Last year, we told you about the FDA’s massive attack on supplements that came in the form of a guidance document. That guidance is meant to provide clarity to supplement companies regarding “new supplements”—referred to as new dietary ingredients, or NDIs. The FDA’s proposed NDI notification process remains one of the largest threats to the supplement industry ever.
Vinpocetine, a natural nootropic (nōəˈträpik), is an active ingredient in several brain boosting supplement formulas. It is also sold as an inexpensive supplement by itself. Nootropics are neurologically active memory and cognitive enhancers, promoting well being and learning potential. It is the sole ingredient of an Eastern European medicine, used since 1978 for recovering stroke victims and other neurological issues called Cavinton. Its use has spread throughout Asia and other parts of Europe. Both Cavinton and Vinpocetine, extracted from the periwinkle plant, have been tested, studied, and tried internationally for several neurological issues with mostly highly positive results since 1978. Along the way, other benefits were discovered related to heart health, vision, hearing, and more. Now there is a current controversy involving the FDA and a Missouri Senator seeking to restrict public access to this supplement which has a long history of use outside the U.S.
The most recent governmental bureaucratic actions against medical cannabis was a joint effort of the DEA and FDA, both of which work together to ensure the pharmaceutical industry can dominate medical applications of cannabis. Early this year, 2017, cannabidiol (CBD) was placed firmly as a Schedule 1 Drug on its controlled substance list, even though CBD is an extract from cannabis that does not have psychotropic effects (no "high" from usage.) Because CBD does not produce any psychotropic effects, and yet is effective for several medical issues, most notably epileptic seizures, it has been allowed for children with epilepsy even in some states that do not permit full plant cannabis with THC medically. Yet now the DEA says it’s as medically useless and dangerous as heroin.
In the waning days of 2016, the US Food and Drug Administration (FDA) ignored the expressed will of Congress. The agency completed a “guidance” document that prohibits traditional compounding pharmacies from stocking doctors’ offices with custom drugs. In December 2015, Congress included a provision in an end-of-the-year spending bill ordering the FDA to issue a guidance document clarifying how physicians and compounding pharmacists could continue the “office use” of drugs. These are custom drugs that a doctor keeps on hand for immediate treatment use. Congress could not have been clearer: the agency was not to forbid office use. The FDA has now answered—by ignoring it.
The Federal Trade Commission (FTC) recently issued a policy statement explaining that the agency will hold efficacy and safety claims for over-the-counter (OTC) homeopathic drugs to the same standard as claims for other OTC drugs. This means homeopathic OTC products will need to back up claims with “competent and reliable scientific evidence” for health-related claims, or else use certain FDA-approved disclaimers. Here are some examples of acceptable disclaimers, as noted in the FTC’s policy statement: “There is no scientific evidence that the product works,” or “The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” The FDA is no doubt pulling the strings on this. The most likely motivation of the FTC is that the homeopathic industry is rapidly expanding, which presents a clear threat to pharmaceutical drug company profits, which is enough for the FDA to put homeopathy in its scopes.
As usual, the agency is using outdated science and is heavily influenced by industry. Action Alert! Following the recent update to the Nutrition Facts label and the approval of the 2015 Dietary Guidelines for Americans, the FDA is proposing to update the definition of “healthy” and in federal regulations. The idea is to harmonize the regulatory definition of “healthy” (as well as related terms) with the “latest nutrition science,” presumably contained in the newly approved guidelines. The FDA has no business defining what “healthy” is, given its lack of scientific expertise (noted in a congressional audit) and especially its extensive crony ties to industry.
According to the most recent data, there are zero deaths from supplements. But the FDA’s tightening of supplement regulations is for our safety, right? Action Alert! Every year, the American Association of Poison Control Center’s National Poison Data System (NPDS) releases an annual report that tracks deaths and serious adverse events as a result of poisoning from a wide variety of substances, including drugs and supplements. NPDS is “the only comprehensive, near real-time, poisoning surveillance database in the United States.” According to the most recent report, ZERO Americans died from taking any supplement in 2013. That includes anything from substances that must be taken with care and medical guidance, such as kava kava or yohimbe, or ayurvedic medicines (which must be sourced with care to be sure they are free of heavy metals), to standard vitamins and amino acids, to the gentlest homeopathic remedies. Of course, to most of us in the natural health world this is unsurprising. Dietary supplements have an exemplary track record of safety. In fact, our partners at ANH International calculated that, according to the European Union’s own data, we are more likely to be struck and killed by lightning than die from taking a supplement.
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.
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."
Why would the FDA attack a company that seeks to bring affordable, convenient testing to millions of Americans? We suspect that the agency is doing everything it can to throttle innovators in this area to protect large, established testing companies and hospitals, which have been funding their deficits, in part, by charging exorbitant prices for tests.
Our national government's attempts at issuing dietary guidelines are usually inappropriate and ludicrous. Unfortunately, those guidelines dictate what the average certified dietitian offers as sound dietary advice. If you've ever had to eat hospital food, you were the recipient of a dietitian's control over the hospital's kitchen. Today there are virtual food fights over different dietary approaches. It seems the advocates of each diet want to create a following and promote how their particular approach to eating assures longevity and good health. But there is no one size fits all diet. This isn't about therapeutic diets for overcoming specific diseases, especially cancer. Rather, this commentary is about assigned bureaucrats effort to decree a day to day dietary intake for maintaining one's health. A recent article decrying current national efforts at dictating dietary advice by journalist Nina Teicholz was recently published in the BMJ (British Medical Journal). Nina authored The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet. Her book received accolades from literally hundreds of Amazon reviewers and some New York based magazines. Those responses struck this author as a carnivores' chorus of affirmation with a prolonged amen.
Now it appears that Barack Obama’s FDA is going after our best domestic artisanal cheeses, also often made from raw milk. What is the stated rationale for this? The FDA and Health Canada issued a joint assessment claiming a higher incidence of listeriosis—the disease caused by the food-borne pathogen listeria—in cheese made from raw milk as compared to cheese made from pasteurized milk. Consider these facts about listeria. Recent evidence from the Centers for Disease Control and Prevention (CDC) shows that, between 2009 and 2011, cheese made from raw milk accounted for one listeria outbreak and fifteen illnesses, whereas cheese from pasteurized milk caused five outbreaks and thirty-six illnesses. Let’s put this in further perspective. The CDC determined that between 1993 and 2006, all raw milk products combined caused 202 hospitalizations and two deaths. If the FDA is truly motivated by food-safety concerns, why not take a more aggressive stance towards Concentrated Animal Feeding Operations (CAFOs), since contaminated meat and poultry sicken an estimated one million people and kill at least one thousand each year? If the FDA receives enough messages protesting the path they are clearly on to ban raw milk cheese, they will likely back off for fear of offending Congress, which has to listen to the voters—so please take action on this issue!
