Hats off to the author of the following piece. She’s been around the issue for a very long time and is familiar with the political terrain. This issue brings up an awful lot of philosophical, and flatly scientific questions. On the philosophical side, shouldn’t we, as human beings created in the image of Yah, have the right to care for and to treat ourselves and our families as we see fit? In the intentional dumbing-down of our society, did we lose our capacity to make decisions? On the more scientific side, how do we know that taking an isolate of a plant is going to be as positive for health as taking the entire plant with all of it’s constituents? Do we actually know how all these various components work together within all the various components of the human being? Or did we just discover an aspect and then presume that we have full understanding? We only discovered DNA in 1952 and the endocannabinoid system in the early 1990’s and how do we know that there isn’t another system within that which we haven’t discovered yet?
At any rate, as one would expect, those who desire profit above all else are setting themselves up to control our access to natural substances in their natural forms. Here is the article:
For those hoping that Big Pharma could still be blocked from the medical cannabis scene there is bad news: the deal is done. Look for the first naturally-derived, Big Pharma-produced cannabis product to be on the market by the first half of 2016, perhaps even sooner.
Epidiolex is a liquid formulation of pure, plant-derived cannabidiol (CBD) manufactured by the British company, G.W. Pharmaceuticals. It is currently on the FDA Fast Track and has entered its final Phase 3 study for pediatric epilepsy disorders such as Dravet’s and Lennox-Gastaut’s syndromes with results scheduled for the first quarter of 2016.
Barring an unlikely catastrophic finding, there are plenty of signs that Epidiolex will breeze through this final stage and will thus have cleared the FDA’s testing requirements. For any other drug the remaining details would be purely administrative but Epidiolex is derived from cannabis and that puts a few more hurdles in the way before marketing can begin. There are, however, plenty of signs that government officials are literally paving the way for this new player.
Among the most significant occurred on June 24, 2015. Before a packed hearing room, the U.S. Senate Caucus on International Narcotics Control, established in 1985 to “expand international cooperation against drug abuse and narcotics trafficking” took on the decidedly domestic issue of what to do about medical cannabis. The meeting was chaired by two unlikely medical cannabis proponents, Senators Charles Grassley (R-Iowa) and Dianne Feinstein (D-CA).
For long-time medical cannabis activists it was a surreal moment to watch these two veteran senators (with a cumulative total of 57 years in the Senate) bob-and-weave their way through unfamiliar territory. Normally these drug warriors would be proposing tougher penalties and increased enforcement. But on June 24th, and in a subsequent editorial in Time Magazine, Grassley and Feinstein supported “expanding compassionate access programs where possible, to benefit as many children as possible.
The hearings were eerily familiar for this medical cannabis pioneer. They immediately hearkened memories of another time when pressure on federal officials forced a “readjustment” of policy. It was 1980 and public interest in medical cannabis was being fueled by heart-wrenching stories from cancer patients undergoing chemotherapy. Their compelling stories of marijuana’s effectiveness in reducing or eliminating chemo-induced nausea and vomiting had led to the passage of state laws that recognized marijuana’s medical value and sought to establish state-wide programs of research using federal supplies of marijuana. There was a big problem, however. The federal government, which regularly grew a research supply of marijuana on a small plot at the University of Mississippi, didn’t have enough marijuana to supply the demand from these states.
In desperation federal officials turned to the synthetic version of the psychoactive ingredient in cannabis, delta-9 tetrahydrocannabinol (THC). The drug was developed in the late 1960s to facilitate animal research. It was not originally intended for human use although researchers did begin using it in humans in the 1970s and in 1980 it was all the government had to stem the demand for medical access to cannabis.
The Task Force hearings lasted all day but it was the afternoon session that would bring the bombshell when representatives from the National Cancer Institute (NCI) announced that delta-9 THC would be released through the NCI’s Group C Treatment Program.
“Under Group C, a compound is considered to have documented medical efficacy for a specific indication and not be a research drug per se, although it remains investigational…We anticipate that this change would make THC available to practicing oncologists around the country….We would hope that at some time in the near future a pharmaceutical company would become interested in marketing this drug, but until that time, we feel a responsibility for providing this controversial, but useful substance, to relieve the suffering of cancer patients…” (Hearings, page 162)
It was an unparalleled moment. The federal government was agreeing to produce and distribute, via the NCI, the most psychoactive compound in cannabis. With the tacit blessing of the Congressional Task Force on Therapeutic Uses of Marihuana and Schedule I Drugs, delta-9 THC would be released to hundreds of NCI pharmacies throughout the country. Oncologists would be notified, patients would have access, and the public pressure to “do something” about medical marijuana would be assuaged.
The government would herald this action as the release of “the pot pill” and the American public, not yet sophisticated with respect to cannabinoid knowledge, would breathe a sigh of relief that relatives would no longer be forced to the black market for their chemotherapy anti-nausea drug.
The Neal hearings paved the way for Marinol and, similarly, the Grassley/Feinstein hearings will pave the way for Epidiolex. The scenarios are slightly different, of course. The involvement of GW Pharmaceuticals from the very beginning has been far more pleasing to the FDA and other federal agencies. There is no “Group C” for pediatric epilepsy patients but it is reported that more than 400 patients are already receiving the drug via expanded access INDs.
The question that haunts this senior observer of the medical cannabis movement is: what will the federal government do once Epidiolex is on the market? Will there be a “crackdown” on the growing and enthusiastic CBD market that is flourishing online? (“Legal” CBD is produced from hemp and contains less the 0.03% delta-9 THC.) As Epidiolex is scheduled in the Controlled Substances Act will authorities tighten the control of natural CBD? Consider that Marinol, a synthetic version of the most psychoactive ingredient in cannabis, is Schedule III while the plant itself is Schedule I. Such inconsistency has, of course, been codified and is rather benignly referred to as “differential” scheduling. But, like so many things in the nation’s drug policy, it strikes many as a little crazy. The craziness of the federal policy with respect to marijuana should not be underestimated, nor should it be assumed that the growing tide of legal cannabis states will automatically signal a reform in federal law.
(((Look, I want to be very clear here. I don’t even use cannabis, because it IS illegal, and the seizure aspects are waaaay too high of a price to consider for something I would only rarely do if it were indeed legal….so I am not trying to get protections for my habit in position.)))
Over the course of the past few months I’ve been doing a fair amount of investigation on the issue of cannabis and various efforts to legalize the plant for the general benefit of humanity. Initially, I looked at the issue of legalizing cannabis as a simple matter of civil liberties with a massive pseudo criminal front propped up by drug court fees, seizure laws, probation and the expenses paid to the system in that, cheap prison labor and increased family court revenues due to foster care and custody issues…And yes, it also incidentally had benefits for people with serious medical issues.
Honestly, I have had a complete paradigm shift. Complete.
Not that the prison industry complex and costs to society associated with those issues are irrelevant, but there is a much larger, and much more evil truth about the control of cannabis that absolutely must become common knowledge. It’s particularly important that those who largely identify with conservative and Christian principles, or strong Constitutionalist ideologies become fully aware of the collusion between government and corporations to remove a beneficial plant from our access. Cannabis actually heals. And it restores life to people who are very ill. Hundreds of studies show this to be true, and also that cannabis is tremendously beneficial for our overall health.
The reason this has come to the forefront for many of us is that it is becoming increasingly difficult to hold to the idea that “Reefer Madness” has any basis in fact. It simply isn’t factual. Sometimes there are people that use cannabis that are just literally criminals and have no regard for their fellow man. These same criminals may also consume carrots, but the carrots are not the cause of their deficient characters. With or without cannabis, these people would be violent. Cannabis does not cause crime. Violent cartels exist because of cannabis being illegal. So in effect, the only violence that can truly be attributed to cannabis is state sanctioned violence through unjust laws. Simply put, the controls on this plant are the reason for violence associated with the plant or it’s distribution.
The tipping point on the truth around cannabis being put into the status of a Schedule One controlled substance (the Schedule One designation means it has NO medicinal value) has been achieved among the people. For those who have some qualms about whether or not this plant needs to be flatly legalized, please watch this video about Rick Simpson oil. This man has given people -as in freely given- cannabis oil, and they have been cured of all manners of disease including multiple types of cancer and terminal cancer. If you watch that video and still have any uncertainty left in you, watch this video, and forgive the one instance of yelling at the very beginning. The facts are that corporate interests paid to have cannabis categorized as a Schedule One controlled substance. Corporate interests, violent cartels, the prison industry and tyrannical seizure laws fattening the wallets of a few, have been the only beneficiaries of cannabis control.
Multitudes of people have died from being denied the best thing on earth to beat cancer. And the people in the corporations, the politicians that continue to be bought off from taking right action, and the pharmaceutical companies, are complicit in their deaths. Yes, I said complicit. The facts are in. Cannabis prohibition must end and will end very soon. Just look at this list of the plethora of studies that show the benefits of cannabis in treating human ailments. There are hundreds of studies on the effectiveness of cannabis, not just in treating symptoms of disease, but actually curing the disease in many instances. It can’t be covered up any longer. However, we do have some questions that we need to answer for ourselves as we move forward on cannabis.
The first question is whether or not we are happy with the current state of controlled and declining health and access to alternative/natural treatments? Currently, the FDA -who took 30 years to admit that vitamin C is helpful in thwarting the common cold- is in control of our food and our medicine. On average, FDA approved medications kill 100,000 people per year. Those are their own reports on the FDA’s website. The FDA has stated they are justified in exercising authority to control what we consume because the Almighty gave commands on dietary laws in Scripture. They think they have as much authority as the Creator of the Universe. Seriously. Check it out here. (page 26 of 30)The FDA also holds the position that “raw milk is inherently dangerous and should never be consumed by any one for any reason.” Never mind the fact that if that were a true statement, there would never have been a second generation of human beings.
Honestly, I could go on for a full-length book about the criminal behavior of the FDA in relation to our food and medicines, but I’ll restrain myself. Just watch network tv for one night, count up the recalls and suits being advertised along with all the new medications you should talk to your doctor about, then ask yourself if you think they are doing work that is truly beneficial for humanity. If you can truthfully say that you are pleased with the quality of our nutrition, not knowing whether or not you are consuming genetically modified organisms, and the health care system in this country, then you need do nothing. If you are not satisfied with the status quo of chronic pain, disease and debilitation, and lack of personal control, then it’s time to do things differently.
The next series of questions we must answer is what kind of business model “We the People” want to follow as we end prohibition on this plant? Do we want to stick with the controlled access, medical industrial cartel dialectic, where production, distribution, and access are licensed and heavily regulated, and keep fascism growing? Or do we want to seek free market enterprise and let everyone who is interested put their own money on the line and succeed or fail on their own merits? Have layers of bureaucrats proven themselves to be beneficial to our literal wellbeing? Do we think we personally should have the ability and choice to make decisions about what we consume? Or do we believe the bureaucrats, paper pushers and corporations have proven themselves to have a legitimate and beneficial hand in securing our health?
Once we’ve answered these questions to our satisfaction, then we must decide how we move forward on the issue of cannabis legalization and access. In Missouri, we will have two very different initiatives on the ballot in 2016 for a proposed Constitutional amendment.
Since I’m from the Show Me state, and these two initiatives are responsible for bringing me to the paradigm shift I mentioned above, I bring you “The Tale of Two Initiatives”. One is very short and flatly legalizes it. The other is 4 pages of small print and proposes to regulate cannabis within the Constitution of the state.
From that short overview, it is very likely that those who know me have already determined which initiative has won my support. But it’s necessary for everyone to make up their own minds about this, so the remainder of this rather lengthy article is going to focus on the nuts and bolts of these two initiatives. Other states have similar proposals in position.
Let’s deal with the short one first. This initiative, identified as 2016-013, was written by Mark Pedersen formerly of the Kansas City NORML group. Even many major proponents of legalizing cannabis have said it was too radical. Notably, the national level of the KC group that worked with Pedersen, NORML (the National Organization for Reform of Marijuana Laws) is reported to be the biggest opponent of this initiative. We’ll have to deal with the reasons behind NORML opposing this amendment in a subsequent article. For now, we’ll just look at the “radical” amendment first and talk about possible pros and cons related to it.
2016-013 is currently being circulated for the collection of signatures to get onto the 2016 November ballot. It proposes to remove cannabis from the controlled substances list. It doesn’t place limits on the amount one person may possess or grow. It also doesn’t have any age limits set within the confines of the proposed amendment to the Constitution. It secures the right of people to grow enough for their personal use and prevents extra regulatory controls on farmers and processors of all cannabis products, including all strains, cannabis sativa, cannabis indica, cannabis ruderalis, and crosses of these cannabis strains. It prohibits the mere presence of cannabis and cannabis products from serving as cause to charge with impaired driving. And I do admit that it does indeed seem radical on its face. But let’s examine the issues so we can make determinations with solid information.
First up, let’s look at the “radical” idea of not limiting the amount that an individual may grow. This is terrifically important. If you watched the Rick Simpson “Run From the Cure” video I linked earlier, you are aware that a single full treatment for cancer or serious health issues requires a pound of cannabis. The oil from the plant is extracted and a pound will render about 2 ounces of oil. It’s a lot of cannabis. What’s more, if a person has received chemo or radiation, they will need at least 2 full protocols of the cannabis oil to fully heal. It can take a lot of plants to get those amounts of cannabis. The street value of a single treatment amount bought by the ounce is about $4800.00 right now. If you can get the entire pound and buy it all at once you might be able to get a discount and get it as low as $3400. Is that too high of a price to cure cancer? Certainly not, but what if you don’t have $3400 to $4800? Does your ability to pay for a treatment make you worthy of having it? Conversely, does the inability to pay make you a less valuable human being? If there aren’t limits placed on the number of plants one may have, it opens the door for people to be better able to heal themselves and to take personal responsibility for their own well being.
Next let’s look at the thing that really struck me personally about the 2016-013 initiative. There is no age limit set forth for possessing or using cannabis. I thought that was pretty over the top, and I told the people who contacted me about the initiative that it was my opinion that it needed an age limit. They made some pretty good arguments against it. One of those arguments was very basic from a freedom advocate’s point of view. The age of majority isn’t stipulated in the Bill of Rights. Also, it isn’t a static thing. It is 21 for some things and 18 for other things and it isn’t something that should be ensconced in our Constitution to secure a right. Even more importantly, in light of the healing potential of cannabis oil, would anyone with any compassion in them want to prohibit a parent faced with a seriously ill child from being able to help that child? I wouldn’t. It would be unconscionable to put anyone in that position, and instead run them through a bureaucratic and medical industrial complex maze to do what every parent must do to be right in the eyes of their Creator and provide for the child help in a time of trouble. Also, it is emphatically evident that parents have a duty to protect their children from ingesting things that they shouldn’t be ingesting. If you are going to have cannabis in the house, you have to be responsible and not allow your children to use it on their own. In other words, BE A PARENT!
Next let’s take an actual look at the issue of THC in the system and driving under the influence. THC being present in the system is simply not at all equal to impairment. Yes, THC is the psychoactive chemical in cannabis, but its presence within a person’s system doesn’t mean that the person is impaired. It isn’t like blood alcohol content, in that a person could have high levels of THC in their system, but still not be impaired. If someone is using cannabis to treat themselves for health reasons, THC will be high, but they are not likely to be impaired if they have been following a protocol for any length of time at all. There is a lot of science behind this fact, and it is important to look at the science and make logical decisions about THC as opposed to emotional decisions predicated on a faulty basis. In no way shape or form am I saying that you cannot be impaired by cannabis consumption. You certainly can be impaired. That impairment would be evident in a motor skills test that was video taped and witnessed by at least two witnesses. Whether people like it or not, that would be evidence of impairment, but THC levels are not a credible assessment of impairment.
A study using coordination testing showed inevitable failure on field sobriety testing if blood THC levels were 25 to 30 ng/ml. But, many failed testing at 90 and 150 minutes after smoking even though plasma concentrations were rather low. The researchers had the foresight to conclude that “establishing a clear relation between THC plasma concentrations and clinical impairment will be much more difficult than for alcohol”. This is because alcohol and THC are chemically different and are metabolized differently inside the body.
Now we are ready to take a look at the “Show Me Cannabis” (aka Mo NORML) initiative proposition.
First off, this initiative, 2016-009, isn’t being circulated for signatures yet because the proponents of the initiative have reportedly “gone back to the drawing board”. However, it is available from the Missouri Secretary of State’s office at this link. I have put in a couple of emails asking for a conversation with the gentleman heading up this initiative and have received no replies, so I cannot relate any responses to questions I have regarding this initiative.
In the first sentence, this initiative is providing for regulatory control of cannabis to Missourians over the age of 21. It stipulates that regulations are to be promulgated for many purposes. Here are a few of those. Promulgate regulations to allow for state licensed producers, retailers, and distributors of cannabis. It states that revenue generated by cannabis will be used to fund police and firefighter pensions and retirement plans as well as elementary and secondary schools. That the revenue will be used to prevent: the establishment of cartels, under age 21 use, and to prevent advertising cannabis to those under the age of 21. It allows for households to grow up to six plants, have up to 16 ounces of dried cannabis, or 20 ounces of liquid cannabis. It proposes to expunge nonviolent cannabis convictions. Also to require a person to get a license to purchase, sell, manufacture, deliver or process cannabis. It requires the labeling of the THC content on all cannabis products, and provides for limitation on the level of THC allowed in cannabis that may be sold. It provides for a 25% excise tax on the first “fair market sale” of all marijuana….And more. Lots more, actually.
Let’s start with the 25% excise tax on the first “fair market sale” of any cannabis. Well, right there we have a problem. “Fair market sale” is defined in this proposed amendment as “means with respect to the sale of a product, a sale in which the purchase price of the product is not less than the price that a willing seller would accept and a willing buyer would pay in the open market and in competition with other similar products.” Hmmm.
If this is absolutely constrained to the FINAL sale of the product to the consumer of the product, that means that if you are buying from a “licensed retail establishment” that you will be paying approximately 33% in taxes to the State. (The 25% excise and the 8% sales tax) It doesn’t state that it is on the final sale though. It says it is on the “first sale in an open market”. So…does that mean when the grower sells to someone for either distribution or manufacturing that the grower has to collect the 25% for the state? Here is the definition of an excise tax. (It’s rather complex, and this article is already very long, so please read the link) It certainly sounds to me as though the tax is something that is supposed to be collected on the sale by the grower after he pays the license fee to be able to sell the product at all.
He must then increase the down line cost of the product by adding an additional 25% cost to the next in line. Then when you get to the retail portion, the cost of goods is further increased by the state sales tax. So, let’s say the licensed grower sells an ounce for $100 for his labor and upkeep, and has to collect $125 from the licensed wholesaler/distributor or manufacturer to whom he sells. The distributor or wholesaler then has to mark up the product by whatever percentage will allow him to pay his license fee and make a living wage to the retailer, who then must again mark up what he sells the product for in order to cover his own living wage. Presume you do typical mark up of 30% for the distributor/wholesaler (more for the manufacturer as there are additional processes involved) as the distributor/wholesaler is supposed to be moving volumes. Now you’re looking at $125 + $37.50= $162.50. Then the retailer usually has to double as they have more insurance liability by having people come in and out of their location, and they have to deal with displays and such. Now you’re looking at $325 per ounce before the typical 8% sales tax ,which is another $26, so the cannabis consumer pays $351 per ounce and the state makes $51 plus licensing fees every step of the way. Mind you, $100 an ounce as a starting price is terrifically low. But is this really going to help out the average person a whole lot? I’m all for the State making money on the retail, but my rule of thumb is what did Yahweh ask for a tithe? Only 10%. Why does the State deserve more than 2 and half times what He requests? Maybe I’m the only one who thinks this way…I kind of doubt it though.
Someone will say, “But you can grow up to six plants, and that surely is enough for a household!” Well, let’s look at the six plant limit. Below you’ll find a little scenario that is not at all unreasonable. Just ask anyone who has ever gardened.
So you decide you like to garden and you’ll grow your own cannabis and therefore bring down the cost of making cannabis available for your household. You order seeds and spend $90 for ten seeds. Really. That’s a pretty good price, too. So you very carefully germinate your seeds and 9 out of ten germinate. Now you have to throw three down the toilet or you’ll be over your six plant limit. You carefully place these in small pots. They begin to put on leaves and now you have your six plants! You’re all legal and looking forward to excellent yields…Then you come home from work and two of your seedlings wilted on you. You mist them and hope they’ll recover. Well, they don’t. So now you have four plants and no more seeds to germinate. You figure that’s all fine because the advertisement said this was a high yielding variety and you can only have 16 ounces of dried product anyway. So whenthey get to be about 15 inches tall you put them outside into the best area of your backyard for good sun, but not too much, and you check on them daily. You patiently wait for September when you should be able to harvest. In the end of June, you and your family go away for the weekend and when you come home, one of your plants has simply disappeared. And the Japanese beetles picked that weekend to hatch out and eat your remaining plants up like crazy. So you set about making a protective enclosure for them and that involves shade cloth and posts and a gate and it takes you the rest of the week to get that done. You only have a couple of hours to work on it every night because this endeavor isn’t one that actually pays the bills. At this point you’re thinking it’s probably a lot easier to just buy the stuff, but you’re stubborn and keep after it until September. They’re looking okay, but the yields in the advertisement don’t look attainable…Harvest time comes and you get a total of three ounces from your three plants. Probably because the Japanese beetles hit right at flowering time…So you have three ounces after 6 months of tending and you’re scratching your head to figure out if it’s even worth trying again.
Imagine going through that when you are ever so hopeful that you will get a good yield on a strain that will help your child with epilepsy, or a parent with debilitating arthritis, diabetes, or cancer. Six plants? At what stage of maturity? And what happens if you are over that level and get caught by Code Enforcers or the police? Well, we can’t answer that other than to say the legislature will authorize fines and penalties for going over the “Household Exemption” level. It does limit it to up to $1000 or a year in jail. Does that sound good? Does it count toward the retirement funds and school funds prescribed in this amendment proposal? The proposed amendment says “revenue”. Do the enforcement fines and penalties count toward revenue?
Let’s consider the issue of using the amendment to aid law enforcement and firefighters pensions and retirements, and helping out the public school system with additional funds. While I am pro-education and pro-firefighter and all for peace officers, don’t we already spend a fair amount of tax money on these things? Are these funds being managed well? Isn’t this what various lottery proceeds are supposed to enhance as well? If we throw more money at them, do the actual students and the actual public servants ever really benefit? With the seizure laws that have been so onerously used, I have a really hard time thinking the public needs to give more money to police so that they can get more money by citing more people for regulatory violations as promoted in this proposed amendment.
There are some good things that are done in this proposed amendment. One is expunging of nonviolent cannabis offenses. But when you compare these two initiatives that, on their face, are supposed to legalize cannabis in Missouri, one flatly does so, and the other creates a plethora of bureaucracies and potential regulatory abuses along with continued legal system fines and penalties.
Let me be very clear here, while there is no part of me that wants to tolerate minors “getting stoned” or people driving while impaired, it is apparent that the ability to control those things still exist within our legal construct. Minors do NOT have the same rights as adults. Nor do they have the same responsibilities. People who drive while they are chemically/physically impaired by cannabis to the point that they cannot properly react to the hazards on the road are not being responsible, and should be charged with driving under the influence. Video evidence should be sufficient for the enforcement of driving while impaired.
Please check out all the links I posted in this incredibly long article. It’s very important that when we have amendments to consider on the ballot that we are wise in our decisions about them. We cannot be reactive and responsible at the same time. Study it out and be certain of your decisions.
I encourage you to read these amendments again, and if you have concerns, please feel free to voice them and let’s see if we the people can positively, and responsibly, disentangle ourselves from the corporately controlled nanny state on this issue.
To me, the Federal level agencies would best serve the citizens of this country by being completely gutted. They have “charges” under specific legislation, and they routinely expand their authority and “boot on the face” approach on people who hurt no one, and they completely fail to do the tasks they were created to accomplish. Yes, this is a broad brush, but we would be better served doing everything ourselves….Case in point below:
Consumers count on the Food and Drug Administration (FDA) to keep food safe, but the agency tests very little of the produce sold in the United States for pesticides and some of its methods were deemed incomplete, according to a recent report.
The Government Accountability Office (GAO) found the FDA “takes relatively few targeted samples to test for pesticide residue and detects what is likely to be a small percentage of the foods that have violative levels of residue. Moreover, FDA does not disclose in its annual monitoring reports that it does not test for some commonly used pesticides that have established tolerances for many commodities.”
The FDA tests only one-tenth of 1% of the food imported for use on U.S. dinner tables, and that’s actually far more testing than happens to domestic food. The GAO said the FDA tests only about a quarter as many domestic products as imported. “According to its recent annual reports, FDA has placed a greater emphasis on testing imported foods because it has found a higher percentage of imported samples with violations,” according to the report.
This is startling considering that “from 1970 to 2007, hundreds of millions of pounds of pesticides were applied annually to U.S. food crops to protect them from pests,” the GAO wrote.
The lack of testing includes pesticides that another federal agency, the Environmental Protection Agency, considers dangerous enough for which to have tolerance levels, Common Dreams noted.
“FDA takes relatively few targeted domestic and imported samples to test for pesticide residues. Additionally, FDA does not test for several widely used pesticides that have established tolerances for many commodities, meaning that it is unable to detect violations of those tolerances,” the GAO reported.
Food safety advocates at the Center for Biological Diversity, a nonprofit conservation organization, criticized the lack of pesticide inspections at the FDA.
“The FDA is supposed to be protecting the American people from dangers in their food and it’s clear they’ve dropped the ball when it comes to pesticides,” Lori Ann Burd, endangered species campaign director for the organization, said in a statement.
This is perhaps the best advertising money can’t buy. If you don’t already get these companies products, you might want to.
Remember it took the FDA 30 years to admit that vitamin C was helpful in combatting another virus…the common cold. BTW, I just started with doTerra. So if you want to get into that, please feel free to email me about it. Young Living has the MOST phenomenal product for helping with eye issues, it’s called Ningxia Juice and it has been tremendously helpful in halting ocular migraines. I can also help get you into that line, although I am not a member. Dr. Rima has been fighting the FDA longer than many of us have been alive. While I haven’t used their products, I think I am going to get some.
I guess I take the contrarian position to the US Federal Government’s agencies. If they are against it, there might very well be good reason to use it. If they recommend it, probably best to stay away from it. Also, my opinions, experiences, thoughts and existence have not been tested, approved, proven effective, nor sanctioned by the FDA.
This photo provided by the Centers for Disease Control and Protection shows the Ebola virus. (CDC via Associated Press)
The U.S. Food and Drug Administration sent letters to three companies this week, warning them against marketing their products as possible treatments or cures for Ebola. The letters, posted online on Wednesday, document multiple claims from the companies or their paid representatives that essential oils and other natural remedies can “help prevent your contracting the Ebola virus” and in at least one instance, “effectively kill the Ebola virus.”
There are currently no approved treatments, cures or vaccines for Ebola.
Natural Solutions Foundation, Young Living, and dōTERRA International LLC all produce products that were promoted on the Web as cures for a variety of ailments, all without FDA approval. The products in question, the letters note, are not FDA-approved drugs, yet their marketing makes the sort of claims that only approved drugs may make — that they can be used to treat, mitigate, prevent and cure diseases.
According to the three letters, those promotions — either on Web sites owned by the companies or on sites and accounts used by paid “consultants” promoting and selling the products — included Pinterest messages, Facebook postings and blog posts claiming products such as “CBD Organic Dark Chocolate Bars,” “Clary Sage” essential oils and the “Family Protection Pack” can do what has not yet been done: Treat, cure or prevent the deadly Ebola virus.
In one letter, to doTERRA, the FDA outlined the extent of those claims:
“Your consultants promote your above mentioned dōTERRA Essential Oil products for conditions including, but not limited to, viral infections (including ebola), bacterial infections, cancer, brain injury, autism, endometriosis, Grave’s Disease, Alzheimer’s Disease, tumor reduction, ADD/ADHD, and other conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Moreover, your consultants redirect consumers to your website, http://www.doterra.com, to register as a customer or member (i.e., consultant), and to purchase your dōTERRA Essential Oil products.”
According to the FDA, these promotions — especially ones related to Ebola — are inaccurate but not unexpected. “Oftentimes with public health incidences, like Ebola or even during H1n1, we see products that are marketed, often online, that claim to treat or cure the disease…without FDA approval,” FDA spokeswoman Stephanie Yao said in an interview, adding that “these sorts of things pop up” in almost any public health crisis.
In August, as the Ebola outbreak was accelerating in West Africa, the agency issued a preemptive warning to consumers, emphasizing that there is no FDA-approved vaccine or drug for the prevention or treatment of Ebola. The letters issued this week are something of a follow-up to that concern, Yao said, based on the results of online monitoring from the agency’s health fraud unit. The FDA will continue to monitor for similar claims.
Here is a sample of one such post, which was at the time this article was published available here:
theoildropper.com
Written by a paid consultant (referred to as a “member”) for Young Living, the post goes on to tout the possible benefits of a few oils sold by the company: “The Higley Essential Oil Reference guide mentions that the Ebola Virus can not live in the presence of cinnamon bark (this is in Thieves) nor Oregano. I would definitely add those two oils to whatever I was using.”
It adds: “I pray we don’t have to hear about this virus coming to the U.S. but if you travel outside of our country or know someone who goes to Africa or lives in Africa, maybe you could send them a care package of Young Living essential oils!”
In a statement provided to The Washington Post, a spokesman for Young Living said that the company was “cooperating fully with the FDA regarding its inquiry.” Young Living “members,” the statement continued, “are provided specific instructions on how to promote our products to their customers. In the coming days we will be contacting all our membership to ensure that they understand how to best use our products and remain compliant with regulatory directives.
“We have already contacted each of the Members cited in the FDA letter to help get them into compliance.”
One company targeted by the FDA, Natural Solutions Foundation, had materials on related Web sites promoting the company’s products as cures to several serious diseases and viruses, including Ebola.
On one YouTube video posted to the Natural Solutions Foundation account, the written text complains that the “WHO, FDA, the New York Times, etc., have gone on a rampage of disonformation [sic] to keep you in the dark about natural ways to dispose of dangerous microbes without damaging your beneficial bacteria.”
The video features Rima Laibow, the company’s medical director, claiming that the Natural Solutions product, Nano Silver, can “inactivate viruses like the HIV Virus, the Hepatitis B and C virus, Influenza viruses like H1N1, and Ebola virus.”
According to the FDA, all three companies have 15 days to respond to the documented violations and notify the agency of any corrective actions. If the companies are unable to correct those violations within 15 days, they’re required to explain why and provide a timeline for completion.
If they don’t take corrective action, the FDA could take any number of enforcement actions against the companies. Those include seizure, or possible criminal charges.
We’ve reached out to all three FDA-warned companies for comment.
With Amendment 1 on the ballot here in Missouri for August 5th, this is terrifically pertinent information. NO independent studies of long term exposure or ingestion have been done in the US!
Scientists at the International Agency for Research on Cancer have found what appears to be a strong link between pesticide exposure and a blood cancer called non-Hodgkin lymphoma.
Analyzing 44 individual research projects published since 1980, the scientists, writing in the International Journal of Environmental Research and Public Health, said that people exposed to the weed killer glyphosate, marked by Monsanto under the brand name Roundup, had double the risk of developing non-Hodgkin’s lymphoma. Those exposed to 2,4-D, another potent weed killer marketed by Dow Chemical, were 40 percent more likely to develop this disease.
The authors, scientists who work in the IARC Section of Environment and Radiation in Lyon, France, theorized that these pesticides were causing genetic mutations in white blood cells, thereby weakening the body’s immune system and ability to fight off disease.
Previous studies have observed that farmers with exposure to 2,4-D have experienced impaired immune systems.
Last month, EWG reported that research by scientists at the Arctic University of Norway had detected “extreme levels” of glyphosate on genetically engineered soybeans.
Crop scientists have genetically engineered soy to survive blasts of glyphosate so that farmers can use this chemical to get rid of weeds near crops. Over time these weeds have become resistant to glyphosate and grown hardier. In turn some farmers have resorted to spraying more of the pesticide to try to kill the tougher “super weeds.”
Genetic engineering’s early promise to reduce pesticide use now seems empty. The U.S. Department of Agriculture recently reported that herbicide use doubled—from 62 million pounds in 1996 to 128 million pounds in 2012. Glyphosate now represents more than 83 percent of the chemical pesticides used in the U.S. annually.
The IARC study was published April 23, as the U.S. Environmental Protection Agency was considering approving GE seeds of corn and soybeans engineered to withstand 2,4-D, a suspected carcinogen. If the EPA approves the new GE seeds and if 2,4-D is used to kill weeds on some of the 170 million acres of corn and soybeans grown in the U.S. annually, the USDA estimates that 2,4-D use is likely to triple, dramatically increasing people’s exposure to a pesticide that may cause cancer.
How can consumers reduce their exposures to these pesticides? When we eat GE foods, we are taking a dose of pesticides with them. Right now, we can’t tell which foods are genetically engineered. We have to guess. EWG believes people have the right to know which foods are genetically engineered. What can you do? Tell your elected representatives to support legislation to label GE foods.
The FDA, Food Destruction Agency, has “clarified” their stance on cheese aged on wood. Short take, not allowed any longer in the US; and because of the lovely take over of all food granted them by the Corporate Board Members referred to as “Congress” under the Food Safety Modernization Act, no cheese imported to the US will be allowed to have been aged on wood either.
If you have thus far failed to see what is happening in this nation and across the world, I’ll sum it up for you. There will be no innovation and no creativity allowed. Our Heavenly Father’s creative attributes that He instills in us as we are created in His image is to be annihilated by rule, regulation, insurance premiums, or other “safety” measure.
This is an excellent article on the issue of cheese and the FDA. Don’t worry, whatever you desire to create/produce will be similarly regulated and destroyed…if it hasn’t already been regulated to death.
A sense of disbelief and distress is quickly rippling through the U.S. artisan cheese community, as the federal Food and Drug Administration (FDA) this week announced it will not permit American cheesemakers to age cheese on wooden boards.
Recently, the FDA inspected several New York state cheesemakers and cited them for using wooden surfaces to age their cheeses. The New York State Department of Agriculture & Markets’ Division of Milk Control and Dairy Services, which (like most every state in the U.S., including Wisconsin), has allowed this practice, reached out to FDA for clarification on the issue. A response was provided by Monica Metz, Branch Chief of FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Dairy and Egg Branch.
In the response, Metz stated that the use of wood for cheese ripening or aging is considered an unsanitary practice by FDA, and a violation of FDA’s current Current Good Manufacturing Practice (cGMP) regulations. Here’s an excerpt:
“Microbial pathogens can be controlled if food facilities engage in good manufacturing practice. Proper cleaning and sanitation of equipment and facilities are absolutely necessary to ensure that pathogens do not find niches to reside and proliferate. Adequate cleaning and sanitation procedures are particularly important in facilities where persistent strains of pathogenic microorganisms like Listeria monocytogenes could be found. The use of wooden shelves, rough or otherwise, for cheese ripening does not conform to cGMP requirements, which require that “all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained.” 21 CFR 110.40(a). Wooden shelves or boards cannot be adequately cleaned and sanitized. The porous structure of wood enables it to absorb and retain bacteria, therefore bacteria generally colonize not only the surface but also the inside layers of wood. The shelves or boards used for aging make direct contact with finished products; hence they could be a potential source of pathogenic microorganisms in the finished products.”
The most interesting part of the FDA’s statement it that it does not consider this to be a new policy, but rather an enforcement of an existing policy. And worse yet, FDA has reiterated that it does not intend to change this policy.
In an email to industry professionals, Rob Ralyea, Senior Extension Associate in the Department of Food Science and the Pilot Plant Manager at Cornell University in New York, says: “According to the FDA this is merely proper enforcement of the policy that was already in place. While the FDA has had jurisdiction in all food plants, it deferred cheese inspections almost exclusively to the states. This has all obviously changed under FSMA.”
Ah, FSMA. For those of you not in the know, the Food Safety Modernization Act is the most sweeping reform of American food safety laws in generations. It was signed into law by President Obama on January 4, 2011 and aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
While most cheesemakers have, perhaps, begrudgingly accepted most of what has been coming down the FSMA pike, including the requirement of HACCP plans and increased federal regulations and inspections, no one expected this giant regulation behemoth to virtually put a stop to innovation in the American artisanal cheese movement.
Many of the most awarded and well-respected American artisan cheeses are currently aged on wooden boards. American Cheese Society triple Best in Show winner Pleasant Ridge Reserve from Uplands Cheese in Wisconsin is cured on wooden boards. Likewise for award-winners Cabot Clothbound in Vermont, current U.S. Champion cheese Marieke Feonegreek, and 2013 Best in Show Runner-Up Bleu Mont Bandaged Cheddar.
Wisconsin cheesemaker Chris Roelli says the FDA’s “clarified” stance on using wooden boards is a “potentially devastating development” for American cheesemakers. He and his family have spent the past eight years re-building Roelli Cheese into a next-generation American artisanal cheese factory. Just last year, he built what most would consider to be a state-of-the-art aging facility into the hillside behind his cheese plant. And Roelli, like hundreds of American artisanal cheesemaekrs, has developed his cheese recipes specifically to be aged on wooden boards.
“The very pillar that we built our niche business on is the ability to age our cheese on wood planks, an art that has been practiced in Europe for thousands of years,” Roelli says. Not allowing American cheesemakers to use this practice puts them “at a global disadvantage because the flavor produced by aging on wood can not be duplicated. This is a major game changer for the dairy industry in Wisconsin, and many other states.”
As if this weren’t all bad enough, the FDA has also “clarified” – I’m really beginning to dislike that word – that in accordance with FSMA, a cheesemaker importing cheese to the United States is subject to the same rules and inspection procedures as American cheesemakers.
Therefore, Cornell University’s Ralyea says, “It stands to reason that if an importer is using wood boards, the FDA would keep these cheeses from reaching our borders until the cheese maker is in compliance. The European Union authorizes and allows the use of wood boards. Further, the great majority of cheeses imported to this country are in fact aged on wooden boards and some are required to be aged on wood by their standard of identity (Comte, Beaufort and Reblochon, to name a few). Therefore, it will be interesting to see how these specific cheeses will be dealt with when it comes to importation into the United States.”
Ralyea continues: “While most everyone agrees that Listeria is a major concern to the dairy industry, it appears that some food safety agencies interpret the science to show that wood boards can be maintained in a sanitary fashion to allow for their use for cheese aging, while others (e.g., the US FDA) believe that a general ban of any wooden materials in food processing facilities is the better approach to assure food safety. At this point, it seems highly unlikely that any new research data or interpretations will change the FDA policies in place.”
In fact, many research papers do in fact conclude that wooden boards are safe. In 2013, the Wisconsin Center for Dairy Research published a paper on the subject, concluding: “Considering the beneficial effects of wood boards on cheese ripening and rind formation, the use of wood boards does not seem to present any danger of contamination by pathogenic bacteria as long as a thorough cleaning procedure is followed.” You can read the whole report on pages 8-9 by clicking on this link.
Interesting side note: Health Canada does not currently have any regulations prohibiting aging and ripening cheese on wood, so apparently if we want to eat most American or European artisan cheeses, we’ll need to drive across the border to do so.
So what’s next? The American Cheese Society has mobilized its Regulatory & Academic Committee to learn more about this issue, and to ensure its members’ interests are represented. The ACS promises to keep us apprised of developments. In the meantime, if you are a cheesemaker, and your operation is inspected and cited for the use of wooden surfaces, please contact the ACS office (720-328-2788 or info@cheesesociety.org).
As anyone who follows the approval of FDA and USDA “science” knows, we no longer have much at all in the way of actual science. Instead we have black balling of those who don’t tote the corporate line, and science based studies that have nothing to do with legitimate science and the scientific method we are supposed to learn in school.
The following interview by Democracy Now! has clearly exposed the issue. Check it out:
I couldn’t possibly agree more with the author of the following article. He did a good job in going back through recent history and finding points that clearly show the insanity in which we now find ourselves regarding regulation of the simplest entrepreneurial effort.
The other day, Forbe’s, whom I take umbrage with over their continued support for GMO shill Henry Miller, did a good piece on the 1000 new businesses that sprang up in California due to the state allowing home food businesses to have a go at it without choking them to death with regulatory controls.
Less regulation is good for children and other living things…Unless of course it is lack of regulation over actual poisons like 24D.
My personal thoughts on this matter are that the regulatory system is effectively choking the spark of life out of us. It’s like replacing our inherent drive to create with the “Dao of Poo” summed up as, “Why bother?”
At any rate, here is the promised article. Hats off to the author, John Aziz!
Yeah, it’s tough out there kid. (Jim Weber/ZUMA Press/Corbis)
Over the last 30 years, it seems like it has gotten a little tougher for kids to start that most Norman Rockwell of ventures, the lemonade stand.
Back in the 1980s and 1990s there were a few instances of local governments shutting kids’ stands down for various reasons, although officials typically bowed to public pressure and allowed them to reopen.
In 1983, 6-year-old Ali Thorn’s lemonade stand in Belleair, Fla., was closed down after police received an anonymous complaint that her sign did not comply with city ordinances, but was quickly allowed to reopen.
In 1988, 9-year-old Max Schilling’s seven-foot high lemonade stand in Watchung, N.J., was shuttered after city officials claimed it was a permanent structure that sat too close to the street and threatened to fine him $500 a day. After a brief legal fight, Schilling’s stand was allowed to reopen.
In 1993, 12-year-old Sarah Knott and 13-year-old Margaret Johnson’s stand in Charleston, S.C., was shut down by police officers because they didn’t have a peddler’s license. However, after a public outcry, the city apologized to the girls and allowed them to continue.
More recently, though, local enforcement of lemonade stands seems to have grown stricter, or at least, more noticeable. The libertarian Freedom Center of Missouri has produced a map to show the locations of these incidents.
In 2010, 7-year-old Julie Murphy’s lemonade stand in Portland, Ore., was shuttered because she did not have a temporary restaurant permit, a license that carries a $120 fee, although that decision was later reversed with a Multnomah County chairman admitting that food inspectors may have overstepped their bounds, saying, “A 7-year-old selling lemonade isn’t the same as a grown-up selling burritos out of a cart.”
In 2011, in Midway, Ga., a lemonade stand run by Kasity Dixon, 14, Tiffany Cassin, 12, and Skylar Roberts, 10 was shuttered because they didn’t have a business license, a peddler’s permit, or a food permit, all of which would have cost them $50 a day to obtain for temporary use or $180 for the year. Despite national media attention and complaints from residents, the city wouldn’t back down.
And also in 2011, Caitlin and Abigail Mills’ girl scout cookie stand in Hazelwood, Mo., was closed for violating an ordinance banning the sale of items from a residential property. The girls’ family attempted to sue the city, but the case appears to have been dropped.
Let’s not overstate it, though. Lemonade stand-shutdowns are not reaching epidemic-like levels, and no one is going to cart off little Suzie to jail for selling cookies outside her house. That said, there is something absurd about shutting down lemonade stands, even if it’s still relatively rare.
The main risk of a tougher approach to children running food stands — and especially demanding that kids comply with costly licensing and strict city zoning laws — is that children will lose out on the entrepreneurial experience of running their first business, serving customers, and making money. If we want to have an entrepreneurial culture, where people innovate and take risks to build businesses, there has to be a certain amount of freedom and space for the young to learn these skills.
While navigating bureaucracy is definitely a useful entrepreneurial skill, expecting kids or their parents to fork out hundreds of dollars for a license to run their first business is punitive and anti-entrepreneurial. And every hour and dollar spent on inspecting or shutting down children’s lemonade stands on technicalities is an hour and dollar not spent on inspecting food safety in actual restaurants, food processing facilities, and stores — places where a lapse in food safety could expose hundreds or thousands of people to illness.
And while city zoning laws are useful for keeping heavy industry away from homes, selling lemonade or girl scout cookies is really a residential activity. Many of the world’s most famous businesses — Amazon, Apple, Disney, Google, Hewlett Packard — were started in garages. An entrepreneurial culture requires the freedom to start a business at home. If we stop businesses and businesspeople from developing, we lose the benefits that come down the road, like job creation and innovation (not that little Suzie’s lemonade stand will likely grow to rival Tropicana, but you get the point…).
The sooner cities and counties realize this, and stop wasting resources going after the entrepreneurs of tomorrow, the better.
In yet another case of avoiding the obvious, the FDA is blaming our obesity (skyrocketing levels since the massive infusion of GMO products) on transfats, and therefore, they are going to ban them. Next thing you know, there will be black market transfats. Potentially a CIA funded underground of trans peddlers could pop up and create yet another agency to deal expressly with outlawed food, or food like products. Why not just label GMO products and let people make their own decisions with actual knowledge? No, instead we’ll forcibly reduce salt, ban transfats, continue to attack real food, and tell you we’re protecting you and that GMO crops stave off starvation on food shortages….The Food Destruction Agency is working it’s science based principles, and they are the ones who said transfats were generally recognized as safe in the first place.
Whatever you do, do not trust the FDA on anything. This time they are accidentally right, but they are the ones who created the proliferation of transfats in the first place.
The United States is over 17 trillion dollars in debt, the national unemployment rate is over seven percent, and one-sixth of the American population is on food stamps. But fixing those problems is just so hard! So, some courageous politicians have decided to spend time and money dictating what we should be allowed to eat. They do this in the name of “keeping us healthy.”
The Food and Drug Administration (FDA) has announced a plan to ban trans fats because they are a “threat to people’s health.”
The FDA is moving forward with this power-grab despite the fact that the amount of trans fats in the average American’s diet has declined rapidly in the last decade.
The food industry will be required to gradually phase out trans fats. Once they have been completely phased out, anyone who wants to use trans fats will be forced to get special permission from the FDA.
The FDA’s deputy commissioner for foods, Michael Taylor, said, “We want to do it in a way that doesn’t unduly disrupt markets.”
As of right now, the exact timeline for the phase-out has not been decided on.
Michael Jacobson, the director of the advocacy group Center for Science, said, “Six months or a year should be more than enough time, especially considering that companies have had a decade to figure out what to do… [The ban is] one of the most important lifesaving actions the FDA could take.”
The FDA claims that trans fats are horrible for your heart — worse than saturated fat — and can contribute to heart diseases.
This is true… But when did it become the government’s job to control what we eat? Have we become a complete nanny state?
Smoking can cause lung cancer — so why don’t we ban cigarettes? Too much sugar often leads to diabetes — let’s go ahead and ban sugar, too! Alcohol can contribute to liver failure — ban it!
You get my point. The government simply cannot ban everything that is a “threat to people’s health.”
America is supposed to be the Land of the Free. If people want to make poor food choices, they should be allowed to. Of course, it is unfair to make the rest of us pay for their heart disease and diabetes. This is why ObamaCare (the biggest government power-grab in a generation) must be overturned immediately. In a free country, government cannot dictate lifestyle choices, nor can it become the overprotective mommy and daddy of its citizens.
Freedom means having the right to make bad choices and then deal with the consequences ourselves.
The FDA can count on mainstream media to mislead the public. Let’s get the truth out and stop this bill. Action Alert!
Sen. Dick Durbin (D-IL)’s bill, S.1425, is meant to “improve the safety of dietary supplements by [requiring] manufacturers of dietary supplements to register dietary supplements with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements.” Sounds innocuous, doesn’t it? But as we reported in August, this is nothing but a smokescreen—a naked power grab for the FDA and an attempt to regulate safe dietary supplements as if they were dangerous FDA-approved prescription drugs.
A recent article in Newsday quotes “a top agency official” (probably FDA’s Division of Dietary Supplement Programs director Dan Fabricant, who is quoted extensively in the article) as saying that 70% of supplement companies have violated FDA’s manufacturing rules over the last five years—with the clear implication that such manufacturing violations somehow puts the American public at risk. There is no mention of the nature, context, or seriousness of these alleged violations, and no link to any official reports or documentation.
The article declares that the number of adverse events caused by supplements “outstrips” those triggered by prescriptions drugs. This is totally false. The Newsday article’s author, Delthia Ricks, tells us that approximately “6,300 people nationwide complained about adverse reactions to dietary supplements between 2008 and 2012, according to FDA statistics. But the actual number may be more than eight times higher, some experts say, because most people don’t believe health products can make them sick.” This “eight times higher” claim has no basis in fact, and no documented source. Even if it were true, this number is far less than for prescription drugs.
The 6,300 figure averages to 1,575 per year, which is extremely low considering that 157 million Americans—half the US population—take supplements. This is in comparison to 526,527 adverse events for prescription drugs, 275,421 of which had “serious outcomes,” including death.
Why would we want to let the agency regulate supplements as if they were drugs when the drugs they approve cause over 400 times the adverse events than supplements do? When the Government Accountability Office (GAO) looked at the number of adverse events for supplements at the request of Senator Durbin, it was unable to uncover anything alarming, as we reported back in March.
On the contrary, the GAO report showed that FDA-approved drugs caused 80% of Poison Control fatalities. More than 100,000 calls to Poison Control Centers, 56,000 emergency room visits, 2,600 hospitalizations, and nearly 500 deaths each year are attributed to acetaminophen (Tylenol) alone!
The Newsday article goes on to describe, in detail, the FDA’s authority to regulate the vitamin supplement industry, noting the agency’s inspection of supplement company facilities, and its ability to issue product warnings, recalls, and seizures and levy steep fines against companies that run afoul of FDA regulation. Inexplicably, the article then quotes Dan Fabricant as saying, “There is little the FDA can do to exercise more power over supplement safety without an act of Congress,” and concludes that FDA has “limited power” to regulate supplements. In what universe does that statement make sense?
The only way it makes sense is if mainstream media pieces like this Newsday article are viewed as propaganda: a concerted alliance between the media, the FDA, and legislators like Sen. Durbin to weaken the public’s determination to keep dietary supplements freely available. Lest this sound too conspiratorial, we need to remember that drug advertising is what keeps much of print media alive in these days of online competition.
The theme of adverse events is very much echoed in Durbin’s legislation. His bill requires that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients (supplements) that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards. Given the FDA’s profound bias against supplements, and the skewed, anti-science recommendations of the IOM’s vitamin D report, these are hardly trustworthy sources of guidance!
By the way, speaking of IOM and adverse events, why does the IOM absolutely refuse to study adverse events from vaccinations? In this case it holds that adverse events are meaningless because not studied, but then refuses to study them.
Returning to supplements, the FDA already has complete authority to keep them safe—it’s just a matter of enforcement, as the FDA’s Fabricant himself said when he worked for the Natural Products Association: “The barriers to enforcement are simple: [FDA] money, manpower, and will.” (You’ll note he doesn’t say “more regulation”!) He also made the distinction between the “legal, safe and healthy dietary supplement industry” and “the seedy, fly-by-night, unsafe world of illegal steroids,” and called on FDA, DEA, and other appropriate agencies to work together to enforce the laws that already exist. Most of the violations cited in the Newsday article are examples of bad manufacturing practices, which are already illegal and subject to FDA enforcement action. All the FDA has to do is enforce existing rules.
Another element in Durbin’s legislation is a greater restriction of health claims: he has said his bill is designed to stop “mislabeling products and making health claims that have no scientific basis.” This is more nonsense.
The vast majority of supplement health claims have plenty of scientific basis—just not the random-controlled trials (RCT) that Durbin and the FDA want. And there’s a very good reason for this: most natural products companies cannot afford to spend up to a billion dollars on RCTs, because in most cases that natural product can’t be patented, so the companies could never hope to make back their investment. In addition, many supplements should be taken with co-factors and so should not be studied in isolation like a drug.
Durbin knows all this. The demand for RCTs is just a backdoor way to get rid of most supplements entirely.
In the past, Dan Fabricant did not support greater restrictions of health claims. In response to IOM’s recommendation that dietary supplement health claims should be subject to the same scrutiny as pharmaceuticals, Fabricant said, “Trying to see foods through the same lens as isolated pharmaceuticals is impractical from a policy standpoint.” He also noted that many widely used general claims about how nutrients work, such as “calcium builds strong bones,” can’t be subjected to the same clinical evaluation as pharmaceutical drugs.
In other words, the FDA’s Fabricant said exactly what we’ve been claiming all along—that supplements are safe and the FDA needs no expanded powers—before he changed employers!
Action Alert! Please write to your senators immediately and tell them to stop Sen. Durbin’s frontal attack on your right to use supplements dead in its tracks! We don’t need this new legislation—all we need is for existing laws to be fully enforced. We need our access to nutritional supplements to be protected. Please write your senators today!
OPINION:
The FDA can count on mainstream media to mislead the public. Let’s get the truth out and stop this bill. 
Truth Farmer 
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