The abbreviation FDA stands for the U.S. Food & Drug Administration. The agency’s budget for 2023 is $6.56 billion. A big chunk of that will come from the pharmaceutical industry in the form of “user fees.” This year they will total $1,151,522,958 and help facilitate faster new drug approvals. The idea of food as medicine seems foreign to the agency. We have concluded that the FDA dismisses food as essential for good health and places far more emphasis on pharmaceuticals.
Food as Medicine is Foreign to the FDA:
Hippocrates has long been considered the father of medicine even though he lived over two thousand years ago. Many people like to quote him as saying:
“let thy food be thy medicine and thy medicine be thy food.”
In actuality, there is no evidence that he really said that.
We have, however, found this quote from his Hippocratic oath:
“I will use those dietary regimens which will benefit my patients according to my greatest ability and judgement, and I will do no harm or injustice to them.”
Why the FDA Dismisses Food as Medicine:
Sadly, the US Food and Drug Administration does not appear to believe in the Hippocratic oath reference to “dietary regimens.” Instead, it favors pharmaceuticals.
You have no doubt heard the phrase:
“put your money where your mouth is”
The Cambridge Dictionary explains this frequently cited quote to mean:
“to show by your actions and not just your words that you support or believe in something”
One way to assess priorities is to look at the number of “Full Time Equivalents” (FTEs) the FDA has on staff. These are full-time regular employees. There are more than 6,000 FTEs devoted to drugs and biologicals. (Biologicals are like the rheumatoid arthritis drugs you see advertised on TV). The number of FDA staffers devoted to “Food Safety and Applied Nutrition” was a little over 1,000.
Another way to consider priorities is to look at how the FDA spends its money. Last year, human drugs got the biggest chunk (33%). If you add in biologics, the total was over 40%. Foods got 18.4%.
Drugs vs. Foods and Human Harm:
Based on the number of employees and dollars spent, we would conclude that the FDA favors pharmaceuticals, which almost always have harmful effects. One need only watch a prescription drug commercial to learn that popular medications can cause heart attacks, kidney damage, strokes, cancer and death.
Remember the Hippocratic Oath:
“I will use those dietary regimens which will benefit my patients according to my greatest ability and judgement, and I will do no harm or injustice to them.”
When you see a prescription drug commercial warning about death as a side effect, you might wonder how well the FDA is protecting you from “harm or injustice.”
Food, on the other hand, is frowned upon by the FDA. If the agency catches an organization saying something about the beneficial effect of food, there is a good chance it will be unhappy.
Cocoa Flavanols and the FDA:
The latest example is cocoa. Although many studies show benefits of cocoa flavanols for blood vessel flexibility and improved immune response, the FDA recently announced that it “will not object to the use of certain qualified health claims” for high-flavanol cocoa products (FDA Constituent Update, Feb. 3, 2023).
As long as a company highlights the “very limited” nature of the scientific evidence, it will be allowed to suggest that a high cocoa flavanol product may reduce the risk of cardiovascular disease. This claim may not be applied to ordinary foods containing cocoa or made from cacao beans.
One piece of scientific evidence was produced by the COSMOS trial (American Journal of Clinical Nutrition, June 7, 2022). The Cocoa Supplement and Multivitamin Outcomes Study was a randomized placebo-controlled trial with 21,000 participants over more than three years. People who took their cocoa extract supplements (CocoaVia) regularly were 27 percent less likely to die of cardiovascular causes during the trial than those taking placebo.
FDA Dismisses Foods like Cocoa Flavanols vs. Drugs:
The FDA “will not object to the use of certain qualified health claims” for cocoa flavanols. That’s after a high-powered clinical trial involving 21,000 participants for more than three years. Most pharmaceuticals are not tested so thoroughly in so many people for so long.
If a medication had produced this kind of outcome, the FDA probably would have allowed the drug company to brag about the cardiovascular benefits with great enthusiasm. You would have seen TV commercials with people dancing and smiling and having lots of fun.
Since there were no worrisome side effects associated with CocoaVia in the COMOS trial, such commercials would not have to list a bunch of scary adverse reactions. Don’t hold your breath, though. The FDA’s qualified support for cocoa flavanols will almost assuredly not permit such commercials anytime soon.
The FDA Is Negative About Nuts:
This isn’t the first time the FDA has been reluctant to endorse the value of food for its health benefits. Over a dozen years ago, the FDA sent a warning letter to a walnut growers’ cooperative (Diamond Foods). The agency was irate about the co-op’s website statement that:
“Every time you munch a few walnuts, you’re doing your body a big favor.”
Even though research suggested that the omega-3 fats in walnuts could help improve cholesterol levels and heart health, the FDA was not buying it. It accused the walnut growers of marketing “drugs.” The letter continued:
“Thus, your walnut products are also misbranded…in that the labeling for these drugs fails to bear adequate directions for use…”
I’ll bet you didn’t know walnuts should come with “directions for use.” What nonsense! You can read more about this sad saga in which the FDA dismisses food as good for your health at this link:
Why Is the FDA So Squirrelly About Nuts?
By the way, studies demonstrating the health benefits of nuts have been published in the New England Journal of Medicine, April 4, 2013.
In this PREDIMED study the investigators found that adding nuts or a lot of olive oil to a Mediterranean diet produced impressive health benefits:
“Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events.”
If makers of olive oil mentioned cardiovascular benefits on their labels it is likely that the FDA would become quite vindictive. We can almost imagine the nasty letters telling the olive oil manufacturers that their products are not “drugs.” Any health claims would be “misbranded” because they “fail to bear adequate directions for use…”
The FDA Dismisses Food Again: Pomegranates and Cherries!
Producers of both pomegranates and cherries have also received warning letters from the FDA. Even though there are a surprising number of scientific studies supporting their anti-inflammatory activity, the FDA considers hints of that benefit as “unauthorized health claims.”
Find that hard to believe? Here is a link to an article we have written about the health benefits of cherries.
Is Life Just A Bowl of Cherries
In that post you will read the FDA’s letter to one tart cherry maker:
“The therapeutic claims on your website establish that the above products (referred to as “your tart cherry concentrate products” in the rest of this letter) are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. The marketing of your tart cherry concentrate products with these claims violates the FD&C Act…
“Your tart cherry concentrate products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.”
You can listen to our podcast with Dr. Malachy McHugh about the health benefits of tart cherries at this link. Despite the FDA’s insistence that describing health benefits of tart cherries violates the FD&C Act, we think Dr. McHugh’s research is quite compelling.
Why the FDA Dismisses Food but Embraces Drugs:
Very few food growers can afford to pay for a randomized controlled trial of nuts, cherries or pomegranates. If the three-year COSMOS trial of cocoa flavanols was conducted by a drug company, the cost would have likely been tens of millions of dollars. The FDA would have embraced the results. How many walnut growers or tart cherry producers can afford that kind of research?
Perhaps the country would be healthier if the FDA embraced Hippocrates’ vision. Dietary regimens that include healthful foods might reduce the need for pharmaceuticals. If that message resonates with you, why not take a few minutes to listen to our podcast #1332 with Dr. Robert Lustig? In it, he compares food to pharmaceuticals when it comes to things like diabetes, heart disease and weight loss. Here is a link:
Show 1332: What Everyone Gets Wrong About Weight Loss
Pediatric neuroendocrinologist Robert Lustig explains what everyone gets wrong about weight loss and why drugs are not the best solution.
Share your own thoughts about food as medicine in the comment section below. Do you think the FDA dismisses food and embraces drugs? We would be interested in your perspective.
