State of Texas v. United States

admin Constitutional Law, Health Law, Statutory Construction, U. S. Court of Appeals, Fifth Circuit

Today our firm filed our ninth amicus brief opposing Obamacare.  This briefs supports challenge to Obamacare brought by the State of Texas and other states based on the fact it is unconstitutional since the penalty for the individual mandate was zeroed out by Congress in December 2017.  Earlier, we filed the only amicus brief supporting the Texas challenge in district court in Texas.  This brief Read More

Comments filed with the FDA regarding its restrictions on use of the word “healthy”

Michael Harless Administrative Law, Health Law

Today, our firm filed comments with the FDA in response to the agency’s request for input regarding its regulation of the term “healthy” in the labeling of food.  In recent years, FDA’s current regulatory scheme has led to absurd results, such as where avocados and almonds were not considered healthy, while Poptarts and Frosted Flakes were.  Now FDA purports to replace its bad regulations Read More

Comments filed with FDA regarding new “Draft Guidance” about Dietary Supplements

Michael Harless Administrative Law, Health Law

Today, our firm filed comments with the Food and Drug Administration (“FDA”), criticizing various parts of the FDA’s new “Draft Guidance” with respect to dietary supplements.

First, we noted that while federal law requires that manufacturers dietary supplements give “notice” to the FDA before they introduce a “new dietary ingredient” into the marketplace. The FDA, however, has adopted Read More

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 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 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 Read More

Article: “More Government than America Needs or Wants”

Michael Harless Health Law, Publications

Homeopathy 4 Everyone (“World’s No. 1 Homeopathy Medical Journal”) published our article explaining the latest chapter in the FDA and FTC’s war against homeopathic medicine. The article was written by Bill Olson and Jeremiah Morgan.

This article was reprinted in the following publications:

https://hpathy.com/homeopathy-papers/more-government-than-america-needs-or-wants/

Read More

King v. Burwell (Obamacare, Round III) — Amicus Brief

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

Today, our firm filed an amicus brief in the U.S. Supreme Court in opposition the Obamacare healthcare “exchanges” created by the federal government contrary to the plain language of the statute.

The Affordable Care Act (“ACA”) authorized tax credits only for taxpayers who purchase qualified health insurance through an “Exchange” which was established by a state. 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:

“The Government believes that this law is fully justified under 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 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).

Our brief argues that the Court of Appeals erroneously 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 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 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 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.

Link to court order

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

On behalf of Daniel Chapter One (“DCO”), today we filed a motion to dismiss the goverment’s complaint and a memorandum of points and authorities in support of the motion to dismiss with the U.S. District Court for the District of Columbia. On behalf of DCO, today we also filed with the Read More