The FDA’s censorship of free speech about the benefits of supplements has now extended into heart health supplements like vitamin B3 and fish oil. When will this lunacy end? Action Alert!
In a slew of warning letters, the FDA has targeted seven companies for claiming that their supplements treat heart disease. Well, not heart disease exactly: what the FDA has issue with is these supplements claiming to be able to lower cholesterol, even though we know they can. This is part of a larger censorship effort by the FDA and the federal government we have reported on a number of times. The point of these attacks on legal claims is to help shore up the monopoly of FDA-approved drugs that fund the agency. It has to stop.
The law allows supplement companies to make “structure/function” claims. These claims allow a company to describe the effect of a nutrient on the normal structure or function of the human body, for example, “calcium builds strong bones.” But in practice, the FDA has barred many legal structure/function claims by claiming they are “implied disease claims,” a term which the FDA invented. For example, the truthful claim that chromium lowers blood sugar levels is deemed an implied claim that the product is a treatment for diabetes. Only FDA-approved drugs can claim to treat, prevent, or mitigate a disease, so the FDA is using an underhanded method to reject many legal health claims on the basis that they are actually “implied disease claims.”
Another strategy the FDA has used is to claim that things like inflammation and hangovers are actually diseases, so supplements can’t make claims related to reducing inflammation or helping with hangovers.
In the press announcement on the newest round of warning letters, the FDA triumphantly claims to be fighting back against companies selling supplements claiming to treat cardiovascular disease, the leading cause of death in the US. A closer look at the warning letters shows that most of the companies aren’t illegally claiming their supplements can treat cardiovascular disease: one company claims its fish oil decreases cholesterol; another claims its vitamin B3, red yeast rice, and pine bark extract product lowers bad cholesterol levels; another company claims its products (hawthorn berry) help with blood pressure.
It seems clear to us that these are legal structure/function claims. The Mayo Clinic—hardly a fringe health organization—says that there is “strong evidence that omega-3 fatty acids can significantly reduce blood triglyceride levels.” WebMD, another mainstream medical organization, says the following about vitamin B3 (niacin): “As a cholesterol treatment, there are good studies showing that niacin can boost levels of good HDL cholesterol and lower triglycerides. Niacin also modestly lowers bad LDL cholesterol.” Mount Sinai, a major academic medical center in New York, writes that “Both animal and human studies suggest hawthorn increases coronary artery blood flow, improves circulation, and lowers blood pressure.”
These supplements work! It begs the question: is the FDA concerned about protecting Americans from “fraudulent” heart disease medicines—or protecting the billions of dollars that statins and other cholesterol-lowering medications make for drug companies?
It’s shameful. The FDA acknowledges that heart disease is the leading cause of death in the US. According to the CDC, one person dies every 34 seconds from cardiovascular disease, and costs us $229 billion every year. Supplements like those described above can help. A recently-released report shows the incredible savings in both lives and healthcare costs that could be achieved with supplements. Supplementing with preventive levels of fish oil, for example, led to a risk reduction of 10 percent for coronary artery disease (CAD) events. If people at risk for CAD events supplement with fish oil, the report estimates that 174,811 CAD events could be avoided, saving $5.63 billion.
The FDA’s attacks on free speech have a real cost, both in lives and in dollars. It is beyond time for Congress eliminate the FDA-created “implied disease claims” that unfairly limit the kinds of information we can learn about natural products.
Action Alert! Write to Congress and tell them to clarify to the FDA that supplements can make structure/function claims! Please send your message immediately.