The FDA issued warning letters this week to the two largest distributors of essentials oils in the United Sates, Young Living and dōTERRA. The FDA is claiming that their products are being marketed as unapproved drugs. The companies have to remove all health claims and take corrective actions, or face very serious legal action, which can include armed federal marshals coming to their warehouses and seizing all of their inventory.
This is of course not the first time that the FDA has gone after companies selling natural products, products that could never be patented, for making health claims about those products. They have a history of issuing warning letters against the producers and marketers of such things as walnuts, cranberries, elderberry juice, coconut oil, and many more. The FDA requires that companies selling natural products and making health claims get their permission first, by going through a lengthy and costly drug approval process.
What is interesting about the FDA targeting these two distributors of essential oils is that they are network-based marketing companies with independent distributors marketing the products on their own websites or out of their homes. This situation presents some unique challenges for both the FDA in seeking compliance, as well as the companies, who will most certainly want to comply. The FDA is taking the position that these independent distributors are “paid consultants,” and that therefore the parent companies have direct control over how they market their products.
The two companies could choose to challenge the FDA’s assertion that they have control over how non-employees choose to distribute their products, especially if the parent companies have issued guidelines and restrictions on how their products can be marketed that do comply with FDA requirements.
With thousands — if not tens of thousands — of distributors of essential oils in the marketplace, the companies could argue that it is nearly impossible for them to ensure 100% compliance, and argue that it is the FDA’s responsibility to enforce compliance of independent businesses. It would be like distributors of soft drinks putting up websites or producing marketing materials claiming their products cured diabetes. Would that be Coke or Pepsi’s fault if independent distributors chose to market their products in such a way without their approval? Wouldn’t the FDA have to go after the businesses making the “illegal” marketing claims, rather than punishing the parent company for the actions of their distributors?
But that won’t happen. Neither company will take the route of challenging the FDA. It would take years to litigate, and in the meantime the FDA would accomplish their goal, by seizing all of their inventory, possibly arresting the corporate leaders, and effectively putting them out of business while they attempt to challenge them in court.
But what happens if both companies do their best to warn and stop distributors from making health claims, but some do not? If the parent companies are aware of it, they would stop selling them their products. But who can police thousands or tens of thousands of independent distributors like that in a network-based marketing company?
Why is the FDA Targeting Essential Oil Distributors Now?
Because of the difficulties and intricacies of a network-based marketing company as mentioned above, the FDA probably has been hesitant to go after these two companies in the past. After all, these two companies have been around for many years, and the independent distributors have been making health claims for the essential oils for a very long time. So why is the FDA acting now?
The answer can clearly be seen in a mainstream media report of this action. In what reads more like a press release directly from the FDA, the Washington Post explains very clearly why the FDA is choosing to act at this time: because essential oils are making claims for being able to cure Ebola.
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. (Source.)
The article reports that the FDA issued warning letters not only to the two large essential oils distributors, but also to the Natural Solutions Foundation, which is marketing a product called Nano Silver which could potentially kill the Ebola virus.
As has been documented in many other places, the Ebola crisis presents a huge market opportunity to the pharmaceutical industry to rush new drugs and vaccines into the market, and I have no doubt that one or more of these pharmaceutical giants have made complaints to the FDA against essential oils and other natural products that might cure Ebola. The U.S. government already owns a patent on the Ebola virus.
This FDA assault on essential oils appears to be a very extensive plan to eliminate as many health claims for essential oils as possible. Just days before issuing these warning letters, they edited a page on their website warning about the dangers of essential oils, adding quite a bit of text clearly designed to scare consumers of essential oils.
Here is the page that was up until just recently, which was last updated in March this year:
And here is the much more lengthy page updated on August 22nd, but also revised on September 19th, just three days before issuing the warning letters to the essential oil companies:
The new version contains significantly more warnings about how essential oils can be “toxic.” Yet, nothing has changed in terms of essential oils available in the marketplace, or how they are marketed, in many years.
As to warnings of toxicity, which are more toxic: FDA approved drugs, or non-approved essential oils?
Using statistics directly from the medical industry, we know that at least 106,000 deaths a year are attributed to FDA-approved prescription drugs, and this does not even include deaths due to over-the-counter drugs which can be purchased without a prescription. There are over 450 deaths a year just from acetaminophen (Tylenol), based on reports from poison control centers.
But according to annual reports from the American Association of Poison Control Centers Annual Reports of National Poison Data Systems (NPDS), deaths due to overdose of essential oils are very rare. There were none in their last report issued in 2012, and you have to go back to 2010 to find that there was one death in total, from ingesting too much eucalyptus oil.
So clearly essential oils are not a public health hazard, especially when compared to the much more toxic pharmaceutical drugs which are approved by the FDA.
For those rare cases where an injury occurs with essential oils, it is always from ingesting them. The most common uses of essential oils, by far, are topical (massage) and through the air (aromatherapy.) Even in the extremely rare cases of injury due to ingesting essential oils, there is no way of knowing if these particular cases were the result of pure essential oils that were 100% plant extracts, or if they were chemical-based fragrances designed for the perfume and fragrance industry, which are highly toxic.
FDA is Watching You on Social Media
Alexander Gaffney of the Regulatory Affairs Professionals Society is reporting that the FDA’s warning letters to these two essential oil companies does something the FDA has never done before: it cites Pinterest as a source of non-compliance and use of false advertising. Gaffney states:
FDA has long included references in its Warning Letters to the social media platforms Facebook and Twitter, and has gone as far as to determine that Facebook “Likes” can be construed as promotional claims that misbrand a product. But despite FDA issuing so-called “social media” guidance, it had yet to so much as mention on particular social network medium: Pinterest. Utah-based Young Living and dōTERRA International both maintain Pinterest accounts used to make false claims about their products, FDA said in its Warning Letters to each company.
The social network is an image-based platform characterized by people “pinning” images that they like to their accounts. For example, FDA maintains a Pinterest account where it pins infographics about its regulatory activities. FDA’s interest in Pinterest is notable in that the medium is far more difficult to scan than text-based platforms like Twitter and Facebook. (Source.)
That’s a lot of effort put in just to find marketing claims on health benefits of essential oils. What does this communicate about the efficacy of essential oils, and the threat they must present to the pharmaceutical industry? If these claims were being made simply for aromatic scents with no therapeutic value whatsoever, would the FDA go this much trouble?
Do Essential Oils Actually Cure Disease?
Absolutely. This is not even a matter of dispute, as the National Institute of Health’s own government database, PubMed.gov, lists thousands, if not tens of thousands, of peer-reviewed articles documenting research on the health properties of hundreds of different essential oils. We summarize much of that research in John Thomas’ article, Using Essential Oils to Cure Disease.
Essential oils, which are distilled aromatic plant oils, have been around and curing people for thousands of years. Many of the original pharmaceutical products were based on the curative properties of various plant oils. But since they cannot be patented, no one is going to step forward and pay the hundreds of millions of dollars required to get something approved by the FDA as a drug, especially if you do not own the patent on that product.
And the FDA would never approve it anyway, because they only approve products from a handful of pharmaceutical companies who control the industry. The only way anyone outside of this tightly controlled industry can hope to get a product approved by the FDA is to discover something that is patentable, get a patent, and then sell it to one of the major pharmaceutical companies. There is no other way.
So in the end, the FDA will be successful in significantly reducing the amount of information available to consumers about the healing properties of essential oils. Anyone can still publish that information because our Constitution still protects freedom of speech, but the FDA has taken that freedom away if the speech is used to promote a specific product for health claims. That is solely their domain, and the domain of powerful pharmaceutical companies.
One can challenge the FDA’s power in restricting free speech in the marketplace, as there have been a few cases where companies have challenged them and succeeded. There are no laws enacted by Congress restricting free speech in the marketplace for health claims. The FDA acts on the basis of their own authority.
Attempts to get Congress to pass legislation protecting that free speech from the overreach of the FDA have also failed, unfortunately, due to the powerful pharmaceutical lobby. So for most companies, if they want to stay in business, they really have no choice but to comply with the FDA.
In the meantime, the consumer in the U.S. has less and less access to non-pharmaceutical health information and natural remedies, such as the myriad of health benefits attributed to essential oils.