The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert! What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.
For more than a decade, the U.S. Food and Drug Administration has had an undeclared war on raw milk cheese, until [last] week, when the FDA finally beat a retreat. At the conclusion of its latest assault against raw milk cheese–a research study of more than 1,600 cheese samples to test for pathogens–the FDA made this remarkable admission: “The data collected by the FDA indicate that the prevalences of Salmonella and pathogenic Shiga toxin- producing E. coli are relatively low and similar to the contamination rates in many other foods.” I added the emphasis, just to highlight the significance of that statement. The FDA has never before gone so far as to suggest that a raw-milk product is as safe as “many other foods.” Instead, the FDA and its buddies at the U.S. Centers for Disease Control (CDC) have gone out of their way to foment fear about raw milk products of any kind, warning people not to consume them under any circumstances.
Want your doctor to help you manage your diabetes with specially formulated foods? The FDA says no way. What does your doctor know about nutrition and its ability to heal illness? That’s a good question for many conventional doctors, but most integrative doctors actually know a lot about it. And the FDA has no business telling them what to do. Recently, the FDA issued its final guidance on medical foods. In doing so, the agency completely ignored the many passionate comments from ANH-USA members and our allies. The agency has decided to severely restrict consumer access to medical foods—and is banning medical foods for diabetes patients. Why? Presumably because the use of medical foods might interfere with Big Pharma profits.
In FDA’s words, the Food Safety Modernization Act (FSMA) “directs FDA to build an integrated national food safety system in partnership with state and local authorities explicitly recognizing that all food safety agencies need to work in integrated ways to achieve public health goals.” To FDA “integrate” means dictating to the states what their food safety laws will be.
Big drug companies want the entire hormone therapy market to themselves. If they’re successful, the price of bioidentical hormone replacement therapy could go through the roof. And you won’t be able to get the therapy in the right form, either. In 2014, TherapeuticsMD, a drug company specializing in women’s healthcare, was granted two new patents for the company’s combination bioidentical-estradiol-and-progesterone drug. The patents are for the particular “recipe” of bioidentical hormones (presumably a particular ratio of estradiol to progesterone, combined with a proprietary solubilizing agent), and for the “method”—that is, the claim that this formulation is a method of treating menopause symptoms in women. The company is also in the midst of conducting a Phase III clinical trial on this drug, meaning that it could be very close to coming to market. Keep in mind that this is occurring against the backdrop of the FDA’s war on natural medicine.
At FDA.gov, it states, “FDA (U.S. Food and Drug Administration) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” That sounds good to me. Too bad it is simply not true. Folks, the FDA does not work for us. It works for Big Pharma. The FDA has started sending letters to companies manufacturing CBD oil informing them to stop producing and marketing it. Then, a Big Pharma company will come in and offer CBD oil for a price many times above what people are paying now. If the FDA was working for us, the citizens, it would not wait 19 years to ban something that has been proven to be harmful. Nor would it allow the second most toxic chemical known to mankind—mercury—in any vaccine. For that matter, it would not allow neurotoxins such as aluminum and MSG in vaccines as well. These failures are mammoth and criminal. Folks, the FDA is beyond fixing. It needs to be replaced with a true agency that is looking out for our health.
It is hard to believe only four senators opposed the confirmation of Robert Califf, who was approved [recently] as the next FDA commissioner. Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute. Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA. In disclosure information for a 2013 article in Circulation, Califf also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche and other companies and equity positions in four medical companies. Gilead is the maker of the $1000-a-pill hepatitis C drug AlterNet recently wrote about. This is FDA commissioner material?
More supplements face the axe at the next meeting of the FDA’s Pharmacy Compounding Advisory Committee. If recent history is any indication, the outlook is not good—unless we push back.
The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) are the two federal agencies in the United States responsible for protecting consumer rights in regards to food safety. Millions of dollars of U.S. taxpayer funds are spent on testing foods annually to monitor the presence of pesticides and herbicides in the nation's food supply. However, the most commonly used herbicide which is sprayed on to genetically modified crops is routinely not tested. Glyphosate, the main ingredient used in Roundup Ready, is the most common herbicide in the world, sprayed on many billions of acres of crops each year. Neither the FDA nor the USDA routinely test for the presence of this herbicide in the nation's food. That is apparently about to change. Civil Eats is reporting that the FDA will now start testing certain foods for the presence of glyphosate.
Dr. Burzynski on Trial Again – Will His Life-saving Cancer Treatments Ever be Available to the Public?
After several years of FDA trial restrictions and medical bureaucratic harassment by the Texas Medical Board (TMB) through the courts system, it appeared that Dr. Burzynski was completely cleared in 2012 of all charges brought against him. The final court decisions that favored Burzynski were upheld in higher courts despite TMB appeals. It was a long, costly and bitter battle, with many former cancer free patients coming to testify on behalf of Dr. Burzynski's treatment authenticity and efficacy. The charges are different this time. Instead of attacking his ingenious new antineoplaston approach, they're charging him and his immediate staff of personal misconduct within various medical guidelines with the intention of removing their medical licenses. The central issue appears to be that Dr. Burzynski is not affiliated with a pharmaceutical company, but he owns the patents for his antineoplastons. In 1982, Dr. Richard Crout, Director of the FDA's Bureau of Drugs openly asserted: "I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances."