Tag: Food and Drug Administration

Dubious for-profit stem cell clinics: Co-opting ClinicalTrials.gov as a marketing tool

Over twenty years ago, cancer quack Stanislaw Burzynski pioneered the abuse of the clinical trial process as a marketing tool to sell his antineoplastons. Now, for-profit stem cell clinics are using ClinicalTrials.gov as a marketing tool for their unproven therapies by listing dubious and scientifically worthless trials in this government database. What can be done?

/ June 17, 2019

Patients Blinded by Stem Cell Therapy: FDA (and consumers) win a legal victory!

The Food and Drug Administration just won a court case supporting the agency's ability to regulate stem cell clinics that rely on client-derived adipose tissues. This is a win for consumer protection, though too late to help those already harmed.

/ June 10, 2019

Walmart sued for deceiving customers in selling homeopathic remedies

A lawsuit claiming Walmart fraudulently deceives consumers in the sale of worthless homeopathic remedies has been filed by the Center for Inquiry (CFI), acting on behalf of the general public. CFI says co-mingling ineffective homeopathic products with science-based treatments on Walmart's pharmacy shelves and website misleads customers into thinking they are equivalent, when "there is not a shred of credible scientific evidence"...

/ June 6, 2019

The FDA’s accelerated drug approval program is failing to protect cancer patients

Drug approval is a process that should be and, for the most part, is rooted in rigorous science. However, there is always a countervailing pressure to approve new drugs rapidly, particularly in cancer. That's why the FDA created the accelerated approval program in the early 1990s. Unfortunately, increasingly this approval process appears to be failing us in oncology. Reform is needed.

/ June 3, 2019

FDA: No CBD in dietary supplements or foods for now, but let’s talk

The FDA reminds everyone that (no matter what your state says) CBD is not a legal ingredient in dietary supplements and foods. The agency is willing to explore changes to the law but unproven claims for CBD health benefits, such cancer cures, will not be tolerated.

/ May 9, 2019

New FDA rule cracks down on compounded drug ingredients

A new FDA rule will require evidence of safety and effectiveness for substances used in compounded drugs, alarming naturopaths and integrative physicians. Experts have recommended that a number of naturopathic compounding favorites be banned.

/ April 11, 2019

FDA promises industry-friendly “modernization” of dietary supplement regulation

The FDA promises the "most significant modernization of dietary supplement regulation" in 25 years while maintaining its industry-friendly regulatory scheme.

/ February 14, 2019

“Right to try” laws create tremendous legal uncertainties; FDA expanded access preferable

The Goldwater Institute and the Kochs pushed "right to try" laws in an attempt to get rid of FDA oversight of access to investigational drugs. Instead, they created tremendous legal uncertainties, making the FDA's expanded access program preferable for all.

/ January 17, 2019

The stem cell hard sell: The Medical Board of California is forming a task force to determine how to regulate physicians offering stem cell therapies.

For-profit stem cell clinics selling unproven and downright quacky stem cell therapies have proliferated over the last several years, with federal and state law seemingly powerless to stop them. Recently, the FDA and FTC have shown signs of acting to crack down on them. Now, the Medical Board of California is forming a task force to determine how to regulate physicians offering...

/ December 10, 2018

FTC settles deceptive advertising claims against amniotic stem cell clinics

An FTC settlement may kill "amniotic stem cell" treatments, but a plethora of other stem cell clinics flourish without regulatory oversight.

/ October 25, 2018