By Kay Whatley
While the US Food and Drug Administration (FDA), and even US Department of Agriculture (USDA) and Federal Trade Commission, set policies in place for reasons, sometimes those policies prevent helpful information from reaching the humans who need it.
For purposes of this article, I’ll focus on the FDA. The FDA is not the source of US medical ills, but its policies and even some actions have led to a lopsided system which seems to favor pharmaceutical giants and restrain natural product advocates.
Disclaimer: I am no expert. I’m just an ordinary human with questions and concerns, who has researched health-related topics over the years for myself, my family, children, and grandchildren. I have a degree, but not in anything medical or science related. In fact, you could title this whole editorial “In My Humble Opinion” as it is a collection of facts I’ve gathered and my opinion based on those facts and others not included. So, please take what I write here with a grain of salt… though salt isn’t considered all that healthy these days. This disclaimer is necessary to ensure my editorial is not taken by anyone, in any way, as any type of medical advice. It is not. OK, that’s out of the way. Let’s get to it!
Agencies Like the FDA are Needed
Certainly, the FDA regulations are supposed to be to keep people safe from “snake oil” or harmful products. This is a good thing. FDA oversight can prevent profit-seeking manufacturers from doing harm by requiring them to meet certain minimum guidelines.
Examples:
- Pittsburgh PA in the 1980s, eye drops were distributed without benefit of government approval and several people were blinded from using the product before it was pulled off the market.
- Bottles of elixirs from the 1800s sold as health products were often mixtures of junk ingredients — including alcohol, various oils, and even soap. This type of useless “health” product gave our society the term snake oil.
- When e. coli made many people ill recently, the FDA testing discovered the cause was flour tainted with e. coli. With their testing, the source was found, the flour recalled, and customers warned to avoid the flour, potentially saving more people from falling ill.
There are some humans — and corporations run by humans — who seek money so hard that they will make and sell products that don’t work. There needs to be a way to stop these types of humans who will harm others with thoughtless, worthless, and dangerous products if it puts cash in their pockets. The FDA has safety guidelines to stop them and/or prosecute them for harm done.
Common Sense is Also Needed
The problem is, while a few “loopholes” have been put in place for products like nutritional supplements, other openings are needed for naturally occurring products from plants with medicinal properties used for thousands of years. With no way available to bring them to market, these products are suppressed.
Examples:
- A US walnut company ended up on the wrong side of the FDA for saying that nuts have health properties. Sent a letter (LINK) telling them to do the medical research (which would cost millions of dollars) or stop claiming health properties for their product (again, nuts). Read the agency’s letter to the company here.
- A company selling products containing powdered ginseng received an FDA letter stating that their product marketing included health benefits, and therefore the products must be tested as a new drug or health benefits removed.
Product manufacturers or distributors who make any health benefit claims may find themselves on the wrong side of the FDA. Letters sent to companies producing things like ginseng powder or skin cream may receive a letter including language like this:
The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body
Once the FDA decides your product is a “New Drug” they want you to go through the drug approval process. This costs millions as it includes fulfilling any requirements that they choose for you, including human studies and scientific confirmation of the “drug’s” benefits. Otherwise, all marketing materials must avoid health claims, or be pulled from the US market.
Small companies cannot afford to test, so they change their marketing or close their doors. Even if the oils or plant products are beneficial, since they are often inexpensive to produce, no one wants to spend millions for approval for something that people could learn to prepare in their own kitchen. So, the pharmaceutical companies prevail by spending millions on products that they can synthesize or patent and then charge money for their proprietary drugs.
Suppression-by-Cost of Cheap, Easily Accessed Alternatives to Drugs
Since it takes millions to get through the approval process, and plants with potential medical benefit may be grown or purchased inexpensively, corporations don’t put money or time into them.
Let’s for the sake of example, say that rosemary oils are thought to help manage diabetes. Saying that it can help is taboo unless the applications and studies are done to get FDA approval as a diabetes treatment. Since rosemary oils are inexpensive and rosemary may be grown, no company will go through the years and high costs of approval. So, rosemary oils are never approved, and can never be claimed to help. It doesn’t mean the natural treatment fails. The system fails, before medical benefit may be tested.
A different path is needed for these medicinal herbs and health-improving plants.
It may not be that the government is intentionally trying to suppress natural medicines that can improve human health. They may be, or it may be just a side-effect of policies aimed so far on the side of safety that common sense, human history, and general knowledge are lost.
Historical Medicine May Not Mean Bad Medicine
Going back before the government and pharmaceutical companies with budgets bigger than some countries, the local druggist provided remedies, cures, tonics, poultices, and more made from herbs and extracts kept in bottles on their drug store shelves. They had their own formulas, in addition to formulas provided to them.
To see what I mean, check out this druggist map from early America. (Source: Collection of David Rumsey.)
Heck, even Dr. Pepper — that tasty, unique soft drink — is based on last-century druggist knowledge. Its ingredients were mixed by the local druggist at the soda fountain using what was on-hand — different herbs, plant extracts, flavorings, or medicinal ingredients — to prepare what was thought to be a tasty and healthful drink.
As medicine and the medical industry evolved, older ideas were not only pushed aside, they were dismissed. Shamanism, ancient elixirs, alchemy, and folk and home remedies were all categorized as “quackery.” In truth, though, it is likely that some of these preparations did nothing, some were placebos, and others actually worked. Our ancestors were intelligent, thinking humans too. If none of these old concoctions had merit, their practitioners would never have been given the status and power that they held in earlier cultures. In dismissing everything not tested in a lab and approved by a governmental agency, our society “threw the baby out with the bathwater.”
Earthly, Natural Things
Your religion or spiritual beliefs may not be the same as mine, but I believe that this planet was given to us freely by our Creator. It wasn’t purchased. No one ordered or paid for it. Earth wasn’t created by intelligent mice — a joking reference to a book by author Douglas Adams. This planet is here and we inhabit it alongside many other creatures. I believe that what we need was created on the Earth for us — foods, medicines, companionship, and even shelter and safety.
Why a government agency should say that a plant’s potential health benefits cannot be shared is puzzling to me. The health of all should be important enough that information should be documented, saved, and shared.
Yet we have a black-out on what we are allowed to know.
Examples:
- Let’s look at the willow tree. Native Americans chewed willow bark for pain relief for thousands — possibly tens of thousands — of years. They had discovered this, and the plant was a part of their culture. They used it freely and taught the next generation how to use it. Then came Bayer. Now, aspirin is created by pharmaceutical companies with permission to distribute it. Public information on how to use willow bark, how much to use, and how to cultivate it, is unavailable — even prohibited.
- Wormwood is a plant naturally occurring on Earth that has the effect of killing internal parasites in humans. This has been known for hundreds of years. It may be cultivated along with other herbs. You can buy wormwood seeds and — so far — it is not illegal to plant them or even eat them. What is not publicly available, however, is any information on how to use the proper “dosage” of wormwood plant parts. When used proportionately, wormwood is known to expel parasites. When too much is ingested, it acts as a poison and can cause the human to die. By now allowing this information on usage and amounts to ingest — and how to eat or drink — people who might benefit health-wise are left wanting.
- Lemon rind extracts were discovered to have properties that helped to fight cancer. A pharmaceutical company focused on synthesizing this chemical and produced a chemotherapy drug that is a synthetic, likely condensed, chemical based on the lemon rind. While it is perfectly fine for the pharmaceutical company to market the synthetic as a chemotherapy drug, anyone marketing the use of natural lemon rind extracts to fight cancer would be shut down for not having an approved drug.
- Essential oils have been used for a long time. They are oils extracted from herbs or plant parts and used for its benefits to the body, mind or spirit. It does not matter, however, how many centuries of human experience show a benefit. Without scientific affirmation, words like “health” or “improves blood sugar” are illegal to use. Yes, illegal.
For those who live by the Bible, you likely know that Numbers 9:9-12 speaks of the need to use “bitter herbs” in cooking, and eat meat before it spoils:
9 Then the Lord said to Moses, 10 “Tell the Israelites: ‘When any of you or your descendants are unclean because of a dead body or are away on a journey, they are still to celebrate the Lord’s Passover, 11 but they are to do it on the fourteenth day of the second month at twilight. They are to eat the lamb, together with unleavened bread and bitter herbs. 12 They must not leave any of it till morning or break any of its bones. When they celebrate the Passover, they must follow all the regulations.
Other cultures over the centuries — through the millenniums — passed good information along to their descendants and helped keep the whole group (tribe, community) healthy. In our “modern” times, this type of information sharing is looked down upon as quackery. Any natural cure or remedy would be suppressed — and anyone trying to share information about such potential would be shut down for practicing medicine without a license. (A contradiction? It isn’t medicine, yet a license is needed to discuss such things?)
(For example, in 2015 North Carolina tried to pass a law making it illegal to share health information with other humans. Luckily, it didn’t pass. If it had, sharing diet tips or human health product information would have been a criminal act.)
Mixing Policies and Common Sense to Move Forward
While words like health, cure, treatment, and prevention have been co-opted by the FDA and are used against producers of natural medicine products, why can’t these other words should be allowed alongside a disclaimer? I would much rather use a natural product for its purported benefits that bears a disclaimer that says its benefits are not confirmed scientifically, approved by the FDA, and must be used at work risk, than use a pharmaceutical product with the same purported benefits and a lengthy list of side effects confirmed through the FDA. How about you?
Now, I don’t mean to bash the FDA. To talk about this issue and how it impacts human healthcare, it is necessary to talk about the governing body and its impact. Don’t blame the FDA. Don’t blame anyone who works at the FDA. We need the FDA; they just need to have a path for untested medicines like our ancestors used to use.
If you feel blame must be cast, then look at the bigger picture — the policies and procedures put in place over many years, with government and management higher-ups demanding compliance without question. Who knows what pressures are placed on FDA employees by elected officials or corporate representatives. Instead of casting blame, we (US residents) would be much better off seeking change to the system that doesn’t negate safety but allows common sense to enter the mix. Perhaps a new category of products is needed with more openness given in return for “use at your own risk” disclaimers. Better to have good medicines available, than have people dying in the process of keeping them safe, don’t you think?
In closing, I do understand there is a purpose to the FDA and other agencies. They attempt to help people avoid quackery, snake oil, and lies being fed from one human (or company) to another. In their ways of accomplishing this, they are, unfortunately, suppressing naturally occurring plant medicines and extracts from being used — despite the unaffordability of healthcare and the inexpense of nature.
A happy medium could allow safe guidelines and dosages for natural products with potential. And, just like our ancestors, we’ll spread the word about the products that help — those will succeed — and about the products that don’t work — letting those companies fail just like past generations probably ran the snake oil peddlers out of town.
With all the human health problems facing humanity, we need all the help that we can get. If our Creator set it before us, who are they to say we cannot know of it?
