'Drug Products Labeled as 'Homeopathic' Guidance for FDA Staff and Industry' Is What Their Title Is.
Playtime is over with immediately and we have to come together yesterday of six years ago! Damn powers that never should have been in the first place! Please share if you care, share if you don't.... Someone cares enough for the both of us!
The FDA (Finances Determines Approval) has already begun the attack on all of our natural and homeopathic remedies and recommendations based on their financial interests ad nothing to do with saving lives or helping people at all!
This guidance describes how we intend to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. As discussed below, FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health.
This complete falsehood created under the guise 'guidance' describes how we intend to prioritize enforcement and regulatory actions for homeopathic natural and previously completely legal and safe until we slap the label as 'drug products' being marketed in the United States without the required pocket padding, from bogus paperwork and falsified data from faked clinical trials FDA approval.
As discussed below, FDA has developed a risk-based to our stakeholders approach under which the Agency intends to prioritize enforcement and regulatory fines, raids, destruction, and genocidal actions involving certain categories of such products that are all natural and in no way potentially pose a higher risk to public health, but poses a significant financial risk for us and our other stakeholders that have been genocidal in depopulating the earth while making a killing making a killing.
In unmistakable collusion with Big Pharma, the concerted effort by government regulators, including the U.S. Food and Drug Administration (FDA), to ban Ivermectin as a safe and effective treatment against COVID-19 has been nothing short of criminal. Likewise, the FDA’s censorship of supplements that have, for over two years, safely and effectively treated COVID-19 is telling. Indeed, countless consumers have turned to dietary supplements to successfully boost their immune systems and protect their health during the pandemic, positively impacting the industry. In the past, Big Pharma and the FDA have tried to ban certain supplements by classifying them as new drugs. Presently, the new draft legislation would demand supplements to undergo the same approval process as pharmaceutical drugs, surely making many obsolete.
The draft legislation would amend the Dietary Supplement Education Act of 1994 (DSHEA) and mandate product listing regulations. When Congress passed DSHEA more than 26 years ago, the industry began to break into the mainstream with $4 billion in annual sales of some 4,000 product offerings. With an estimated 50,000 to 80,000 different nutritional supplements currently available, the global dietary supplement market is forecast to reach a market value of $185.1 billion in 2025. In 2021, it was estimated to be worth around $137 billion. The market has been growing since 2018 and is expected to continue to grow through 2028. The U.S. market alone rose an estimated 12 percent in 2020 to a record $52 billion.
The proposed Mandatory Product Listing (MPL) is an argument that has come up for several years as discussions persist about updating the DSHEA. Cara Welch, the FDA’s new director of the Office of Dietary Supplements Program (ODSP), has advocated for making the change in the past. The MPL would mean manufacturers would be required to register a new product with the FDA before putting it on the market. On several public occasions, FDA officials have stated that not having a solid grasp of what supplements are on the market impedes its ability to effectively regulate the market.
The U.S. Food and Drug Administration’s (FDA) swift and deceitful approval of the damaging COVID-19 experimental “vaccines,” coupled with the agency’s massive campaign to promote the jabs, overwhelmingly supports the fact that the agency gets a large chunk of its funding from pharmaceutical company user fees. Essentially, Big Pharma is a client of the FDA. That realization explains why the FDA—which is also tasked with regulating the distribution of more natural approaches to healthcare—wants to ban vitamins and supplements. On top of that, the FDA has issued guidance designed to make all homeopathic drugs illegal.
In 2015, the FDA held a hearing to evaluate its enforcement policies for homeopathic products, as reported by Alliance for Natural Health (ANH). The now-removed FDA hearing notice announced its intent to “obtain information and comments from stakeholders about the current use of humandrug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products.” These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic.
According to ANH, homeopathic medicines were intended to be grandfathered when the Food, Drug, and Cosmetic Act came into being, yet the FDA is completely ignoring this. Similarly, the Federal Trade Commission (FTC) has its sites set on prohibiting homeopathic treatments. The agency asserts that an over-the-counter homeopathic drug claim that is not substantiated by “competent and reliable” scientific evidence is considered deceptive if it doesn’t include the following disclaimer: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
As aptly pointed out by ANH, the bottom line is that “homeopathy lacks hugely expensive drug trials.” ANH notes: “The truth is that homeopathic medicines are overwhelmingly safe. One review of safety data from 17 countries between 1978 and 2010 found a total of just 1,159 adverse events. This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. Contrast this record of safety for homeopathic medicines with adverse events from FDA-approved drugs. From 1978 to 2010, there were more than 3.5 million serious adverse events and 571,398 deaths, according to the FDA’s database.”
Ignoring the intent for homeopathic treatments to be grandfathered, under the Federal Food, Drug, and Cosmetic Act, homeopathic products are subject to identical requirements related to approval, adulteration, and misbranding as other drug products. The FDA website notes that “Products labeled as homeopathic and currently marketed in the U.S. have not been reviewed by the FDA for safety and effectiveness to diagnose, treat, cure, prevent or mitigate any diseases or conditions.” The FDA currently approves no homeopathic products.
Highlighting the FDA’s aggressive approach to banning homeopathy (despite being historically known for moving incredibly slowly), the FDA and other government agencies are moving quickly (as they did with the untested COVID jabs) to make natural medicines unavailable to American citizens. A look at recent activity at the Office of Management and Budget (OMB)—the recipient of the FDA’s draft guidance for homeopathic medicines—hints at the speed at which they are moving to ban natural therapies. OMB’s Office of Information and Regulatory Affairs (OIRA) is tasked with reviewing significant rules and regulations to ensure adequate consideration of costs and benefits. OIRA also affirms that the agency issuing the rules (the FDA) has made a “reasonable determination that the benefits justify the costs.” On December 1, 2022, in an article titled “Homeopathy Bombshell Coming,” ANH reported:“Unsurprisingly, OIRA concluded on November 28th, just eleven days after receiving the guidance from the FDA, that no changes are needed to the guidance—meaning the FDA can move forward with issuing a final version.”
ANH, founded by Scientific Director Robert Verkerk, Ph.D., emphasized the stakes with the FDA’s attack on natural medicines couldn’t be higher. Indeed, as reported by UncoverDC, the FDA has positioned itself to fast-track more and more mRNA jabs for myriad ailments. The FDA’s draft against homeopathy effectively declares that every single homeopathic medicine on the market is illegal. Already intently assailing homeopathic products, the FDA draft guidance says:
Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
FDA has not determined that any homeopathic drugs are GRAS/E;
A new drug cannot be marketed unless it goes through the FDA’s approval process;
No homeopathic drugs have gone through FDA approval.
As previously mentioned (and noted by ANH), Big Pharma is a significant client of the FDA. Homeopathic medicines, including supplements and other natural products, compete directly with pharmaceutical products; therefore, the FDA—the taxpayer-funded agency responsible for protecting public health—is using its tremendous power to “tilt the scales in favor of the drug companies.”
Explaining the FDA’s attack as an entry point to completely eliminate homeopathic medicine, ANH (which has an urgent Action Alert link below, entitled “Tell Congress and FDA: Stop the Attack on Homeopathy”) explained: “And because natural products and homeopathic medicines generally cannot be patent-protected like drugs can, they can’t afford FDA-approval and so the health claims they can make are severely restricted. It is one among many ways cronyism is undermining healthcare in this country.”
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