The latest power grab from an agency that is out of control. Action Alert!
In a slew of warning letters, the FDA attacked companies selling “unapproved” cures for hangovers. In its explanation, the agency states that hangovers are included in the federal definition of disease, so products claiming to treat them must receive FDA approval. This is the latest attack from an agency that, for years, has worked to protect patented pharmaceutical drugs from competition from natural products. We must reform this crony health system that is keeping healthcare costs high—and more importantly, keeping us sick.
The idea that a hangover is a disease may seem bizarre: welcome to our federal government. It is important to remember what a hangover is— an acute response to overindulgence resulting in temporary dehydration, electrolyte imbalance, disruption to key hormone and nutrient levels. It is an acute event, rather than a chronic exposure or state—in other words, not like anything in the FDA definition of disease.* It is like a sunburn. It is temporary pain resulting from a specific event. And like excessive sun exposure, which can lead to diseases like melanoma, chronic alcohol abuse leads to a host of disease states. Conflating acute injury with a state of disease is nefarious wordplay that could invalidate all structure/function claims (see here for an explanation of these claims). Perhaps FDA will target aloe vera next regarding its claims of reducing the symptoms of a sunburn, since by their application a sunburn is akin to melanoma.
The agency has claimed that inflammation is a disease, blocking supplement companies from making any claim about a nutrient’s ability to help this natural protective response of the human body. Previously, the agency has also attacked companies for “implied disease claims,” a term which the FDA invented to further prevent legal and truthful claims about the benefits of supplements.
- The truthful claim that niacin lowers cholesterol is deemed an implied claim that the product is a treatment for hypercholesterolemia.
- The truthful claim that chromium lowers blood sugar levels is deemed an implied claim that the product is a treatment for diabetes.
- The truthful claim that magnesium lowers blood pressure levels is deemed an implied claim that the product is a treatment for hypertension.
Note that this censorship not only denies consumers helpful information about the benefits of these products, but also presents safety concerns. Patients who are already on blood sugar lowering drugs may experience negative effects if they take a supplement that further lowers blood sugar, but the FDA banishes this information from the label.
Perhaps we shouldn’t be surprised any more by the actions of an agency that would threaten cherry and walnut growers with fines and jail time for citing respected scientific studies about the health benefits of those foods.
Why does the FDA do this? It appears to be all about the cronyism baked into our health system. Censoring information about supplements clears the way for more drug sales, and drug companies directly pay FDA salaries.
Unfortunately, regular readers of our newsletter will know that this censorship is nothing new. The FDA, together with the FTC, has issued hundreds of warning letters to doctors and clinics for educating the public about how to treat or prevent COVID-19 infection with natural products that have strong scientific evidence to support them. But in order to make any kind of health claim, a supplement would need to go through FDA drug approval, which is an exorbitantly expensive process costing billions. But because supplements are generally not patentable like drugs are, no company will fund the research necessary to gain FDA approval. The result is that promising natural treatments are completely ignored by our health system. If we have any hope of improving healthcare in this country, this arrangement needs to change.
*Federal rules block supplements from making any claim to have “an effect on the characteristic signs or symptoms of a specific disease or class of diseases.” As far as health claims go, federal rules define “disease” as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” According to the FDA’s logic, a hangover is a “sign or symptom” of alcohol intoxication, which the agency considers a disease.
Action Alert! Sign our petition that seeks to reform a healthcare system that blocks access to natural treatments that generally cannot go through FDA approval. Please send your message immediately.