
By Wes Siegner – In an exercise in hairsplitting, FDA’s Mike Taylor has written to Herbalife to complain about a YouTube video, in which a former FDA official now working for Herbalife, Bill Frankos, allegedly (the video has been removed at FDA’s request) states the following: …
By Jennifer M. Thomas – Last month, the U.S. District Court for the District of Utah dealt a significant blow to the Federal Trade Commission (“FTC”) when it denied FTC’s motion summary judgment in a case against Basic Research, LLC (“Basic Research”). The Court’s decision marks …
By Riëtte van Laack – On Nov. 13, 2014, DOJ announced another Consent Decree of permanent injunction regarding the manufacture and distribution of dietary supplements. Under the Consent Decree, contract manufacturer SciLabs, Inc. and its CEO Paul Edalat are prohibited from the manufacture and distribution of dietary …
