Comments to FDA on Regulatory Status of Vinpocetine

Michael Harless Administrative Law, Health Law

Today our firm filed comments with the FDA in response to a request for comment on its “tentative conclusion” that the ingredient vinpocetine does not meet the definition of a “dietary supplement.” Our comments explained that vinpocetine fits within the definition of “dietary supplement” as a “constituent of a botanical.” Then we analyzed the four statutory requirements for removal of a dietary supplement from the market, and in this case, at least two of these requirements have not been met. Finally, we addressed the ways in which vinpocetine has been beneficial to Americans with a wide variety of health problems, including symptoms of Alzheimer’s.

Read More

Comments filed with FDA to Defend Compounding Pharmacists

Michael Harless Administrative Law, Health Law

An FDA Advisory Committee is considering imposing new and unnecessary limitations on what Compounding Pharmacists may use to create products that are needed by many people, especially seniors.  Remarkably, the FDA Advisory Committee is reported to have only one member who has experience with Compounding.  We filed comments for The Senior Citizens League and the Center for Medical Freedom with the FDA opposing these arbitrary limitations.

Read More

Book: ‘Defining Drugs: How Government Became the Arbiter of Pharmaceutical Fact”

Michael Harless Administrative Law, Health Law, Publications

Bill Olson was honored to write the Foreword for the re-issuance of what may prove to be the most important book ever written questioning the authority of the federal government over the sale and use of pharmaceuticals.  Professor of Pharmacy Richard Henry Parrish II originally wrote his book, “Defining Drugs:  How Government Became the Arbiter of Pharmaceutical Fact” in 2003. Now issued in paperback with a new Introduction and new Foreword, Professor Parrish has charted the growing evidence of corruption in the FDA and FTC, and those agencies’ lawless assertion of power over all aspects of all substances and devices in any way related to healthcare.  This book is even more important now than when first written.

Read More

Dept. of Health and Human Services, et al. v. State of Florida, et al. (Obamacare), Amicus Brief for Virginia Delegate Bob Marshall et al. in the U.S. Supreme Court

Michael Harless Health Law, U. S. Supreme Court

Today our firm filed an amicus brief in the case of Dept. of Health and Human Services, et al. v. State of Florida, et al.(Obamacare) in the United States Supreme Court in support of respondents (minimum coverage provision). The brief asked the Court to overturn two of its most extreme, and controversial, Commerce Clause holdings:

Read More

Virginia v. Sebelius, Amicus Brief for Virginia Delegate Bob Marshall et al. in the U.S. Supreme Court

Michael Harless Constitutional Law, Health Law, U. S. Supreme Court

Today our firm filed an amicus brief in the case of Virginia v. Kathleen Sebelius in the United States Supreme Court in support of petitioner. This petition presents to the Supreme Court a clash between a federal law mandating the individual purchase of its approved healthcare insurance — the Patient Protection and Affordable Care Act (“PPACA”) — and a state law securing to state residents the freedom to choose whether or not to purchase such insurance — the Virginia Health Care Freedom Act (“VHCFA”).

Read More

Daniel Chapter One v. Federal Trade Commission, Amicus Brief in the U.S. Supreme Court

Michael Harless Health Law, U. S. Supreme Court

Today our firm filed an amicus brief in the case of Daniel Chapter One, et al. v. Federal Trade Commission in the United States Supreme Court in support of petitioners’ petition for writ of certiorari. Our amicus brief was filed on behalf of U.S. Justice Foundation (www.usjf.net) and Conservative Legal Defense and Education Fund (www.cldef.org).

Read More

Virginia v. Sebelius, Amicus Brief for Virginia Delegate Bob Marshall et al. U.S. Court of Appeals for the Fourth Circuit

Michael Harless Health Law, U. S. Court of Appeals, Fourth Circuit

Today our firm filed an amicus brief in the case of Commonwealth of Virginia v. Kathleen Sebelius in the United States Court of Appeals for the Fourth Circuit on behalf of Virginia Delegate Bob Marshall, Gun Owners of America, Inc., Gun Owners Foundation, American Life League, Inc., Institute on the Constitution, the Lincoln Institute for Research and Education, Public Advocate of the United States, Conservative Legal Defense and Education Fund, The Liberty Committee, Downsize DC Foundation, DownsizeDC.org, and Policy Analysis Center.

Read More

Federal Trade Commission v. Daniel Chapter One A Story of Government Suppression of Alternative Medicine

Michael Harless Health Law, Publications

Bill Olson and Herb Titus wrote “Federal Trade Commission v. Daniel Chapter One, A Story of Government Suppression of Alternative Medicine” which covers our firms representation of Daniel Chapter One, a historical perspective of the attack on alternative medicine, the federal assault on dietary supplements and alternative medicine, the story of Daniel Chapter One, and the litigation proceedings of the FTC’s abusive campaign against Daniel Chapter One.

Read More

Daniel Chapter One Reply Brief of Petitioners

Michael Harless Health Law, Litigation, U. S. Court of Appeals, District of Columbia Circuit

On behalf of Daniel Chapter One (“DCO”), today we filed with the U.S. Court of Appeals for the D.C. Circuit the reply brief of petitioners. The DCO reply brief argues that the FTC brief unjustifiedly disparages DCO and the Feijos’ relationship to it in an erroneous effort to assert jurisdiction over a ministry. Further, the FTC brief’s claim that DCO’s ads created the overall net impression that its products claims were based upon controlled clinical studies is not supported in fact or by law. Finally, the FTC brief is mistaken about DCO’s constitutional and Religious Freedom Restoration Act claims.

Read More

Daniel Chapter One — District Court Order

Michael Harless Health Law, Litigation, U. S. District Court, District of Columbia

The U.S. District Court for the District of Columbia denied the Daniel Chapter One (“DCO”) motion to dismiss, denied the government’s motion for a preliminary injunction enjoining defendants from violating the FTC’s order, and stayed the case pending resolution of DCO’s appeal before the U.S. Court of Appeals for the D.C. Circuit.

Read More

Daniel Chapter One Motion to Dismiss and Opposition to Government’s Motion for Preliminary Injunction

Michael Harless Health Law, Litigation, U. S. District Court, District of Columbia

Daniel Chapter One Brief of Petitioners

Michael Harless Health Law, U. S. Court of Appeals, District of Columbia Circuit

On behalf of Daniel Chapter One (“DCO”), today we filed with the U.S. Court of Appeals for the D.C. Circuit the brief of petitioners. The DCO brief argues that the FTC failed to establish jurisdiction over DCO and exceeded its statutory authority by misuse of its “reasonable basis” theory and test. Further, the FTC order is arbitrary and capricious, being the product of a blind adherence to the religion of scientism. Finally, the FTC action and order unconstitutionally abridged DCO’s freedom of speech, and the FTC erroneously dismissed DCO’s Religious Freedom Restoration Act and First Amendment “speaker autonomy” claims.

Read More