FDA wants to act as your physician and regulate your access to customized medications. Action Alert! With its new guidance, the FDA is further tightening the screws on pharmacies that produce customized medications for individual patients. The agency is inserting itself into the role of “doctor” by deciding for patients whether there is a “clinical need” for certain medicines to be made at pharmacies. The reason? We believe they want to protect the monopoly of FDA-approved drugs. In its latest guidance, the FDA is signaling that it will further restrict the medicines that can be made at outsourcing pharmacies by adopting a stringent definition of “clinical need” if there is already an FDA-approved drug for a given condition.
The FDA wants to up-end the homeopathic industry—because it’s become too popular. Help us stop this insanity! Action Alert! Considering the myriad public health problems facing this country, including the opioid epidemic and the overuse of antibiotics, it is ludicrous that the agency is focusing on homeopathic drugs. Could it be that, like supplements, homeopathic drugs compete with pharmaceutical drugs? Recall, too, that the FDA has announced that they are targeting alternatives to opioids in the midst of an epidemic of opioid addiction that is killing 115 Americans every day. We must encourage our senators and representatives to sign on to the Hatch and Costello letters and send a clear message to the FDA: the previous regulatory policy was sufficient to ensure consumer access to safe homeopathic remedies, and we don’t need to fix what isn’t broken.
In one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally. The FDA says that it does not intend to take action against such products at this time, but the writing is on the wall. If it wants to, the FDA could go after any homeopathic drug currently on the market. FDA’s process started two years ago, when the agency held a public hearing to evaluate its enforcement policies for homeopathic products. We suspected the agency was planning to tighten its grip on homeopathy, which, after all, competes with the pharmaceutical drugs that fund the FDA. We cannot let the FDA eliminate consumer access to homeopathy.
Is the European Medical Agency Experimenting on Babies with the Meningitis Vaccine Only Approved for Age 10 and Above?
In 2016, we published an article on the dangers of the meningitis B vaccination, Bexsero, titled, Are Ineffective New Meningitis B Vaccines Causing Harm to Children? At the time of publication, according to the FDA product information leaflet, the vaccine had in fact only been approved for children over the age of ten. Despite this fact however, in the UK, the meningitis B vaccine Bexsero is being administered to infants as young as 2 months, despite the fact that we could find no evidence to support that this vaccine was safe to be administered to babies. It has been brought to our attention that there are in fact two product information leaflets on the same vaccination. However, what is different about the second product information leaflet, published on January 14, 2015, by the European Medical Agency (EMA) is that the information that it provides, is the polar opposite, of the information provided by the FDA. Is the UK government conducting clinical trials on infants, and if they are, then are parents aware of this fact?
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.