Quack Miranda Warning
The Quack Miranda Warning (a reference to the "Miranda warning", the statement of rights recited by police officers before questioning a detained person under United States law) is a phrase coined by PalMD (erstwhile RationalWiki editor and current well known blogger) to describe the following phrase or variations thereof:
- This/these statement(s) have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Unsurprisingly, it offers no protection from legal consequences.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) (proposed by Tom Harkin), Title 21 of the Code of Federal Regulations requires that all labels and marketing materials for products sold as dietary supplements contain the warning in boldface type no smaller than a sixteenth of an inch tall if the product's marketing materials or packaging "claims, explicitly or implicitly, that the product… has an effect on a specific disease or class of diseases."
Just the fact of putting a Quack Miranda Warning on a dietary supplement does not absolve the manufacturer of legal consequences. In 2017, the FDA sent warning letters to 14 companies marketing "bogus cancer cures", noting that:
“”"Hoping to skirt the law on a technicality, some sellers made false claims and in small print provided a disclaimer that their products are not intended to diagnose, treat, cure or prevent any disease.
Making such obvious claims and then saying later that you are not doing so might seem clever, but the technique does not comply with federal laws intended to protect public health.
|—Donald D. Ashley & Douglas Stearn (US FDA)|
Before 1906, it was legal in most US states to claim any medicine treated any condition, and a "caveat emptor" marketplace was normal. The prevalence of quackery led to a popular push for more regulation. The Food and Drug Act of 1906 empowered the USDA Bureau of Chemistry (soon to be renamed the Food and Drug Administration) the legal power to scientifically verify the claims of medications.. These powers extended to virtually any claim of treating illnesses.
In 1994, a new law was passed, under the auspices of preventing government overreach. The Dietary Supplement Health and Education Act of 1994 allowed manufacturers to claim virtually anything about "nutritional supplements" provided that 3 criteria were met:
- The supplement consisted of substances that could be found in foods.
- It didn't specifically claim to treat any illness.
- It was labeled somewhere, in tiny font, with the disclaimer "This statement has not been evaluated by the FDA."
Though not instant and dramatic, the effects of the bill have been almost entirely negative. Many pharmacies have entire aisles of useless medications with deceptive claims placed right next to medicines that went through years of research and dozens of clinical trials to be sold as safe and effective treatments. While not claiming to treat the symptoms or progression of illnesses, these products will often include vague claims like "boosting your immune system". Very little research has shown that the availability of unprescribed supplements has had any substantial benefit, and they've led to a much more deceptive medical marketplace.
If a remedy is homeopathic, it doesn't fall under DSHEA, and doesn't need to carry the above warning label. This has the unfortunate side effect of making homeopathic remedies look even more legitimate.
As a consequence, some dietary supplements which would otherwise have fallen under DSHEA have managed to get themselves classified as an official homeopathic remedy. Zinc, for example, can now be sold as "Zincum 1X", and thereby avoid having the dreaded "not evaluated by the FDA" label stuck on it.
There are three ways to look at this requirement: the truthful way, the sinister way, and the bat-shit insane way.
- Truth: Anyone who wants to sell you something that's a load of crap must use this statement to cover themselves legally.
- Sinister: Variation of above—someone wants to sell you something that you are supposed to believe is medically useful, but at the same time they tell you in fine print that it is not medically useful. When it doesn't work, they don't get sued. Why would anyone buy something with that disclaimer attached to it? When a real doctor treats someone for a medical problem, they pretty much say that they intend to diagnose, treat, cure, or prevent a disease. Why would they say otherwise? It would be a lie. Also, who would go to see a doctor that told you that they didn't intend to diagnose or treat disease? The whole thing is bizarre.
- Bat-shit insane: The FDA and Big Pharma are in cahoots with the AMA to keep you from learning all the simple ways to treat diseases. They want your money, and they'll do anything they can to get it from you, including suppressing the knowledge that anyone can learn on the Internet how to heal cancer.
People who believe #3 are probably beyond help. People who are willing to suspend their paranoia should read #'s 1 and 2 a few times. Unless you're being arrested, no one should be reading you your rights. The Quack Miranda Warning is the red flag that should send you running.
- White Coat Underground — Quack Miranda Warning
- What are the type size requirements for the disclosure statement?, From DSHEA Guidelines
- CFR, Title 21 volume 2 §101.93(f)
- FDA Takes Action Against 'Bogus Cancer Cures' by Zosia Chustecka (April 25, 2017) Medscape.
- FDA Takes Action Against Fraudulent Cancer Products by Donald D. Ashley & Douglas Stearn (April 25, 2017) FDA Voice.
- FDA History — Part I
- It has boosted employment in Utah however: Dietary supplements become Utah’s #1 industry, topping $7.2 billion.