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 with more regulations.
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our firm filed comments with the Food and Drug Administration (“FDA”), criticizing various parts of the FDA’s new “Draft Guidance” with respect to dietary supplements.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 an approach which requires manufacturers to submit separate notices every time they introduce a “new dietary supplement” which uses the “new dietary ingredient” in a different way. This compounds the notice requirement for the supplements industry far beyond what Congress permitted.
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.
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.
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.
Today we filed our sixth brief opposing Obamacare, five of which briefs have been filed in the U.S. Supreme Court. Maybe this will be the case that will have this terrible law struck down as the unconstitutional monstrosity it has been since it was enacted in 2010.
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:
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. However, after ACA was enacted, state legislatures reflected popular opposition to Obamacare, and only 16 states created such Exchanges, despite being offered federal bribes to do so.
Our comments on behalf of Gun Owners America, Inc. to the Department of Health and Human Services on proposed HIPPA rules were cited in an article by Stephanie E. Pearl, “HIPPA: Caught in the Cross Fire,” published in the Duke University Law Journal, vol. 64, no. 3, p. 559, 565, n. 39 (2014).
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 this Court’s Commerce Clause jurisprudence, particularly relying on United States v. Darby and Wickard v. Filburn. These revolutionary Supreme Court decisions cast aside settled constitutional doctrine for reasons of political expediency in the wake of President Franklin D. Roosevelt’s threat to pack the Court. The time has come that they should be re-examined and overturned, lest Congress conclude that it can compel whatever behavior it believes would make us a more healthy People — leading us to a totalitarian state where everything not prohibited is mandated.”
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”).
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 allowed the FTC to assert jurisdiction over Daniel Chapter One and that requiring Daniel Chapter One to substantiate its product claims by “controlled clinical studies” is outside FTC’s statutory authority. Further our brief argues that no government has authority to dictate the health care choices of competent individuals. Lastly, parts of the FTC’s order substantially burden Daniel Chapter One’s exercise of religion in violation of the Religious Freedom Restoration Act and contravene the First Amendment principle of speaker autonomy.
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.
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.
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.
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.
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 U.S. District Court for the District of Columbia a memorandum of points and authorities in opposition to the government’s revised motion for preliminary injunction. The memorandum was supported by the following declarations:
Declaration of James Feijo
Declaration of Patricia Feijo
Declaration of Tedd Koren
Declaration of Sally Lamont
Declaration of James A. Duke
Declaration of Karen S. Orr, D.C.
Declaration of Deane Mink, D.C.
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.
The U.S. Court of Appeals for the D.C. Circuit denied the Daniel Chapter One (“DCO”) motion requesting a hearing on the DCO claim under the Religious Freedom Restoration Act (“RFRA”).
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