Needed: Reform or Replace the FDA
Revise DSHEA to protect natural health products, their producers and sellers.
In this past year or two, the FDA has been coming down hard on natural health products — especially on producers of these products. Animosity from the FDA toward the whole natural health industry is nothing new; but this past year or two has seen the kinds of pressures placed upon producers and sellers of these products, the likes of which we have not experienced since 1994. Because of this, I feel the obligation to inform you of what is happening and ask that you take action to see these things reversed.
For reasons I will outline here, I have very grave concerns about the Food and Drug Administration (FDA). It is an out-of-control agency, an indicator of big government run amok. The problem is huge, and the consequences are critical and immediate.
The two-pronged attack on the natural health industry
So, just what is going on? It's basically two-pronged.
- The FDA has been applying pressure to natural health products manufacturers by greatly increasing their record-keeping requirements. This has had a crushing effect on small companies, while offering nothing by way of increased safety of products. Compliance costs for this increased record-keeping have made many ingredients in natural health products way too expensive to source, effectively forcing them to be removed from the market. In some instances, companies have been pushed to the brink of insolvency; others have been pushed over the edge. For example, because of this crushing regulatory weight, Atrium was forced to close its doors this past July. Atrium had been a great company, with truly excellent products, and played a substantial role in my regaining enough functionality to start my business.
- The FDA has been applying pressure to natural health companies by tightening its regulatory control over what can and cannot be said about their products. Since 1994, when the Dietary Supplement Health and Education Act (DSHEA) of 1994 was signed into law, the standard has been truthful claims; now, the FDA requires companies to have at least two placebo-controlled studies for any health claim — something that is suitable for pharmaceuticals, with their synthetic, high-risk products, but not for natural products, which present very low risks to consumers. As a result of the FDA's intense pressure on the home company of my essential oils website, it was left with no option but to require that all independent websites, like mine, be shut-down. Despite the fact that my essential oils website was in full compliance with these regulations, the FDA essentially forced its shutdown, as well as an informational website I had been working on for about 15 years.
To give you an idea of how this works, there was a cherry farmer who, in advertising his product, made the claim that cherries are high in antioxidants. The FDA swooped in, accused him of selling mislabeled and non-approved drugs, and threatened to throw him in jail unless he signed a written confession of his "crime" and paid a hefty fine. Since there was no way he could afford to fight this in court, he was effectively put out of business.
This sounds insane, but it is what we are up against with this FDA.
The personal effect of this regulatory shift, among many other things, has been the loss of about 60% - 70% of my net income.
An aside: EverythingEssential.me and EOEBooks.com
The same regulatory pressures that have forced the shut-down of my websites have also forced the shut-down of many other informational websites and valuable facebook pages. This not only violates the First Amendment; it creates unfair hardships for those who owned these websites, depending on them for their livelihood. And, just as importantly, it shuts me — and thousands of others like me — off from information that is vital for our health and well-being. I have relied on this health information for many years, and regularly used it in my attempts to regain and maintain functionality. In many cases, there are no other accessible sources for this information. This is, in effect, robbing me — and many others — of the opportunity to be well.
One such website was EverythingEssential.me. The loss of access to this information has seriously impeded my ability to effectively care for my health needs. (By the way, the owners have started a new website: www.eoebooks.com, which I highly recommend to you.)
The human impact of this
Let me share a little about my story, to show some of the human impact of all this.
Back in 1961, when I was eight years old, following the administration of the Sabin oral polio vaccine, I had an encounter with an atypical polio virus. Since that time, life has been a struggle; and from 1971 on, I have been severely disabled, dependent on others for my material support. The medical community has had absolutely nothing to offer, in terms of any real help. But, over the years, I had found a number of natural health products that have greatly improved my levels of both comfort and functionality.
But, from the mid-1980s to the signing of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the FDA was presenting a serious threat to the availability of natural health products. Mel Gibson even did an ad, depicting a SWAT raid on his home, because he was taking vitamin C — "Like in oranges," he said, with his hands up. If you are familiar with the story of Dr Jonathan Wright, you know this was not hyperbole. Because of my dependence on these products, I was part of the supplements war that led to the passage of DSHEA.
While DSHEA was something of a victory for those, like me, who used natural health products, I always knew that the victory was always more apparent than real. It failed to codify the meaning of terms like "truthful claim" and left far too much regulatory discretion in the hands of the FDA, which had, by then, demonstrated a long history of strong bias against the natural health products industry. At least DSHEA put a leash on the FDA; but now, under this administration, the leash has come off and we are seeing how truly illusionary that victory was.
However, under the apparent safeguards provided by DSHEA, in August 2000, I took advantage of the opportunity provided by a new level of functionality and the internet to start my own business. While I have nothing close to normal capacities, and have no ability to work outside my home, for the past 15 years, I have been building an online business, selling products from websites that I have built. I know of no other work that I could possibly do. I had found these products to be especially beneficial to my own health; and in offering them on my websites, I was able to help many others.
Due to my physical limitations, it has taken a very long time and every ounce of energy I could muster. But, over the past 2-3 years, I had started to make a reasonable income from my websites, enabling me to be self-supporting for the first time in my life. It even made if possible for my wife and I to buy our first house. My business was even starting to generate enough income that, when Linda was laid off from her old job (after more than 15 years — her job going to Mexico) and, in this economy, could not find another, she had the financial freedom to join me full-time in the business.
But, since this past spring, I've seen my business pretty thoroughly devastated by the regulatory over-reach of the FDA. With the shut-down of two of my websites, my net income is off by about 60%-70%. At this point, I honestly don't know if my wife and I can stay above the poverty level (although, for now, we are getting by), or if, long-term, we'll be able to keep our house. And the FDA's new regulations are also threatening the products I need, in order to have any sense of normalcy in my life, as well as the information I need to use them most effectively.
With my business, I've operated two income-generating websites.
On the one website, one of the product lines I offered (Atrium) is no longer available. The company was forced to close its doors. (I have found another company (Bio-Design) that offers essentially equivalent products and have been working hard to get them added to my website.) The cost of compliance with the added FDA-required paperwork had increased so drastically that the company could no longer afford to stay in business. This was a great company, with products that I had depended on since 1982. They literally brought me back from the verge of death. I not only sold those products, I used them to maintain some semblance of health.
Another line of products offered on this website, including homeopathics and liquefied herbals, has been forced to discontinue several hundreds of its products. The expense of new FDA-required record keeping had made those excellent products unprofitable. Ingredients had become increasingly hard to source; and if they could be found, at all, they were too expensive to acquire.
This company is struggling under this heavy regulatory burden. I'm not sure how long it will stay in business. Again, I not only sell these products (they have accounted for about 30%-40% of my net income, before the shut-down of my other website; they now account for about 80% of my income), I've used them for many years, to support my own functionality.
It should be noted that, in both of these instances, the new FDA regulations have to do with Good Manufacturing Practices. However, both of these companies have been following the procedures required by the FDA; the difference now is in the record-keeping. No actual practices needed to be changed; it was all about labor-intensive paperwork. A large pharmaceutical company might be able to afford this; but for small companies that sell natural products, which cannot be patented, the costs of compliance are devastating.
A third prong to the FDA's threat.
Besides this two-pronged attack on natural health products noted above, the hand of the FDA is at work in the background with another prong of attack. What is that? They are doing an investigation into the purchasing experience of those who use OTC homeopathic remedies: "Are you comfortable with making purchasing decisions on your own?" Basically, after years of uppression of information about the uses and benefits of these products, the FDA wants to use that very lack of information as a reason to remove them from the market. It's utterly outrageous.
If the FDA concludes that it must protect us from uncomfortable purchasing decisions, it would destroy the company from which I purchase these products and put an end to a very large part of what's left of my business. That would have the effect of reducing my business to less than 10% of what it was a year ago, virtually destroying what has taken me 15 years to build.
A re-cap and summary
As I said before, I used to have an essential oils website. It, and the business associated with it, was my largest source of income. It is what literally enabled me to pay my bills. I was counting on it for retirement and some security for my wife, should I no longer be in the picture. It was what enabled me, despite my disability, to grow my business and support myself and my wife. Just as importantly, it enabled me to improve the lives of hundreds of people directly and, by extension, thousands of lives. But since July 2015, because of strong pressure being applied by the FDA on the parent company, I can no longer operate this website. The President and CEO of the parent company — who is, in no way, a whiner — said it is "unfair".
I don't know all the ins and outs of this; but I know it has nothing to do with Good Manufacturing Practices or any adverse effects experienced with the use of any of the products. Most people who have used them would describe their effects as transformative — in a very good sense. I know that, for me, they are the primary reason I have been able to start and operate my business.
So, despite the unquestionable value of these products and, I might add, the entirely compliant language on my website, I had to shut it down. And, if I don't have this website, I have zero possibilities of working this part of my business. Since my income was modest before, the effect of this is devastating.
And now, the FDA is applying severe pressure on the other parts of my business, threatening its viability and my only hope of being self-supporting.
Here is the problem:
- The FDA has used its regulatory power (which it exercises well beyond its actual authority) to impose costly regulations on manufacturers of dietary supplements and other natural health products that are neither needed nor helpful for the industry or consumer. History has shown that the old laws and regulations have been completely adequate to assuring the public of the safety and effectiveness of these products.
- The FDA has abused its regulatory power (which it exercises well beyond its actual authority) to stifle free speech about the nature of natural products and what they can do to support health. This creates a very seriously harmful effect on public health, by denying people of safer, more effective alternatives to pharmaceutical options.
- This abridgment of our First Amendment rights, which makes it very hard to help those in need — or find products that can help me — is then used as a pretext for removing products from the market. Without access to reliable information about these products, the public cannot feel comfortable making choices, so the FDA must remove the choice from consumers. This is insane.
There is a very interesting graphic online that shows the relative dangers of a long list of things people might encounter in the modern world (see here). It shows, among other things, that the death rate from taking prescription drugs, under the supervision of a licensed medical professional, is greater than that from cardiovascular disease and all cancers combined. Modern medicine is, in fact, the leading cause of death in America; pharmaceutical drugs, used under the supervision of doctors, are the third leading cause of death. You are more likely to die from a lightning strike, being eaten by an alligator or drinking water than from taking dietary supplements and other natural health products. It just doesn't happen. Yet the FDA seems determined to restrict your access to information about these products, and to remove them from the market, at the same time they are fast-tracking pharmaceutical approvals, all of which have horrendous side effects, including deaths. Drug companies are also allowed to make health claims about these products that are largely unsubstantiated by science or experience, and may "work" for fewer than 25% of those who use them.
It is my firm conviction that the FDA has long-since abandoned its mandate.
Its regulatory control was once justified because we had to be sure our drinking water is safe; yet today, studies have shown that our municipal water supplies are contaminated with over 43 different pharmaceutical agents. That does not count the fluoride and chlorine added to the water, which have been shown to damage the immune system, disrupt hormones, disrupt absorption of nutrients and a host of other things. Drinking tap water makes me violently ill; taking a shower in unfiltered municipal water leaves me feeling like I did three rounds with Mike Tyson.
The FDA was also tasked with making sure our pharmaceuticals were safe and effective. There is no pretense of this anymore, as drugs are approved, despite the very long list of very serious side-effects. The dangers are very real. What is largely unknown by the public is that the effectiveness rates of pharmaceuticals are not very good, either. If a drug works 40% of the time, it's an all-star. Often times, the side-effects or death rates from these drugs are far worse than the diseases they are supposed to treat.
As an agency for the public welfare, the FDA is largely a failure. My life, going all the way back to 1961 and the Sabin oral vaccine for polio, would have been much better if the FDA had just stopped trying to help me. The FDA is not doing its job, and it has become a kind of tyranny, equal to or greater than the IRS.
Is this still America?
America used to be a place where people with different views and philosophies could live side-by-side, speak freely of their beliefs and make choices about how they will live their lives. It was called liberty. Apparently, that America is no more. Today, some bureaucrats in Maryland feel they have the right to tell me what I can know, what I can say about what I know, and what choices I can make based on what I know. It is no longer accepted to have an unapproved point of view.
Instead of a country where different views are tolerated — even Constitutionally protected — when it comes to healthcare, the FDA wants total(itarian) control, a monopoly of view-point, and is willing to crush, either directly or through the weight of regulations, anything that doesn't fit their agenda. For me, personally, this not only denies me of my right to life and liberty, but also my pursuit of happiness, as it drives me out of business and removes from me the only means I have of making a living.
It is, I feel, well past time to rein in the FDA and return it to something of its mandate.
And, it is time to return freedom of choice to the American people.
Actually, I would like to see the FDA shut down, altogether. I realize that is no more realistic than shutting down the IRS; however, it would not be inconceivable to revise the Dietary Supplement Health and Education Act (DSHEA) of 1994 to separate out the oversight of natural health products — from dietary supplements, homeopathic remedies and essential oils to organic, whole foods — from FDA oversight.
As any reasonable person could easily recognize, giving the FDA regulatory authority over natural health products does not serve the public interest. As an agency with the power to destroy industries that it doesn't like, the FDA has clearly demonstrated, over the course of many years:
- that it is not responsive to the public, to Congress or the courts,
- that it has little, if any, understanding of the products it is regulating, including basic science,
- that it has a long-standing demonstrable bias against natural health products.
In addition, between the revolving door between the FDA and pharmaceutical companies and the fact that pharmaceutical companies provide about 98% of the FDA's budget, the conflict of interest should shock anyone of sound mind. And with the financial pressures on pharmaceutical companies, as many of their patents are running out, there is even more pressure on the FDA to eliminate, to the extent possible, any competition from alternative options in health care.
No one can fix the FDA. As an agency, it is thoroughly corrupt. The only hope, to restore American freedoms and informed choice in health care, is to revise the Dietary Supplement Health and Education Act (DSHEA) of 1994 to create a new agency to provide any necessary regulatory oversight of the natural health products industry. It needs to be directed and staffed by people with a good understanding of and support for natural health products, their producers and sellers. And the provisions of DSHEA need to be amended to acknowledge that these products do have healing properties, providing potent alternatives to the conventional medical model.
All of this is of critical importance today, as the FDA is effectively destroying companies it doesn't like, through regulatory over-reach, and the ACA is making medical care beyond reach for a large segment of the population. We need access to alternatives in health care, and we need access to information about these alternatives, so we can make educated choices.
As a consumer of natural health products, I would encourage you to 1) visit, 2) call, 3) write a letter and 4) send an email to your Senators and your Representative in the House, expressing your concern about these issues. Visiting or calling someone on their staffs, in their district offices, is also effective. Feel free to use any part of this article as a guide to what you could say. It is also important to create a wider reach. Use this information on your facebook page, forward it to anyone who might care about these issues. It might also be good to send a copy to anyone in the media you can think of. This story needs to get out while we still have a natural health industry.
Thank-you for your time and support.
Yours in better health,
Tom Anson | Essential-Vitamins.com
Unique dietary supplement formulas for natural health, wellness and longevity
215 N 75th Court | Lincoln, NE 68505
Phone: 402-489-5064 | www.essential-vitamins.com