Relatively new to the food products market, Dr. Bronner’s Magic Soaps, a Southern California-based family company famous for its organic, fair-trade pure castile soaps, has come under scrutiny by the U.S. Food and Drug Administration (FDA) for merely sharing with its customers the proven health benefits of eating extra-virgin coconut oil.
The FDA sent a letter to Dr. Bronner’s on July 8, 2014, warning that its Magic “All-One!” Fresh-Pressed Virgin Coconut Oil had suddenly transformed into an “unapproved drug” based on one simple health claim indicated on its packaging. By selling its coconut oil with the stated claim, maintains the FDA, Dr. Bronner’s is engaging in the sale and distribution of an illegal drug.
“Based on our review of the product label, we have determined that your product is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act),” claims the FDA in its letter. “
What the FDA doesn’t want you to know…
So what dastardly thing did Dr. Bronner’s print on its coconut oil label that sent the FDA into regulatory enforcement hyperdrive? Here is the original health claim as it was printed on the Magic “All-One!” Fresh-Pressed Virgin Coconut Oil label, before Dr. Bronner’s voluntarily removed it:
“Clinical research confirms that the saturated medium chain fatty acids (MCT’s) in [Virgin Coconut Oil], such as lauric acid, actually improve blood cholesterol by increasing the ratio of HDL to LDL cholesterol.”
To the FDA, this simple statement, which is thoroughly backed by peer-reviewed science, suggests that extra-virgin coconut oil is a “drug,” as only drugs are capable of affecting human health. In fact, the FDA’s position, based on this claim, is that Dr. Bronner’s Magic “All-One!” Fresh-Pressed Virgin Coconut Oil is unsafe, unless, of course, Dr. Bronner’s is willing to pay off the agency to declare it safe with an expensive new drug application.
The Science is Freely Available
But the science is already freely available. In one animal study, the MCTs in coconut oil were found to lower serum cholesterol levels in rats and calves, as well as cholesterol in the liver and other tissues. Generally speaking, MCTs have demonstrated anti-coagulation effects, meaning they can help prevent the development of atherosclerosis and cardiovascular disease.
Dr. Ward Dean, M.D., has compiled an extensive listing of the health benefits associated with MCTs, which is available through Nutrition Review.
FDA: enemy number one of public health
The health claims made by Dr. Bronner’s about the cholesterol-moderating effects of coconut oil are most definitely true. But the FDA refuses to acknowledge this, insisting that coconut oil be redefined as a “drug” so that it falls under the agency’s regulatory jurisdiction. In order to tell the truth about coconut oil, in other words, Dr. Bronner’s has to get permission from the FDA first, permission that is only granted alongside a large cash payment.
The FDA says sponsors of new drug applications must demonstrate “substantial evidence” of the drug’s clinical benefits, with “substantial evidence” being defined as “adequate and well-controlled investigations… by [qualified] experts.” These investigations tend to cost tens of millions of dollars to conduct in accordance with the FDA’s requirements, meaning they typically don’t occur……Read Full Article