FDA opens a new front in the war against natural medicine. Action Alert!
In the midst of an opioid epidemic that is killing nearly 100 people every day, the FDA has taken action against a natural medical food that offers patients an alternative to opioids.
Last November, the FDA posted a warning on its website concerning Limbrel, a medical food* marketed by Primus Pharmaceuticals for the management of osteoarthritis. Then, in December, the agency recommended that Primus voluntarily recall Limbrel. The stated reason for the warning is that the FDA is investigating serious adverse events involving Limbrel. In a letter to Primus, the FDA states that 194 adverse event reports for Limbrel were received between 2007 and 2017—about 20 a year.
Consider that NSAIDs (non-steroidal anti-inflammatory drugs), an alternative treatment for arthritis, cause approximately 107,000 hospitalizations every year, along with an estimated 16,500 deaths among arthritis patients alone.
Limbrel’s two main ingredients are Chinese skullcap and catechin, a flavonol and antioxidant found in blueberries and other fruits, as well as brewed tea, chocolate, and red wine. Chinese skullcap has been used safely in traditional Chinese medicine for many, many years.
Further, FDA asserts that Limbrel doesn’t meet the definition of a medical food. To those familiar with the FDA’s final guidance on medical foods, this should come as no surprise. As we’ve detailed previously, that guidance drastically limits the number of medical conditions that medical foods can claim to help manage. FDA’s examples are restricted to rare genetic conditions that affect a small fraction of people, and are not applicable to patients who have more common disorders, no matter how controllable the condition might be with medical foods.
To give a sense for how outrageous the agency’s thinking is on this matter, the guidance specifically excludes diabetes—both type 1 and type 2, as well as gestational diabetes—because, according to the FDA, diabetes can be controlled by simply managing or tweaking one’s normal diet (together with taking FDA-approved drugs, of course).
This is consistent with the usual FDA stance that there should be as little competition as possible for approved drugs. By contrast, nearly all integrative physicians and even many conventional doctors would argue that diabetes requires very aggressive nutritional intervention, and medical foods can be a vital part of the treatment plan.
Restricting medical foods will have real consequences. Merely tweaking one’s normal diet is not sufficient to provide enough nutrients to correct certain conditions. Leaving aside our nutrient-depleted soil, there’s the fact that many (or even most) people have extremely poor eating habits. Perhaps it’s because they haven’t been clearly taught about a proper diet for their disease, or perhaps they lack the discipline required to monitor their eating carefully. Whatever the reason, making a few changes to the standard American diet, without the support of medical foods, will almost certainly not be enough to manage conditions like diabetes or nutrient-deficient diseases.
Given that opioids, including legal drugs like morphine and fentanyl, are killing 100 people a day, it is difficult to believe that the FDA is motivated by safety concerns in its actions against Limbrel, a product that could be substantially reducing that death toll. Sadly, it is more likely that the agency is sending a message to the medical foods industry, because these products compete with the pharmaceutical drugs that fund the FDA.
*Medical foods form a separate category from conventional foods and supplements in that they are intended to meet specific nutritional requirements for the management of a disease or condition, and are used under medical supervision. Like drugs, medical foods can make disease claims, but unlike drugs medical foods do not require FDA premarket approval and do not need to substantiate disease claims with random controlled trials.
Action Alert! Write to the FDA and tell them that 1) this attack on Limbrel, an alternative to opioids, is outrageous in the midst of an opioid epidemic, and 2) the agency must amend its restrictive position on medical foods. Please send your message immediately.
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I encountered similar opposition when I suggested supplementing my daughter’s cancer treatment with herbal/alternative treatments to increase her t-cell count, boost her immune system, and revive her gut flora. I was told that those treatments had a 20% chance of causing septicemia, which is unacceptable. The doctor that told me this is the same one who touted the chemotherapy treatment as successful, since it had only a 60% chance of causing her to develop leukemia later in life. How can they make such remarks in good conscience?
money, money, money, stupidity, stupidity, stupidity, and the feds want you dead. the deep state and shadow government anyway.
I guess ignorance is bliss, arrogance is stupidity.
I use natural products that work for me so there is no reason you can’t do What a right for you
do not understand taking away or labeling medicine used for 20 something years as dangerous and as an opoid for siezuere medication and nerve damage
always been a health advocate
but a small amount to stop seiuzeres i just do not get it. kill alot more Americans trying to take it away from them trying alternatives than to continue use at a small doses. i am not advocate for drug abuse, but i believe if we use for what intended for and amount prescribed then should not be a problem. sure is, letsget all these older folks under fire say this an opiod take it away.
they have been on alternative/ herbal too.
totally believe it preserves life
hundred years ago what did they eat or use for medicine berrys/ bark, etc
True medicine is discontinued after the healing is complete Drugs taken for extended period of time is pure addiction, not medicine. There is no healing going on with those types of drugs – just addiction
The problem is not the people that actually need it. The problem is when you go to a physcian’s assistant and you have an obvious cyst on your hand that took about 1 minute to remove from a hand specialist and the P.A. tells you because you are over 50 that you have arthritis and need pain meds, and writes you a prescription. P.A. are trained to give out prescriptions about the only medical training they actually have. Yet we are charged the same premium price as seeing an actual Dr. for someone trained for a couple of years in Pharmaceuticals.
Hippocrates was quoted as saying: “Let thy food be thy medicine and thy medicine be thy food.” End of discussion.
I do not share with my doctor any herbal supplements or vitamins I take. If they ask me about the vitamins, I do tell them I take the recommended dose (which is true) but don’t reveal if I take a larger dose as recommended by homeopathy. Actually, no doctor has asked me about herbals. And I do a lot of research on the herbals to make sure they are not counter-indicated to my condition and/or medication.
This is coming from someone who has virtually NO respect for the FDA…. but in all fairness, the FDA has the most difficult job in the US. They are “responsible” for protecting 300+ million people from every rouge, charlatan, and scoundrel with a test tube in their garage from making snake oil that can kill people. With that said…. and in typical Government fashion, they take their job to the most illogical extreme and wind up hurting people. Somehow the FDA doesn’t say a feaking thing about smoking..(which only kills 450,000 people a year), because it’s a choice thing. Well, taking medications, (although anecdotal), that have been in use for millennia, seems to get them a little pissy and they want to shut ALL OF THEM DOWN. It couldn’t be that they cut into the profits of BIG PHARMA who literally funds the FDA? NAH… it couldn’t be that!!! If smoking tobacco that has been clearly demonstrated as something that WILL kill you is an “acceptable” choice, then the Gov’t has NO EXCUSE as to why taking an Herbal “supplement” from a reputable source to improve your general health should be such an issue and is really an embarrassment to them and should be our choice as well; as long as it is an informed one.
It is called cigarette tax that keeps them selling. The Government (federal and state) receives billions every year. This is why they are still allowed on the market.
Yet many processed foods will cause cancers and contaminated foods are allowed in our food chain. One only has to ask who the FDA employee’s previously worked for? How many stocks do they still own in these companies still? The USA is at least 20 years behind most countries in holistic and natural medicines. Then you have some countries that you have to have a Dr. prescribe these natural and holistic alternatives the same ones the USA is trying to outlaw. Yet we are supposed to trust the FDA and our medical providers along with the government without question?
I’m not sure I completely agree. I take Chinese skullcap sometimes and EGCG. Both are readily available. By combining them and calling it a medical food the price can be drastically increased. They can always sell this combination as an aid to arthritis but they can’t charge as much.