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As usual, the agency is using outdated science and is heavily influenced by industry.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.