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Comments filed with FDA regarding new “Draft Guidance” about Dietary Supplements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our firm filed comments with the Food and Drug Administration (“FDA”), criticizing various parts of the FDA’s new “Draft Guidance” with respect to dietary supplements.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

Obamacare Contraception/Abortion Services Mandate Conestoga Wood Specialties Corp. v. Sebelius U.S. Supreme Court Amicus Brief

Michael Harless Constitutional Law, U. S. Supreme Court

The story is told of a grizzled Master Sargent who, reflecting on his years of service, said: “When I joined up, homosexuality was prohibited; now it’s tolerated; and I darn sure am getting out before it’s mandatory.” So it is with respect to homosexual and abortion rights. First, the goal is said to be tolerance. Then, governmental approval and support. Lastly, any pretense of tolerance 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

Bill Olson Interviewed on Conservative Roundtable TV Show on Health Freedom Issues

Michael Harless Appearances, Health Law, Press Coverage

Bill Olson was a guest on Conservative Roundtable’s Television show to discuss health freedom issues. Among the matters discussed was the Daniel Chapter One case, where our firm is assisting in the defense of a health-related ministry promoting herbal and alternative medical products from an attack by the FTC. Information about the FTC attack on this ministry.

Link to video

Supreme Court Decides Wyeth Case

Michael Harless Constitutional Law, Health Law

The Supreme Court ruled by a 6 to 3 vote that approval of a drug by the Food and Drug Administration (FDA) does not prohibit a state court jury from finding a pharmaceutical manufacturer liable for personal injury caused by the inadequacy of an FDA-approved warning label on that drug. We had filed an amicus Read More

Wyeth v. Levine Amicus Brief Filed in the U.S. Supreme Court on Behalf of The Senior Citizens League

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

On behalf of The Senior Citizens League (“TSCL”), we filed an amicus curiae brief in the Supreme Court in Wyeth v. Levine (Supreme Court Docket No. 06-1249) on behalf of the respondent, Diana Levine. The issue in this case is whether approval of a drug and its labeling by the Food and Drug Administration preempts Read More

TSCL Comments on FDA Report “FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology”

Michael Harless Administrative Law, Health Law

On behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s Science Board Report Entitled “FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology.”

The Report asserts that the FDA is in danger of not being able to perform its mission without a vast and unprecedented doubling Read More

Abigail Alliance Case — Amicus Brief Filed In U.S. Supreme Court for The Seniors Citizen League

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

Today we filed an amicus curiae brief in the Supreme Court in the case of Abigail Alliance v. VonEschenbach, Commissioner of the FDA.  The U.S. Supreme Court had been asked by an alliance of terminally ill patients with no conventional medical alternatives to overturn an en banc decision of the U.S. Court of Appeals for the D.C. Circuit which allows the FDA to bar these patients’ access to certain Read More

TSCL Comments on FDA Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims

Michael Harless Administrative Law, Health Law

On behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s  “Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims”.

The FDA Draft Guidance asserts that the FDA is authorized by the NLEA to treat health claims for both conventional food and health Read More

FDA Draft Guidance for Industry on Complementary and Alternative Medicine

Michael Harless Administrative Law, Health Law

Today, on behalf of TREA Senior Citizens League, we filed with the FDA for both Clarification of, and Extension of, the deadline for comments in response to the FDA’s rulemaking in Docket No. R2006D-0480, entitled “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by Food and Drug Administration.”

Link to request