The latest power grab from an agency that is out of control. Action Alert!
In a slew of warning letters, the FDA attacked companies selling “unapproved” cures for hangovers. In its explanation, the agency states that hangovers are included in the federal definition of disease, so products claiming to treat them must receive FDA approval. This is the latest attack from an agency that, for years, has worked to protect patented pharmaceutical drugs from competition from natural products. We must reform this crony health system that is keeping healthcare costs high—and more importantly, keeping us sick.
The idea that a hangover is a disease may seem bizarre: welcome to our federal government. It is important to remember what a hangover is— an acute response to overindulgence resulting in temporary dehydration, electrolyte imbalance, disruption to key hormone and nutrient levels. It is an acute event, rather than a chronic exposure or state—in other words, not like anything in the FDA definition of disease.* It is like a sunburn. It is temporary pain resulting from a specific event. And like excessive sun exposure, which can lead to diseases like melanoma, chronic alcohol abuse leads to a host of disease states. Conflating acute injury with a state of disease is nefarious wordplay that could invalidate all structure/function claims (see here for an explanation of these claims). Perhaps FDA will target aloe vera next regarding its claims of reducing the symptoms of a sunburn, since by their application a sunburn is akin to melanoma.
The agency has claimed that inflammation is a disease, blocking supplement companies from making any claim about a nutrient’s ability to help this natural protective response of the human body. Previously, the agency has also attacked companies for “implied disease claims,” a term which the FDA invented to further prevent legal and truthful claims about the benefits of supplements.
For example:
- The truthful claim that niacin lowers cholesterol is deemed an implied claim that the product is a treatment for hypercholesterolemia.
- The truthful claim that chromium lowers blood sugar levels is deemed an implied claim that the product is a treatment for diabetes.
- The truthful claim that magnesium lowers blood pressure levels is deemed an implied claim that the product is a treatment for hypertension.
Note that this censorship not only denies consumers helpful information about the benefits of these products, but also presents safety concerns. Patients who are already on blood sugar lowering drugs may experience negative effects if they take a supplement that further lowers blood sugar, but the FDA banishes this information from the label.
Perhaps we shouldn’t be surprised any more by the actions of an agency that would threaten cherry and walnut growers with fines and jail time for citing respected scientific studies about the health benefits of those foods.
Why does the FDA do this? It appears to be all about the cronyism baked into our health system. Censoring information about supplements clears the way for more drug sales, and drug companies directly pay FDA salaries.
Unfortunately, regular readers of our newsletter will know that this censorship is nothing new. The FDA, together with the FTC, has issued hundreds of warning letters to doctors and clinics for educating the public about how to treat or prevent COVID-19 infection with natural products that have strong scientific evidence to support them. But in order to make any kind of health claim, a supplement would need to go through FDA drug approval, which is an exorbitantly expensive process costing billions. But because supplements are generally not patentable like drugs are, no company will fund the research necessary to gain FDA approval. The result is that promising natural treatments are completely ignored by our health system. If we have any hope of improving healthcare in this country, this arrangement needs to change.
*Federal rules block supplements from making any claim to have “an effect on the characteristic signs or symptoms of a specific disease or class of diseases.” As far as health claims go, federal rules define “disease” as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” According to the FDA’s logic, a hangover is a “sign or symptom” of alcohol intoxication, which the agency considers a disease.
Action Alert! Sign our petition that seeks to reform a healthcare system that blocks access to natural treatments that generally cannot go through FDA approval. Please send your message immediately.
The FDA has one agenda. Remove all natural and healthy products from the market so all people are driven to drugs like cattle to the slaughter house.
The FDA needs to be purged of all the lobbyists and former pharma cronies, and peopled with experts who will not be beholden to any special interests.
Time to start dismantling out of control agencies and get back to living our lives free of clowns thinking everything we the people do is subject to their whims, greedy, or just plain outright power grabs.
Before too long they will be calling breathing nd eating diseases
Time to get rid of the FDA. They are full bonified sales arm of the drug manufacturing industry.
Time after time the letter to legislators is the same boilerplate language, not the subject of the article, so I don’t send.
Hi Jeff,
Thank you for your support! We are currently focusing on overall healthcare reform in regards to protection of natural healthcare access. From government Covid response to FDA oversight, cronyism continues to threaten natural treatments and impact government policy. In utilizing one petition for our campaigns, we are able to show the vast impact that cronyism is having across a broad spectrum of natural health options.
Get the FDA out of our lives. We need natural foods and natural treatments to be available. It seems that the FDA is just an arm of big Pharma.
you are too stupid!
This is absolutely ridiculous ! ! ! WE, the people, must take back our government from these insane gangsters who have ruined our way of life. They need to be put in prison.
Do not block access to natural treatments.
The FDA approval process is hypocritical: vaccines do not require the same stringency yet they are approved for human use and consumption.
Natural remedies have been around much, much longer that either drugs or vaccines.
In fact, in the history of drugs, they started out by taking natural remedies, adding a chemical change, patenting it, and now having a monopoly on the new “drug” based on a natural cure.
Keep natural cures easily and readily available.
I urge the FDA to allow Americans to continue to have access to information about the action of food and nutrients on the human body. At a time when 60% of Americans have at least one chronic disease and 40% have two or more (CDC), the knowledge that specific foods and nutrients play a role in optimizing metabolic function and reducing disease burden is essential. Preventing obesity, diabetes, and cardiovascular disease is the way out of this silent epidemic that is bankrupting our country. People need to understand the central role of food and nutrients in their health and disease.
It is sad, sinister and systemic that we are not free to know, share and implement cures and remedies that don’t come from a laboratory. Mankind has been enslaved by dishonest, greedy, self-righteous people who care nothing about whomever they harm…they will always take the low road where they slither amongst their own.
I am a doctor, and have come to realize that the FDA is out of control. There needs to be an overhaul. Yes, I can treat people for these so called disease. A hangover is a physiological negative response, not a disease. And supplements, that are properly prescribed can rectify the situation. Even more important, water is one of the best cures for a hangover, since a person is dehydrated after drinking.
We need to stop the FDA and big pharma from their bull crap! They want to keep us sick and pad their pocket book at the same time! Enough is enough!
Another rogue federal agency that doesn’t have enough to do. Cut their funding.
We the people want control of who we listen to and who and what we believe. Government control is always too costly and seldom is the best way.
It is the out of control FDA that should be defunded and disband, and each director charged and tried for crimes against American citizens.
A hangover is not a disease
Hi Elected Officials
I don’t understand why the FDA has so much power to restrict my freedom of choice. Please leave some decision making to me – a citizen – where I can select from an open variety of options that have not been narrowed down to nothing by overzealous agency people. It just seems to me that there is something wrong with the system. Hangovers and inflammation are not diseases but result from the consequence of less than stellar dietary decisions.
Thank you,
Censoring information about supplements clears the way for more drug sales, and drug companies directly pay FDA salaries.
The federal government has grown much too intrusive. It has gone from protecting people from charlatans to oppressing the citizen. The FDA is in the pockets of big pharma. That needs to end. First, lets get Trump re-elected and go from there.
I appreciate all your research, work, and dedication.
However, there is no reason for the wording, “The Trump administration’s FDA and FTC…”
The FDA and FTC will exist after November’s election, no matter the results of the Presidential election.
If you choose to remove the political slant, I will eagerly sign these petitions, and also pass them along.
You do excellent work; please consider making this change.
Thank you. God bless you.
Hi Deborah,
Thank you for your support! We reference Trump only to highlight how this particular administration’s government agencies have responded to naturopathic prevention/treatment methods, but we do not list Trump as either an enemy or ally. We also allow our message to be edited so that you can change anything you don’t agree with.
Reform a healthcare system that blocks access to natural treatments that generally cannot go through FDA approval.
Having the same people approve the drugs that combat the food they approve!!!!!
That’s like using a wolf as a livestock guardian for your goats
When I click on Take Action, the letter that comes up is about COVID-19, not about this????? Please fix that. This is not the first time that the Take Action draft letter is not related to the message above????? Please be more careful
Hi Bill,
Thank you for your support! We are currently focusing on overall healthcare reform in regards to protection of natural healthcare access. From government Covid response to FDA oversight, cronyism continues to threaten natural treatments and impact government policy. In utilizing one petition for our campaigns, we are able to show the vast impact that cronyism is having across a broad spectrum of natural health options.
In my opinion the FDA does more harm than good and it would suit me if it were completely disbanded.
Absolutely disgusting – welcome to 1984 (George Orwell). What is the ultimate objective? Mind and body control? For whose benefit? I think we are dealing with very dark forces.
I agree the FDA has to go and they need to be disbanded NOW!!! all I take is natural supplements and herbs and guess what they work fantastic. my body responds to natural stuff better than prescription drugs, I never ever take a prescription medicine unless I get something like strep throat then I have no choice but to take it. but other than that, it’s natural medicine for me all the way and that’s never going to stop either.
This is “call to action” is ridiculous! Fake claims to fix hangovers have no basis in medicine. They should be blocked. Under the guise of protecting natural cures, unregulated untested offers are enabled. The science behind these “cures” doesn’t exist and removing regulations just lets snake oil offer grow. don’t support without research!
Here is one review of this group at mediabiasfactcheck
I signed and sent my letter–AFTER I omitted the first few words about “Trump’s FDA…”. This is not about President Trump, this is about an agency that has gone over the deep end for the past 30 years? Perhaps longer? This is about an agency that is simply an arm of pharma, and the toxic rot is so deep rooted that it will take more than a president to get rid of it. Eventually, enough people are going to be affected, even those not part of the “natural/holistic” community, and then Congress might step in. But the way things are going with coronavirus, I don’t see it happening any time soon.
So let’s separate out liberal agendas, because the leftists are just as bad, if not worse, about these things. Many conservatives are libertarians, few leftists are. And while libertarianism has its downsides (sometimes not enough oversight of greedy organizations that need it), the alternative is far worse.