In honor of my first “Wild Wednesday” post, I am going to ask a wild question: “Is coconut oil a drug?” That probably is the wildest question you’ve heard today. But there is method behind my madness. Allow me to explain…
You know how when you buy an herbal product, or some kind of supposed fat-burning or body-cleansing product you will see a disclaimer on the label like “This product is not intended to cure, treat, prevent or diagnose any disease”? That’s because in January of 2003, Congress made legal a section of the US Code 21 that reads like this:
Sales under false or misleading name, other marking or labeling or in containers of misleading form or size; trade names, and other marking, labeling, and containers approved by Secretary. No article subject to this subchapter shall be sold or offered for sale by any person, firm, or corporation, in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted.
Translation: if you’re selling a product that is not a drug, and either on the label or on the website you state that research has suggested that the particular product has certain health benefits, the FDA will go after you.
This is exactly what has happened with numerous small businesses who were just trying to provide a health-promoting product to the public, such as an herbal remedy or coconut oil. Yes, ladies and gentlemen, it is perfectly legal for drug companies to promote and sell their poisonous and sometimes deadly wares as “curing” or “preventing” disease, but if you want to tell everyone that coconut oil is great for boosting the immune system, watch out!
(DISCLAIMER! DISCLAIMER! I am not making any claim that coconut oil does any such thing, just giving an example.)
Most recently, a small family-run business was sued by the government for “making claims” on their website and on labels for coconut oil and several herbs. But it’s not just making “falsified claims” that is the problem. According to the Code, making the claims somehow converts the products into drugs.
Yep. The official court document refers to these products as “new drugs…that are neither approved under 21USC [paragraph]355, nor exempt from approval….” In other words, because the company was promoting the REASEARCH-BASED health benefits of coconut oil, the product suddenly and magically becomes, by US government definition, a drug. (I would link to a site that provides the studies behind the goodness of coconut oil, but I don’t want to get anyone into any more trouble. You know how to Google. Go for it. 
)
Is it just me, or does the wording/interpretation of a law that converts a healthy food into a drug a tad bit ridiculous?
Anyway, the document goes on to demand that either the company apply for an application for new drug approval, or remove all claims from the website, labels, and promotional materials.
As a former schoolteacher, I understand that the FDA has to reinforce the rules lest chaos ensue. I also happen to have a jar of coconut oil from said guilty company. The label does indeed make a health claim, and does not have the usual disclaimer (“This product is not intended to cure…”). That was unwise and short-sighted on their part.
However, as a teacher I also learned something about people. With probably the majority, a firm reminder by authority of the rules, and threat of future consequence is usually enough to get them back into compliance. Only a handful require immediate and severe punishment in order to “get” it.
But because of our crazy letter-based legal system, that small company is receiving punishment to, if not the fullest extent of the law, then to a great extent.
I’m going to stop here, except to say that coconut oil is good for you, and that you would not be remiss in making it a regular part of your diet. (But of course it won’t cure, prevent, or treat any disease, even if studies have shown….)
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